Sumatriptan Succinate Prescribing Information
Sumatriptan Succinate Injection
For Subcutaneous Use Only
Sumatriptan succinate injection is a selective 5-hydroxytryptamine receptor subtype 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.
The maximum single recommended adult dose of sumatriptan succinate injection is 6 mg injected subcutaneously. If side effects are dose limiting, then lower doses may be used.
The maximum recommended dose that may be given in 24 hours is two 6 mg injections separated by at least 1 hour. Controlled clinical trials have failed to show that clear benefit is associated with the administration of a second 6 mg dose in patients who have failed to respond to a first injection.
In patients receiving MAO inhibitors, decreased doses of sumatriptan should be considered (see WARNINGS: Concomitant Drug Use and CLINICAL PHARMACOLOGY: Drug Interactions: Monoamine Oxidase Inhibitors).
An autoinjector is available for use with the 6 mg prefilled syringe to facilitate self-administration in patients using the 6 mg dose. With this autoinjector, the needle penetrates approximately 4 to 7 mm. Since the injection is intended to be given subcutaneously, intramuscular or intravascular delivery should be avoided. Patients should be directed to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.
In patients receiving doses other than 6 mg, only the 6 mg single-dose vial dosage form should be used. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
Sumatriptan succinate injection, 6 mg/0.5 mL contains sumatriptan 6 mg (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:
(NDC 47335-276-40) sumatriptan succinate injection autoinjector with 1 prefilled single-dose syringe and instructions for use.
(NDC 47335-276-41) sumatriptan succinate injection autoinjector with 1 prefilled single-dose syringe, two such autoinjectors and instructions for use are packaged in carton.
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
Protect from light.
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Read Patient Information carefully before you start to take sumatriptan succinate injection. Keep the leaflet for reference because it gives you a summary of important information about sumatriptan succinate injection. Read the leaflet that comes with each refill of your prescription because there may be new information. This leaflet does not have all the information about sumatriptan succinate injection. Ask your healthcare provider for more information or advice.
Report Adverse Event or to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088
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