Relpax (Eletriptan Hydrobromide) - Indications and Dosage

INDICATIONS AND USAGE

RELPAX is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

• Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks.
• RELPAX is not intended for the prevention of migraine attacks.
• Safety and effectiveness of RELPAX have not been established for cluster headache.

DOSAGE AND ADMINISTRATION

The maximum recommended single dose is 40 mg.

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].

If the migraine has not resolved by 2 hours after taking RELPAX, or returns after transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose should not exceed 80 mg.

The safety of treating an average of more than 3 migraine attacks in a 30-day period has not been established.

DOSAGE FORMS AND STRENGTHS

20 mg Tablets: Orange, round, convex shaped, film-coated, with "PFIZER" and "REP20" debossed.

40 mg Tablets: Orange, round, convex shaped, film-coated, with "PFIZER" and "REP40" debossed.

HOW SUPPLIED/STORAGE AND HANDLING

RELPAX Tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. RELPAX Tablets are orange, round, convex shaped, film-coated tablets with appropriate debossing.

They are supplied in the following strengths and package configurations:

Relpax Tablets

Package Configuration	Tablet Strength (mg)	NDC Code	Debossing
Carton of 12 tablets. Two blisters of 6 tablets in each carton.	40 mg	0049-2340-05	REP40 and Pfizer
Blister of 6 tablets	20 mg	0049-2330-45	REP20 and Pfizer
Blister of 6 tablets	40 mg	0049-2340-45	REP40 and Pfizer

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].