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Almotriptan: Drug information

Almotriptan: Drug information
(For additional information see "Almotriptan: Patient drug information" and see "Almotriptan: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • MYLAN-Almotriptan;
  • SANDOZ Almotriptan;
  • TEVA-Almotriptan
Pharmacologic Category
  • Antimigraine Agent;
  • Serotonin 5-HT1B, 1D Receptor Agonist
Dosing: Adult
Migraine, moderate to severe, acute treatment

Migraine, moderate to severe, acute treatment:

Note: Do not use within 24 hours of an ergotamine preparation or a different triptan. Limit use to <10 days per month to avoid medication-overuse headache. Administration early in the course of a migraine attack, at the first sign of pain, may improve response to treatment. When attack is complicated by severe nausea or vomiting, a non-oral medication may be more effective (Ref).

Oral: 12.5 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum: 12.5 mg/dose; 25 mg per 24 hours (Ref).

Dosage adjustment with concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl >30 mL/minute: No dosage adjustment necessary.

CrCl ≤30 mL/minute: 6.25 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum: 12.5 mg per 24 hours.

Dosing: Hepatic Impairment: Adult

6.25 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum: 12.5 mg per 24 hours.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Almotriptan: Pediatric drug information")

Migraine

Migraine: Children ≥12 years and Adolescents: Oral: Initial: 6.25 to 12.5 mg in a single dose; if headache returns, may repeat the dose after 2 hours; maximum 2 doses/day; maximum daily dose: 25 mg/day. Note: The safety of treating >4 migraines/month has not been established.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children ≥12 years and Adolescents: Severe renal impairment (CrCl ≤30 mL/minute): Initial: 6.25 mg in a single dose; maximum daily dose: 12.5 mg/day

Dosing: Hepatic Impairment: Pediatric

Children ≥12 years and Adolescents: Initial: 6.25 mg in a single dose; maximum daily dose: 12.5 mg/day

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Central nervous system: Drowsiness (≤5%), dizziness (≤4%), headache (≤2%)

Gastrointestinal: Nausea (1% to 3%), vomiting (≤2%), xerostomia (1%)

Neuromuscular & skeletal: Paresthesia (≤1%)

<1%, postmarketing, and/or case reports: Abdominal cramps, abdominal discomfort, abdominal pain, abnormal dreams, altered sense of smell, anaphylactic shock, anaphylaxis, angina pectoris, angioedema, anxiety, arthralgia, arthritis, ataxia, back pain, blepharospasm, blurred vision, bronchitis, central nervous system stimulation, chest pain, chills, cold extremities, colitis, confusion, conjunctivitis, coronary artery vasospasm, decreased visual acuity, depression, dermatitis, diaphoresis, diarrhea, diplopia, dry eye syndrome, dysgeusia, dysmenorrhea, dyspepsia, dyspnea, epistaxis, erythema, euphoria, eye irritation, eye pain, fatigue, fever, gastritis, gastroenteritis, gastroesophageal reflux disease, hemiplegia, hyperacusis, hypercholesterolemia, hyperglycemia, hyperhidrosis, hyperreflexia, hypersensitivity reaction, hypertension, hypertonia, hyperventilation, hypoesthesia, increased creatine phosphokinase, increased gamma-glutamyl transferase, increased thirst, insomnia, ischemic heart disease, lack of concentration, laryngismus, laryngitis, limb pain, malaise, mastalgia, myalgia, myasthenia, myocardial infarction, myopathy, neck pain, neck stiffness, nervousness, neuropathy, nightmares, nystagmus, otalgia, otitis media, palpitations, pharyngitis, pruritus, restlessness, rhinitis, scotoma, seizure, shakiness, sialorrhea, sinusitis, skin photosensitivity, skin rash, sneezing, syncope, tachycardia, tinnitus, tremor, vasodilation, ventricular fibrillation, ventricular tachycardia, vertigo, weakness

Contraindications

Hypersensitivity to almotriptan or any component of the formulation; hemiplegic migraine or migraine with brainstem aura; known or suspected ischemic heart disease (eg, angina pectoris, MI, documented silent ischemia, coronary artery vasospasm, Prinzmetal's variant angina) or other significant underlying cardiovascular disease; cerebrovascular syndromes (eg, stroke, transient ischemic attacks); peripheral vascular disease (including ischemic bowel disease); uncontrolled hypertension; use within 24 hours of another 5-HT1 agonist; use within 24 hours of ergotamine derivatives and/or ergotamine-containing medications (eg, dihydroergotamine, ergotamine).

