Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Almotriptan malate tablets are available as follows: 6.25 mg: White to off-white, round, convex, film-coated tablets debossed with “93” on one side and “A1” on the other side in boxes of 1 card X 6 tablets (NDC 0093-5260-18). 12.5 mg: White to off-white, round, convex, film-coated tablets debossed with “93” on one side and “A2” on the other side in boxes of 2 cards X 6 tablets (NDC 0093-5261-29). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].; Package/Label Display Panel image Almotriptan Malate Tablets 6.25 mg, 6s Carton Text NDC 0093- 5260 -18 Almotriptan Malate Tablets 6.25 mg* PHARMACIST: PLEASE DISPENSE WITH ENCLOSED PATIENT INFORMATION LEAFLET Rx only 6 TABLETS TEVA; Package/Label Display Panel image Almotriptan Malate Tablets 12.5 mg, 12s Carton Text NDC 0093- 5261 -29 Almotriptan Malate Tablets 12.5 mg* PHARMACIST: PLEASE DISPENSE WITH ENCLOSED PATIENT INFORMATION LEAFLET Rx only 12 TABLETS TEVA
- 16 HOW SUPPLIED/STORAGE AND HANDLING Almotriptan malate tablets are available as follows: 6.25 mg: White to off-white, round, convex, film-coated tablets debossed with “93” on one side and “A1” on the other side in boxes of 1 card X 6 tablets (NDC 0093-5260-18). 12.5 mg: White to off-white, round, convex, film-coated tablets debossed with “93” on one side and “A2” on the other side in boxes of 2 cards X 6 tablets (NDC 0093-5261-29). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
- Package/Label Display Panel image Almotriptan Malate Tablets 6.25 mg, 6s Carton Text NDC 0093- 5260 -18 Almotriptan Malate Tablets 6.25 mg* PHARMACIST: PLEASE DISPENSE WITH ENCLOSED PATIENT INFORMATION LEAFLET Rx only 6 TABLETS TEVA
- Package/Label Display Panel image Almotriptan Malate Tablets 12.5 mg, 12s Carton Text NDC 0093- 5261 -29 Almotriptan Malate Tablets 12.5 mg* PHARMACIST: PLEASE DISPENSE WITH ENCLOSED PATIENT INFORMATION LEAFLET Rx only 12 TABLETS TEVA
Overview
Almotriptan malate tablets contain almotriptan malate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Almotriptan malate is chemically designated as 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidine(±)-hydroxybutanedioate (1:1), and its structural formula is: C 17 H 25 N 3 O 2 S-C 4 H 6 O 5 M.W. 469.56 Almotriptan is a white to off white crystalline powder that is soluble in water. Almotriptan malate tablets for oral administration contain almotriptan malate equivalent to 6.25 mg or 12.5 mg of almotriptan. Each compressed tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, macrogol/PEG 8000, mannitol, microcrystalline cellulose, polydextrose FCC, povidone, sodium stearyl fumarate, titanium dioxide, and triacetin/glycerol triacetate. Chemical Structure
Indications & Usage
Almotriptan malate tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for: Acute treatment of migraine attacks in adults with a history of migraine with or without aura ( 1.1 ) Acute treatment of 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 ( 1.1 ) Important limitations: Use only after a clear diagnosis of migraine has been established ( 1.2 ) In adolescents age 12 to 17 years, efficacy of almotriptan malate tablets on migraine-associated symptoms was not established ( 1.2 ) Not intended for the prophylactic therapy of migraine ( 1.2 ) Not indicated for the treatment of cluster headache ( 1.2 ) 1.1 Acute Treatment of Migraine Attacks Adults Almotriptan malate tablets 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 malate tablets 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 malate 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 malate tablets, the diagnosis of migraine should be reconsidered before almotriptan malate tablets are administered to treat any subsequent attacks. In adolescents age 12 to 17 years, efficacy of almotriptan malate tablets on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. Almotriptan malate 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 malate tablets have not been established for cluster headache which is present in an older, predominantly male population.
