Almotriptan Malate 6.25 mg Tablet, Film Coated, 6-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin-1b and Serotonin-1d Receptor Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Almotriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes come with nausea and a strong reaction to sound and light). Almotriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels around the brain, stopping pain signals from being sent to the brain, and stops the release of certain natural substances that cause pain, nausea, and other symptoms of migraines. Almotriptan does not stop migraine attacks from coming or reduce the number of headaches you have.
Read the full MedlinePlus article ↗- No, almotriptan is not a regular painkiller like ibuprofen or acetaminophen. It's a specific migraine medicine called a triptan. It works by targeting the serotonin receptors invol...
- What exactly is almotriptan for — is it the same as a regular painkiller?
- It's best to take almotriptan as soon as you recognize a migraine is starting — you don't need to wait for the pain to peak. Taking it early generally gives the best results. If th...
- When should I take it — do I wait until the headache is really bad?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
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Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $17.023 | $102.14 / 6 tablets |
| Medicaid paysCMS SDUD · 12 mo | $20.31 | $121.84 / 6 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Almotriptan Malate 6.25 mg 00093-5260-18 | Teva | 1 tablet | $17.023 | AB | Availability likely | — |
| Almotriptan Malate 6.25 mgthis 00378-5245-85 | Mylan | 6 tablets | $17.023 | AB | Availability likely | — |
| almotriptan 6.25 mg 27241-0041-11 | Ajanta | 6 tablets | $17.023 | AB | Availability likely | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00378-5245-85 You're viewing this | 1 BLISTER PACK in 1 CARTON (0378-5245-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-5245-32) | 2015-11-10 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Almotriptan 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 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 )
1.1Acute Treatment of Migraine Attacks Adults Almotriptan tablets (almotriptan malate) 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 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).
1.2Important 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND 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 )
2.1Acute Treatment of Migraine Attacks The recommended dose of almotriptan tablets (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 almotriptan tablets, the choice of dose should be made on an individual basis. If the headache is relieved after the initial almotriptan tablet 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.
2.2Hepatic Impairment The recommended starting dose of almotriptan 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) ] .
2.3Renal Impairment The recommended starting dose of almotriptan 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) ] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Almotriptan Tablets, USP are available containing 8.75 mg or 17.50 mg of almotriptan malate, USP equivalent to 6.25 mg or 12.5 mg of almotriptan, respectively. • The 6.25 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and AL1 on the other side. • The 12.5 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and AL2 on the other side. Tablets: 6.25 mg and 12.5 mg ( 3 )
⛔ Contraindications ▾
4 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 tablets 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 tablets ( 4.8 )
4.1Ischemic or Vasospastic Coronary Artery Disease, or Other Significant Underlying Cardiovascular Disease Do not use almotriptan tablets (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) ] .
4.2Cerebrovascular 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) ] .
4.3Peripheral 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) ] .
4.4Uncontrolled Hypertension Because almotriptan may increase blood pressure, do not use almotriptan tablets in patients with uncontrolled hypertension [see Warnings and Precautions (5.7) ] .
4.5Ergotamine-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) ] .
4.6Concomitant Use with 5-HT 1 Agonists (e.g., Triptans) Almotriptan 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) ].
4.7Hemiplegic or Basilar Migraine Do not use almotriptan tablets in patients with hemiplegic or basilar migraine.
4.8Hypersensitivity Almotriptan tablets are contraindicated in patients with known hypersensitivity to almotriptan or any of their inactive ingredients.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm ( 5.1 ) • It is strongly recommended that almotriptan tablets 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 tablet use in the absence of known cardiovascular disease. If almotriptan tablets are 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 )
5.1Risk 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 tablets (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 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 three 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 caus…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Serious cardiac reactions, including myocardial infarction, have occurred following the use of almotriptan (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 tablets and 386 adult patients who received placebo.
The most common adverse reactions during treatment with almotriptan tablets 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 tablets and 172 adolescent patients who received placebo.
