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Rebetol

Generic Name: ribavirin (Oral route)

rye-ba-VYE-rin

Inhalation, oral/nebulization routePowder for Solution

INHALATION
- Use of aerosolized ribavirin in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with the specific ventilator being used and this mode of administration of the drug. Strict attention must be paid to procedures that have been shown to minimize the accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressures.
- Sudden deterioration of respiratory function has been associated with initiation of aerosolized ribavirin use in infants. Respiratory function should be carefully monitored during treatment. If initiation of aerosolized ribavirin treatment appears to produce sudden deterioration of respiratory function, treatment should be stopped and reinstituted only with extreme caution, continuous monitoring and consideration of concomitant administration of bronchodilators.
- Ribavirin is not indicated for use in adults. Physicians and patients should be aware that ribavirin has been shown to produce testicular lesions in rodents and to be teratogenic in all animal species in which adequate studies have been conducted (rodents and rabbits) .

Use caution when administering aerosolized ribavirin to patients requiring mechanical ventilator assistance. Sudden deterioration of respiratory function has been associated with initiation of aerosolized ribavirin use in infants. Monitor respiratory function during treatment. Ribavirin is not indicated for use in adults. Ribavirin has been shown to produce testicular lesions in rodents and to be teratogenic in all animal species in which adequate studies have been conducted (rodents and rabbits) .

Oral routeTabletCapsuleSolution

ORAL
- Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.
- The primary toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin.
- Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has multiple-dose half-life of 12 days, and so it may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period .

Ribavirin is not effective for monotherapy treatment of chronic hepatitis C virus infection. The primary toxicity is hemolytic anemia which may result in worsening of cardiac disease and fatal and nonfatal myocardial infarctions. Avoid use in patients with significant or unstable cardiac disease. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Ribavirin is contraindicated in women who are pregnant and in male partners of women who are pregnant. Use 2 reliable forms of contraception and avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin .

Commonly used brand name(s):

In the U.S.

Copegus
Rebetol
RibaPak
Ribasphere
RibaTab

Available Dosage Forms:

Tablet
Capsule
Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Viral RNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

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Uses For Rebetol

Ribavirin is used in combination with injectable interferon alfa-2b, peginterferon alfa-2a, or peginterferon alfa-2b to treat chronic hepatitis C infection. The combination treatment of ribavirin and peginterferon alfa-2b is use to treat adults and children 3 years of age and older who show symptoms of liver damage.

This medicine is available only with your doctor's prescription.

Before Using Rebetol

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 ribavirin tablets in the pediatric population. Appropriate studies have also not been performed on the relationship of age to the effects of ribavirin capsules in children below 5 years of age, and oral solution in children below 3 years of age. Safety and efficacy of ribavirin tablets, capsules, and oral solution have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ribavirin 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 ribavirin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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

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.

Didanosine

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.

Abacavir
Azathioprine
Lamivudine
Stavudine
Zalcitabine
Zidovudine

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.

Interferon Alfa-2b

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 ribavirin

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

To help clear up your infection completely, ribavirin must be given for the full time of treatment, even if you or your child begins to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, ribavirin must be given on a regular or continuous schedule.

You should take the oral tablets with food.

You may take the oral capsules and oral solution with or without food, but after you choose, you should always take these forms the same way every day.

Swallow the capsule whole. Do not crush, break, or open it.

Measure the oral solution with a marked measuring cup or spoon. Wash the cup or spoon after each use.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

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 hepatitis C virus infection, in combination with interferon alfa-2b:
- For oral dosage form (capsules):
  - Adults—1000 to 1200 milligrams (mg) per day, two or three capsules in the morning and three capsules at night. The dose is based on body weight and must be determined by your doctor.
  - Children 5 years of age and older—The dose is based on body weight and must be determined by your doctor.
  - Children below 5 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (solution):
  - Adults—The dose is based on body weight and must be determined by your doctor. The oral solution form of this medicine is not usually prescribed for adults and teenagers.
  - Children 3 years of age and older—The dose is based on body weight and must be determined by your doctor.
  - Children below 3 years of age—Use and dose must be determined by your doctor.
For hepatitis C virus infection, in combination with peginterferon alfa-2b:
- For oral dosage form (capsules):
  - Adults—800 milligrams (mg) per day, two capsules in the morning and two capsules at night. Your doctor may adjust your dose if needed. The dose is based on body weight and must be determined by your doctor.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (solution):
  - Adults—The dose is based on body weight and must be determined by your doctor. The oral solution form of this medicine is not usually prescribed for adults and teenagers.
  - Children—Use and dose must be determined by your doctor.
For hepatitic C virus infection, in combination with peginterferon alfa-2a:
- For oral dosage form (tablets):
  - Adults—800 to 1200 milligrams (mg) daily, divided into two doses (once in the morning and once at night). The dose is based on body weight and must be determined by your doctor.
  - Children—Use and dose must be determined by your doctor.