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiac events: Coronary artery vasospasm, transient ischemia, myocardial infarction, ventricular tachycardia/fibrillation, cardiac arrest, and death have been reported with 5-HT1 agonist administration. Patients who experience sensations of chest pain/pressure/tightness or symptoms suggestive of angina following dosing should be evaluated for coronary artery disease or Prinzmetal's angina before receiving additional doses; if dosing is resumed and similar symptoms recur, monitor with ECG.

• Cerebrovascular events: Cerebral/subarachnoid hemorrhage and stroke have been reported with 5-HT1 agonist administration.

• Elevated blood pressure: Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions following 5-HT1 agonist administration in patients with and without a history of hypertension.

• Headaches: Acute migraine agents (eg, triptans, opioids, ergotamine, or a combination of the agents) used for 10 or more days per month may lead to worsening of headaches (medication overuse headache); withdrawal treatment may be necessary in the setting of overuse.

• Ocular effects: Transient and permanent blindness and partial vision loss have been reported (rare) with 5-HT1 agonist administration.

• Sulfonamide allergy: Almotriptan contains a sulfonyl group which is structurally different from a sulfonamide. Cross-reactivity in patients with sulfonamide allergy has not been evaluated; however, the manufacturer recommends that caution be exercised in this patient population.

• Vasospasm-related events: Peripheral vascular ischemia and colonic ischemia have been reported with 5-HT1 agonist administration.

Disease-related concerns:

• Coronary artery disease: Almotriptan should not be given to patients with documented ischemic or vasospastic CAD. Patients with risk factors for CAD (eg, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, menopause, male >40 years of age) should undergo adequate cardiac evaluation prior to administration; if the cardiac evaluation is “satisfactory,” first dose should be given in the healthcare provider's office (consider ECG monitoring). All patients should undergo periodic evaluation of cardiovascular status during treatment.

• Hepatic impairment: Use with caution in patients with hepatic impairment. Drug clearance may be reduced leading to increased plasma concentrations; dosage reduction is recommended.

• Renal impairment: Use with caution in patients with moderate-to-severe renal failure. Drug clearance may be reduced leading to increased plasma concentrations; dosage reduction is recommended for severe renal impairment.

Concurrent drug therapy issues:

• Serotonin syndrome: Symptoms of agitation, confusion, hallucinations, hyper-reflexia, myoclonus, shivering, and tachycardia may occur with concomitant proserotonergic drugs (ie, SSRIs/SNRIs or triptans) or agents which reduce almotriptan's metabolism. Concurrent use of serotonin precursors (eg, tryptophan) is not recommended. If concomitant administration with SSRIs is warranted, monitor closely, especially at initiation and with dose increases.

Other warnings/precautions:

• Appropriate use: Only indicated for treatment of acute migraine; it is not indicated for migraine prophylaxis, or for the treatment of cluster headaches, hemiplegic migraine, or migraine with brainstem aura. If a patient does not respond to the first dose, the diagnosis of acute migraine should be reconsidered.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as maleate:

Generic: 6.25 mg, 12.5 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Almotriptan Malate Oral)

6.25 mg (per each): $41.91 - $41.97

12.5 mg (per each): $41.92 - $41.97

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as maleate:

Generic: 6.25 mg, 12.5 mg

Administration: Adult

Administer without regard to meals.

Administration: Pediatric

Oral: May administer without regard to meals.

Use: Labeled Indications

Migraine, moderate to severe, acute treatment: Treatment of migraine with or without aura in adults (with a history of migraine) and adolescents (with a history of migraine lasting ≥4 hours when left untreated).

