The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions 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. Sixty-one percent of the patients were Caucasian, and fifty-six percent of the patients were female. Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks. Headache response, defined as a reduction of moderate or severe headache pain to no or mild headache pain, was assessed for up to 2 hours (Study 1) or up to 4 hours after dosing (Studies 2, 3 and 4).
All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug. Do not use MAXALT for a condition for which it was not prescribed.
3801 — MAXALT-MLT Orally Disintegrating Tablets, 10 mg, 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.
Limitations of Use • MAXALT should only be used where a clear diagnosis of migraine has been established. Rizatriptan is minimally bound (14%) to plasma proteins.The primary route of rizatriptan metabolism is via oxidative deamination by monoamine oxidase-A (MAO-A) to the indole acetic acid metabolite, which is not active at the 5-HTThe total radioactivity of the administered dose recovered over 120 hours in urine and feces was 82% and 12%, respectively, following a single 10-mg oral administration of The plasma half-life of rizatriptan in males and females averages 2-3 hours.Rizatriptan is not an inhibitor of the activities of human liver cytochrome P450 isoforms 3A4/5, 1A2, 2C9, 2C19, or 2E1; rizatriptan is a competitive inhibitor (KThe efficacy of MAXALT Tablets was established in four multicenter, randomized, placebo-controlled trials. The 5- and 10-mg orally disintegrating tablets contain 1.1 and 2.1 mg phenylalanine, respectively.No overdoses of MAXALT were reported during clinical trials in adults.Some adult patients who received 40 mg of MAXALT either a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence.In a clinical pharmacology study in which 12 adult subjects received MAXALT, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence.In the long-term, open label study, involving 606 treated pediatric migraineurs 12 to 17 years of age (of which 432 were treated for at least 12 months), 151 patients (25%) took two 10-mg doses of MAXALT-MLT within a 24-hour period. Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate.Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor.Rizatriptan binds with high affinity to human cloned 5-HTRizatriptan is completely absorbed following oral administration. The recommended dose of MAXALT is 5 mg in patients weighing less than 40 kg (88 lb), and 10 mg in patients weighing 40 kg (88 lb) 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.For MAXALT-MLT Orally Disintegrating Tablets, administration with liquid is not necessary. 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. A second dose of MAXALT Tablets was allowed 2 to 24 hours after dosing for treatment of recurrent headache in Studies 1 and 2.
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