The most common adverse reactions during treatment with almotriptan tablets 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 Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Almotriptan Tablet Clinical Trials Adults Table 1 lists the adverse events that occurred in at least 1% of the adult patients treated with almotriptan tablets, 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 Tablets, and at an Incidence Greater than Placebo) System/Organ Class Adverse Event Almotriptan Tablets 6.25 mg (n = 527) % Almotriptan Tablets 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
0.5The 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 tablet-treated adolescents age 12…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Do not use almotriptan tablets and ergotamine-containing or ergot-type medications within 24 hours of each other ( 4.5 , 7.1 ) • Do not use almotriptan tablets and other 5-HT 1 agonist (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 tablets 6.25 mg; maximum almotriptan tablets daily dose 12.5 mg ( 7.4 )
7.1Ergot-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 tablets (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 tablets is contraindicated [see Contraindications (4.6) ] .
7.3Selective 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) ] .
7.4Ketoconazole and Other Potent CYP3A4 Inhibitors Co-administration 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 tablets is 6.25 mg.
The maximum daily dose should not exceed 12.5 mg within a 24-hour period. Concomitant use of almotriptan tablets and potent CYP3A4 inhibitors should be avoided in patients with renal or hepatic impairment [see Clinical Pharmacology (12.3) ] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pregnancy: based on animal data, may cause fetal harm ( 8.1 ) • Nursing mothers: use almotriptan tablets with caution ( 8.3 ) • Pediatric use: almotriptan tablets have not been studied in children under 12 years ( 8.4 ) • Geriatric use: insufficient safety and efficacy data; use with caution, usually starting with the 6.25 mg dose ( 8.5 ) • Hepatic impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg ( 2.2 , 8.6 ) • Severe renal impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg ( 2.3 , 8.7 )
8.1Pregnancy Pregnancy Category C In animal studies, almotriptan produced developmental toxicity (increased embryolethality and fetal skeletal variations, and decreased offspring body weight) at doses greater than those used clinically. There are no adequate and well-controlled studies in pregnant women; therefore, almotriptan tablets (almotriptan malate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When almotriptan (125 mg/kg/day, 250 mg/kg/day, 500 mg/kg/day, or 1000 mg/kg/day) was administered orally to pregnant rats throughout the period of organogenesis, increased incidences of fetal skeletal variations (decreased ossification) were noted at a dose of 250 mg/kg/day or greater and an increase in embryolethality was seen at the highest dose.
The no-effect dose for embryo-fetal developmental toxicity in rats (125 mg/kg/day) is approximately 100 times the maximum recommended human dose (MRHD) of 25 mg/day on a body surface area (mg/m 2 ) basis. Similar studies in pregnant rabbits conducted with almotriptan (oral doses of 5 mg/kg/day, 20 mg/kg/day, or 60 mg/kg/day) demonstrated increases in embryolethality at the highest dose. The no-effect dose for embryo-fetal developmental toxicity in rabbits (20 mg/kg/day) is approximately 15 times the MRHD on a mg/m 2 basis.
When almotriptan (25 mg/kg/day, 100 mg/kg/day, or 400 mg/kg/day) was administered orally to rats throughout the periods of gestation and lactation, gestation length was increased and litter size and offspring body weight were decreased at the highest dose. The decrease in pup weight persisted throughout lactation. The no-effect dose in this study (100 mg/kg/day) is 40 times the MRHD on a mg/m 2 basis.
8.2Labor and Delivery The effect of almotriptan tablets on labor and delivery in humans is unknown.
8.3Nursing Mothers It is not known whether almotriptan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when almotriptan tablets are administered to a nursing woman. Levels of almotriptan in rat milk were up to 7 times higher than in rat plasma.