Medication Safety Issues
International issues:

Axert [Puerto Rico] may be confused with Antivert brand name for meclizine [US]

Metabolism/Transport Effects

Substrate of CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Bromocriptine: May enhance the adverse/toxic effect of Serotonin 5-HT1D Receptor Agonists (Triptans). Management: Consider alternatives to this combination when possible. If combined, monitor for increased bromocriptine and triptan toxicities. Risk D: Consider therapy modification

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Almotriptan. Management: Limit initial almotriptan dose to 6.25 mg and maximum dose to 12.5 mg in any 24-period when used with a strong CYP3A4 inhibitor. Avoid concurrent use in patients with impaired hepatic or renal function. Risk D: Consider therapy modification

Droxidopa: Serotonin 5-HT1D Receptor Agonists (Triptans) may enhance the hypertensive effect of Droxidopa. Risk C: Monitor therapy

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): Serotonin 5-HT1D Receptor Agonists (Triptans) may enhance the vasoconstricting effect of Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates). Risk X: Avoid combination

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Monoamine Oxidase Inhibitors: Serotonin 5-HT1D Receptor Agonists (Triptans) may enhance the serotonergic effect of Monoamine Oxidase Inhibitors. This could result in serotonin syndrome. Monoamine Oxidase Inhibitors may increase the serum concentration of Serotonin 5-HT1D Receptor Agonists (Triptans). Risk X: Avoid combination

Nefazodone: Almotriptan may enhance the serotonergic effect of Nefazodone. This could result in serotonin syndrome. Nefazodone may increase the serum concentration of Almotriptan. Management: Limit the initial almotriptan dose to 6.25 mg when combined with nefazodone, and do not exceed 12.5 mg in any 24-hour period. Avoid concomitant use in patients with impaired hepatic or renal function. Monitor for serotonin syndrome. Risk D: Consider therapy modification

Serotonergic Agents (High Risk): Almotriptan may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Risk C: Monitor therapy

Serotonin 5-HT1D Receptor Agonists (Triptans): May enhance the vasoconstricting effect of other Serotonin 5-HT1D Receptor Agonists (Triptans). Risk X: Avoid combination

Pregnancy Considerations

Outcome data following maternal use of almotriptan during pregnancy are limited in comparison to other 5-HT1B/1D agonists (triptans) (Källén 2011; Nezvalová-Henriksen 2010; Nezvalová-Henriksen 2012; Nezvalová-Henriksen 2013; Spielmann 2018).

Triptans relieve migraine pain by selectively binding to serotonin receptors, resulting in vasoconstriction of cranial arteries. Although the effects on uterine blood flow have not been evaluated, a case report suggests excessive use of almotriptan may cause placental hypoperfusion. A patient presented at 31 weeks' gestation with decreased amniotic fluid and fetal growth restriction. Likely causes were ruled out, however, the mother admitted to >2 doses/week of almotriptan including several days of daily administration for migraine headaches. Due to worsening symptoms and decreased fetal movements, the mother underwent a cesarean delivery at 34 weeks' gestation (ACOG 2022; Viard 2021). Treatment for migraine headaches in pregnant patients should be individualized (AHS [Ailani 2021]). Triptans are not the preferred initial treatment for acute migraine headache in pregnant patients (ACOG 2022). Until additional data are available, almotriptan is not the preferred triptan when first-line therapy is ineffective. Triptans should be avoided in pregnant patients with cardiac disease or hypertension (ACOG 2022; CHS [Worthington 2013]).

Breastfeeding Considerations

Almotriptan is present in breast milk.

Data related to the presence of 5-HT1B/1D agonists (triptans) in breast milk is available from a study of 19 lactating women (6 weeks to 30 months postpartum) treated for migraine headaches. During the study, infants were fed previously expressed breast milk. Breast milk was sampled prior to and at intervals up to 24 hours after the dose in one patient taking almotriptan 12.5 mg. Using the average breast milk concentration observed, authors of the study calculated the estimated exposure of almotriptan to the breastfed infant to be 4.4 mcg/kg/day, providing a relative infant dose (RID) of 1.8% based on the weight-adjusted maternal dose. Using the maximum breast milk concentration, the RID of almotriptan was calculated to be 6.5%. A large interindividual variability among breast milk concentrations was found with all the triptans in the study, even when considering dose and dosage form (Amundsen 2021). In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The manufacturer recommends that caution be exercised when administering almotriptan to lactating patients. Treatment for migraine headaches in lactating patients should be individualized (AHS [Ailani 2021]). Withholding breastfeeding for 24 hours after the maternal dose will minimize infant exposure via breast milk. The decision to withhold breastfeeding following a dose of almotriptan should be part of a shared decision-making process (ACOG 2022).

