Generic Name
Rizatriptan
Brand Names
Maxalt, Maxalt-Mlt
FDA approval date: June 25, 2012
Classification: Serotonin-1b and Serotonin-1d Receptor Agonist
Form: Tablet
What is Maxalt (Rizatriptan)?
Rizatriptan benzoate orally disintegrating tablets 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 Rizatriptan benzoate orally disintegrating tablets 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 rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks., Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine., Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks., Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache. Rizatriptan benzoate is a serotonin 1B/1D receptor agonist indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age Limitations of Use:, Use only after clear diagnosis of migraine has been established , Not indicated for the prophylactic therapy of migraine , Not indicated for the treatment of cluster headache
Approved To Treat
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Related Clinical Trials
A Comparison of Rimegepant Orally Disintegrating Tablet (Nurtec ODT) to Rizatriptan Benzoate Orally Disintegrating Tablet (Maxalt MLT-ODT) in Adult Patients Presenting to the ED With Migraine Headache: Randomized, Double-Blind, Clinical Trial
Summary: Rimegepant (Nurtec) is an orally administered small molecule CGRP receptor antagonist with efficacy in the acute treatment of migraine. Rizatriptan benzoate (MAXALT), is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan binds with high affinity to human cloned 5-HT1B and 5-HT1D receptors which leads to activation of these receptors results in cranial vessel constrictio...
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Brand Information
MAXALT (rizatriptan benzoate)
1INDICATIONS AND USAGE
MAXALT
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
- MAXALT is not indicated for the prevention of migraine attacks.
- Safety and effectiveness of MAXALT have not been established for cluster headache.
2DOSAGE AND ADMINISTRATION
Although rizatriptan benzoate 5 mg tablets and orally disintegrating tablets are available in the marketplace, MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are no longer marketed in the 5 mg strength.
2.1Dosing Information in Adults
The recommended starting dose of rizatriptan benzoate 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
2.2Dosing 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 rizatriptan benzoate 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 rizatriptan benzoate within 24 hours in pediatric patients 6 to 17 years of age have not been established.
2.3Administration 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.
3CONTRAINDICATIONS
MAXALT is contraindicated in patients with:
- Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease
- Coronary artery vasospasm including Prinzmetal's angina
- History of stroke or transient ischemic attack (TIA)
- Peripheral vascular disease (PVD)
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent use (i.e., within 24 hours) of another 5-HT
- Hemiplegic or basilar migraine
- Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor
- Hypersensitivity to rizatriptan or any of the excipients (angioedema and anaphylaxis seen)
4ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina
- Arrhythmias
- Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure
- Cerebrovascular Events
- Other Vasospasm Reactions
- Medication Overuse Headache
- Serotonin Syndrome
- Increase in Blood Pressure
4.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated include all except those already listed in other sections of the labeling or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of MAXALT in their causation cannot be reliably determined.
Neurological/Psychiatric: Seizure.
General: Allergic conditions including anaphylaxis/anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis [see
Special Senses: Dysgeusia.
5OVERDOSAGE
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. Adverse reactions for 3 of these patients included abdominal discomfort, fatigue, and dyspnea.
In addition, based on the pharmacology of MAXALT, hypertension or myocardial ischemia could occur after overdosage. Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with MAXALT. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
The effects of hemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.
6DESCRIPTION
MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine
Rizatriptan benzoate is described chemically as:
Its empirical formula is C
MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in a strength of 10 mg (corresponding to 14.53 mg of the benzoate salt). 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.
7HOW SUPPLIED/STORAGE AND HANDLING
MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other:
NDC 78206-142-01, carton of 18 tablets.
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. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows:
NDC 78206-143-01, 6 × unit of use carrying case of 3 orally disintegrating tablets (18 tablets total).
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - 10 mg Tablet Pouch Carton
Maxalt®
(rizatriptan benzoate)
10 mg
TABLETS
(rizatriptan benzoate)
10 mg
TABLETS
NDC 78206-142-01
Each tablet contains 14.53 mg of rizatriptan benzoate,
18 Tablets
USUAL DOSAGE:
See accompanying circular.
See accompanying circular.
Rx only
Manuf. by:
10PRINCIPAL DISPLAY PANEL - 10 mg Tablet Case Carton
Maxalt-MLT®
(rizatriptan benzoate)
ORALLY DISINTEGRATING TABLETS
(rizatriptan benzoate)
ORALLY DISINTEGRATING TABLETS
NDC 78206-143-01
Each tablet contains 14.53 mg of rizatriptan benzoate, equivalent to 10 mg rizatriptan.
Phenylketonurics: contains phenylalanine (a component of aspartame)
6 Carrying Cases, Each Containing
USUAL DOSAGE: See accompanying circular.
Rx only
Rx only
Manuf. by: Catalent UK Swindon, Zydis Ltd.
Dist. by: Organon LLC, a subsidiary of
Rizatriptan benzoate (active ingred.) Made in Ireland. Formulated in UK.
