Almotriptan Malate (almotriptan malate)

Available as almotriptan malate; dosage is expressed in terms of almotriptan.

Almotriptan is available in a tablet formulation for oral administration.

Almotriptan can be administered without regard to meals.

Tablets should be stored at 25degreesC with excursions permitted between 15-30degreesC.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

5-Ht1d Agonists/Ergot Alkaloids

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: The 5-HT1D agonists and ergot alkaloids can produce vasospastic reactions.

CLINICAL EFFECTS: Concurrent therapy may produce additive vasospastic effects.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer states that sumatriptan should not be used within 24 hours of an ergotamine-containing or ergotamine-like medication (such as dihydroergotamine or methysergide).(1,2) The Australian(3) and UK(4,5) manufacturers state that 24 hours should elapse before sumatriptan is administered following an ergotamine-containing preparation and 6 hours should elapse before an ergotamine-containing preparation is administered following sumatriptan. The US manufacturer states that zolmitriptan should not be used within 24 hours of an ergotamine-containing or ergotamine-like medication.(6) The UK manufacturer states that zolmitriptan should not be used within 6 hours of an ergotamine-containing or ergotamine-like medication.(7) The The Australian manufacturer states that 24 hours should elapse before zolmitriptan is administered following an ergotamine-containing preparation and 6 hours should elapse before an ergotamine-containing medication is administered following zolmitriptan.(8) The US manufacturer states that the use of rizatriptan within 24 hours of an ergotamine-containing or ergot-type medication is contraindicated.(9) The US manufacturer states that the use of naratriptan within 24 hours of an ergotamine-containing or ergot-type medication is contraindicated.(10) The Australian manufacturer states that concurrent use of naratriptan and ergotamine or ergotamine derivatives is not recommended.(11) The US manufacturer states that the use of eletriptan within 24 hours of an ergotamine-containing or ergot-type medication is contraindicated.(12) The UK manufacturer states that the use of eletriptan within 24 hours of an ergotamine-containing or ergot-type medication is not recommended.(13)

DISCUSSION: Because of the theoretical risk of additive vasospastic effects, the US manufacturer states that the use of sumatriptan within 24 hours of an ergotamine-containing or ergotamine-like medication is contraindicated.(1,2) The Australian(3) and UK(4,5) manufacturer states that 24 hours should elapse before sumatriptan is administered following an ergotamine-containing preparation and 6 hours should elapse before an ergotamine-containing medication is administered following sumatriptan. Although the pharmacokinetics of zolmitriptan were not affected by ergotamine, the UK manufacturer of zolmitriptan recommends that 6 hours should elapse between the administration of zolmitriptan and an ergotamine preparation.(7) The US manufacturer of zolmitriptan states under contraindications that zolmitriptan should not be used within 24 hours of an ergotamine-containing or ergot-type medication.(6) The Australian manufacturer states that 24 hours should elapse before zolmitriptan is administered following an ergotamine-containing preparation and 6 hours should elapse before an ergotamine-containing medication is administered following zolmitriptan.(8) Because of the additive risk of prolonged vasospastic reactions, the manufacturers of rizatriptan(9) and naratriptan(10) in the US state that the use of ergotamine-containing or ergot-type medications and these agents is contraindicated. The Australian manufacturer states that concurrent use of naratriptan and ergotamine or ergotamine derivatives is not recommended.(11) Administration of oral ergotamine one and two hours after eletriptan resulted in additive increases in blood pressure.(13)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia), coronary artery vasospasm (e.g., Prinzmetal variant angina), uncontrolled hypertension, or other serious underlying cardiovascular disease.

*Cerebrovascular syndromes (e.g., stroke of any type, transient ischemic attack), peripheral vascular disease, or ischemic bowel disease.

*Hemiplegic or basilar migraine.

*Recent (i.e., 24 hours or less) treatment with another 5-HT1 receptor agonist or an ergotamine-containing or ergot-type drug.

*Known hypersensitivity to almotriptan or any ingredient in the formulation.

