8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
10.1 Signs and Symptoms
10.2 Recommended Treatment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Adults
14.2 Adolescents Age 12 to 17 Years
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
1.1 Acute Treatment of Migraine Attacks
Adults
AXERT® (almotriptan malate) is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.
Adolescents Age 12 to 17 Years
AXERT® is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).
1.2 Important Limitations
AXERT® should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with AXERT®, the diagnosis of migraine should be reconsidered before AXERT® is administered to treat any subsequent attacks.
In adolescents age 12 to 17 years, efficacy of AXERT® on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. AXERT® is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS (4.7)].
Safety and effectiveness of AXERT® have not been established for cluster headache which is present in an older, predominantly male population.
2 DOSAGE AND ADMINISTRATION
2.1 Acute Treatment of Migraine Attacks
The recommended dose of AXERT® (almotriptan malate) 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 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.
2.2 Hepatic Impairment
The recommended starting dose of AXERT® in patients with hepatic impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [see WARNINGS AND PRECAUTIONS (5.9) and CLINICAL PHARMACOLOGY (12.3)].
2.3 Renal Impairment
The recommended starting dose of AXERT® in patients with severe renal impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [see WARNINGS AND PRECAUTIONS (5.9) and CLINICAL PHARMACOLOGY (12.3)].
3 DOSAGE FORMS AND STRENGTHS
AXERT® (almotriptan malate) Tablets are available as white, coated, circular, biconvex tablets in the following dosage strengths:
6.25 mg tablet with red code imprint "2080"
12.5 mg tablet with blue stylized imprint "A."
4 CONTRAINDICATIONS
4.1 Ischemic or Vasospastic Coro |
