July 30, 2016
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Treximet

"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"...

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Treximet




Indications
Dosage
How Supplied

INDICATIONS

TREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.

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.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].

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.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].

Dosing In Patients With Hepatic Impairment

TREXIMET is contraindicated in patients with severe hepatic impairment [see CONTRAINDICATIONS, Use in Specific Populations, CLINICAL PHARMACOLOGY].

In patients with mild to moderate hepatic impairment, the recommended dosage in a 24-hour period is 1 tablet of TREXIMET 10/60 mg [see Use in Specific Populations, CLINICAL PHARMACOLOGY].

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].

Administration Information

TREXIMET may be administered with or without food. Tablets should not be split, crushed, or chewed.

HOW SUPPLIED

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 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/25/2016

Indications
Dosage
How Supplied

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