Almotriptan

ALMOTRIPTAN — almotriptan malate tablet, film coated
Ajanta Pharma USA Inc.

1 INDICATIONS AND USAGE

1.1 Acute Treatment of Migraine Attacks

Adults

Almotriptan tablets, USP are 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

Almotriptan tablets, USP are 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

Almotriptan tablets 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 almotriptan tablets, the diagnosis of migraine should be reconsidered before almotriptan tablets are administered to treat any subsequent attacks.

In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. Almotriptan tablets are 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 almotriptan tablets 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 almotriptan tablets, USP 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 almotriptan tablets, the choice of dose should be made on an individual basis.

If the headache is relieved after the initial almotriptan tablets 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 almotriptan tablets, USP 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 almotriptan tablets, USP 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

Almotriptan tablets, USP are available as white, circular, biconvex, film-coated tablets in the following dosage strengths:

6.25 mg tablet debossed with ‘A1’ on one side and plain on other side.

12.5 mg tablet debossed with ‘A2’ on one side and plain on other side.

4 CONTRAINDICATIONS

4.1 Ischemic or Vasospastic Coronary Artery Disease, or Other Significant Underlying Cardiovascular Disease

Do not use almotriptan tablets in patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or in patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina, or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1)].

4.2 Cerebrovascular Syndromes

Do not use almotriptan tablets in patients with cerebrovascular syndromes including (but not limited to) stroke of any type as well as transient ischemic attacks [see Warnings and Precautions (5.3)].

4.3 Peripheral Vascular Disease

Do not use almotriptan tablets in patients with peripheral vascular disease including (but not limited to) ischemic bowel disease [see Warnings and Precautions (5.4)].

4.4 Uncontrolled Hypertension

Because almotriptan tablets may increase blood pressure, do not use almotriptan tablets in patients with uncontrolled hypertension [see Warnings and Precautions (5.7)].

4.5 Ergotamine-Containing and Ergot-Type Medications

Do not use almotriptan tablets and ergotamine-containing or ergot-derived medications like dihydroergotamine, ergotamine tartrate, or methysergide within 24 hours of each other [see Drug Interactions (7.1)].

4.6 Concomitant Use With 5-HT1 Agonists (e.g., Triptans)

Almotriptan tablets and other 5-HT1 agonists (e.g., triptans) should not be administered within 24 hours of each other [see Warnings and Precautions (5.1) and (5.2)].

4.7 Hemiplegic or Basilar Migraine

Do not use almotriptan tablets in patients with hemiplegic or basilar migraine.

4.8 Hypersensitivity

Almotriptan tablets are contraindicated in patients with known hypersensitivity to almotriptan or any of its inactive ingredients.

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events

Cardiac Events and Fatalities with 5-HT1 Agonists
Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following administration of almotriptan tablets. Life-threatening disturbances of cardiac rhythm and death have been reported within a few hours following the administration of other triptans. Considering the extent of use of triptans in patients with migraine, the incidence of these events is extremely low.

Almotriptan tablets can cause coronary vasospasm; at least one of these events occurred in a patient with no cardiac history and with documented absence of coronary artery disease. Because of the close proximity of the events to use of almotriptan tablets, a causal relationship cannot be excluded. Patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of coronary artery disease (CAD) or a predisposition to Prinzmetal’s variant angina before receiving additional doses of medication, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur.

Premarketing Experience with Almotriptan Tablets in Adults
Among the 3865 subjects/patients who received almotriptan tablets in premarketing clinical trials, one patient was hospitalized for observation after a scheduled electrocardiogram (ECG) was found to be abnormal (negative T-waves on the left leads) 48 hours after taking a single 6.25 mg dose of almotriptan. The patient, a 48-year-old female, had previously taken 3 other doses for earlier migraine attacks. Myocardial enzymes at the time of the abnormal ECG were normal. The patient was diagnosed as having had myocardial ischemia and that she had a family history of coronary disease. An ECG performed 2 days later was normal, as was a follow-up coronary angiography. The patient recovered without incident.

Postmarketing Experience with Almotriptan Tablets in Adults
Serious cardiovascular events have been reported in association with the use of almotriptan tablets. The uncontrolled nature of postmarketing surveillance, however, makes it impossible to definitively determine the proportion of the reported cases that were actually caused by almotriptan or to reliably assess causation in individual cases [see Adverse Reactions (6.3)].

Patients with Documented Coronary Artery Disease
Because of the potential of this class of compound (5-HT1 agonists) to cause coronary vasospasm, almotriptan tablets should not be given to patients with documented ischemic or vasospastic coronary artery disease [see Contraindications (4.1)].

Patients with Risk Factors for CAD
It is strongly recommended that almotriptan tablets not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient’s medical history, electrocardiographic or other investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, almotriptan tablets should not be administered [see Contraindications (4.1)].

For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of almotriptan tablets take place in the setting of a physician’s office or similar medically staffed and equipped facility unless the patient has previously received almotriptan tablets. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an ECG during the interval immediately following almotriptan tablets, in these patients with risk factors. It is recommended that patients who are intermittent long-term users of almotriptan tablets and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use almotriptan tablets.

The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to almotriptan tablets. The ability of cardiac diagnostic procedures to detect all cardiovascular diseases or predisposition to coronary artery vasospasm is modest at best. Cardiovascular events associated with triptan treatment have occurred in patients with no cardiac history and with documented absence of coronary artery disease.

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