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 firm's auxilairy will unveil Almotriptan Malate tablets in US soon.
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.