RIBAVIRIN capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

State of Florida DOH Central Pharmacy

INN (International Name):

RIBAVIRIN

Sammensetning:

RIBAVIRIN 200 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ribavirin capsules are indicated in combination with INTRON A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon or in patients 18 years of age and older who have relapsed following alpha interferon therapy. The safety and efficacy of ribavirin capsules with non-pegylated interferons other than the INTRON A product have not been established. Adults with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research-based RT-PCR assay) who were previously untreated with alpha interferon therapy were enrolled into two multi-center, double-blind trials (US and International) and randomized to receive ribavirin capsules 1200 mg/day (1000 mg/day for patients weighing ≤75 kg) plus INTRON A Injection 3 MIU TIW or INTRON A Injection plus placebo for 24 or 48 weeks followed by 24 weeks of off-therapy follow-up. The International stu

Produkt oppsummering:

Ribavirin capsules, 200 mg are white, opaque, hard gelatin capsules imprinted (in blue) RIBAVIRIN over 200 mg on cap and GG 608 on body, and are supplied as follows: NDC 0781-2043-42 in bottles of 42 capsules NDC 0781-2043-16 in bottles of 56 capsules NDC 0781-2043-67 in bottles of 70 capsules NDC 0781-2043-04 in bottles of 84 capsules NDC 0781-2043-01 in bottles of 100 capsules NDC 0781-2043-28 in bottles of 168 capsules NDC 0781-2043-10 in bottles of 1000 capsules NDC 0781-2043-13 in unit dose packages of 100 capsules Dispense in a tight container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Ribavirin capsules, 200 mg are white, opaque, hard gelatin capsules imprinted (in blue) RIBAVIRIN over 200 mg on cap and GG 608 on body. They are supplied by State of Florida DOH Central Pharmacy as follows: Dispense in a tight container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. INTRON A Injection is a clear, colorless solution packaged in single dose and multidose vials, and a multidose pen. INTRON A Injection and the INTRON A Multidose Pen should be stored refrigerated between 2° and 8°C (36° and 46°F). INTRON® A is a registered trademark of Schering Corporation. Mylanta® is a registered trademark of Johnson & Johnson-Merck Consumer Pharmaceuticals Co. REBETOL® is a registered trademark of Schering Corporation. REBETRON® is a registered trademark of Schering Corporation.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

RIBAVIRIN - RIBAVIRIN CAPSULE
State of Florida DOH Central Pharmacy
----------
MEDICATION GUIDE
RIBAVIRIN CAPSULES 200 MG
Read this medication guide carefully before you begin taking ribavirin
capsules, and each time you refill
your prescription in case new information has been included. This
summary does not tell you everything
about ribavirin capsules. Your health care provider is the best source
of information about this medicine.
After reading this medication guide, talk with your health care
provider if you have any questions about
ribavirin.
What is the most important information I should know about therapy
with ribavirin capsules?
•
Ribavirin capsules may cause birth defects or death of an unborn
child. Therefore, if you are
pregnant or your sexual partner is pregnant, do not take ribavirin. If
you could become pregnant,
you must not become pregnant during therapy and for 6 months after you
have stopped therapy.
During this time you must use 2 forms of birth control, and you must
have pregnancy tests that
show that you are not pregnant.
Female sexual partners of male patients being treated with ribavirin
must not become pregnant
during treatment and for 6 months after treatment has stopped.
Therefore, you must use 2 forms of
birth control during this time.
If you or a female sexual partner becomes pregnant, you should tell
your health care provider.
There is a Ribavirin Pregnancy Registry that collects information
about pregnancy outcomes in
female patients and female partners of male patients exposed to
ribavirin. You or your health care
provider are encouraged to contact the Ribavirin Pregnancy Registry at
1-800-593-2214.
Be assured that any information you tell the Registry will be kept
confidential. (See “What should
I avoid while taking ribavirin capsules?”)
•
Ribavirin capsules can cause a dangerous drop in your red blood cell
count. Ribavirin capsules can
cause anemia, which is a decrease in the number of red blood cells.
This can be dangerous,
especially if you have heart or breathing probl

Preparatomtale

RIBAVIRIN - RIBAVIRIN CAPSULE
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
RIBAVIRIN CAPSULES
200 MG
Ribavirin monotherapy is not effective for the treatment of chronic
hepatitis C virus infection
and should not be used alone for this indication. (See WARNINGS).
The primary toxicity of ribavirin is hemolytic anemia. The anemia
associated with ribavirin
therapy may result in worsening of cardiac disease that has lead to
fatal and nonfatal
myocardial infarctions. Patients with a history of significant or
unstable cardiac disease
should not be treated with ribavirin. (See WARNINGS, ADVERSE
REACTIONS, and
DOSAGE AND ADMINISTRATION).
Significant teratogenic and/or embryocidal effects have been
demonstrated in all animal
species exposed to ribavirin. In addition, ribavirin has a
multiple-dose half-life of 12 days, and
so it may persist in nonplasma compartments for as long as 6 months.
Therefore, ribavirin
therapy 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. At least two reliable forms of
effective contraception must
be utilized during treatment and during the 6-month posttreatment
follow-up period. (See
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS: Information for Patients and
Pregnancy Category X).
DESCRIPTION
Ribavirin is a nucleoside analog. The chemical name of ribavirin is
1-β-D-ribofuranosyl-1_H_-1,2,4-
triazole-3-carboxamide and has the following structural formula:
Ribavirin is a white, crystalline powder. It is freely soluble in
water and slightly soluble in anhydrous
alcohol. The empirical formula is C H N O and the molecular weight is
244.21.
Ribavirin capsules consist of white powder in a white, opaque, gelatin
capsule. Each capsule, for oral
administration, contains 200 mg ribavirin. In addition, each capsule
contains the following inactive
ingredient