RIBAVIRIN- ribavirin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Richmond Pharmaceuticals, 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 combination therapy with peginterferon alfa-2b or interferon alfa-2b: Ribavirin combination therapy is contraindicated in: Pregnancy Category X [See Contraindications (4), Warnings and Precautions (5.1), and Nonclinical Toxicology (13.1) ]. Treatment and Posttreatment Potential Risk to the Fetus Ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. It is not known whether ribavirin contained in sperm will exert a potential teratogenic effect upon fertilization of the ova. In a study in rats, it was concluded that dominant lethality was not induced by ribavirin at doses up to 200 mg/kg for 5 days (estimat

Product summary:

Ribavirin capsules, 200 mg are white, opaque, gelatin capsules printed horizontally with "riba 200" on both the body and the cap of the capsule in edible, green pharmaceutical ink. Ribavirin capsules, 200 mg are packaged in HDPE bottles with child-resistant closures containing 42 capsules (NDC 54738-953-42), 56 capsules (NDC 54738-953-56), 70 capsules (NDC 54738-953-70), 84 capsules (NDC 54738-953-84), and 180 capsules (NDC 54738-953-18). The bottle of ribavirin capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RIBAVIRIN- RIBAVIRIN CAPSULE
Richmond Pharmaceuticals, Inc.
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MEDICATION GUIDE
Ribavirin Capsules
Rx Only
Read this Medication Guide before you start taking ribavirin capsules,
and each time you get a refill.
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.
What is the most important information I should know about ribavirin
capsules?
1.
Do Not take ribavirin capsules alone to treat chronic hepatitis C
infection. Ribavirin capsules should
be used in combination with either interferon alfa-2b (Intron A®1) or
peginterferon alfa-2b
(PegIntron®2) to treat chronic hepatitis C infection.
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. Seek medical
attention right away if you
experience chest pain.
3.
Ribavirin capsules may cause Birth Defects 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 within 6 months after discontinuing ribavirin capsules
therapy. You must use 2 forms of
birth control when you take ribavirin capsules and for the 6 months
after treatment.
○ Females must have a pregnancy test before starting ribavirin
capsules, every month while taking
ribavirin capsules, and every month for the 6 months after the last
dose of ribavirin capsules.
○ If you or your female sexual partner becomes pregnant while taking
ribavirin capsules, tell your
healthcare provider right away. You or your healthcare provider should
contact the Ribavirin
Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy
Registry collects
information about what happens to mothers and their babies if the
mother takes ri

Summary of Product characteristics

RIBAVIRIN- RIBAVIRIN CAPSULE
RICHMOND PHARMACEUTICALS, 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 200 MG
INITIAL U.S. APPROVAL: 1998
WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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RECENT MAJOR CHANGES
Warnings and Precautions (_5.8_) [01/2011]
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_)
DOSAGE AND ADMINISTRATION
Ribavirin is administered according to body weight. (_2.1_, _2.2_)
Dose reduction or discontinuation is recommended in patients
experiencing certain adverse reactions or renal dysfunction
(_2.4_, _2.5_, _12.3_)
DOSAGE FORMS AND STRENGTHS
Ribavirin capsules 200mg (_3_)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Patients exhibiting the following conditions should be closely
monitored and may require dose reduction or discontinuation
of therapy:
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ADVERSE REACTIONS
Hemolytic anemia (_6.1_)
Most common adverse reactions (approximately 40%) in adult patients
receiving ribavirin/peginterferon alfa-2b or
interferon alfa-2b combination therapy are injection site reaction,
fatigue/asthenia, headache, rigors, fevers, nausea,
myalgia and anxiety/emotional lability/irritability. (_6.1_, _6.2_)
RIBAVIRIN MONOTHERAPY IS NOT EFFECTIVE FOR THE TREATMENT OF CHRONIC
HEPATITIS C (_5.10_).
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 CAPSULES
(_2.4_, _5.2_,