Dosage & Administration
Adults and adolescents age 12 to 17 years: 6.25 mg or 12.5 mg single dose; may repeat after 2 hours if headache returns; benefit of second dose in patients who have failed to respond to first dose has not been established; maximum daily dose 25 mg ( 2.1 ) Patients with hepatic or severe renal impairment: 6.25 mg starting dose; maximum daily dose 12.5 mg ( 2.2 , 2.3 ) 2.1 Acute Treatment of Migraine Attacks The recommended dose of almotriptan malate tablets 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 malate tablets, the choice of dose should be made on an individual basis. If the headache is relieved after the initial almotriptan malate 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 malate tablets 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 malate tablets 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 )] .
Warnings & Precautions
Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm ( 5.1 ) It is strongly recommended that almotriptan malate not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors. In very rare cases, serious cardiovascular events have been reported in association with almotriptan malate use in the absence of known cardiovascular disease. If almotriptan malate is considered, patients should first have a cardiovascular evaluation. If the evaluation is satisfactory, first dose should take place in a physician’s office setting ( 5.1 ) Sensations of pain, tightness, pressure, and heaviness in the chest, throat, neck, and jaw: generally not associated with myocardial ischemia, but patients with signs or symptoms suggestive of angina should be evaluated for the presence of CAD ( 5.2 ) Cerebrovascular events, some fatal ( 5.3 ) Gastrointestinal ischemic events and peripheral vasospastic reactions (e.g., Raynaud’s syndrome) ( 5.4 ) Potentially life-threatening serotonin syndrome, particularly in combination with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Monitor patients for neurologic changes and gastrointestinal symptoms if concomitant treatment is clinically warranted ( 5.5 , 7.3 ) Medication overuse headache: Detoxification may be necessary (5.6) Increase in blood pressure, very rarely associated with significant clinical events ( 4.4 , 5.7 ) Use with caution in patients with a known hypersensitivity to sulfonamides ( 5.8 ) 5.1 Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events Cardiac Events and Fatalities with 5-HT 1 Agonists Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following administration of almotriptan malate. 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 malate 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 malate, 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 Malate in Adults Among the 3865 subjects/patients who received almotriptan malate 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 Malate in Adults Serious cardiovascular events have been reported in association with the use of almotriptan malate. 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-HT 1 agonists) to cause coronary vasospasm, almotriptan malate 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 malate 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 malate 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 malate take place in the setting of a physician’s office or similar medically staffed and equipped facility unless the patient has previously received almotriptan malate. 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 malate, in these patients with risk factors. It is recommended that patients who are intermittent long-term users of almotriptan malate and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use almotriptan malate. The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to almotriptan malate. 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. 5.2 Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck, and Jaw As with other 5-HT 1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw have been reported after treatment with almotriptan malate. Because 5-HT 1 agonists may cause coronary vasospasm, patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of 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 occur. Patients shown to have CAD and those with Prinzmetal’s variant angina should not receive 5-HT 1 agonists [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1 )] . 5.3 Cerebrovascular Events and Fatalities Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with other triptans and some events have resulted in fatalities. In a number of cases, it appeared possible that the cerebrovascular events were primary, the triptan having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, and transient ischemic attack) [see Contraindications ( 4.2 )] . 5.4 Other Vasospasm-Related Events, Including Peripheral Vascular Ischemia and Colonic Ischemia Triptans, including almotriptan malate, may cause vasospastic reactions other than coronary artery vasospasm, such as peripheral and gastrointestinal vascular ischemia with abdominal pain and bloody diarrhea. Very rare reports of transient and permanent blindness and significant partial vision loss have been reported with the use of triptans. Visual disorders may also be part of a migraine attack. Patients who experience symptoms or signs suggestive of decreased arterial flow following the use of any triptan, such as ischemic bowel syndrome or Raynaud’s syndrome, are candidates for further evaluation [see Contraindications ( 4.3 )] . 