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Maxalt

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Maxalt

Maxalt

INDICATIONS

MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.

Limitations of Use

  • MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks.
  • MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS].
  • MAXALT is not indicated for the prevention of migraine attacks.
  • Safety and effectiveness of MAXALT have not been established for cluster headache.

DOSAGE AND ADMINISTRATION

Dosing Information in Adults

The recommended starting dose of MAXALT is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions [see Clinical Studies].

Redosing in Adults

Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.

Dosing Information in Pediatric Patients (Age 6 to 17 Years)

Dosing in pediatric patients is based on the patient's body weight. The recommended dose of MAXALT is 5 mg in patients weighing less than 40 kg (88 Ib), and 10 mg in patients weighing 40 kg (88 Ib) or more.

The efficacy and safety of treatment with more than one dose of MAXALT within 24 hours in pediatric patients 6 to 17 years of age have not been established.

Administration of MAXALT-MLT Orally Disintegrating Tablets

For MAXALT-MLT Orally Disintegrating Tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister within an outer aluminum pouch and patients should not remove the blister from the outer pouch until just prior to dosing. The blister pack should then be peeled open with dry hands and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.

Dosage Adjustment for Patients on Propranolol

Adult Patients

In adult patients taking propranolol, only the 5-mg dose of MAXALT is recommended, up to a maximum of 3 doses in any 24-hour period (15mg) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Pediatric Patients

For pediatric patients weighing ≥ 40 kg (88 Ib) taking propranolol, only a single 5-mg dose of MAXALT is recommended (maximum dose of 5 mg in a 24-hour period). MAXALT should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg (88 Ib) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms and Strengths

MAXALT Tablets
  • 5 mg tablets are pale pink, capsule-shaped, compressed tablets coded MRK on one side and 266 on the other.
  • 10 mg tablets are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other.
MAXALT-MLT Orally Disintegrating Tablets
  • 5 mg orally disintegrating tablets are white to off-white, round lyophilized tablets debossed with a modified triangle on one side.
  • 10 mg orally disintegrating tablets are white to off-white, round lyophilized tablets debossed with a modified square on one side.

No. 3732 — MAXALT Tablets, 5 mg, are pale pink, capsule-shaped, compressed tablets coded MRK on one side and 266 on the other:

NDC 0006-0266-18, carton of 18 tablets.

No. 3733— MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other:

NDC 0006-0267-18, carton of 18 tablets.

No. 3800 — MAXALT-MLT Orally Disintegrating Tablets, 5 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified triangle on one side, and measuring 10.0-11.5 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows:

NDC 0006-3800-18, 6 x unit of use carrying case of 3 orally disintegrating tablets (18 tablets total).

No. 3801— MAXALT-MLT Orally Disintegrating Tablets, 10mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows:

NDC 0006-3801-18, 6 x unit of use carrying case of 3 orally disintegrating tablets (18 tablets total).

Storage

Store MAXALT Tablets at room temperature, 15-30°C (59-86T).

Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15-30°C (59-86T).

MAXALT Tablets are manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK&CO.,INC,Whitehouse Station, NJ 08889, USA. By: MSD, Ltd. Cramlington, Northumberland, NE23 3JU, UK. MAXALT-MLT Orally Disintegrating Tablets are manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK&CO.,INC,Whitehouse Station, NJ 08889, USA By: Catalent UK Swindon, Zydis Ltd. Swindon, Wiltshire, SN5 8RU, UK. Revised: 12/2011

Last reviewed on RxList: 1/5/2012
This monograph has been modified to include the generic and brand name in many instances.

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