8.4Pediatric Use Safety and efficacy of almotriptan tablets in pediatric patients under the age of 12 years have not been established. The pharmacokinetics, efficacy, and safety of almotriptan tablets have been evaluated in adolescent patients, age 12 to 17 years [see Clinical Pharmacology (12.3) and Clinical Studies (14.2) ] . In a clinical study, almotriptan tablets 6.25 mg and 12.5 mg were found to be effective for the relief of migraine headache pain in adolescent patients age 12 to 17 years.
Efficacy on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. The most common adverse reactions (incidence of ≥ 1%) associated with almotriptan tablet treatment were dizziness, somnolence, headache, paresthesia, nausea, and vomiting [see Adverse Reactions (6.1) ] . The safety and tolerability profile of almotriptan tablet treatment in adolescents is similar to the profile observed in adults.
Postmarketing experience with other triptans include a limited number of reports that describe pediatric patients who have experienced clinically serious adverse events that are similar in nature to those reported rarely in adults.
8.5 Geriatric Use Clinical studies of almotriptan tablets did not include sufficient…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C In animal studies, almotriptan produced developmental toxicity (increased embryolethality and fetal skeletal variations, and decreased offspring body weight) at doses greater than those used clinically. There are no adequate and well-controlled studies in pregnant women; therefore, almotriptan tablets (almotriptan malate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When almotriptan (125 mg/kg/day, 250 mg/kg/day, 500 mg/kg/day, or 1000 mg/kg/day) was administered orally to pregnant rats throughout the period of organogenesis, increased incidences of fetal skeletal variations (decreased ossification) were noted at a dose of 250 mg/kg/day or greater and an increase in embryolethality was seen at the highest dose.
The no-effect dose for embryo-fetal developmental toxicity in rats (125 mg/kg/day) is approximately 100 times the maximum recommended human dose (MRHD) of 25 mg/day on a body surface area (mg/m 2 ) basis. Similar studies in pregnant rabbits conducted with almotriptan (oral doses of 5 mg/kg/day, 20 mg/kg/day, or 60 mg/kg/day) demonstrated increases in embryolethality at the highest dose. The no-effect dose for embryo-fetal developmental toxicity in rabbits (20 mg/kg/day) is approximately 15 times the MRHD on a mg/m 2 basis.
When almotriptan (25 mg/kg/day, 100 mg/kg/day, or 400 mg/kg/day) was administered orally to rats throughout the periods of gestation and lactation, gestation length was increased and litter size and offspring body weight were decreased at the highest dose. The decrease in pup weight persisted throughout lactation. The no-effect dose in this study (100 mg/kg/day) is 40 times the MRHD on a mg/m 2 basis.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of almotriptan tablets in pediatric patients under the age of 12 years have not been established. The pharmacokinetics, efficacy, and safety of almotriptan tablets have been evaluated in adolescent patients, age 12 to 17 years [see Clinical Pharmacology (12.3) and Clinical Studies (14.2) ] . In a clinical study, almotriptan tablets 6.25 mg and 12.5 mg were found to be effective for the relief of migraine headache pain in adolescent patients age 12 to 17 years.
Efficacy on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. The most common adverse reactions (incidence of ≥ 1%) associated with almotriptan tablet treatment were dizziness, somnolence, headache, paresthesia, nausea, and vomiting [see Adverse Reactions (6.1) ] . The safety and tolerability profile of almotriptan tablet treatment in adolescents is similar to the profile observed in adults.
Postmarketing experience with other triptans include a limited number of reports that describe pediatric patients who have experienced clinically serious adverse events that are similar in nature to those reported rarely in adults.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of almotriptan tablets did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Clearance of almotriptan was lower in elderly volunteers than in younger individuals, but there were no observed differences in the safety and tolerability between the two populations [see Clinical Pharmacology (12.3) ] . In general, dose selection for an elderly patient should be cautious, usually starting at the low dose, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
The recommended dose of almotriptan tablets for elderly patients with normal renal function for their age is the same as that recommended for younger adults.
