Web Content Directory Utah: September 2016

Wednesday, September 28, 2016

Risperdal

Generic Name: risperidone (Oral route)

ris-PER-i-done

Oral route(Tablet;Tablet, Disintegrating;Solution)

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from the observational studies to what extent these mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Risperidone is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s)

In the U.S.

Risperdal

Risperdal M-Tab

Available Dosage Forms:

Tablet, Disintegrating

Tablet

Solution

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

Uses For Risperdal

Risperidone is used to treat the symptoms of psychotic disorders, such as schizophrenia, mania or bipolar disorder, or irritability associated with autistic disorder. This medicine should NOT be used to treat behavioral problems in older adult patients who have dementia .

Risperidone is available only with your doctor's prescription.

Before Using Risperdal

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children less than 13 years of age with schizophrenia. Safety and efficacy have not been established .

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children less than 10 years of age with bipolar disorder. Safety and efficacy have not been established .

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children less than 5 years of age with autistic disorder. Safety and efficacy have not been established .

Geriatric

Elderly people may be especially sensitive to the effects of risperidone. This may increase the chance of having side effects during treatment. This medicine should not be used for behavioral problems in older adults with dementia.

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of risperidone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving risperidone .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil

Cisapride

Levomethadyl

Mesoridazine

Metoclopramide

Pimozide

Terfenadine

Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide

Ajmaline

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Aprindine

Arsenic Trioxide

Asenapine

Astemizole

Azimilide

Bretylium

Chloral Hydrate

Chloroquine

Chlorpromazine

Citalopram

Clarithromycin

Desipramine

Dibenzepin

Disopyramide

Dofetilide

Dolasetron

Doxepin

Droperidol

Encainide

Enflurane

Erythromycin

Flecainide

Fluconazole

Foscarnet

Gemifloxacin

Ginkgo Biloba

Halofantrine

Haloperidol

Halothane

Hydromorphone

Hydroquinidine

Ibutilide

Imipramine

Isoflurane

Isradipine

Lidoflazine

Linezolid

Lithium

Lorcainide

Mefloquine

Milnacipran

Nortriptyline

Octreotide

Pentamidine

Pirmenol

Prajmaline

Probucol

Procainamide

Prochlorperazine

Propafenone

Protriptyline

Quetiapine

Sematilide

Sertindole

Simvastatin

Sotalol

Spiramycin

Sulfamethoxazole

Sultopride

Tedisamil

Telithromycin

Tetrabenazine

Tramadol

Trifluoperazine

Trimethoprim

Trimipramine

Vasopressin

Zolmitriptan

Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Bupropion

Carbamazepine

Cimetidine

Fluoxetine

Itraconazole

Lamotrigine

Levorphanol

Methadone

Midodrine

Paroxetine

Phenobarbital

Phenytoin

Ranitidine

Ritonavir

Valproic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of risperidone

This section provides information on the proper use of a number of products that contain risperidone. It may not be specific to Risperdal. Please read with care.

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more or less of it, do not take it more or less often, and do not take it for a longer or shorter time than your doctor ordered.

You may take this medicine with or without food .

For patients taking the oral solution form of risperidone:

Measure the dose with the measuring device provided with your medicine. Stir the dose into a small glass (3 to 4 ounces) of water, coffee, orange juice, or low-fat milk just before taking it. Do not mix this medicine with cola or tea.

Rinse the empty measuring device with water and place it back in its storage case. Put the plastic cap back on the bottle of medicine.

For patients taking the orally disintegrating tablet form of risperidone:

Do not open the package until you are ready to take your medicine. To remove one tablet, separate one of the four tablets by tearing apart on perforations. Bend the corner as shown on the package. Peel back the foil to get to the tablet. Do not push the tablet through the foil because that could damage the tablet.

Use dry hands and take the tablet out of the package and immediately place it on your tongue. The tablet needs to be used immediately because it cannot be stored once it is taken out of the package. Once the tablet is on your tongue it will disintegrate in seconds. You can swallow it with or without liquid. It is important not to split or chew the tablet.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (oral solution, tablets, or orally disintegrating tablets):
- For bipolar mania:
  - Adults—At first, 2 to 3 milligrams (mg) per day, given on a once a day schedule. Your doctor may increase your dose as needed. However, the dose usually is not more than 6 mg a day.
  - Children 10 to 17 years of age—At first, 0.5 milligrams (mg) per day, given on a once a day schedule either in the morning or evening. Your doctor may increase your dose as needed. However, the dose usually is not more than 6 mg a day.
  - Children younger than 10 years of age—Use and dose must be determined by your doctor.
  - Older adults—At first, 0.25 mg or 0.5 mg (0.5 mL) two times a day. The medicine can be given on a once a day schedule after your doctor has found the correct dose for you. Your doctor may increase your dose as needed. However, the dose usually is not more than 3 mg (3 mL) a day .
- For irritability associated with autistic disorder:
  - Children 5 to 16 years of age weighing 20 kilograms (kg) or greater—At first, 0.5 milligrams (mg) per day, given on a once a day or twice a day schedule. Your doctor may increase your dose as needed.
  - Children 5 to 16 years of age weighing less than 20 kilograms (kg)—At first, 0.25 milligrams (mg) per day, given on a once a day or twice a day schedule. Your doctor may increase your dose as needed.
  - Children younger than 5 years of age—Use and dose must be determined by your doctor .
- For schizophrenia:
  - Adults—At first, 2 milligrams (mg) per day, given on a once a day or twice a day schedule. Your doctor may increase your dose as needed. However, the dose usually is not more than 16 mg a day.
  - Children 13 to 17 years of age—At first, 0.5 milligrams (mg) per day, given on a once a day schedule either in the morning or evening. Your doctor may increase your dose as needed. However, the dose usually is not more than 6 mg a day.
  - Children younger than 13 years of age—Use and dose must be determined by your doctor.
  - Older adults—At first, 0.25 mg or 0.5 mg (0.5 mL) two times a day. The medicine can be given on a once a day schedule after your doctor has found the correct dose for you. Your doctor may increase your dose as needed. However, the dose usually is not more than 3 mg (3 mL) a day .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Risperdal

Your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow the dosage to be changed if necessary to meet your needs.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to prevent side effects and to keep your condition from becoming worse.

This medicine may add to the effects of alcohol and other CNS depressants (medicine that makes you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking risperidone together with medicines that are used during surgery, dental, or emergency treatments may increase the CNS depressant effects.

This medicine may cause blurred vision, dizziness, or drowsiness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Risperidone may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

Wear protective clothing, including a hat. Also, wear sunglasses.

Apply a sun block product that has a skin protection factor (SPF) of at least 15. You may require a product with a higher SPF number, especially if you have a fair complexion. If you have any questions about this, check with your health care professional.

Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.

Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

This medicine may make it more difficult for your body to keep a constant temperature. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heatstroke. Hot baths or saunas may make you feel dizzy or faint while you are taking this medicine. Also, use extra care not to become too cold while you are taking risperidone. If you become too cold, you may feel drowsy, confused, or clumsy.

