almotriptan malate


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Related to almotriptan malate: Naratriptan, Axert

almotriptan malate

Axert

Pharmacologic class: Serotonin (5-hydroxytryptamine [5-HT]) receptor agonist

Therapeutic class: Vascular headache suppressant, antimigraine drug

Pregnancy risk category C

Action

Promotes vascular constriction and relieves migraine by stimulating specific 5-HT receptors in intracranial blood vessels and sensory trigeminal nerves

Availability

Tablets: 6.25 mg, 12.5 mg

Indications and dosages

Acute migraine

Adults: Single dose of 6.25 to 12.5 mg P.O. at first sign or symptom of migraine; may be repeated after 2 hours. Don't exceed two doses in a 24-hour period.

Dosage adjustment

• Severe renal or hepatic impairment

Contraindications

• Hypersensitivity to drug

• Ischemic heart disease, history of myocardial infarction (MI), documented silent ischemia, symptoms or findings consistent with ischemic heart disease, cerebrovascular accident, uncontrolled hypertension, coronary artery vasospasm

• Ischemic bowel disease

• Basilar or hemiplegic migraine

• MAO inhibitor use in past 14 days

• Use of other 5-HT agonists or ergotamine-containing or ergot-type drugs within past 24 hours

Precautions

Use cautiously in:

• impaired renal or hepatic function

• cardiovascular risk factors

• pregnant or breastfeeding patients

• children younger than age 18 (use not recommended).

Administration

• Give with or without food.

• Wait at least 2 hours after initial dose before giving repeat dose.

• Don't exceed two doses in 24 hours.

Don't give within 14 days of MAO inhibitors or within 24 hours of other 5-HT agonists or ergotamine-containing or ergot-type drugs.

Adverse reactions

CNS: headache, anxiety, dizziness, fatigue, malaise, weakness, cold or hot sensations, sedation, numbness, burning or tingling sensations

CV: blood pressure changes, palpitations, tachycardia, coronary artery vasospasm, MI, ventricular fibrillation, ventricular tachycardia

EENT: vision changes; nasal, throat, and mouth discomfort

GI: nausea, abdominal distress, dysphagia, dry mouth

Musculoskeletal: weakness, stiff neck, muscle pain

Respiratory: chest tightness or pressure

Skin: sweating, flushing

Interactions

Drug-drug. CYP2D6 inhibitors (erythromycin, itraconazole, ritonavir): increased almotriptan effect

Ergot derivatives, other 5-HT agonists: prolonged vasoactive action

Ketoconazole and other CYP3A inhibitors: increased almotriptan blood level, leading to toxicity

MAO inhibitors: decreased almotriptan absorption

Selective serotonin reuptake inhibitors: weakness, hyperreflexia, poor coordination

Patient monitoring

• Assess patient's cardiovascular status, noting chest tightness or pressure.

• Monitor vital signs.

Patient teaching

Tell patient to immediately report chest tightness or pressure.

• Inform patient that he may take drug with or without food.

• If second dose is needed, tell patient to take it at least 2 hours after first.

• Caution patient not to take more than two doses in 24 hours.

• Instruct patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

Axert

A selective serotonin 5-HT1B/1D receptor agonist, which is used for acute management of severe migraine in adults.
 
Adverse effects
Nausea, somnolence, headache, paraesthesia, dry mouth.
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References in periodicals archive ?
The ANDA for almotriptan malate tablets submitted by Teva to the FDA on December 7, 2005, was the first ANDA submitted by a generics company containing a Paragraph IV certification for Janssen Pharmaceuticals' Axert.
The company added that it was the first applicant to submit an Abbreviated New Drug Application (ANDA) for almotriptan malate tablets containing a Paragraph IV patent certification for Janssen Pharmaceuticals Axert.