RIBAVIRIN- ribavirin tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Richmond Pharmaceuticals, Inc.

INN (Medzinárodný Name):

RIBAVIRIN

Zloženie:

RIBAVIRIN 200 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Ribavirin in combination with peginterferon alfa-2a is 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 combination therapy with peginterferon alfa-2a: Ribavirin is contraindicated in: Ribavirin and peginterferon alfa-2a combination therapy is contraindicated in patients with: Teratogenic Effects Pregnancy: Category X [see Contraindications (4)] . Ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. Malformations of the skull, palate, eye, jaw, limbs, skeleton, and gastrointestinal tract were noted. The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced [see Contraindications (4) and Warnings and Precautions (5.1)] . In

Prehľad produktov:

Ribavirin Tablets are available as tablets for oral administration. Each ribavirin 200-mg tablet contains 200 mg of ribavirin, USP and is a capsule-shaped, light blue colored, film-coated tablet, debossed with “200” on one side and the logo “3RP” on the other side. Each ribavirin 400-mg tablet contains 400 mg of ribavirin, USP and is a capsule-shaped, medium blue colored, film-coated tablet, debossed with “400” on one side and the logo “3RP” on the other side. Each ribavirin 600-mg tablet contains 600 mg of ribavirin, USP and is a capsule-shaped, dark blue colored, film-coated tablet, debossed with “600” on one side and the logo “3RP” on the other side. They are packaged as follows: 200 mg    Bottles of 168   NDC 54738-950-16 400 mg    Bottles of 56     NDC 54738-951-56 600 mg    Bottles of 56     NDC 54738-952-56 Storage and Handling Store the Ribavirin Tablets bottle at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

RIBAVIRIN- RIBAVIRIN TABLET, FILM COATED
Richmond Pharmaceuticals, Inc.
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MEDICATION GUIDE
Ribavirin
Tablets
Read this Medication Guide carefully before you start taking ribavirin
and read the Medication Guide
each time you get more ribavirin. 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 PEGASYS1 (peginterferon alfa-2a).
What is the most important information I should know about ribavirin?
•
You should not take ribavirin alone to treat chronic hepatitis C
infection. Ribavirin should be used
with peginterferon alfa-2a to treat chronic hepatitis C infection.
•
Ribavirin 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 may not be right for you.
If you have chest pain while
you take Ribavirin, get emergency medical attention right away.
•
Ribavirin may cause birth defects or death of your unborn baby. If you
are pregnant or your sexual
partner is pregnant, do not take ribavirin. You or your sexual partner
should not become pregnant
while you take ribavirin and for 6 months after treatment is over. You
must use two forms of birth
control when you take ribavirin and for the 6 months after treatment.
1.
Females must have a pregnancy test before starting ribavirin, every
month while treated with
ribavirin, and every month for the 6 months after treatment with
ribavirin.
2.
If you or your female sexual partner becomes pregnant while taking
ribavirin or within 6
months after you stop taking ribavirin, 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 ribavirin while she

Súhrn charakteristických

RIBAVIRIN- RIBAVIRIN TABLET, FILM COATED
RICHMOND PHARMACEUTICALS, INC.
----------
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 RIBAVIRIN-ASSOCIATED EFFECTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.8) 09/2017
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
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
•
CONTRAINDICATIONS
•
•
•
Ribavirin tablets in combination with peginterferon alfa-2a is
contraindicated in patients with:
•
•
WARNINGS AND PRECAUTIONS
•
RIBAVIRIN MONOTHERAPY, INCLUDING RIBAVIRIN TABLETS, 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 TABLETS
(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).
CHC: Ribavirin is administered according to bod