Uses
Vascular Headaches
Acute treatment of migraine attacks with or without aura.
Not recommended for management of hemiplegic or basilar migraine or for prophylaxis of migraine.
Safety and efficacy not established for management of cluster headaches.
Dosage and Administration
Administration
Oral Administration
Administer orally without regard to meals.
Dosage
Available as almotriptan malate; dosage is expressed in terms of almotriptan.
Adults
Vascular Headaches
Migraine
Oral
6.25 or 12.5 mg as a single dose; individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 12.5-mg dose. In clinical studies, doses >12.5 mg did not lead to substantially greater response.
If headache recurs, dose may be repeated after 2 hours.
Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.
Prescribing Limits
Adults
Vascular Headaches
Migraine
Oral
Maximum 12.5 mg as a single dose; do not exceed 2 doses in any 24-hour period.
Safety of treating an average of >4 headaches per 30-day period has not been established.
Special Populations
Dosage in Hepatic Impairment
Initial dose of 6.25 mg; maximum dosage of 12.5 mg over a 24-hour period.
Dosage in Renal Impairment
Initial dose of 6.25 mg; maximum dosage of 12.5 mg over a 24-hour period.
Geriatric Patients
Cautious dosage selection recommended; generally start at low end of dosing range due to greater frequency of decreased hepatic, renal, or cardiac function and of concomitant illnesses or other drug therapy in geriatric population.
In geriatric patients with normal renal function for their age, dosage is the same as that recommended for younger adults.
Cautions
Contraindications
- Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).
- Coronary artery vasospasm (e.g., Prinzmetal variant angina).
- Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).
- Hemiplegic or basilar migraine.
- Treatment within previous 24 hours with another 5-HT1 receptor agonist or an ergot alkaloid. (See Specific Drugs under Interactions.)
- Known hypersensitivity to almotriptan or any ingredient in the formulation.
Warnings/Precautions
Warnings
Use only in patients in whom a clear diagnosis of migraine has been established.
Cardiac Effects
Possible myocardial ischemia and/or infarction, coronary vasospasm, life-threatening cardiac rhythm disturbances, and death.
Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.
Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.
Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.
Patients with symptoms suggestive of angina after receiving almotriptan should be evaluated for the presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses; if administration is resumed and such signs or symptoms recur, ECG evaluation recommended.
Cerebrovascular Events
Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal.
Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.
Other Cardiovascular or Vasospastic Effects
Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT1 receptor agonists. Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic colitis, Raynaud’s phenomenon) occur following administration.
Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT1 receptor agonists in patients with or without history of hypertension.
Increases in mean pulmonary artery pressure observed following administration of a 5-HT1 receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.
Serotonin Syndrome
Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT1 receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs). Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).
General Precautions
Ocular Effects
Possible accumulation of almotriptan in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.
Specific Populations
Pregnancy
Category C.
Lactation
Distributed into milk in rats; not known whether distributed into milk in humans. Caution advised if almotriptan is used.
Pediatric Use
Safety and efficacy not established in children <18 years of age; use not recommended.
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults. (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Use with caution; dosage adjustment recommended. (See Hepatic Impairment under Dosage and Administration.)
Renal Impairment
Use with caution; dosage adjustment recommended. (See Renal Impairment under Dosage and Administration.)
Common Adverse Effects
Nausea, somnolence, headache, paresthesia, dry mouth.
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