• Acute myocardial infarction
• Angina
• Cerebral ischemia
• Cerebrovascular accident
• Coronary artery disease
• Hemiplegic migraine
• Ischemic bowel disease
• Myocardial ischemia
• Peripheral vascular disease
• Prinzmetal angina
• Serotonin syndrome
• Severe uncontrolled hypertension

• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Disease of liver
• Familial history of ischemic heart disease
• Tachyarrhythmia

• Kidney disease with likely reduction in glomerular filtration rate (GFr)
• Raynaud's phenomenon

The most common adverse reactions (>=1% and greater than placebo) in adults include nausea, dry mouth, and paresthesia.

The most common adverse reactions (>=1% and greater than placebo) in adolescents include dizziness, somnolence, headache, paresthesia, nausea, and vomiting.

Less Frequent

• Allergic dermatitis
• Chest pain
• Conjunctivitis
• Dyspnea
• Erythema
• Laryngismus
• Neck pain
• Ocular irritation
• Palpitations
• Pruritus of skin
• Skin rash
• Tachycardia

Rare or Very Rare

• Acute bacterial otitis media
• Acute myocardial infarction
• Anaphylaxis
• Angina
• Angioedema
• Cerebrovascular accident
• Colitis
• Coronary artery spasm
• Fever
• Gastritis
• Gastroenteritis
• Gastroesophageal reflux disease
• Hemiplegia
• Hypertension
• Hyperventilation
• Ischemic bowel disease
• Myocardial ischemia
• Ocular pain
• Scotomata
• Seizure disorder
• Serotonin syndrome
• Syncope
• Tongue swelling
• Ventricular fibrillation

More Frequent

• Dizziness
• Drowsy
• Headache disorder
• Nausea
• Paresthesia
• Xerostomia

Less Frequent

• Abdominal pain with cramps
• Back pain
• Bronchitis
• Chills
• Diarrhea
• Dysgeusia
• Dysmenorrhea
• Dyspepsia
• Earache
• Epistaxis
• Fatigue
• General weakness
• Hyperacusis
• Hyperhidrosis
• Insomnia
• Medication overuse headache
• Muscle weakness
• Myalgia
• Nervousness
• Pharyngitis
• Rhinitis
• Sinusitis
• Symptoms of anxiety
• Tremor
• Vasodilation of blood vessels
• Vertigo
• Vomiting

Rare or Very Rare

• Acute cognitive impairment
• Arthralgia
• Arthritis
• Ataxia
• Blepharospasm
• Concentration difficulty
• Depression
• Diplopia
• Dry eye
• Euphoria
• Hyperglycemia
• Hyperreflexia
• Hypertonia
• Hypoesthesia
• Laryngitis
• Malaise
• Mastalgia
• Myopathy
• Nightmares
• Nystagmus
• Parosmia
• Peripheral sensory neuropathy
• Sensation of cold
• Sialorrhea
• Skin photosensitivity
• Sneezing
• Tinnitus
• Visual changes

No enhanced messaging available.

Safety and efficacy of almotriptan have not been established in pediatric patients younger than 12 years of age. In a clinical study, 6.25 mg and 12.5 mg doses of almotriptan were effective for the relief of migraine headache pain in adolescents 12 to 17 years of age. The efficacy of almotriptan on migraine-associated symptoms (e.g., nausea, photophobia, phonophobia) was not established. Safety and tolerability of almotriptan in adolescents 12-17 years of age is similar to that in adults. Serious adverse events have been reported during postmarketing experience in a limited number of pediatric patients receiving 5-HT1 receptor agonists.

Almotriptan produced increased embryolethality, fetal skeletal variations, and decreased offspring body weight in animal studies at doses greater than those used clinically. There are no adequate and well-controlled studies of almotriptan therapy in pregnant women; almotriptan should be used during pregnancy only if the potential benefit justifies the potential fetal risk.

Almotriptan is distributed into milk in rats; it is not known whether almotriptan is distributed into human milk. Caution is advised if used in nursing women.

There is no specific dosage recommendation in geriatric patients. In general, dose selection should be cautious, usually starting at the lowest dose, reflecting the greater frequency of reduced hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Experience in those 65 years of age and older is insufficient to determine whether they respond differently from younger adults; cautious dosage selection, usually starting at the lowest dose, is recommended.