Dosing and uses of Maxalt, Maxalt MLT (rizatriptan)
Adult dosage forms and strengths
tablet
- 5mg
- 10mg
tablet, oral disintegrating
- 5mg
- 10mg
Migraine Headache
Acute treatment of migraine with or without aura
5-10 mg PO at onset of symptoms; repeat dose after 2 hours if necessary; not to exceed 30 mg/24 hr
Dosing considerations
- Patients taking propranolol: Limit dose to 5 mg PO and do not exceed 15 mg/24 hr
Pediatric dosage forms and strengths
tablet
- 5mg
- 10mg
tablet, oral disintegrating
- 5mg
- 10mg
Migraine Headache
Acute treatment of migraine with or without aura
<6 years: Safety and efficacy not established
6-17 years (<40 kg): 5 mg PO once q24hr
6-17 years: (40 kg or greater): 10 mg PO once q24hr
Dosing considerations
- Efficacy and safety of treatment with more than 1 dose within 24 hours in pediatric patients has not been established
- 6-17 years (<40 kg) taking propranolol: Do not administer rizatriptan
- 6-17 years (≥40 kg) taking propranolol: Limit dose to 5 mg PO once q24hr as necessary; not to exceed 5 mg/24hr
Maxalt, Maxalt MLT (rizatriptan) adverse (side) effects
>10%
Drowsiness (13-30%, dose related)
Fatigue (13-30%, dose related)
Dizziness (11-15%)
1-10%
Dizziness (4-9%)
Somnolence (4-8%)
Fatigue (4-7%; dose related)
Nausea (4-6%)
Asthenia (1-5%)
Hot flashes (1-5%)
Paresthesia (3-4%)
Dry mouth (3%)
Chest pain (2-3%)
Pain/pressure in chest, neck, throat, jaw (<2%)
Headache (<2%)
Dyspnea (>1%)
Hypoesthesia (>1%)
Palpations (>1%)
Skin flushing (>1%)
<1%
Tachycardia
Angioedema
Wheezing
Hypertensive crisis
Bradycardia
Hallucination
Epidermal necrolysis
Hearing impairment
Arrhythmias
Myocardial infarction and coronary artery vasospasm in patients with CAD risk factors
Warnings
Contraindications
Hypersensitivity
Ischemic heart disease, uncontrolled hypertension, or other significant cardiovascular disease
Coronary artery vasospasm
History of stroke or transient ischemic attack
Ischemic boweL
Peripheral vascular disease
Basilar or hemiplegic migraine
Within 24 hours of another 5-HT1 agonist or ergot derivative
Within 2 weeks of MAOI
Cautions
Use caution in hepatic/renal insufficiency
Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or combination of these drugs for ≥10 days/month) may lead to exacerbation of headache (medication overuse headache)
Potentially life-threatening serotonin syndrome may occur, particularly during combined use with SSRIs (eg, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRIs (eg, venlafaxine, duloxetine)
Coronary artery vasospasm, ventricular tachycardia/fibrillation, cardiac arrest, myocardial infarction, transient ischemia, and death reported with the use of 5-HT1 agonists
Cerebral/subarachnoid hemorrhage and stroke reported with the use of 5-HT1 agonists
Significant hypertension or hypertensive crisis reported in patients with and without history of hypertension
Not for use in the prevention of migraine or the treatment of cluster headaches
Maxalt-MLT tablets contain phenylalanine (not for use in patients with phenylketonuria)
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown; use with caution in breastfeeding
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Maxalt, Maxalt MLT (rizatriptan)
Mechanism of action
Selective 5-HT1 receptor agonist in cranial arteries; causes vasoconstriction and reduces inflammation associated with antidromic neuronal transmission linked to relief of migraine
Absorption
Bioavailability: 45-50%
Onset of action: Within 2 hr
Peak plasma time: 1-1.5 hr
AUC: 30% higher in females than in males
Distribution
Protein bound: 14%
Vd: 110 L (female); 140 L (male)
Metabolism
Metabolized by MAO-O
Metabolites: N-monodesmethyl-rizatriptan
Elimination
Half-life elimination: 2-3 hr
Excretion: Urine (82%); feces (12%)
