RIBAVIRIN capsule

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 capsules in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease [see Warnings and Precautions (5.9, 5.10), and Use in Specific Populations (8.4)]. The following points should be considered when initiating ribavirin capsules combination therapy with PegIntron® or INTRON A® : - Combination therapy with ribavirin /PegIntron is preferred over ribavirin /INTRON A as this combination provides substantially better response rates [see Clinical Studies (14) ]. - Patients with the following characteristics are less likely to benefit from retreatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see Clinical Studies (14) ]. - No safety and efficacy data are available for treatment duration lasting longer than

Product summary:

Ribavirin capsules USP, 200 mg are white to off-white granular powder filled in size '0' hard gelatin capsules with white colored cap printed with "ZA-12" in black ink and white colored body printed with "200mg" in black ink and are supplied as follows: NDC 68382-260-04 in bottle of 42 capsules NDC 68382-260-07 in bottle of 56 capsules NDC 68382-260-09 in bottle of 70 capsules NDC 68382-260-12 in bottle of 84 capsules NDC 68382-260-13 in bottle of 140 capsules NDC 68382-260-03 in bottle of 168 capsules NDC 68382-260-28 in bottle of 180 capsules NDC 68382-260-10 in bottle of 1000 capsules NDC 68382-260-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Dispense in a tight container. Storage Conditions: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled  Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Ribavirin (rye" ba vye' rin) Capsules, USP
What is the most important information I should know about ribavirin
capsules?
1.
Ribavirin capsules may cause birth defects, miscarriage or death of
your unborn baby. Do not take
ribavirin capsules if you or your sexual partner is pregnant or plan
to become pregnant. Do not
become pregnant during treatment or within 6 months after stopping
treatment with ribavirin
capsules. You must use effective birth control during treatment with
ribavirin capsules and for 6
months after stopping treatment.
•
Females must have a pregnancy test before starting ribavirin capsules,
during treatment with ribavirin
capsules, and for 6 months after the last dose of ribavirin capsules.
•
If you or your female sexual partner becomes pregnant during treatment
with ribavirin capsules or
within 6 months after you stop taking ribavirin capsules, tell your
healthcare provider right away.
2. Ribavirin capsules may cause a significant drop in your red blood
cell count and cause anemia in some
cases. Anemia has been associated with worsening of heart problems,
and in rare cases can cause a heart
attack and death. Tell your healthcare provider if you have ever had
any heart problems. Ribavirin capsules
may not be right for you. Get medical help right away if you
experience chest pain.
3. Do not take ribavirin capsules alone to treat chronic hepatitis C
infection. Ribavirin capsules should be
used in combination with either interferon alfa-2b or peginterferon
alfa-2b to treat chronic hepatitis C
infection.
What are ribavirin capsules?
Ribavirin capsules are a medicine used with either interferon alfa-2b
or peginterferon alfa-2b to treat chronic
(lasting a long time) hepatitis C infection in people 3 years and
older with liver disease.
It is not known if ribavirin capsules use for longer than 1 year is
safe and will work.
It is not known if ribavirin capsules use in children younger than 3
years old is safe and will work.
Who should not take

Summary of Product characteristics

RIBAVIRIN - RIBAVIRIN CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIBAVIRIN CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RIBAVIRIN
CAPSULES.
RIBAVIRIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: EMBRYO-FETAL TOXICITY, HEMOLYTIC ANEMIA, AND MONOTHERAPY NOT
RECOMMENDED
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SIGNIFICANT TERATOGENIC AND EMBRYOCIDAL EFFECTS HAVE BEEN DEMONSTRATED
IN ALL
ANIMAL SPECIES EXPOSED TO RIBAVIRIN. THEREFORE, RIBAVIRIN THERAPY IS
CONTRAINDICATED
IN WOMEN WHO ARE PREGNANT AND IN THE MALE PARTNERS OF WOMEN WHO ARE
PREGNANT.
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, 8.3,13.1).
THE HEMOLYTIC ANEMIA ASSOCIATED WITH RIBAVIRIN THERAPY MAY RESULT IN
WORSENING OF
CARDIAC DISEASE THAT HAS LED TO FATAL AND NONFATAL MYOCARDIAL
INFARCTIONS. PATIENTS
WITH A HISTORY OF SIGNIFICANT OR UNSTABLE CARDIAC DISEASE SHOULD NOT
BE TREATED WITH
RIBAVIRIN. (2.5, 5.2,6.1)
RIBAVIRIN MONOTHERAPY IS NOT EFFECTIVE FOR THE TREATMENT OF CHRONIC
HEPATITIS C.
(5.10)
INDICATIONS AND USAGE
Ribavirin is a nucleoside analogue indicated in combination with
interferon alfa- 2b (pegylated and
nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in
patients 3 years of age or older with
compensated liver disease. (1.1)
Patients with the following characteristics are less likely to benefit
from re-treatment after failing a course
of therapy: previous nonresponse, previous pegylated interferon
treatment, significant bridging fibrosis or
cirrhosis, and genotype 1 infection.
DOSAGE AND ADMINISTRATION
Ribavirin capsules are administered according to body weight. (2.1,
2.2, 2.3)
Dose reduction or discontinuation is recommended in patients
experiencing certain adverse reactions or
renal dysfunction. (2.5, 2.6, 12.3)
DOSA