Drug Information for IMITREX (sumatriptan succinate) InjectionFor Subcutaneous Use Only. (GlaxoSmithKline LLC): DOSAGE AND ADMINISTRATION

The maximum single recommended adult dose of IMITREX Injection is 6 mg injected subcutaneously. If side effects are dose limiting, then lower doses may be used (see Table 1).

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 autoinjection device is available for use with the 4- and 6-mg prefilled syringe cartridges to facilitate self-administration in patients using the 4- or 6-mg dose. With this device, the needle penetrates approximately 1/4 inch (5 to 6 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 4 or 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.