Risperdal Side Effects

Along with its needed effects, risperidone can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. These include neuroleptic malignant syndrome (NMS), which may cause severe muscle stiffness, fever, severe tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, or seizures. You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

Convulsions (seizures)

difficult or fast breathing

fast heartbeat or irregular pulse

fever (high)

high or low blood pressure

increased sweating

loss of bladder control

muscle stiffness (severe)

unusual tiredness or weakness (severe)

unusually pale skin

Check with your doctor immediately if any of the following side effects occur:

More common

Difficulty in speaking or swallowing

inability to move eyes

muscle spasms of face, neck, and back

twisting movements of body

Less common

Speech or vision problems

sudden weakness or numbness in the face, arms or legs

Rare

High body temperature (dizziness; fast, shallow breathing; fast, weak heartbeat; headache; muscle cramps; pale, clammy skin; increased thirst)

lip smacking or puckering

low body temperature (confusion, drowsiness, poor coordination, shivering)

prolonged, painful, inappropriate erection of the penis

puffing of cheeks

rapid or worm-like movements of tongue

uncontrolled chewing movements

uncontrolled movements of arms and legs

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Anxiety or nervousness

changes in vision, including blurred vision

decreased sexual desire or performance

loss of balance control

mask-like face

menstrual changes

mood or mental changes, including aggressive behavior, agitation, difficulty in concentration, and memory problems

problems in urination or increase in amount of urine

restlessness or need to keep moving (severe)

shuffling walk

skin rash or itching

stiffness or weakness of arms or legs

tic-like or twitching movements

trembling and shaking of fingers and hands

trouble in sleeping

Less common

Back pain

chest pain

unusual secretion of milk

Rare

Extreme thirst

increased blinking or spasms of eyelid

loss of appetite

talking, feeling, and acting with excitement and activity that cannot be controlled

uncontrolled twisting movements of neck, trunk, arms, or legs

unusual bleeding or bruising

unusual facial expressions or body positions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

coughing

diarrhea

drowsiness

dryness of mouth

headache

heartburn

increased dream activity

increased length of sleep

nausea

sleepiness or unusual drowsiness

sore throat

stuffy or runny nose

unusual tiredness or weakness

weight gain

Less common

Back pain

body aches or pain

chills

dandruff

darkening of skin color

dry skin

ear congestion

fever

increase in body movements

increased sensitivity of the skin to sun

increased watering of mouth

joint pain

loss of voice

nasal congestion

oily skin

pain or tenderness around eyes and cheekbones

shortness of breath or troubled breathing

sneezing

stomach pain

tightness of chest or wheezing

toothache

vomiting

weight loss

Some side effects, such as uncontrolled movements of the mouth, tongue, and jaw, or uncontrolled movements of arms and legs, may occur after you have stopped taking this medicine. If you notice any of these effects, check with your doctor as soon as possible.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Risperdal side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Risperdal resources

Risperdal Side Effects (in more detail)
Risperdal Use in Pregnancy & Breastfeeding
Drug Images
Risperdal Drug Interactions
Risperdal Support Group
74 Reviews for Risperdal - Add your own review/rating

Risperdal Consumer Overview

Risperdal Prescribing Information (FDA)

Risperdal MedFacts Consumer Leaflet (Wolters Kluwer)

Risperdal Monograph (AHFS DI)

Risperdal Consta Prescribing Information (FDA)

Risperdal Consta MedFacts Consumer Leaflet (Wolters Kluwer)

Risperdal Consta Consumer Overview

Risperdal M-Tab Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Risperidone Prescribing Information (FDA)

Risperidone Professional Patient Advice (Wolters Kluwer)

Compare Risperdal with other medications

Asperger Syndrome
Autism
Bipolar Disorder
Mania
Schizoaffective Disorder
Schizophrenia

Platelet-stimulating agents

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Platelet-stimulating agents encourage the body to produce more platelets.

These agents may work by different mechanisms. They can stimulate megakaryocytes, precursors of platelets, to produce platelets faster than normal or they may act as c-mpl (TpoR) receptor agonists. The c-mpl (TpoR) receptor is a target for thrombopoietin, a hormone that stimulates development of megakaryocytes.

Platelet-stimulating agents are used to treat chronic idiopathic thrombocytopenic purpura.

Tuesday, September 27, 2016

Ramicomp Genericon

Ramicomp Genericon may be available in the countries listed below.

Ingredient matches for Ramicomp Genericon

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Ramicomp Genericon in the following countries:

Austria

Ramipril

Ramipril is reported as an ingredient of Ramicomp Genericon in the following countries:

Austria

International Drug Name Search

ReVital Jell Cups

Pronunciation: e-LECK-troe-lite
Generic Name: Electrolyte
Brand Name: ReVital Jell Cups

ReVital Jell Cups are used for:

Treating or preventing dehydration caused by vomiting or diarrhea. It may also be used for other conditions as determined by your doctor.

ReVital Jell Cups are a carbohydrate and electrolyte combination. It works by replacing electrolytes and carbohydrates in the body to prevent dehydration.

Do NOT use ReVital Jell Cups if:

you are allergic to any ingredient in ReVital Jell Cups

you have high blood potassium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using ReVital Jell Cups:

Some medical conditions may interact with ReVital Jell Cups. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have heart failure, fluid retention (eg, swelling of the hands, ankles, or feet), intestinal holes or punctures, difficulty urinating, kidney problems, or unexplained rectal bleeding

if you have severe or persistent vomiting, severe diarrhea, or if you are dehydrated

if you are unable to properly absorb glucose from food

Some MEDICINES MAY INTERACT with ReVital Jell Cups. However, no specific interactions with ReVital Jell Cups are known at this time.

Ask your health care provider if ReVital Jell Cups may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ReVital Jell Cups:

Use ReVital Jell Cups as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take ReVital Jell Cups by mouth with or without food.

Do not mix ReVital Jell Cups with water or any other liquid.

Do not heat ReVital Jell Cups.

After opening, refrigerate the jell cup for up to 72 hours.

Do not reuse the container.

If you miss a dose of ReVital Jell Cups, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use ReVital Jell Cups.

Important safety information:

If vomiting, fever, or stomach pain or bloating occurs, or diarrhea continues for longer than 24 hours, check with your doctor.

Do not use ReVital Jell Cups in CHILDREN younger than 1 year old without first checking with your doctor.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using ReVital Jell Cups while you are pregnant. It is not known if ReVital Jell Cups are found in breast milk. If you are or will be breast-feeding while you use ReVital Jell Cups, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of ReVital Jell Cups:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: ReVital side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ReVital Jell Cups:

Before opening, store ReVital Jell Cups at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. After opening, store ReVital Jell Cups in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away any unused medicine after 72 hours. Keep ReVital Jell Cups out of the reach of children and away from pets.

General information:

If you have any questions about ReVital Jell Cups, please talk with your doctor, pharmacist, or other health care provider.

ReVital Jell Cups are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about ReVital Jell Cups. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More ReVital resources

ReVital Side Effects (in more detail)
ReVital Support Group
0 Reviews · Be the first to review/rate this drug

Monday, September 26, 2016

Dobutan

Dobutan may be available in the countries listed below.

Ingredient matches for Dobutan

Dobutamine

Dobutamine hydrochloride (a derivative of Dobutamine) is reported as an ingredient of Dobutan in the following countries:

Greece

International Drug Name Search

Rheopolydex

Rheopolydex may be available in the countries listed below.

Ingredient matches for Rheopolydex

Dextran

Dextran is reported as an ingredient of Rheopolydex in the following countries:

Russian Federation

International Drug Name Search

Novacrom

Novacrom may be available in the countries listed below.

Ingredient matches for Novacrom

Cromoglicic Acid

Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Novacrom in the following countries:

Bangladesh

International Drug Name Search

Friday, September 23, 2016

Recombinate recombinant

Generic Name: antihemophilic factor (recombinant) (ant ee hee moe FIL ik FAK tor (ree KOM bin ant))

Brand Names: Advate rAHF-PFM, Helixate FS, Kogenate FS, Kogenate FS with Bioset, Recombinate, Refacto, Xyntha, Xyntha Solofuse

What is recombinant antihemophilic factor?

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A.

This medication works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Recombinant antihemophilic factor is used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia, and to prevent joint damage in people age 16 or older with severe hemophilia A and no prior joint damage.

Recombinant antihemophilic factor is not for use in people with von Willebrand disease.

Recombinant antihemophilic factor may also be used for purposes not listed in this medication guide.

What is the most important information I should know about recombinant antihemophilic factor?

Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse or beef proteins.

Before using recombinant antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Human antihemophilic factor will not treat von Willebrand disease.

Your body may develop antibodies to this medication, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

What should I discuss with my health care provider before using recombinant antihemophilic factor?

Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse or beef proteins.

Before using recombinant antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Recombinant antihemophilic factor will not treat von Willebrand disease.

FDA pregnancy category C. It is not known whether recombinant antihemophilic factor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether recombinant antihemophilic factor passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use recombinant antihemophilic factor?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Recombinant antihemophilic factor is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Always wash your hands before preparing and giving your injection.

