"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
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 attack treated with IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks.
- IMITREX is not indicated for the prevention of migraine attacks.
DOSAGE AND ADMINISTRATION
The maximum single recommended adult dose of IMITREX Injection for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously. For the treatment of migraine, if side effects are dose limiting, lower doses (1 to 5 mg) may be used [see Clinical Studies]. For the treatment of cluster headache, the efficacy of lower doses has not been established.
The maximum cumulative dose that may be given in 24 hours is 12 mg, two 6-mg injections separated by at least 1 hour. A second 6-mg dose should only be considered if some response to a first injection was observed.
Administration Using the IMITREX STATdose Pen®
An autoinjector device (IMITREX STATdose Pen) is available for use with 4- and 6-mg prefilled syringe cartridges. With this device, the needle penetrates approximately 1/4 inch (5 to 6 mm). The injection is intended to be given subcutaneously, and intramuscular or intravascular delivery must be avoided. Instruct patients on the proper use of IMITREX STATdose Pen and direct them to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.
Administration of Doses of IMITREX Other Than 4 or 6 mg
In patients receiving doses other than 4 or 6 mg, use the 6-mg single-dose vial; do not use the IMITREX STATdose Pen. Visually inspect the vial for particulate matter and discoloration before administration. Do not use if particulates and discolorations are noted.
Dosage Forms And Strengths
- Injection: 4- and 6-mg single-dose prefilled syringe cartridges for use with the IMITREX STATdose Pen
- Injection: 6-mg single-dose vial
Storage And Handling
IMITREX Injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:
Prefilled Syringe and/or Autoinjector Pen
Each pack contains a PATIENT INFORMATION and Patients Instructions for Use leaflet.
IMITREX STATdose System®, 4 mg, containing 1 IMITREX STATdose Pen, 2 prefilled single-dose syringe cartridges, and 1 carrying case (NDC 0173-0739-00).
IMITREX STATdose System, 6 mg, containing 1 IMITREX STATdose Pen, 2 prefilled single-dose syringe cartridges, and 1 carrying case (NDC 0173-0479-00).
Two 4-mg single-dose prefilled syringe cartridges for use with IMITREX STATdose System (NDC 0173-0739-02).
Two 6-mg single-dose prefilled syringe cartridges for use with IMITREX STATdose System (NDC 0173-0478-00).
IMITREX Injection single-dose vial (6 mg/0.5 mL) in cartons containing 5 vials (NDC 01730449-02).
Store between 2° and 30°C (36° and 86°F). Protect from light.
GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: 09/2012
Last reviewed on RxList: 10/15/2012
This monograph has been modified to include the generic and brand name in many instances.
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