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Signs and Symptoms Patients and volunteers receiving single oral doses of 100 mg to 150 mg of almotriptan did not experience significant adverse events. Six additional normal volunteers received single oral doses of 200 mg without serious adverse events. During clinical trials with almotriptan tablets (almotriptan malate), one patient ingested 62.5 mg in a 5-hour period and another patient ingested 100 mg in a 38-hour period.
Neither patient experienced adverse reactions. Based on the pharmacology of triptans, hypertension or other more serious cardiovascular symptoms could occur after overdosage.
10.2Recommended Treatment There is no specific antidote to almotriptan tablets. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. Clinical and electrocardiographic monitoring should be continued for at least 20 hours even if clinical symptoms are not observed.
It is unknown what effect hemodialysis or peritoneal dialysis has on plasma concentrations of almotriptan.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Almotriptan binds with high affinity to 5-HT 1D , 5-HT 1B , and 5-HT 1F receptors. Almotriptan has weak affinity for 5-HT 1A and 5-HT 7 receptors, but has no significant affinity or pharmacological activity at 5-HT 2 , 5-HT 3 , 5-HT 4 , 5-HT 6 ; alpha or beta adrenergic; adenosine (A 1 , A 2 ); angiotensin (AT 1 , AT 2 ); dopamine (D 1 , D 2 ); endothelin (ET A , ET B ); or tachykinin (NK 1 , NK 2 , NK 3 ) binding sites.
12.2Pharmacodynamics Current theories on the etiology of migraine headache suggest that symptoms are due to local cranial vasodilatation and/or to the release of vasoactive and pro-inflammatory peptides from sensory nerve endings in an activated trigeminal system. The therapeutic activity of almotriptan in migraine can most likely be attributed to agonist effects at 5-HT 1B/1D receptors on the extracerebral, intracranial blood vessels that become dilated during a migraine attack and on nerve terminals in the trigeminal system.
Activation of these receptors results in cranial vessel constriction, inhibition of neuropeptide release, and reduced transmission in trigeminal pain pathways.
12.3Pharmacokinetics Absorption The absolute bioavailability of almotriptan is about 70%, with peak plasma levels occurring 1 to 3 hours after administration; food does not affect pharmacokinetics. Distribution Almotriptan is minimally protein bound (approximately 35%) and the mean apparent volume of distribution is approximately 180 to 200 liters. Metabolism Almotriptan is metabolized by two major and one minor pathways.
Monoamine oxidase (MAO)-mediated oxidative deamination (approximately 27% of the dose), and cytochrome P450-mediated oxidation (approximately 12% of the dose) are the major routes of metabolism, while flavin monooxygenase is the minor route. MAO-A is responsible for the formation of the indoleacetic acid metabolite, whereas cytochrome P450 (3A4 and 2D6) catalyzes the hydroxylation of the pyrrolidine ring to an intermediate that is further oxidized by aldehyde dehydrogenase to the gamma-aminobutyric acid derivative. Both metabolites are inactive.
Excretion Almotriptan has a mean half-life of 3 to 4 hours. Almotriptan is eliminated primarily by renal excretion (about 75% of the oral dose), with approximately 40% of an administered dose excreted unchanged in urine. Renal clearance exceeds the glomerular filtration rate by approximately 3-fold, indicating an active mechanism.
Approximately 13% of the administered dose is excreted via feces, both unchanged and metabolized. Drug-Drug Interactions All drug interaction studies were performed in healthy volunteers using a single 12.5 mg dose of almotriptan and multiple doses of the other drug. Monoamine Oxidase Inhibitors Co-administration of almotriptan and moclobemide (150 mg twice daily for 8 days) resulted in a 27% decrease in almotriptan clearance and an increase in C max of approximately 6%.
