Almotriptan Malate
Generic Name: almotriptan malate
Brand Names:
Almotriptan Malate
11 DESCRIPTION Almotriptan malate tablets contain almotriptan malate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Almotriptan malate is chemically designated as 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidine(±)-hydroxybutanedioate (1:1), and its structural formula is: C 17 H 25 N 3 O 2 S-C 4 H 6 O 5 M.W. 469.56 Almotriptan is a white to off white crystalline powder that is soluble in water.
Overview
11 DESCRIPTION Almotriptan malate tablets contain almotriptan malate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Almotriptan malate is chemically designated as 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidine(±)-hydroxybutanedioate (1:1), and its structural formula is: C 17 H 25 N 3 O 2 S-C 4 H 6 O 5 M.W. 469.56 Almotriptan is a white to off white crystalline powder that is soluble in water.
Uses
1 INDICATIONS AND USAGE Almotriptan malate tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for: Acute treatment of migraine attacks in adults with a history of migraine with or without aura ( 1.1 ) Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more ( 1.1 ) Important limitations: Use only after a clear diagnosis of migraine has been established ( 1.2 ) In adolescents age 12 to 17 years, efficacy of almotriptan malate tablets on migraine-associated symptoms was not established ( 1.2 ) Not intended for the prophylactic therapy of migraine ( 1.2 ) Not indicated for the treatment of cluster headache ( 1.2 ) 1.1 Acute Treatment of Migraine Attacks A...
Dosage
2 DOSAGE AND ADMINISTRATION Adults and adolescents age 12 to 17 years: 6.25 mg or 12.5 mg single dose; may repeat after 2 hours if headache returns; benefit of second dose in patients who have failed to respond to first dose has not been established; maximum daily dose 25 mg ( 2.1 ) Patients with hepatic or severe renal impairment: 6.25 mg starting dose; maximum daily dose 12.5 mg ( 2.2 , 2.3 ) 2.1 Acute Treatment of Migraine Attacks The recommended dose of almotriptan malate tablets in adults and adolescents age 12 to 17 years is 6.25 mg to 12.5 mg, with the 12.5 mg dose tending to be a more effective dose in adults. As individuals may vary in their response to different doses of almotriptan malate tablets, the choice of dose should be made on an individual basis.
Side Effects
6 ADVERSE REACTIONS Serious cardiac reactions, including myocardial infarction, have occurred following the use of almotriptan malate tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported in association with triptans have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1 )] .
Interactions
7 DRUG INTERACTIONS Do not use almotriptan malate and ergotamine-containing or ergot-type medications within 24 hours of each other ( 4.5 , 7.1 ) Do not use almotriptan malate and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other ( 4.6 , 7.2 ) SSRI or SNRI: life-threatening serotonin syndrome reported during combined use with triptans ( 5.5 , 7.3 ) Ketoconazole: use single dose of almotriptan malate 6.25 mg; maximum almotriptan malate daily dose 12.5 mg ( 7.4 ) 7.1 Ergot-Containing Drugs These drugs have been reported to cause prolonged vasospastic reactions.
Warnings
5 WARNINGS AND PRECAUTIONS Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm ( 5.1 ) It is strongly recommended that almotriptan malate not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors. In very rare cases, serious cardiovascular events have been reported in association with almotriptan malate use in the absence of known cardiovascular disease. If almotriptan malate is considered, patients should first have a cardiovascular evaluation. 4 CONTRAINDICATIONS Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease ( 4.1 ) Cerebrovascular syndromes (e.g., history of stroke or TIA) ( 4.2 ) Peripheral vascular disease (including ischemic bowel disease) ( 4.3 ) Uncontrolled hypertension ( 4.4 ) Do not use almotriptan malate within 24 hours of an ergotamine-containing, or ergot-type medic...
Pregnancy
8.1 Pregnancy Pregnancy Category C In animal studies, almotriptan produced developmental toxicity (increased embryolethality and fetal skeletal variations, and decreased offspring body weight) at doses greater than those used clinically. There are no adequate and well-controlled studies in pregnant women; therefore, almotriptan malate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Almotriptan malate tablets are available as follows: 6.25 mg: White to off-white, round, convex, film-coated tablets debossed with “93” on one side and “A1” on the other side in boxes of 1 card X 6 tablets (NDC 0093-5260-18).
Frequently Asked Questions
What is Almotriptan Malate used for?▼
1 INDICATIONS AND USAGE Almotriptan malate tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for: Acute treatment of migraine attacks in adults with a history of migraine with or without aura ( 1.1 ) Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more ( 1.1 ) Important limitations: Use only after a clear diagnosis of migraine has been established ( 1.2 ) In adolescents age 12 to 17 years, efficacy of almotriptan malate tablets on migraine-associated symptoms was not established ( 1.2 ) Not intended for the prophylactic therapy of migraine ( 1.2 ) Not indicated for the treatment of cluster headache ( 1.2 ) 1.1 Acute Treatment of Migraine Attacks A...
What are the side effects of Almotriptan Malate?▼
6 ADVERSE REACTIONS Serious cardiac reactions, including myocardial infarction, have occurred following the use of almotriptan malate tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported in association with triptans have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1 )] .
Can I take Almotriptan Malate during pregnancy?▼
8.1 Pregnancy Pregnancy Category C In animal studies, almotriptan produced developmental toxicity (increased embryolethality and fetal skeletal variations, and decreased offspring body weight) at doses greater than those used clinically. There are no adequate and well-controlled studies in pregnant women; therefore, almotriptan malate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
What are the important warnings for Almotriptan Malate?▼
5 WARNINGS AND PRECAUTIONS Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm ( 5.1 ) It is strongly recommended that almotriptan malate not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors. In very rare cases, serious cardiovascular events have been reported in association with almotriptan malate use in the absence of known cardiovascular disease. If almotriptan malate is considered, patients should first have a cardiovascular evaluation. 4 CONTRAINDICATIONS Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease ( 4.1 ) Cerebrovascular syndromes (e.g., history of stroke or TIA) ( 4.2 ) Peripheral vascular disease (including ischemic bowel disease) ( 4.3 ) Uncontrolled hypertension ( 4.4 ) Do not use almotriptan malate within 24 hours of an ergotamine-containing, or ergot-type medic...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.