Dosing Considerations: Adults: pms-SUMATRIPTAN (sumatriptan succinate) is indicated for the acute treatment of migraine headache with or without aura. pms-SUMATRIPTAN should not be used prophylactically. The safety of treating an average of more than four headaches in a 30-day period has not been established. The recommended dose of pms-SUMATRIPTAN should not be exceeded.
In addition to relieving the pain of migraine, sumatriptan has also been shown to be effective in relieving associated symptoms of migraine (nausea, vomiting, phonophobia, photophobia). Sumatriptan is equally effective when administered at any stage of a migraine attack. Long term (12-24 months) clinical studies with maximum recommended doses of sumatriptan indicate that there is no evidence of the development of tachyphylaxis, or medication-induced (rebound) headache.
Geriatrics: No differences have been observed between the pharmacokinetic parameters in healthy elderly volunteers compared with younger volunteers (less than 65 years old).
Pediatrics (patients under 18 years of age): The safety and efficacy of sumatriptan succinate in pediatrics have not been established and its use in this age group is not recommended. (See Use in Children under Precautions.)
Significant relief begins about 30 minutes following oral administration.
Recommended Dose and Dosage Adjustment: The minimal effective single adult dose of pms-SUMATRIPTAN tablets is 25 mg. The maximum recommended single dose is 100 mg. The optimal dose is a single 50 mg tablet. However, depending on individual patient's needs and response to treatment, some patients may require 100 mg. The recommended dose should not be exceeded.
Clinical trials have shown that approximately 50 - 75% of patients have headache relief within two hours after oral dosing with 100 mg, and that a further 15 - 25% have headache relief by 4 hours. Comparator studies have shown similar efficacy rates with the 50 mg and 100 mg tablets. There is evidence that doses of 50 and 100 mg may provide greater effect than 25 mg.
If the migraine headache returns, or if a patient has a partial response to the initial dose, the dose may be repeated after 2 hours. Not more than 200 mg should be taken in any 24-hour period.
If a patient does not respond to the first dose of pms-SUMATRIPTAN tablets, a second dose should not be taken for the same attack, as it is unlikely to be of clinical benefit. pms-SUMATRIPTAN may be taken to treat subsequent migraine attacks.
Special Populations: Adults with Mild to Moderate Hepatic Impairment: In patients with mild or moderate hepatic impairment, plasma sumatriptan concentrations up to two times those seen in healthy subjects have been observed. Therefore, a 25 mg dose (single tablet) may be considered in these patients (Child Pugh grade A or B) (see Hepatic Impairment under Precautions).
Adults with Severe Hepatic Impairment: Oral sumatriptan are contraindicated in patients with severe hepatic impairment (see Contraindications). pms-SUMATRIPTAN is contraindicated in patients with severe hepatic impairment (see Contraindications).
Administration: The tablet should be swallowed whole with water, not crushed, chewed or split.