Almotriptan

Almotriptan
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Almotriptan is a 5HT1B/1D receptor agonist that is FDA approved for the {{{indicationType}}} of acute treatment of migraine attacks in adults with a history of migraine with or without aura and 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. Common adverse reactions include dry mouth, paresthesia, dizziness, somnolence, headache, paresthesia, nausea and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Migraine

• AXERT® (almotriptan malate) is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.

• The recommended dose of AXERT® (almotriptan malate) in adults 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 AXERT®, the choice of dose should be made on an individual basis.

• If the headache is relieved after the initial AXERT® dose but returns, the dose may be repeated after 2 hours. The effectiveness of a second dose has not been established in placebo-controlled trials. The maximum daily dose should not exceed 25 mg. The safety of treating an average of more than four migraines in a 30-day period has not been established.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Almotriptan in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Almotriptan in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Almotriptan in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Almotriptan in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Almotriptan in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Almotriptan in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Almotriptan in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Almotriptan in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Almotriptan during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Almotriptan with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Almotriptan with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Almotriptan with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Almotriptan with respect to specific gender populations.

Race

There is no FDA guidance on the use of Almotriptan with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Almotriptan in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Almotriptan in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Almotriptan in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Almotriptan in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Almotriptan in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Almotriptan in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Almotriptan in the drug label.

Pharmacology

There is limited information regarding Almotriptan Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Almotriptan in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Almotriptan in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Almotriptan in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Almotriptan in the drug label.

How Supplied

Storage

There is limited information regarding Almotriptan Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Almotriptan in the drug label.

Precautions with Alcohol

• Alcohol-Almotriptan interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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