5.5 Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome may occur with triptans, including almotriptan malate, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with almotriptan malate and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) [see Drug Interactions ( 7.3 )] . 5.6 Medication Overuse Headache Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. 5.7 Increases in Blood Pressure As with other triptans, significant elevations in systemic blood pressure have been reported on rare occasions with almotriptan malate use, in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events. Almotriptan malate is contraindicated in patients with uncontrolled hypertension [see Contraindications ( 4.4 )] . In normotensive healthy subjects and patients with hypertension controlled by medication, small, but clinically insignificant, increases in mean systolic (0.21 and 4.87 mm Hg, respectively) and diastolic (1.35 and 0.26 mm Hg, respectively) blood pressure relative to placebo were seen over the first 4 hours after oral administration of 12.5 mg of almotriptan. An 18% increase in mean pulmonary artery pressure was seen following dosing with another triptan in a study evaluating subjects undergoing cardiac catheterization. 5.8 Hypersensitivity to Sulfonamides Caution should be exercised when prescribing almotriptan malate to patients with known hypersensitivity to sulfonamides. The chemical structure of almotriptan contains a sulfonyl group, which is structurally different from a sulfonamide. Cross-sensitivity to almotriptan in patients allergic to sulfonamides has not been systematically evaluated. 5.9 Impaired Hepatic or Renal Function Almotriptan malate should be administered with caution to patients with diseases that may alter the absorption, metabolism, or excretion of drugs, such as those with impaired hepatic or renal function [see Dosage and Administration ( 2.2 ), ( 2.3 ) and Clinical Pharmacology ( 12.3 )] . 5.10 Binding to Melanin-Containing Tissues When pigmented rats were given a single oral dose of 5 mg/kg of radiolabeled almotriptan, the elimination half-life of radioactivity from the eye was 22 days. This finding suggests that almotriptan and/or its metabolites may bind to melanin in the eye. Because almotriptan could accumulate in melanin-rich tissues over time, there is the possibility that it could cause toxicity in these tissues with extended use. However, no adverse retinal effects related to treatment with almotriptan were noted in a 52-week toxicity study in dogs given up to 12.5 mg/kg/day (resulting in exposure [AUC] to parent drug approximately 20 times that in humans receiving the maximum recommended human dose of 25 mg/day). Although no systematic monitoring of ophthalmologic function was undertaken in clinical trials, and no specific recommendations for ophthalmologic monitoring are offered, prescribers should be aware of the possibility of long-term ophthalmologic effects. 5.11 Corneal Opacities Three male dogs (out of a total of 14 treated) in a 52-week toxicity study of oral almotriptan developed slight corneal opacities that were noted after 51 weeks, but not after 25 weeks of treatment. The doses at which this occurred were 2, 5, and 12.5 mg/kg/day. The opacity reversed after a 4-week drug-free period in the affected dog treated with the highest dose. Systemic exposure (plasma AUC) to parent drug at 2 mg/kg/day was approximately 2.5 times the exposure in humans receiving the maximum recommended human daily dose of 25 mg. A no-effect dose was not established.
Contraindications
Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease ( 4.1 ) Cerebrovascular syndromes (e.g., history of stroke or TIA) ( 4.2 ) Peripheral vascular disease (including ischemic bowel disease) ( 4.3 ) Uncontrolled hypertension ( 4.4 ) Do not use almotriptan malate within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT 1 agonist, e.g., another triptan ( 4.5 , 4.6 ) Hemiplegic or basilar migraine ( 4.7 ) Known hypersensitivity to almotriptan malate ( 4.8 ) 4.1 Ischemic or Vasospastic Coronary Artery Disease, or Other Significant Underlying Cardiovascular Disease Do not use almotriptan malate 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 malate 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 malate 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 malate may increase blood pressure, do not use almotriptan malate tablets in patients with uncontrolled hypertension [see Warnings and Precautions ( 5.7 )] . 4.5 Ergotamine-Containing and Ergot-Type Medications Do not use almotriptan malate 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-HT 1 Agonists (e.g., Triptans) Almotriptan malate tablets and other 5-HT 1 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 malate tablets in patients with hemiplegic or basilar migraine. 4.8 Hypersensitivity Almotriptan malate tablets are contraindicated in patients with known hypersensitivity to almotriptan or any of its inactive ingredients.
