A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rebetol Overdose, Contraindications and Information - Ribavirin
Rebetol Overdose, Contraindications and Information - Ribavirin
OVERDOSE
There is limited experience with overdosage. Acute ingestion of up to 20 grams
of REBETOL Capsules, INTRON A ingestion of up to 120 million units, and subcutaneous
doses of INTRON A up to 10 times the recommended doses have been reported. Primary
effects that have been observed are increased incidence and severity of the
adverse events related to the therapeutic use of INTRON A and REBETOL. However,
hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction
have been reported with administration of single subcutaneous doses of INTRON
A that exceed dosing recommendations.
There is no specific antidote for INTRON A or REBETOL, and hemodialysis and
peritoneal dialysis are not effective treatment of overdose of either agent.
CONTRAINDICATIONS
Combination REBETOL/INTRON A therapy must not be used by women who are pregnant
or by men whose female partners are pregnant. Extreme care must be taken to
avoid pregnancy in female patients and in female partners of male patients taking
combination REBETOL/INTRON A therapy. Combination REBETOL/INTRON A therapy should
not be initiated until a report of a negative pregnancy test has been obtained
immediately prior to initiation of therapy. Women of childbearing potential
and men must use two forms of effective contraception during treatment and during
the 6 months after treatment has been concluded. Significant teratogenic and/or
embryocidal effects have been demonstrated for ribavirin in all animal species
in which adequate studies have been conducted. These effects occurred at doses
as low as one twentieth of the recommended human dose of REBETOL Capsules. If
pregnancy occurs in a patient or partner of a patient during treatment or during
the 6 months after treatment stops, physicians are encouraged to report such
cases by calling (800) 727-7064. See boxed CONTRAINDICATIONS
AND WARNINGS . See WARNINGS.
REBETOL Capsules in combination with INTRON A Injection is contraindicated
in patients with a history of hypersensitivity to ribavirin and/or alpha interferon
or any component of the capsule and/or injection.
Patients with autoimmune hepatitis must not be treated with combination REBETOL/INTRON
A therapy.
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