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
Rebetron Overdose, Contraindications and Information - Ribavirin
Rebetron Overdose, Contraindications and Information - Ribavirin
OVERDOSE
In combination REBETOL/INTRON A clinical trials, the maximum
overdose reported was a dose of 39 million units of INTRON A (13 subcutaneous
injections of 3 million IU each) taken with 10 g of REBETOL (fifty 200-mg capsules)
in an investigator-initiated trial. The patient was observed for 2 days in the
emergency room during which time no adverse event from the overdose was noted.
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 hypersensi-tivity 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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