Recombinant antihemophilic factor must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to reach room temperature before mixing them.

Gently swirl the medicine and diluent to mix them and allow the medicine to completely dissolve.

After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.

Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Recombinant antihemophilic factor is usually given every 8 to 24 hours for 1 to 4 days, depending on the reason you are using the medication.

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

Your body may develop antibodies to antihemophilic factor, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. Store the medication and the diluent in the refrigerator and do not allow them to freeze. You may also store the medication and diluent at room temperature until the expiration date on the label. Some brands of this medicine can be stored at room temperature for only a certain number of months, or until the expiration date (whichever comes first). Follow the storage directions on the medicine label.

Do not store this medicine in bright light. Throw away any leftover medicine and diluent if the expiration date has passed.

What happens if I miss a dose?

Recombinant antihemophilic factor is sometimes used only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using recombinant antihemophilic factor?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Recombinant antihemophilic factor side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat. Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

chest pain;

easy bruising, increased bleeding episodes; or

bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

sore throat, cough, runny nose;

fever or chills;

mild nausea, vomiting;

unusual or unpleasant taste in your mouth;

skin itching or rash;

warmth, redness, itching, or tingling under your skin;

joint pain or swelling;

dizziness;

headache; or

swelling, stinging, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect recombinant antihemophilic factor?

There may be other drugs that can interact with recombinant antihemophilic factor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Recombinate resources

Recombinate Side Effects (in more detail)
Recombinate Use in Pregnancy & Breastfeeding
Recombinate Support Group
0 Reviews for Recombinate - Add your own review/rating

Compare Recombinate with other medications

Hemophilia A

Where can I get more information?

Your pharmacist can provide more information about recombinant antihemophilic factor.

See also: Recombinate side effects (in more detail)

Tiagabine Hydrochloride

Tiagabine Hydrochloride may be available in the countries listed below.

Ingredient matches for Tiagabine Hydrochloride

Tiagabine

Tiagabine Hydrochloride (BANM, USAN) is known as Tiagabine in the US.

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Rhophylac

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)

Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM Ultra-Filtered Plus, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don't (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

To make sure you can safely receive RHo (D) immune globulin, tell your doctor if you have any of these other conditions:

heart disease or a history of coronary artery disease (hardened arteries);

high triglycerides (a type of fat in the blood);

a bleeding disorder (such as hemophilia); or

immune globulin A (IgA) deficiency.

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

RHo (D) immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving RHo (D) immune globulin?

Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

RHo (D) immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, chills, shaking, back pain, dark colored urine;

rapid breathing, feeling short of breath.

urinating less than usual or not at all, swelling, rapid weight gain; or

pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

Less serious side effects may include:

joint or muscle pain;

headache, dizziness;

feeling weak or tired;

mild itching or skin rash;

nausea, diarrhea, vomiting, stomach pain; or

pain or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Rhophylac resources

Rhophylac Side Effects (in more detail)
Rhophylac Use in Pregnancy & Breastfeeding
Rhophylac Drug Interactions
Rhophylac Support Group
0 Reviews for Rhophylac - Add your own review/rating

Rhophylac Prescribing Information (FDA)

Rhophylac Consumer Overview

Rhophylac Advanced Consumer (Micromedex) - Includes Dosage Information

Rhophylac MedFacts Consumer Leaflet (Wolters Kluwer)

Bayrho-D full dose

HyperRHO S/D Full Dose Prescribing Information (FDA)

MICRhoGAM MedFacts Consumer Leaflet (Wolters Kluwer)

RhoGAM Ultra-Filtered PLUS Prescribing Information (FDA)

WinRho SDF MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Rhophylac with other medications

Idiopathic Thrombocytopenic Purpura
Rh-Isoimmunization

Where can I get more information?

Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

See also: Rhophylac side effects (in more detail)

acetylcysteine inhalation

Generic Name: acetylcysteine (inhalation) (a SEET il SIS teen)

Brand names: Mucomyst-10, ...show all 9 brand names.

What is acetylcysteine?

Acetylcysteine is a mucolytic (myoo-koe-LIT-ik) drug that breaks down mucus, the substance that lubricates many parts of the body such as the mouth, throat, and lungs.

Acetylcysteine is used to thin the mucus in people with certain lung conditions such as cystic fibrosis, emphysema, bronchitis, tuberculosis. Acetylcysteine is also used during surgery or anesthesia, and to prepare the throat or lungs for a medical test.

Acetylcysteine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about acetylcysteine?

Do not use acetylcysteine at home if you do not fully understand all instructions that are specific to your use of this medication. Use only the inhaler device provided with your medicine or you may not get the correct dose.

Acetylcysteine solution can be inhaled directly from the nebulizer, or with a face mask, mouth piece, tent, or intermittent positive pressure breathing (IPPB) machine.

Do not mix your dose of acetylcysteine until you are ready to use the medication. Diluted acetylcysteine must be used within 1 hour of mixing.

Acetylcysteine liquid may change color once you have opened the bottle. This is caused by a chemical reaction and will not affect the medicine.

You may sense an unusual or unpleasant smell while using acetylcysteine.

Other side effects may include sticky feeling around the nebulizer mask, white patches or sores inside your mouth or on your lips, nausea, fever, runny nose, sore throat, drowsiness, skin rash, or clammy skin.

There may be other drugs that can affect acetylcysteine, or that should not be used in the same nebulizer. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What should I discuss with my health care provider before taking acetylcysteine?

Do not use this medication if you are allergic to acetylcysteine.

Before using acetylcysteine, tell your doctor if you are allergic to any drugs, or if you have asthma. You may not be able to use acetylcysteine, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether acetylcysteine inhalation passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetylcysteine?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Acetylcysteine liquid may change color once you have opened the bottle. This is caused by a chemical reaction and will not affect the medicine.

Do not mix your dose of acetylcysteine until you are ready to use the medication. Diluted acetylcysteine must be used within 1 hour of mixing.

Acetylcysteine solution can be inhaled directly from the nebulizer, or with a face mask, mouth piece, tent, or intermittent positive pressure breathing (IPPB) machine.

The Mucomyst brand of acetylcysteine should not be placed directly in a heated nebulizer.

Clean your nebulizer right after each use. The residue from acetylcysteine can clog the parts of the nebulizer.

Store an unopened vial (bottle) of acetylcysteine at room temperature, away from moisture and heat. Diluted acetylcystine may also be stored in a refrigerator, but you must use it within 96 hours (4 days) after mixing. Do not allow the medication to freeze.

See also: Acetylcysteine dosage (in more detail)

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an acetylcysteine overdose are not known.

What should I avoid while taking acetylcysteine?

Do not mix other medicines in a nebulizer with acetylcysteine, unless your doctor has told you to.

Acetylcysteine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using acetylcysteine and call your doctor at once if you have chest tightness or trouble breathing.

Less serious side effects of acetylcysteine include:

unusual or unpleasant smell while using the medication;

sticky feeling around the nebulizer mask;

white patches or sores inside your mouth or on your lips;

nausea, vomiting;

fever;

runny nose, sore throat;

drowsiness; or

skin rash or clammy feeling.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Acetylcysteine Dosing Information

Usual Adult Dose for Acetaminophen Overdose:

Give within 24 hours of suspected or known acetaminophen overdose:

Oral:
Loading Dose: 140 mg/kg actual body weight (1.4 mL/kg of a 10% solution) orally, (minimum 4 grams; maximum 15 grams) orally once as a loading dose, followed by,
Maintenance Dose: 70 mg/kg actual body weight (0.7 mL/kg of a 10% solution) orally 4 hours after the loading dose and every 4 hours for 17 total maintenance doses or unless repeated acetaminophen assays reveal nontoxic levels. If the patient vomits the loading dose or any maintenance dose within 1 hour of administration, repeat doses are recommended.

