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FDA Labeling Changes
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Sumatriptan injection, USP 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 or cluster headache attack treated with sumatriptan injection, USP, reconsider the diagnosis before sumatriptan injection, USP is administered to treat any subsequent attacks.
- Sumatriptan injection, USP is not indicated for the prevention of migraine or cluster headache attacks.
There is currently no drug history available for this drug.
Sumatriptan injection, USP contains sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:
The molecular formula is C14H21N3O2S•C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white to off-white powder that is readily soluble in water and in saline.
Sumatriptan injection, USP is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection, USP 12 mg/mL solution contains 6 mg of sumatriptan (base) as the succinate salt and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of solution is approximately 4.2 to 5.3. The osmolality of injection is 291 mOsmol.