RIBAVIRIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K)

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

RIBAVIRIN

Composition:

RIBAVIRIN 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. The following points should be considered when initiating ribavirin tablets combination therapy with peginterferon alfa-2a: - This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm3 . - This indication is based on achieving undetectable HCV RNA after treatment for 24 or 48 weeks, based on HCV genotype, and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose. - Safety and efficacy data are not available for treatment longer than 48 weeks. - The safe

Product summary:

Ribavirin Tablets, 200 mg are light pink to pink, round, biconvex, beveled, film-coated tablets debossed with the logo of 'ZC19' on one side, other side plain and supplied as follows: NDC 68382-046-03 in bottle of 168 tablets NDC 68382-046-28 in bottle of 180 tablets NDC 68382-046-10 in bottle of 1000 tablets NDC 68382-046-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Ribavirin Tablets, 400 mg are light pink to pink, capsule shaped, biconvex, film-coated tablets debossed with 'ZD' and '07' on one side and plain on other side and supplied as follows: NDC 68382-127-17 in bottle of 28 tablets NDC 68382-127-07 in bottle of 56 tablets NDC 68382-127-14 in bottle of 60 tablets Ribavirin Tablets, 500 mg are light pink to pink, modified capsule shaped, biconvex, film-coated tablets debossed with 'ZC56' on one side and plain on the other side and supplied as follows: NDC 68382-128-17 in bottle of 28 tablets NDC 68382-128-07 in bottle of 56 tablets NDC 68382-128-14 in bottle of 60 tablets Ribavirin Tablets, 600 mg are light pink to pink, modified capsule shaped, biconvex, film-coated tablets debossed with 'ZD' and '08' on one side and plain on other side and supplied as follows: NDC 68382-129-17 in bottle of 28 tablets NDC 68382-129-07 in bottle of 56 tablets NDC 68382-129-14 in bottle of 60 tablets Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Ribavirin (rye" ba vye' rin) Tablets
Read this Medication Guide carefully before you start taking ribavirin
tablets and read the Medication Guide
each time you get more ribavirin tablets. There may be new
information. This information does not take the
place of talking to your healthcare provider about your medical
condition or your treatment.
Also read the Medication Guide for peginterferon alfa-2a.
What is the most important information I should know about ribavirin
tablets?
1.
You should not take ribavirin tablets alone to treat chronic hepatitis
C infection. Ribavirin tablets
should be used with peginterferon alfa-2a to treat chronic hepatitis C
infection.
2.
Ribavirin tablets may cause you to have a blood problem (hemolytic
anemia) that can worsen any
heart problems you have, and cause you to have a heart attack or die.
Tell your healthcare provider if
you have ever had any heart problems. Ribavirin tablets may not be
right for you. If you have chest
pain while you take ribavirin tablets, get emergency medical attention
right away.
3.
Ribavirin tablets may cause birth defects or death of your unborn
baby. If you are pregnant or your
sexual partner is pregnant, do not take ribavirin tablets. You or your
sexual partner should not become
pregnant while you take ribavirin tablets and for 6 months after
treatment is over. You must use two
forms of birth control when you take ribavirin tablets and for the 6
months after treatment.
•
Females must have a pregnancy test before starting ribavirin tablets,
every month while treated with
ribavirin tablets, and every month for the 6 months after treatment
with ribavirin tablets.
•
If you or your female sexual partner becomes pregnant while taking
ribavirin tablets or within 6
months after you stop taking ribavirin tablets, tell your healthcare
provider right away.
What are ribavirin tablets?
Ribavirin tablets are a prescription medicine used with another
medicine called peginterferon alfa-2a to treat
chronic

Summary of Product characteristics

RIBAVIRIN - RIBAVIRIN TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIBAVIRIN TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RIBAVIRIN
TABLETS.
RIBAVIRIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRINASSOCIATED EFFECTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
RIBAVIRIN MONOTHERAPY, INCLUDING RIBAVIRIN, IS NOT EFFECTIVE FOR THE
TREATMENT OF
CHRONIC HEPATITIS C VIRUS INFECTION (BOXED WARNING).
THE HEMOLYTIC ANEMIA ASSOCIATED WITH RIBAVIRIN THERAPY MAY RESULT IN
WORSENING OF
CARDIAC DISEASE AND LEAD TO FATAL AND NONFATAL MYOCARDIAL INFARCTIONS.
PATIENTS WITH
A HISTORY OF SIGNIFICANT OR UNSTABLE CARDIAC DISEASE SHOULD NOT BE
TREATED WITH
RIBAVIRIN (2.3, 5.2, 6.1).
SIGNIFICANT TERATOGENIC AND EMBRYOCIDAL EFFECTS HAVE BEEN DEMONSTRATED
IN ALL
ANIMAL SPECIES EXPOSED TO RIBAVIRIN. THEREFORE, RIBAVIRIN IS
CONTRAINDICATED IN WOMEN
WHO ARE PREGNANT AND IN THE 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 (4, 5.1, 8.1).
INDICATIONS AND USAGE
Ribavirin is a nucleoside analogue indicated for the treatment of
chronic hepatitis C (CHC) virus infection in
combination with peginterferon alfa-2a in patients 5 years of age and
older with compensated liver disease
not previously treated with interferon alpha, and in adult CHC
patients coinfected with HIV (1)
DOSAGE AND ADMINISTRATION
CHC: Ribavirin is administered according to body weight and genotype
(2.1)
CHC with HIV coinfection: 800 mg by mouth daily for a total of 48
weeks, regardless of genotype (2.2)
Dose reduction or discontinuation is recommended in patients
experiencing certain adverse reactions
or renal impairment (2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
Ribavirin tab