Intravenous:
Loading Dose: 150 mg/kg in 200 mL of 5% dextrose intravenously over 60 minutes (maximum: 15 g).
Second Dose: 50 mg/kg in 500 mL 5% dextrose intravenously over 4 hours (maximum: 5 g). Third Dose: 100 mg/kg in 1000 mL of 5% dextrose intravenously over 16 hours (maximum: 10 g.

Acetylcysteine is most useful within 24 hours of acetaminophen ingestion. Knowledge of acetaminophen levels are not required prior to giving this potentially lifesaving drug. If the first acetaminophen level is in the toxic range, the entire course of acetylcysteine is recommended.

If the intravenous product is not available and the patient is unable to tolerate oral administration, the Rocky Mountain Poison Center can be contacted at 1.800.525.6115 for information on the protocol and preparation of IV acetylcysteine.

Usual Adult Dose for Mucolytic:

5 to 10 mL of a 10% or 20% solution by nebulizer every 4 to 6 hours,

- or-

1 to 2 mL of a 10% or 20% solution directly instilled into a tracheostomy as often as every hour,

- or-

2 to 4 mL of a 10% solution or 1 to 2 mL of a 20% solution intratracheally every 1 to 4 hours.

Usual Adult Dose for Diagnostic Bronchograms:

to decrease bronchopulmonary secretions prior to diagnostic bronchogram:

2 to 4 mL of a 10% solution or 1 to 2 mL of a 20% solution by nebulizer or by intratracheal instillation 2 to 3 times prior to the procedure.

Usual Pediatric Dose for Acetaminophen Overdose:

Give within 24 hours of suspected or known acetaminophen overdose:

Oral:
Loading Dose: 140 mg/kg actual body weight (1.4 mL/kg of a 10% solution) orally, (minimum 4 grams; maximum 15 grams) orally once as a loading dose.
Maintenance Dose: 70 mg/kg actual body weight (0.7 mL/kg of a 10% solution) orally 4 hours after the loading dose and every 4 hours for 17 total maintenance doses or unless repeated acetaminophen assays reveal nontoxic levels.

Intravenous:
Loading Dose: 150 mg/kg in 200 mL of 5% dextrose intravenously over 60 minutes (maximum: 15 g).
Second Dose: 50 mg/kg in 500 mL 5% dextrose intravenously over 4 hours (maximum: 5 g). Third Dose: 100 mg/kg in 1000 mL of 5% dextrose intravenously over 16 hours (maximum: 10 g).

Acetylcysteine is most useful within 24 hours of acetaminophen ingestion. Knowledge of acetaminophen levels are not required prior to giving this potentially lifesaving drug. If the first acetaminophen level is in the toxic range, the entire course of acetylcysteine is recommended.

Usual Pediatric Dose for Mucolytic:

1 month to 11 months:
2 to 4 mL of a 10% solution or 1 to 2 mL of a 20% solution by nebulizer three or four times a day.
1 year to 11 years:
6 to 10 mL of a 10% solution or 3 to 5 mL of a 20% solution by nebulizer three to four times a day,
12 years or older:
5 to 10 mL of a 10% or 20% solution by nebulizer three to four times a day,
- or-
1 to 2 mL of a 10% or 20% solution directly instilled into a tracheostomy as often as every hour,
- or-
2 to 4 mL of a 10% solution or 1 to 2 mL of a 20% solution intratracheally every 1 to 4 hours.

What other drugs will affect acetylcysteine?

More acetylcysteine resources

Acetylcysteine Side Effects (in more detail)
Acetylcysteine Dosage
Acetylcysteine Use in Pregnancy & Breastfeeding
Acetylcysteine Drug Interactions
Acetylcysteine Support Group
4 Reviews for Acetylcysteine - Add your own review/rating

Compare acetylcysteine with other medications

Acetaminophen Overdose
Diagnostic Bronchograms
Expectoration

Where can I get more information?

Your pharmacist has information about acetylcysteine written for health professionals that you may read.

See also: acetylcysteine side effects (in more detail)

Thursday, September 22, 2016

Reyataz

Pronunciation: A-ta-ZAN-a-vir
Generic Name: Atazanavir
Brand Name: Reyataz

Taking Reyataz with other medicines may result in serious or life-threatening side effects. Ask your doctor or pharmacist if you have any questions about which medicines should not be taken with Reyataz.

Reyataz is used for:

Treating HIV infection along with other medicines.

Reyataz is an HIV protease inhibitor. It works by inhibiting HIV protease, which is the enzyme required to form functional proteins in HIV-infected cells.

Do NOT use Reyataz if:

you are allergic to any ingredient in Reyataz

you are taking alfuzosin, certain benzodiazepines (eg, oral midazolam, triazolam), cisapride, an ergot derivative (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), indinavir, irinotecan, nevirapine, pimozide, rifampin, salmeterol, or St. John's wort

you are taking sildenafil for pulmonary arterial hypertension (PAH)

you are taking voriconazole and you take ritonavir along with Reyataz

you are taking bosentan (unless you also take ritonavir along with Reyataz)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Reyataz:

Some medical conditions may interact with Reyataz. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a blood disorder (eg, hemophilia), diabetes, heart problems (eg, atrioventricular block), or liver problems (including hepatitis B or hepatitis C)

if you have kidney problems or are on dialysis

Some MEDICINES MAY INTERACT with Reyataz. Tell your health care provider if you are taking any other medicines, especially any of the following:

Certain benzodiazepines (eg, oral midazolam, triazolam), cisapride, ergot derivatives (eg, ergotamine), pimozide, or salmeterol because serious side effects, such as breathing problems, blood vessel problems, or irregular heartbeat, may occur

Certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin) because the risk of serious muscle effects may be increased

Alfuzosin because the risk of severe low blood pressure may be increased

Indinavir because it may increase the risk of Reyataz's side effects

Bosentan (unless you also take ritonavir with Reyataz), nevirapine, rifampin or, St. John's wort because they may decrease Reyataz's effectiveness

Irinotecan or sildenafil (when used for PAH) because the risk of its side effects may be increased by Reyataz

Voriconazole (if you take ritonavir along with Reyataz) because its effectiveness may be decreased

Many prescription and nonprescription medicines (eg, used for aches and pains, angina, asthma, birth control, blood pressure, blood thinning, cancer, depression, erectile dysfunction, heartburn or reflux disease, gout, immune system suppression, infections, inflammation, irregular heartbeat, heart problems, high blood pressure, high cholesterol, HIV, mental or mood problems, migraine, opioid addiction, pain, PAH, overactive bladder, seizures, sleep aid), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Reyataz, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Reyataz may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Reyataz:

Use Reyataz as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Reyataz. Talk to your pharmacist if you have questions about this information.

Take Reyataz by mouth with food.

Swallow Reyataz whole. Do not break, crush, or chew before swallowing.

Take Reyataz on a regular schedule to get the most benefit from it.

Taking Reyataz at the same time each day will help you remember to take it.

If you also take a proton pump inhibitor (eg, omeprazole), take it about 12 hours before you take Reyataz.

If you also take an H₂ antagonist (eg, cimetidine), talk with your doctor about how to take it with Reyataz.

If you also take an antacid or didanosine, take Reyataz at least 2 hours before or 1 hour after the antacid or didanosine.

Continue to use Reyataz even if you feel well. Do not miss any doses.

If you miss a dose of Reyataz, take it as soon as possible. If it is within 6 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Reyataz.

Important safety information:

Reyataz may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Reyataz with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Reyataz is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.

When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Reyataz, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.

Reyataz does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.

Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Reyataz. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.

Hormonal birth control (eg, birth control pills) may not work as well while you are using Reyataz. To prevent pregnancy, use an extra form of birth control (eg, condoms).

Reyataz may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of an infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Reyataz.

Reyataz may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

Diabetes patients - Reyataz may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Lab tests, including liver function, bilirubin levels, lipid or cholesterol levels, and electrocardiograms, may be performed while you use Reyataz. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Reyataz with caution in the ELDERLY; they may be more sensitive to its effects.

Reyataz should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

Reyataz should not be used in CHILDREN younger than 3 months old; a type of brain damage caused by high blood bilirubin levels (kernicterus) may occur.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Reyataz while you are pregnant. It is not known if Reyataz is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Reyataz to the baby.

