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
Relpax Indications, Dosage, Storage, Stability - Eletriptan hydrobromide
Relpax Indications, Dosage, Storage, Stability - Eletriptan hydrobromide
INDICATIONS AND USAGE
RELPAX is indicated for the acute treatment of migraine with
or without aura in adults. RELPAX is not intended for the prophylactic therapy
of migraine or for use in the management of hemiplegic or basilar migraine (see
CONTRAINDICATIONS). Safety and effectiveness
of RELPAX Tablets have not been established for cluster headache, which is present
in an older, predominantly male population.
DOSAGE AND ADMINISTRATION
In controlled clinical trials, single doses of 20 mg and 40
mg were effective for the acute treatment of migraine in adults. A greater proportion
of patients had a response following a 40 mg dose than following a 20 mg dose
(see CLINICAL STUDIES). Individuals may vary in
response to doses of RELPAX Tablets. The choice of dose should therefore be
made on an individual basis. An 80 mg dose, although
also effective, was associated with an increased incidence of adverse events.
Therefore, the maximum recommended single dose is 40 mg. If after the initial
dose, headache improves but then returns, a repeat dose may be beneficial. If
a second dose is required, it should be taken at least 2 hours after the initial
dose. If the initial dose is ineffective, controlled clinical trials have not
shown a benefit of a second dose to treat the same attack. The maximum daily
dose should not exceed 80 mg. The safety of treating an average of more than
3 headaches in a 30-day period has not been established.
CYP3A4 Inhibitors: Eletriptan is metabolized by the
CYP3A4 enzyme. Eletriptan should not be used within at least 72 hours of treatment
with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone,
troleandomycin, clarithromycin, ritonavir and nelfinavir. Eletriptan should
not be used within 72 hours with drugs that have demonstrated potent CYP3A4
inhibition and have this potent effect described in the CONTRAINDICATIONS, WARNINGS
or PRECAUTIONS sections of their labeling (see WARNINGS
and CLINICAL PHARMACOLOGY: Drug Interactions).
Hepatic Impairment: The drug should not be given to
patients with severe hepatic impairment since the effect of severe hepatic impairment
on eletriptan metabolism was not evaluated. No dose adjustment is necessary
in mild to moderate impairment (see CLINICAL PHARMACOLOGY,
CONTRAINDICATIONS and PRECAUTIONS).
HOW SUPPLIED
RELPAX® Tablets of 20 mg and 40 mg eletriptan
(base) as the hydrobromide. RELPAX Tablets are orange, round, convex shaped,
film-coated tablets with appropriate debossing. 20 mg Tablets are identified
with "REP20" on one side and "Pfizer" on the reverse. They
are supplied in displays containing 2 folded blister cards with 6 tablets on
each card (NDC 0049-2330-34). 40 mg Tablets are identified with "REP40"
on one side and "Pfizer" on the reverse. They are supplied in displays
containing 2 folded blister cards with 6 tablets on each card (NDC 0049-2340-34).
Store at 25°C (77°F);
excursions permitted to 15-30°C (59-86°F)
[see USP Controlled Room Temperature].
Updated on July 29, 2003
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