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Sumatriptan (Sumatriptan Succinate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.

Limitations of Use:

  • Use only if a clear diagnosis of migraine or cluster headache has been established.
  • If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks.
  • Sumatriptan is not indicated for the prevention of migraine attacks.

DOSAGE AND ADMINISTRATION

Dosing Information

The maximum single recommended adult dose of sumatriptan injection for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously. For the treatment of migraine, if side effects are dose limiting, lower doses (1 to 5 mg) may be used [see Clinical Studies (14.1)]. For the treatment of cluster headache, the efficacy of lower doses has not been established.

The maximum cumulative dose that may be given in 24 hours is 12 mg, two 6 mg injections separated by at least 1 hour. A second 6 mg dose should only be considered if some response to a first injection was observed.

Administration of Doses of Sumatriptan Injection Other Than 4 or 6 mg

In patients receiving doses other than 4 or 6 mg, use the 6 mg single-dose vial. Visually inspect the vial for particulate matter and discoloration before administration. Do not use if particulates and discolorations are noted.

DOSAGE FORMS AND STRENGTHS

  • Injection: 6 mg single-dose vial

HOW SUPPLIED/STORAGE AND HANDLING

Sumatriptan injection, USP contains sumatriptan (base) as the succinate salt and is supplied as follows:

NDC
Sumatriptan  Injection USP
Package  Factor
76126-072-05
6 mg per 0.5 mL Single-Dose Vial
5 vials per carton

Sumatriptan injection, USP is a clear, colorless to pale yellow solution.

Storage Conditions

Store between 2°C and 30°C (36°F and 86°F). Protect from light.

Protect from light. Retain in carton until time of use. 

Sterile, Nonpyrogenic.

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