Possible side effects of Reyataz:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in body fat; cough; diarrhea; fatigue; headache; increased cough; muscle pain; nausea; pain; stomach pain; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; chest pain; dizziness; fever, chills, or sore throat; increased urination or thirst; irregular heartbeat; lightheadedness; mental or mood changes (eg, depression); numbness, tingling, or extreme weakness especially in the arms or legs; painful urination; red, blistered, or swollen skin; severe nausea or vomiting; severe stomach or side pain; trouble breathing; unusual bleeding or bruising; yellowing of skin or eyes.

See also: Reyataz side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe dizziness and lightheadedness; yellowing of the eyes or skin.

Proper storage of Reyataz:

Store Reyataz at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Reyataz out of the reach of children and away from pets.

General information:

If you have any questions about Reyataz, please talk with your doctor, pharmacist, or other health care provider.

Reyataz is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Reyataz. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Reyataz resources

Reyataz Side Effects (in more detail)
Reyataz Use in Pregnancy & Breastfeeding
Drug Images
Reyataz Drug Interactions
Reyataz Support Group
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Reyataz Prescribing Information (FDA)

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HIV Infection
Nonoccupational Exposure

Meomel

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Meloxicam

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Greece

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Risperigamma

Risperigamma may be available in the countries listed below.

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Risperidone

Risperidone is reported as an ingredient of Risperigamma in the following countries:

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Wednesday, September 21, 2016

Naproxen sodium and Pseudoephedrine hydrochloride

Ingredient matches for Naproxen sodium and Pseudoephedrine hydrochloride

Naproxen

Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Naproxen sodium and Pseudoephedrine hydrochloride in the following countries:

United States

Pseudoephedrine

Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Naproxen sodium and Pseudoephedrine hydrochloride in the following countries:

United States

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Tuesday, September 20, 2016

Retrovir Infusion

Dosage Form: injection, solution
RETROVIR®

(zidovudine)

IV Infusion

FOR INTRAVENOUS INFUSION ONLY

Warning

RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND SEVERE ANEMIA, PARTICULARLY IN PATIENTS WITH ADVANCED HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE (SEE WARNINGS). PROLONGED USE OF RETROVIR HAS BEEN ASSOCIATED WITH SYMPTOMATIC MYOPATHY.

LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING RETROVIR AND OTHER ANTIRETROVIRALS (SEE WARNINGS).

Retrovir Infusion Description

RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV. RETROVIR IV Infusion is a sterile solution for intravenous infusion only. Each mL contains 10 mg zidovudine in Water for Injection. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH to approximately 5.5. RETROVIR IV Infusion contains no preservatives.

The chemical name of zidovudine is 3′-azido-3′-deoxythymidine; it has the following structural formula:

Zidovudine is a white to beige, odorless, crystalline solid with a molecular weight of 267.24 and a solubility of 20.1 mg/mL in water at 25°C. The molecular formula is C10H13N5O4.

MICROBIOLOGY

Mechanism of Action:

Zidovudine is a synthetic nucleoside analogue. Intracellularly, zidovudine is phosphorylated to its active 5′-triphosphate metabolite, zidovudine triphosphate (ZDV-TP). The principal mode of action of ZDV-TP is inhibition of reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue. ZDV-TP is a weak inhibitor of the cellular DNA polymerases α and γ and has been reported to be incorporated into the DNA of cells in culture.

Antiviral Activity:

Activity of zidovudine against HIV-1 was assessed in a number of cell lines (including monocytes and fresh human peripheral blood lymphocytes). The EC50 and EC90 values for zidovudine were 0.01 to 0.49 µM (1 μM = 0.27 mcg/mL) and 0.1 to 9 μM, respectively. HIV from therapy-naive subjects with no mutations associated with resistance gave median EC50 values of 0.011 µM (range: 0.005 to 0.110 µM) from Virco (n = 93 baseline samples from COLA40263) and 0.02 µM (0.01 to 0.03 µM) from Monogram Biosciences (n = 135 baseline samples from ESS30009). The EC50 values of zidovudine against different HIV-1 clades (A-G) ranged from 0.00018 to 0.02 μM, and against HIV-2 isolates from 0.00049 to 0.004 μM. In cell culture drug combination studies, zidovudine demonstrates synergistic activity with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir, didanosine, lamivudine, and zalcitabine; the non-nucleoside reverse transcriptase inhibitors (NNRTIs) delavirdine and nevirapine; and the protease inhibitors (PIs) indinavir, nelfinavir, ritonavir, and saquinavir; and additive activity with interferon alfa. Ribavirin has been found to inhibit the phosphorylation of zidovudine in cell culture.

Resistance:

Genotypic analyses of the isolates selected in cell culture and recovered from zidovudine-treated patients showed mutations in the HIV-1 RT gene resulting in 6 amino acid substitutions (M41L, D67N, K70R, L210W, T215Y or F, and K219Q) that confer zidovudine resistance. In general, higher levels of resistance were associated with greater number of mutations. In some patients harboring zidovudine-resistant virus at baseline, phenotypic sensitivity to zidovudine was restored by 12 weeks of treatment with lamivudine and zidovudine. Combination therapy with lamivudine plus zidovudine delayed the emergence of mutations conferring resistance to zidovudine.

Cross-Resistance:

In a study of 167 HIV-infected patients, isolates (n = 2) with multi-drug resistance to didanosine, lamivudine, stavudine, zalcitabine, and zidovudine were recovered from patients treated for ≥1 year with zidovudine plus didanosine or zidovudine plus zalcitabine. The pattern of resistance-associated mutations with such combination therapies was different (A62V, V75I, F77L, F116Y, Q151M) from the pattern with zidovudine monotherapy, with the Q151M mutation being most commonly associated with multi-drug resistance. The mutation at codon 151 in combination with mutations at 62, 75, 77, and 116 results in a virus with reduced susceptibility to didanosine, lamivudine, stavudine, zalcitabine, and zidovudine. Thymidine analogue mutations (TAMs) are selected by zidovudine and confer cross-resistance to abacavir, didanosine, stavudine, tenofovir, and zalcitabine.

Retrovir Infusion - Clinical Pharmacology

Pharmacokinetics:

Adults: The pharmacokinetics of zidovudine have been evaluated in 22 adult HIV-infected patients in a Phase 1 dose-escalation study. Following intravenous (IV) dosing, dose-independent kinetics was observed over the range of 1 to 5 mg/kg. The major metabolite of zidovudine is 3′-azido-3′-deoxy-5′-O-β-D-glucopyranuronosylthymidine (GZDV). GZDV area under the curve (AUC) is about 3-fold greater than the zidovudine AUC. Urinary recovery of zidovudine and GZDV accounts for 18% and 60%, respectively, following IV dosing. A second metabolite, 3′-amino-3′-deoxythymidine (AMT), has been identified in the plasma following single-dose IV administration of zidovudine. The AMT AUC was one-fifth of the zidovudine AUC.

The mean steady-state peak and trough concentrations of zidovudine at 2.5 mg/kg every 4 hours were 1.06 and 0.12 mcg/mL, respectively.

The zidovudine cerebrospinal fluid (CSF)/plasma concentration ratio was determined in 39 patients receiving chronic therapy with RETROVIR. The median ratio measured in 50 paired samples drawn 1 to 8 hours after the last dose of RETROVIR was 0.6.

Table 1. Zidovudine Pharmacokinetic Parameters Following Intravenous Administration in HIV-Infected Patients
Parameter	Mean ± SD (except where noted)
Apparent volume of distribution (L/kg)	1.6 ± 0.6 (n = 11)
Plasma protein binding (%)	<38
CSF:plasma ratioa	0.6 [0.04 to 2.62] (n = 39)
Systemic clearance (L/hr/kg)	1.6 (0.8 to 2.7) (n =18)
Renal clearance (L/hr/kg)	0.34 ± 0.05 (n = 16)
Elimination half-life (hr)b	1.1 (0.5 to 2.9) (n = 19)
aMedian [range].
bApproximate range.

