"Most of us get headaches from time to time. Some are mild. Others cause throbbing pain. They can last for minutes or days. There are many different types of headaches. How you treat yours depends on which kind you have.
Limitations of Use
- Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with TREXIMET, reconsider the diagnosis of migraine before TREXIMET is administered to treat any subsequent attacks.
- TREXIMET is not indicated for the prevention of migraine attacks.
- Safety and effectiveness of TREXIMET have not been established for cluster headache.
DOSAGE AND ADMINISTRATION
Dosage In Adults
The recommended dosage for adults is 1 tablet of TREXIMET 85/500 mg. TREXIMET 85/500 mg contains a dose of sumatriptan higher than the lowest effective dose. The choice of the dose of sumatriptan, and of the use of a fixed combination such as in TREXIMET 85/500 mg should be made on an individual basis, weighing the possible benefit of a higher dose of sumatriptan with the potential for a greater risk of adverse reactions.
The maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart.
The safety of treating an average of more than 5 migraine headaches in adults in a 30-day period has not been established.
Dosage In Pediatric Patients 12 To 17 Years Of Age
The recommended dosage for pediatric patients 12 to 17 years of age is 1 tablet of TREXIMET 10/60 mg.
The maximum recommended dosage in a 24-hour period is 1 tablet of TREXIMET 85/500 mg.
The safety of treating an average of more than 2 migraine headaches in pediatric patients in a 30-day period has not been established.
Dosing In Patients With Hepatic Impairment
TREXIMET may be administered with or without food. Tablets should not be split, crushed, or chewed.
Dosage Forms And Strengths
10 mg sumatriptan/60 mg naproxen sodium, light-blue film-coated tablets, debossed on one side with “TREXIMET” and the other side with “10-60”.
85 mg sumatriptan/500 mg naproxen sodium, blue film-coated tablets, debossed on one side with “TREXIMET”.
Storage And Handling
TREXIMET 85/500 mg contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium and is supplied as blue film-coated tablets debossed on one side with TREXIMET in bottles of 9 tablets with desiccant (NDC 65224850-09).
TREXIMET 10/60 mg contains 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium and is supplied as light-blue film-coated tablets debossed on one side with TREXIMET and the other side with 10-60 in bottles of 9 tablets with desiccant (NDC 65224-860-09).
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Do not repackage; dispense and store in original container with desiccant.
Pernix Ireland Limited. distributed by Pernix Therapeutics, LLC; Morristown, NJ 07960. Revised: May 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/10/2015
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