Imitrex Injection (Sumatriptan Succinate Injection) - Indications and Dosage

INDICATIONS AND USAGE

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).

DOSAGE AND ADMINISTRATION

The maximum single recommended adult dose of IMITREX Injection is 6 mg injected subcutaneously. 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.

The maximum recommended dose that may be given in 24 hours is two 6-mg injections separated by at least 1 hour. Although the recommended dose is 6 mg, if side effects are dose limiting, then lower doses may be used (see CLINICAL PHARMACOLOGY). In patients receiving MAO inhibitors, decreased doses of sumatriptan should be considered (see WARNINGS and CLINICAL PHARMACOLOGY). In patients receiving doses lower than 6 mg, only the single-dose vial dosage form should be used. An autoinjection device is available for use with 6-mg prefilled syringe cartridges to facilitate self-administration in patients in whom this dose is deemed necessary. 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

HOW SUPPLIED

IMITREX Injection 6 mg (12 mg/mL) containing sumatriptan (base) as the succinate salt is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:

(NDC 0173-0479-00) IMITREX STATdose System^® containing 2 prefilled single-dose syringe cartridges, 1 IMITREX STATdose Pen^® , and instructions for use.

(NDC 0173-0478-00 IMITREX Injection cartridge pack containing 2 prefilled syringe cartridges for refill of IMITREX STATdose System only.

(NDC 0173-0449-02) 6-mg Single-dose vials (0.5 mL in 2 mL) in cartons of 5 vials.

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