Adults With Impaired Renal Function: Zidovudine clearance was decreased resulting in increased zidovudine and GZDV half-life and AUC in patients with impaired renal function (n = 14) following a single 200-mg oral dose (Table 2). Plasma concentrations of AMT were not determined. A dose adjustment should not be necessary for patients with creatinine clearance (CrCl) ≥15 mL/min.

Table 2. Zidovudine Pharmacokinetic Parameters in Patients With Severe Renal Impairmenta
Parameter	Control Subjects (Normal Renal Function) (n = 6)	Patients With Renal Impairment (n = 14)
CrCl (mL/min)	120 ± 8	18 ± 2
Zidovudine AUC (ng•hr/mL)	1,400 ± 200	3,100 ± 300
Zidovudine half-life (hr)	1.0 ± 0.2	1.4 ± 0.1
aData are expressed as mean ± standard deviation.

The pharmacokinetics and tolerance of oral zidovudine were evaluated in a multiple-dose study in patients undergoing hemodialysis (n = 5) or peritoneal dialysis (n = 6) receiving escalating doses up to 200 mg 5 times daily for 8 weeks. Daily doses of 500 mg or less were well tolerated despite significantly elevated GZDV plasma concentrations. Apparent zidovudine oral clearance was approximately 50% of that reported in patients with normal renal function. Hemodialysis and peritoneal dialysis appeared to have a negligible effect on the removal of zidovudine, whereas GZDV elimination was enhanced. A dosage adjustment is recommended for patients undergoing hemodialysis or peritoneal dialysis (see DOSAGE AND ADMINISTRATION: Dose Adjustment).

Adults With Impaired Hepatic Function: Data describing the effect of hepatic impairment on the pharmacokinetics of zidovudine are limited. However, because zidovudine is eliminated primarily by hepatic metabolism, it is expected that zidovudine clearance would be decreased and plasma concentrations would be increased following administration of the recommended adult doses to patients with hepatic impairment (see DOSAGE AND ADMINISTRATION: Dose Adjustment).

Pediatrics: Zidovudine pharmacokinetics have been evaluated in HIV-infected pediatric patients (Table 3).

Patients Aged 3 Months to 12 Years: Overall, zidovudine pharmacokinetics in pediatric patients >3 months of age are similar to those in adult patients. Proportional increases in plasma zidovudine concentrations were observed following administration of oral solution from 90 to 240 mg/m2 every 6 hours. Oral bioavailability, terminal half-life, and oral clearance were comparable to adult values. As in adult patients, the major route of elimination was by metabolism to GZDV. After intravenous dosing, about 29% of the dose was excreted in the urine unchanged and about 45% of the dose was excreted as GZDV (see DOSAGE AND ADMINISTRATION: Pediatrics).

Patients Aged Less Than 3 Months: Zidovudine pharmacokinetics have been evaluated in pediatric patients from birth to 3 months of life. Zidovudine elimination was determined immediately following birth in 8 neonates who were exposed to zidovudine in utero. The half-life was 13.0 ± 5.8 hours. In neonates ≤14 days old, bioavailability was greater, total body clearance was slower, and half-life was longer than in pediatric patients >14 days old. For dose recommendations for neonates, see DOSAGE AND ADMINISTRATION: Neonatal Dosing.

Table 3. Zidovudine Pharmacokinetic Parameters in Pediatric Patientsa
Parameter	Birth to 14 Days	Aged 14 Days to 3 Months	Aged 3 Months to 12 Years
Oral bioavailability (%)	89 ± 19 (n = 15)	61 ± 19 (n = 17)	65 ± 24 (n = 18)
CSF:plasma ratio	no data	no data	0.26 ± 0.17b (n = 28)
CL (L/hr/kg)	0.65 ± 0.29 (n = 18)	1.14 ± 0.24 (n = 16)	1.85 ± 0.47 (n = 20)
Elimination half-life (hr)	3.1 ± 1.2 (n = 21)	1.9 ± 0.7 (n = 18)	1.5 ± 0.7 (n = 21)
aData presented as mean ± standard deviation except where noted.
bCSF ratio determined at steady-state on constant intravenous infusion.

Pregnancy: Zidovudine pharmacokinetics have been studied in a Phase 1 study of 8 women during the last trimester of pregnancy. As pregnancy progressed, there was no evidence of drug accumulation. Zidovudine pharmacokinetics were similar to those of nonpregnant adults. Consistent with passive transmission of the drug across the placenta, zidovudine concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery. Although data are limited, methadone maintenance therapy in 5 pregnant women did not appear to alter zidovudine pharmacokinetics. However, in another patient population, a potential for interaction has been identified (see PRECAUTIONS).

Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. After administration of a single dose of 200 mg zidovudine to 13 HIV-infected women, the mean concentration of zidovudine was similar in human milk and serum (see PRECAUTIONS: Nursing Mothers).

Geriatric Patients: Zidovudine pharmacokinetics have not been studied in patients over 65 years of age.

Gender: A pharmacokinetic study in healthy male (n = 12) and female (n = 12) subjects showed no differences in zidovudine exposure (AUC) when a single dose of zidovudine was administered as the 300-mg RETROVIR Tablet.

Drug Interactions:

See Table 4 and PRECAUTIONS: Drug Interactions.

Zidovudine Plus Lamivudine: No clinically significant alterations in lamivudine or zidovudine pharmacokinetics were observed in 12 asymptomatic HIV-infected adult patients given a single oral dose of zidovudine (200 mg) in combination with multiple oral doses of lamivudine (300 mg every 12 hours).

Table 4. Effect of Coadministered Drugs on Zidovudine AUCa Note: ROUTINE DOSE MODIFICATION OF ZIDOVUDINE IS NOT WARRANTED WITH COADMINISTRATION OF THE FOLLOWING DRUGS.
Coadministered Drug and Dose	Zidovudine Oral Dose	n	Zidovudine Concentrations		Concentration of Coadministered Drug
Coadministered Drug and Dose	Zidovudine Oral Dose	n	AUC	Variability	Concentration of Coadministered Drug
Atovaquone 750 mg q 12 hr with food	200 mg q 8 hr	14	↑AUC 31%	Range 23% to 78%b	↔
Fluconazole 400 mg daily	200 mg q 8 hr	12	↑AUC 74%	95% CI: 54% to 98%	Not Reported
Methadone 30 to 90 mg daily	200 mg q 4 hr	9	↑AUC 43%	Range 16% to 64%b	↔
Nelfinavir 750 mg q 8 hr x 7 to 10 days	single 200 mg	11	↓AUC 35%	Range 28% to 41%	↔
Probenecid 500 mg q 6 hr x 2 days	2 mg/kg q 8 hr x 3 days	3	↑AUC 106%	Range 100% to 170%b	Not Assessed
Rifampin 600 mg daily x 14 days	200 mg q 8 hr x 14 days	8	↓AUC 47%	90% CI: 41% to 53%	Not Assessed
Ritonavir 300 mg q 6 hr x 4 days	200 mg q 8 hr x 4 days	9	↓AUC 25%	95% CI: 15% to 34%	↔
Valproic acid 250 mg or 500 mg q 8 hr x 4 days	100 mg q 8 hr x 4 days	6	↑AUC 80%	Range 64% to 130%b	Not Assessed
↑ = Increase; ↓ = Decrease;↔ = no significant change; AUC = area under the concentration versus time curve; CI = confidence interval.
aThis table is not all inclusive.
bEstimated range of percent difference.

Ribavirin: In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine, and zidovudine. However, no pharmacokinetic (e.g., plasma concentrations or intracellular triphosphorylated active metabolite concentrations) or pharmacodynamic (e.g., loss of HIV/HCV virologic suppression) interaction was observed when ribavirin and lamivudine (n = 18), stavudine (n = 10), or zidovudine (n = 6) were coadministered as part of a multi-drug regimen to HIV/HCV co-infected patients (see WARNINGS).

Indications and Usage for Retrovir Infusion

RETROVIR IV Infusion in combination with other antiretroviral agents is indicated for the treatment of HIV infection.