Adverse Reactions
Serious cardiac reactions, including myocardial infarction, have occurred following the use of almotriptan malate tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported in association with triptans have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1 )] . The following adverse reactions are discussed in more detail in other sections of the labeling: Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events [see Warnings and Precautions ( 5.1 )] Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck, and Jaw [see Warnings and Precautions ( 5.2 )] Cerebrovascular Events and Fatalities [see Warnings and Precautions ( 5.3 )] Other Vasospasm-Related Events, including Peripheral Vascular Ischemia and Colonic Ischemia [see Warnings and Precautions ( 5.4 )] Serotonin Syndrome [see Warnings and Precautions ( 5.5 )] Increases in Blood Pressure [see Warnings and Precautions ( 5.7 )] Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of almotriptan malate and 386 adult patients who received placebo. The most common adverse reactions during treatment with almotriptan malate were nausea, somnolence, headache, paresthesia, and dry mouth. In long-term open-label studies where patients were allowed to treat multiple attacks for up to 1 year, 5% (63 out of 1347 patients) withdrew due to adverse experiences. Adverse events were assessed in controlled clinical trials that included 362 adolescent patients who received almotriptan malate and 172 adolescent patients who received placebo. The most common adverse reactions during treatment with almotriptan malate were dizziness, somnolence, headache, paresthesia, nausea, and vomiting. In a long-term, open-label study where patients were allowed to treat multiple attacks for up to 1 year, 2% (10 out of 420 adolescent patients) withdrew due to adverse events. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥ 1% and greater than placebo) are: In adults: nausea, dry mouth and paresthesia ( 6.1 ) In adolescents: dizziness, somnolence, headache, paresthesia, nausea and vomiting ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Almotriptan Malate Clinical Trials Adults Table 1 lists the adverse events that occurred in at least 1% of the adult patients treated with almotriptan malate, and at an incidence greater than in patients treated with placebo, regardless of drug relationship. Table 1. Incidence of Adverse Events in Controlled Clinical Trials (Reported in at Least 1% of Adult Patients Treated with Almotriptan Malate, and at an Incidence Greater than Placebo) System/Organ Class Adverse Event Almotriptan 6.25 mg (n = 527) % Almotriptan 12.5 mg (n = 1313) % Placebo (n = 386) % Digestive Disorders Nausea 1 2 1 Dry mouth 1 1 0.5 Nervous System Disorders Paresthesia 1 1 0.5 The incidence of adverse events in controlled clinical trials was not affected by gender, weight, age, presence of aura, or use of prophylactic medications or oral contraceptives. There were insufficient data to assess the effect of race on the incidence of adverse events. Adolescents Table 2 lists the adverse reactions reported by 1% or more of almotriptan malate-treated adolescents age 12 to 17 years in 1 placebo-controlled, double-blind clinical trial. Table 2. Adverse Reactions Reported by ≥ 1% of Adolescent Patients Treated with Almotriptan Malate in 1 Placebo-Controlled, Double-Blind Clinical Trial System/Organ Class Adverse Reaction Almotriptan 6.25 mg (n = 180) % Almotriptan 12.5 mg (n = 182) % Placebo (n = 172) % Nervous System Disorders Dizziness 4 3 2 Somnolence < 1 5 2 Headache 1 2 1 Paresthesia < 1 1 < 1 Gastrointestinal Disorders Nausea 1 3 0 Vomiting 2 0 < 1 6.2 Other Adverse Reactions Observed in Almotriptan Malate Clinical Trials In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. The reports include adverse reactions in 5 adult controlled studies and 1 adolescent controlled study. Variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Reaction frequencies are calculated as the number of patients who used almotriptan malate and reported a reaction divided by the total number of patients exposed to almotriptan malate (n = 3047, all doses). All reported reactions are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Reactions are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are those occurring in 1/100 or more patients, infrequent adverse reactions are those occurring in fewer than 1/100 to 1/1000 patients, and rare adverse reactions are those occurring in fewer than 1/1000 patients. Body: Frequent: Headache. Infrequent: Abdominal cramp or pain, Asthenia, Chills, Back pain, Chest pain, Neck pain, Fatigue, and Rigid neck. Rare: Fever and Photosensitivity reaction. Cardiovascular: Infrequent: Vasodilation, Palpitations, and Tachycardia. Rare: Hypertension and Syncope. Digestive: Infrequent: Diarrhea, Vomiting, Dyspepsia, Gastroenteritis and Increased thirst. Rare: Colitis, Gastritis, Esophageal reflux, and Increased salivation. Metabolic: Infrequent: Hyperglycemia and Increased serum creatine phosphokinase. Rare: Increased gamma glutamyl transpeptidase and Hypercholesteremia. Musculo-Skeletal: Infrequent: Myalgia. Rare: Arthralgia, Arthritis, Myopathy and Muscle weakness. Nervous: Frequent: Dizziness and Somnolence. Infrequent: Tremor, Vertigo, Anxiety, Hypoesthesia, Restlessness, CNS stimulation, and Shakiness. Rare: Change in dreams, Impaired concentration, Abnormal coordination, Depressive symptoms, Euphoria, Hyperreflexia, Hypertonia, Nervousness, Neuropathy, Nightmares, Nystagmus and Insomnia. Respiratory: Infrequent: Pharyngitis, Rhinitis, Dyspnea, Laryngismus, Sinusitis and Bronchitis. Rare: Hyperventilation, Laryngitis, Sneezing and Epistaxis. Skin: Infrequent: Diaphoresis, Pruritus, and Rash. Rare: Dermatitis and Erythema. Special Senses: Infrequent: Ear pain and Tinnitus. Rare: Diplopia, Dry eyes, Eye pain, Otitis media, Parosmia, Scotoma, Conjunctivitis, Eye irritation, Hyperacusis and Taste alteration. Urogenital: Infrequent: Dysmenorrhea. 6.3 Postmarketing Experience The following adverse reactions have been identified during postapproval use of almotriptan malate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Hypersensitivity reactions (including angioedema, anaphylactic reactions and anaphylactic shock) Psychiatric disorders: Confusional state, Restlessness Nervous System Disorders: Hemiplegia, Hypoesthesia, Seizures Eye Disorders: Blepharospasm, Visual impairment, Vision blurred Ear and Labyrinth Disorders: vertigo Cardiac Disorders: Acute myocardial infarction, Coronary artery vasospasm, Angina pectoris, Tachycardia Gastrointestinal Disorders: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Colitis, Hypoesthesia oral, Swollen tongue Skin and Subcutaneous Tissue Disorders: Cold sweat, Erythema, Hyperhidrosis Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, Myalgia, Pain in extremity Reproductive System and Breast Disorders: Breast pain General Disorders: Malaise, Peripheral coldness.
Drug Interactions
Do not use almotriptan malate and ergotamine-containing or ergot-type medications within 24 hours of each other ( 4.5 , 7.1 ) Do not use almotriptan malate and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other ( 4.6 , 7.2 ) SSRI or SNRI: life-threatening serotonin syndrome reported during combined use with triptans ( 5.5 , 7.3 ) Ketoconazole: use single dose of almotriptan malate 6.25 mg; maximum almotriptan malate daily dose 12.5 mg ( 7.4 ) 7.1 Ergot-Containing Drugs These drugs have been reported to cause prolonged vasospastic reactions. Because, in theory, vasospastic effects may be additive, ergotamine-containing or ergot-type medications (like dihydroergotamine, ergotamine tartrate, or methysergide) and almotriptan malate should not be used within 24 hours of each other [see Contraindications ( 4.5 )] . 7.2 5-HT 1 Agonists (e.g., Triptans) Concomitant use of other 5-HT 1 agonists (e.g., triptans) within 24 hours of treatment with almotriptan malate is contraindicated [see Contraindications ( 4.6 )] . 7.3 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors Cases of life-threatening serotonin syndrome have been reported during combined use of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions ( 5.5 ), Clinical Pharmacology (12.3) ] . 7.4 Ketoconazole and Other Potent CYP3A4 Inhibitors Coadministration of almotriptan and oral ketoconazole, a potent CYP3A4 inhibitor, resulted in an approximately 60% increase in exposure of almotriptan. Increased exposures to almotriptan may be expected when almotriptan is used concomitantly with other potent CYP3A4 inhibitors [see Clinical Pharmacology (12.3) ] . In patients concomitantly using potent CYP3A4 inhibitors, the recommended starting dose of almotriptan is 6.25 mg. The maximum daily dose should not exceed 12.5 mg within a 24-hour period. Concomitant use of almotriptan malate and potent CYP3A4 inhibitors should be avoided in patients with renal or hepatic impairment [see Clinical Pharmacology (12.3) ] .
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