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 Rebetol

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away. Do not breastfeed while you are using this medicine.

A negative pregnancy test is needed in women who are of childbearing age before starting treatment with this medicine. Two forms of birth control must be used during treatment and for six months after treatment ends. You will need to have pregnancy tests done regularly to make sure you are not pregnant while being treated with this medicine and after your treatment ends.

Ribavirin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Check with your doctor right away if you are having back, leg, or stomach pains; bleeding gums; chills; dark urine; difficulty breathing; fatigue; fever; general body swelling; headache; loss of appetite; nausea or vomiting; nosebleeds; pale skin; sore throat; or yellowing of the eyes or skin. These could be symptoms of a blood disorder called anemia.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

You should not drink alcoholic beverages while you are taking this medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, operate machinery, or do anything else that could be dangerous if you are not alert.

This medicine may cause teeth and gum problems. This medicine may cause dryness of the mouth, and a dry mouth may damage your teeth and gums if you take the medicine for a long time. To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.

Some patients who have used this medicine have had vomiting. If you vomit during your treatment, rinse your mouth out with water. This may also help prevent damage to your teeth and gums.

This medicine when used together with injectable peginterferon alfa-2b may affect your child's growth. Your doctor may need to check your child's height and weight during and after treatment with these medicines.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Rebetol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

Anxiety
black, tarry stools
body aches or pain
chest pain
congestion
cough or hoarseness
crying
depersonalization
diarrhea
difficult or labored breathing
discouragement
dry mouth
dryness of the throat
dysphoria
euphoria
feeling sad or empty
feeling unusually cold
fever or chills
general feeling of discomfort or illness
headache
hyperventilation
irregular heartbeats
irritability
joint pain
lack of appetite
loss of interest or pleasure
lower back or side pain
mental depression
muscle aches and pains
nausea
nervousness
painful or difficult urination
pale skin
paranoia
poor concentration
quick to react or overreact emotionally
rapidly changing moods
restlessness
right upper abdominal pain
runny nose
shaking
shivering
shortness of breath
sleeplessness
sore throat
sores, ulcers, or white spots on the lips or in the mouth
sweating
tender, swollen glands in the neck
tightness in the chest
trouble with concentrating
trouble with sleeping
trouble with swallowing
troubled breathing with exertion
unable to sleep
unusual bleeding or bruising
unusual tiredness or weakness
voice changes
vomiting
wheezing

Less common

Bleeding gums
blood in the urine or stools
constipation
depressed mood
dry skin and hair
feeling cold
hair loss
husky voice
muscle cramps and stiffness
pinpoint red spots on the skin
right upper abdominal fullness
slowed heartbeat
weight gain

Incidence not known

Blistering, flaking, or peeling of the skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach cramps
confusion
convulsions
drowsiness
irregular heartbeats
mood or mental changes
muscle cramps in the hands, arms, feet, legs, or face
muscle spasms (tetany) or twitching
numbness and tingling around the mouth, fingertips, or feet
seizures
tremor

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

Acid or sour stomach
being forgetful
belching
blurred vision
bone pain
change in taste or bad, unusual, or unpleasant (after) taste
cracked, scaly skin
crusting, irritation, itching, or reddening of skin
difficulty with moving
dizziness or lightheadedness
feeling of constant movement of self or surroundings
hair loss or thinning of the hair
heartburn
indigestion
lack or loss of strength
menstrual changes
pain or tenderness around the eyes and cheekbones
rash
sensation of spinning
sneezing
stomach discomfort, upset, or pain
stuffy nose
swelling
swollen joints
weight loss

Less common

Back pain
burning, dry, or itching eyes
discharge, excessive tearing
feeling of warmth
redness of the face, neck, arms, and occasionally, upper chest
redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
skin rash, encrusted, scaly and oozing

Incidence not known

Change in hearing
loss of hearing

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

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