Maternal-Fetal HIV Transmission:

RETROVIR is also indicated for the prevention of maternal-fetal HIV transmission as part of a regimen that includes oral RETROVIR beginning between 14 and 34 weeks of gestation, intravenous RETROVIR during labor, and administration of RETROVIR Syrup to the neonate after birth. The efficacy of this regimen for preventing HIV transmission in women who have received RETROVIR for a prolonged period before pregnancy has not been evaluated. The safety of RETROVIR for the mother or fetus during the first trimester of pregnancy has not been assessed (see Description of Clinical Studies).

Description of Clinical Studies:

Therapy with RETROVIR has been shown to prolong survival and decrease the incidence of opportunistic infections in patients with advanced HIV disease at the initiation of therapy and to delay disease progression in asymptomatic HIV-infected patients.

RETROVIR in combination with other antiretroviral agents has been shown to be superior to monotherapy in one or more of the following endpoints: delaying death, delaying development of AIDS, increasing CD4+ cell counts, and decreasing plasma HIV-1 RNA. The complete prescribing information for each drug should be consulted before combination therapy that includes RETROVIR is initiated.

Pregnant Women and Their Neonates: The utility of RETROVIR for the prevention of maternal-fetal HIV transmission was demonstrated in a randomized, double-blind, placebo-controlled trial (ACTG 076) conducted in HIV-infected pregnant women with CD4+ cell counts of 200 to 1,818 cells/mm3 (median in the treated group: 560 cells/mm3) who had little or no previous exposure to RETROVIR. Oral RETROVIR was initiated between 14 and 34 weeks of gestation (median 11 weeks of therapy) followed by intravenous administration of RETROVIR during labor and delivery. Following birth, neonates received oral RETROVIR Syrup for 6 weeks. The study showed a statistically significant difference in the incidence of HIV infection in the neonates (based on viral culture from peripheral blood) between the group receiving RETROVIR and the group receiving placebo. Of 363 neonates evaluated in the study, the estimated risk of HIV infection was 7.8% in the group receiving RETROVIR and 24.9% in the placebo group, a relative reduction in transmission risk of 68.7%. RETROVIR was well tolerated by mothers and infants. There was no difference in pregnancy-related adverse events between the treatment groups.

Contraindications

RETROVIR IV Infusion is contraindicated for patients who have potentially life-threatening allergic reactions to any of the components of the formulation.

Warnings

COMBIVIR® (lamivudine and zidovudine) Tablets and TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine) Tablets are combination product tablets that contain zidovudine as one of their components. RETROVIR should not be administered concomitantly with COMBIVIR or TRIZIVIR.

The incidence of adverse reactions appears to increase with disease progression; patients should be monitored carefully, especially as disease progression occurs.

Bone Marrow Suppression:

RETROVIR should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count <1,000 cells/mm3 or hemoglobin <9.5 g/dL. In patients with advanced symptomatic HIV disease, anemia and neutropenia were the most significant adverse events observed. There have been reports of pancytopenia associated with the use of RETROVIR, which was reversible in most instances, after discontinuance of the drug. However, significant anemia, in many cases requiring dose adjustment, discontinuation of RETROVIR, and/or blood transfusions, has occurred during treatment with RETROVIR alone or in combination with other antiretrovirals.

Frequent blood counts are strongly recommended in patients with advanced HIV disease who are treated with RETROVIR. For HIV-infected individuals and patients with asymptomatic or early HIV disease, periodic blood counts are recommended. If anemia or neutropenia develops, dosage adjustments may be necessary (see DOSAGE AND ADMINISTRATION).

Myopathy:

Myopathy and myositis with pathological changes, similar to that produced by HIV disease, have been associated with prolonged use of RETROVIR.

Lactic Acidosis/Severe Hepatomegaly with Steatosis:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including zidovudine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged exposure to antiretroviral nucleoside analogues may be risk factors. Particular caution should be exercised when administering RETROVIR to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with RETROVIR should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

Use With Interferon- and Ribavirin-Based Regimens:

In vitro studies have shown ribavirin can reduce the phosphorylation of pyrimidine nucleoside analogues such as zidovudine. Although no evidence of a pharmacokinetic or pharmacodynamic interaction (e.g., loss of HIV/HCV virologic suppression) was seen when ribavirin was coadministered with zidovudine in HIV/HCV co-infected patients (see CLINICAL PHARMACOLOGY: Drug Interactions), hepatic decompensation (some fatal) has occurred in HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon alfa with or without ribavirin. Patients receiving interferon alfa with or without ribavirin and RETROVIR should be closely monitored for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia. Discontinuation of RETROVIR should be considered as medically appropriate. Dose reduction or discontinuation of interferon alfa, ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Childs Pugh >6) (see the complete prescribing information for interferon and ribavirin).

Precautions

General:

Zidovudine is eliminated from the body primarily by renal excretion following metabolism in the liver (glucuronidation). In patients with severely impaired renal function (CrCl<15 mL/min), dosage reduction is recommended. Although the data are limited, zidovudine concentrations appear to be increased in patients with severely impaired hepatic function, which may increase the risk of hematologic toxicity (see CLINICAL PHARMACOLOGY: Pharmacokinetics and DOSAGE AND ADMINISTRATION).

Immune Reconstitution Syndrome:

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including RETROVIR. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.

Information for Patients:

RETROVIR is not a cure for HIV-1 infection, and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using RETROVIR.

Patients should be advised to avoid doing things that can spread HIV-1 infection to others.

Do not share needles or other injection equipment.

Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.

Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Do not breastfeed. Zidovudine is excreted in human breast milk. Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

The safety and efficacy of RETROVIR in treating women, intravenous drug users, and racial minorities is not significantly different than that observed in white males.

Patients should be informed that the major toxicities of RETROVIR are neutropenia and/or anemia. The frequency and severity of these toxicities are greater in patients with more advanced disease and in those who initiate therapy later in the course of their infection. They should be told that if toxicity develops, they may require transfusions or drug discontinuation. They should be told of the extreme importance of having their blood counts followed closely while on therapy, especially for patients with advanced symptomatic HIV disease. They should be cautioned about the use of other medications, including ganciclovir and interferon alfa, which may exacerbate the toxicity of RETROVIR (see PRECAUTIONS: Drug Interactions). Patients should be informed that other adverse effects of RETROVIR include nausea and vomiting. Patients should also be encouraged to contact their physician if they experience muscle weakness, shortness of breath, symptoms of hepatitis or pancreatitis, or any other unexpected adverse events while being treated with RETROVIR.

Pregnant women considering the use of RETROVIR during pregnancy for prevention of HIV transmission to their infants should be advised that transmission may still occur in some cases despite therapy. The long-term consequences of in utero and neonatal exposure to RETROVIR are unknown, including the possible risk of cancer.

HIV-infected pregnant women should be advised not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.

Drug Interactions:

See CLINICAL PHARMACOLOGY section (Table 4) for information on zidovudine concentrations when coadministered with other drugs. For patients experiencing pronounced anemia or other severe zidovudine-associated events while receiving chronic administration of zidovudine and some of the drugs (e.g., fluconazole, valproic acid) listed in Table 4, zidovudine dose reduction may be considered.

Antiretroviral Agents: Concomitant use of zidovudine with stavudine should be avoided since an antagonistic relationship has been demonstrated in vitro.

Some nucleoside analogues affecting DNA replication, such as ribavirin, antagonize the in vitro antiviral activity of RETROVIR against HIV; concomitant use of such drugs should be avoided.

Doxorubicin: Concomitant use of zidovudine with doxorubicin should be avoided since an antagonistic relationship has been demonstrated in vitro (see CLINICAL PHARMACOLOGY for additional drug interactions).

Phenytoin: Phenytoin plasma levels have been reported to be low in some patients receiving RETROVIR, while in 1 case a high level was documented. However, in a pharmacokinetic interaction study in which 12 HIV-positive volunteers received a single 300-mg phenytoin dose alone and during steady-state zidovudine conditions (200 mg every 4 hours), no change in phenytoin kinetics was observed. Although not designed to optimally assess the effect of phenytoin on zidovudine kinetics, a 30% decrease in oral zidovudine clearance was observed with phenytoin.