No dose adjustment is necessary. Propranolol Co-administration of almotriptan and propranolol (80 mg twice daily for 7 days) resulted in no significant changes in the pharmacokinetics of almotriptan. Fluoxetine Co-administration of almotriptan and fluoxetine (60 mg daily for 8 days), a potent inhibitor of CYP2D6, had no effect on almotriptan clearance, but maximal concentrations of almotriptan were increased 18%.
This difference is not clinically significant. Verapamil Co-administration of almotriptan and verapamil (120 mg sustained-release tablets twice daily for 7 days), an inhibitor of CYP3A4, resulted in a 20% increase in the area under the plasma concentration-time curve, and in a 24% increase in maximal plasma concentrations of almotriptan. Neither of these changes is clinically significant.
No dose adjustment is necessary. Ketoconazole and Other Potent CYP3A4 Inhibitors Co-administration of almotriptan and ketoconazole, a potent CYP3A4 inhibitor, resulted in an approximately 60% increase in exposure of almotriptan. Incre…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Almotriptan binds with high affinity to 5-HT 1D , 5-HT 1B , and 5-HT 1F receptors. Almotriptan has weak affinity for 5-HT 1A and 5-HT 7 receptors, but has no significant affinity or pharmacological activity at 5-HT 2 , 5-HT 3 , 5-HT 4 , 5-HT 6 ; alpha or beta adrenergic; adenosine (A 1 , A 2 ); angiotensin (AT 1 , AT 2 ); dopamine (D 1 , D 2 ); endothelin (ET A , ET B ); or tachykinin (NK 1 , NK 2 , NK 3 ) binding sites.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Almotriptan Tablets, USP are available containing 8.75 mg or 17.50 mg of almotriptan malate, USP equivalent to 6.25 mg or 12.5 mg of almotriptan, respectively. The 6.25 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and AL1 on the other side. They are available as follows: NDC 0378-5245-85 carton of 6 unit-dose tablets (1 x 6) The 12.5 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and AL2 on the other side.
They are available as follows: NDC 0378-5246-85 carton of 12 unit-dose tablets (2 x 6) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Almotriptan tablets, USP 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: Its molecular formula is C 17 H 25 N 3 O 2 S•C 4 H 6 O 5 , representing a molecular weight of 469.56. Almotriptan malate, USP is a white to light yellow color crystalline powder that is soluble in water.
Almotriptan tablets for oral administration contain 8.75 mg or 17.50 mg of almotriptan malate equivalent to 6.25 mg or 12.5 mg of almotriptan, respectively. Each compressed tablet contains the following inactive ingredients: hypromellose, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), sodium stearyl fumarate and titanium dioxide. Almotriptan Malate Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Drug Interactions: Advise patients to talk with their physician or pharmacist before taking any new medicines, including prescription and non-prescription drugs and supplements [see Contraindications (4.5) and (4.6) and Drug Interactions (7) ] . Hypersensitivity: Inform patients to tell their physician if they develop a rash, itching, or breathing difficulties after taking almotriptan tablets [see Warnings and Precautions (5.8) ] .
Risk of Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, Other Vasospasm-Related Events, and Cerebrovascular Events: Inform patients that almotriptan tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, or slurring of speech, and should ask for medical advice when observing any indicative signs or symptoms.
Apprise the patient of the importance of this follow-up [see Warnings and Precautions (5.1) , (5.2) , (5.3) , and (5.4) ] . Serotonin Syndrome: Caution patients about the risk of serotonin syndrome with the use of almotriptan tablets or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.5) ] . Medication Overuse Headache: Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6) ] .
Pregnancy: Advise patients to notify their physician if they become pregnant during treatment or intend to become pregnant [see Use in Specific Populations (8.1) ] . Nursing Mothers: Advise patients to notify their physician if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3) ] . Ability to Operate Machinery or Vehicles: Counsel patients that almotriptan tablets may cause dizziness, somnolence, visual disturbances, and other CNS symptoms that can interfere with driving or operating machinery.
Accordingly, advise the patient not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience with almotriptan tablets to gauge whether they affect their mental or visual performance adversely.