IMITREX Injection is indicated for 1) the acute treatment of migraine attacks with or without aura and 2) the acute treatment of cluster headache episodes.

IMITREX Injection is not for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS).

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.

IMITREX Injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:

(NDC 0173-0739-00) IMITREX STATdose System^Ò , 4 mg, containing 2 prefilled single-dose syringe cartridges, 1 IMITREX STATdose Pen^Ò , and instructions for use.
(NDC 0173-0739-02) Two 4-mg single-dose prefilled syringe cartridges for use with IMITREX STATdose System.
(NDC 0173-0479-00) IMITREX STATdose System, 6 mg, containing 2 prefilled single-dose syringe cartridges, 1 IMITREX STATdose Pen, and instructions for use.
(NDC 0173-0478-00) Two 6-mg single-dose prefilled syringe cartridges for use with IMITREX STATdose System.
(NDC 0173-0449-02) IMITREX Injection single-dose vial (6 mg/0.5 mL) in cartons containing 5 vials.

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