Source: FDA, National Drug Code (US) Revision Year: 2020
IMITREX tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
The recommended dose of IMITREX tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25-mg dose, but doses of 100 mg may not provide a greater effect than the 50-mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14)].
If the migraine has not resolved by 2 hours after taking IMITREX tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24-hour period.
If the migraine returns following an initial treatment with IMITREX (sumatriptan) injection, additional single IMITREX tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.
The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Patients in clinical trials (N=670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N=174) received single oral doses of 140 to 400 mg without serious adverse reactions.
Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.
The elimination half-life of sumatriptan is approximately 2.5 hours [see Clinical Pharmacology (12.3)], and therefore monitoring of patients after overdose with IMITREX tablets should continue for at least 12 hours or while symptoms or signs persist.
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
Store between 2°C and 30°C (36°F and 86°F).
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