Overlapping Toxicities: Coadministration of ganciclovir, interferon alfa, and other bone marrow suppressive or cytotoxic agents may increase the hematologic toxicity of zidovudine.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Zidovudine was administered orally at 3 dosage levels to separate groups of mice and rats (60 females and 60 males in each group). Initial single daily doses were 30, 60, and 120 mg/kg/day in mice and 80, 220, and 600 mg/kg/day in rats. The doses in mice were reduced to 20, 30, and 40 mg/kg/day after day 90 because of treatment-related anemia, whereas in rats only the high dose was reduced to 450 mg/kg/day on day 91, and then to 300 mg/kg/day on day 279.

In mice, 7 late-appearing (after 19 months) vaginal neoplasms (5 nonmetastasizing squamous cell carcinomas, 1 squamous cell papilloma, and 1 squamous polyp) occurred in animals given the highest dose. One late-appearing squamous cell papilloma occurred in the vagina of a middle-dose animal. No vaginal tumors were found at the lowest dose.

In rats, 2 late-appearing (after 20 months), nonmetastasizing vaginal squamous cell carcinomas occurred in animals given the highest dose. No vaginal tumors occurred at the low or middle dose in rats. No other drug-related tumors were observed in either sex of either species.

At doses that produced tumors in mice and rats, the estimated drug exposure (as measured by AUC) was approximately 3 times (mouse) and 24 times (rat) the estimated human exposure at the recommended therapeutic dose of 100 mg every 4 hours.

Two transplacental carcinogenicity studies were conducted in mice. One study administered zidovudine at doses of 20 mg/kg/day or 40 mg/kg/day from gestation day 10 through parturition and lactation with dosing continuing in offspring for 24 months postnatally. The doses of zidovudine employed in this study produced zidovudine exposures approximately 3 times the estimated human exposure at recommended doses. After 24 months, an increase in incidence of vaginal tumors was noted with no increase in tumors in the liver or lung or any other organ in either gender. These findings are consistent with results of the standard oral carcinogenicity study in mice, as described earlier. A second study administered zidovudine at maximum tolerated doses of 12.5 mg/day or 25 mg/day (∼1,000 mg/kg nonpregnant body weight or ∼450 mg/kg of term body weight) to pregnant mice from days 12 through 18 of gestation. There was an increase in the number of tumors in the lung, liver, and female reproductive tracts in the offspring of mice receiving the higher dose level of zidovudine. It is not known how predictive the results of rodent carcinogenicity studies may be for humans.

Zidovudine was mutagenic in a 5178Y/TK+/- mouse lymphoma assay, positive in an in vitro cell transformation assay, clastogenic in a cytogenetic assay using cultured human lymphocytes, and positive in mouse and rat micronucleus tests after repeated doses. It was negative in a cytogenetic study in rats given a single dose.

Zidovudine, administered to male and female rats at doses up to 7 times the usual adult dose based on body surface area considerations, had no effect on fertility judged by conception rates.

Pregnancy:

Pregnancy Category C. Oral teratology studies in the rat and in the rabbit at doses up to 500 mg/kg/day revealed no evidence of teratogenicity with zidovudine. Zidovudine treatment resulted in embryo/fetal toxicity as evidenced by an increase in the incidence of fetal resorptions in rats given 150 or 450 mg/kg/day and rabbits given 500 mg/kg/day. The doses used in the teratology studies resulted in peak zidovudine plasma concentrations (after one half of the daily dose) in rats 66 to 226 times, and in rabbits 12 to 87 times, mean steady-state peak human plasma concentrations (after one sixth of the daily dose) achieved with the recommended daily dose (100 mg every 4 hours). In an in vitro experiment with fertilized mouse oocytes, zidovudine exposure resulted in a dose-dependent reduction in blastocyst formation. In an additional teratology study in rats, a dose of 3,000 mg/kg/day (very near the oral median lethal dose in rats of 3,683 mg/kg) caused marked maternal toxicity and an increase in the incidence of fetal malformations. This dose resulted in peak zidovudine plasma concentrations 350 times peak human plasma concentrations. (Estimated area under the curve [AUC] in rats at this dose level was 300 times the daily AUC in humans given 600 mg per day.) No evidence of teratogenicity was seen in this experiment at doses of 600 mg/kg/day or less.

Two rodent transplacental carcinogenicity studies were conducted (see Carcinogenesis, Mutagenesis, Impairment of Fertility).

A randomized, double-blind, placebo-controlled trial was conducted in HIV-infected pregnant women to determine the utility of RETROVIR for the prevention of maternal-fetal HIV transmission (see INDICATIONS AND USAGE: Description of Clinical Studies). Congenital abnormalities occurred with similar frequency between neonates born to mothers who received RETROVIR and neonates born to mothers who received placebo. Abnormalities were either problems in embryogenesis (prior to 14 weeks) or were recognized on ultrasound before or immediately after initiation of study drug.

Antiretroviral Pregnancy Registry: To monitor maternal-fetal outcomes of pregnant women exposed to RETROVIR, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.

Nursing Mothers:

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV.

Zidovudine is excreted in human milk (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Nursing Mothers). Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving RETROVIR (see Pediatric Use and INDICATIONS AND USAGE: Maternal-Fetal HIV Transmission).

Pediatric Use:

RETROVIR has been studied in HIV-infected pediatric patients over 3 months of age who had HIV-related symptoms or who were asymptomatic with abnormal laboratory values indicating significant HIV-related immunosuppression. RETROVIR has also been studied in neonates perinatally exposed to HIV (see ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION, INDICATIONS AND USAGE: Description of Clinical Studies, and CLINICAL PHARMACOLOGY: Pharmacokinetics).

Geriatric Use:

Clinical studies of RETROVIR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

The adverse events reported during intravenous administration of RETROVIR IV Infusion are similar to those reported with oral administration; neutropenia and anemia were reported most frequently. Long-term intravenous administration beyond 2 to 4 weeks has not been studied in adults and may enhance hematologic adverse events. Local reaction, pain, and slight irritation during intravenous administration occur infrequently.

Adults:

The frequency and severity of adverse events associated with the use of RETROVIR are greater in patients with more advanced infection at the time of initiation of therapy.

Table 5 summarizes events reported at a statistically significantly greater incidence for patients receiving RETROVIR orally in a monotherapy study:

Table 5. Percentage (%) of Patients with Adverse Eventsa in Asymptomatic HIV Infection (ACTG 019)
Adverse Event	RETROVIR 500 mg/day (n = 453)	Placebo (n = 428)
Body as a whole
Asthenia	8.6%b	5.8%
Headache	62.5%	52.6%
Malaise	53.2%	44.9%
Gastrointestinal
Anorexia	20.1%	10.5%
Constipation	6.4%b	3.5%
Nausea	51.4%	29.9%
Vomiting	17.2%	9.8%
aReported in ≥5% of study population.
bNot statistically significant versus placebo.

In addition to the adverse events listed in Table 5, other adverse events observed in clinical studies were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, hyperbilirubinemia, insomnia, musculoskeletal pain, myalgia, and neuropathy.

Selected laboratory abnormalities observed during a clinical study of monotherapy with oral RETROVIR are shown in Table 6.

Table 6. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Patients with Asymptomatic HIV Infection (ACTG 019)
Adverse Event	RETROVIR 500 mg/day (n = 453)	Placebo (n = 428)
Anemia (Hgb<8 g/dL)	1.1%	0.2%
Granulocytopenia (<750 cells/mm3)	1.8%	1.6%
Thrombocytopenia (platelets<50,000/mm3)	0%	0.5%
ALT (>5 x ULN)	3.1%	2.6%
AST (>5 x ULN)

Wednesday, September 28, 2016

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Tuesday, September 27, 2016

Ingredient matches for Ramicomp Genericon

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Monday, September 26, 2016

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Friday, September 23, 2016

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Thursday, September 22, 2016

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