Monitoring Parameters

Headache severity, BP, signs/symptoms suggestive of angina; perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease), monitor ECG with first dose in patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, and consider periodic cardiovascular evaluation in such patients if they are intermittent long-term users.

Mechanism of Action

Selective agonist for serotonin (5-HT1B and 5-HT1D receptors) in cranial arteries; causes vasoconstriction and reduces sterile inflammation associated with antidromic neuronal transmission correlating with relief of migraine

Pharmacokinetics (Adult Data Unless Noted)

Note: Reported values are similar between adolescent and adult patients (Baldwin 2004).

Absorption: Well absorbed

Distribution: Vd: ~180 to 200 L

Protein binding: ~35%

Metabolism: Via MAO type A oxidative deamination (~27% of dose) and CYP3A4 and 2D6 (~12% of dose) to inactive metabolites

Bioavailability: ~70%

Half-life elimination: Mean: 3 to 5 hours (Baldwin 2004; McEnroe 2005)

Time to peak, plasma: 1 to 3 hours

Excretion: Urine (~75%; ~40% of total dose as unchanged drug); feces (~13% of total dose as unchanged drug and metabolites)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Clearance is decreased approximately 65% in those with CrCl 10 to 30 mL/minute and decreased approximately 40% in those with CrCl 31 to 71 mL/minute. Cmax increased approximately 80%.

Hepatic function impairment: The maximum decrease expected in almotriptan clearance due to hepatic function impairment would be 60%.

Older adult: A longer terminal half-life (3.7 vs 3.2 h) and a 25% higher AUC has been observed in elderly patients.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Almogran;
  • (BD) Bangladesh: Almitan | Altrip;
  • (BE) Belgium: Almogran | Almotriptan;
  • (DE) Germany: Almogran | Almotriptan | Dolortriptan bei migraene;
  • (EE) Estonia: Almotriptan zentiva;
  • (EG) Egypt: Almotrip forte | Migratrend | Migrostop | Triptagrain;
  • (ES) Spain: Almogran | Almotriptan cinfa | Almotriptan combix | Almotriptan kern pharma | Almotriptan mylan | Almotriptan normon | Almotriptan ratiopharm | Almotriptan sandoz | Almotriptan stada | Almotriptan Teva | Almotriptan vir | Amignul | Riptanax;
  • (ET) Ethiopia: Almotan;
  • (FI) Finland: Almogran | Almotriptan orifarm | Almotriptan sandoz;
  • (FR) France: Almogran | Almotriptan arrow | Almotriptan biogaran | Almotriptan eg | Almotriptan mylan | Almotriptan sandoz | Almotriptan Teva | Almotriptan zentiva | Almotriptan Zydus;
  • (GB) United Kingdom: Almogran | Almotriptan;
  • (GR) Greece: Almogran;
  • (IE) Ireland: Almogran;
  • (IN) India: Almigra | Almogril | Almotan;
  • (IT) Italy: Almogran | Almotrex | Almotriptan Aurobindo | Almotriptan doc generici | Almotriptan eg | Almotriptan mylan | Almotriptan sandoz | Almotriptan teva italia | Almotriptan zentiva;
  • (KR) Korea, Republic of: Almogran;
  • (LB) Lebanon: Almovitae;
  • (LT) Lithuania: Almotriptan zentiva;
  • (LU) Luxembourg: Almogran | Almotriptan;
  • (LV) Latvia: Almotriptan zentiva;
  • (MX) Mexico: Almogran;
  • (NL) Netherlands: Almogran | Almotriptan eureco pharma | Almotriptan sandoz;
  • (NO) Norway: Almogran | Almotriptan orifarm;
  • (PL) Poland: Almozen;
  • (PR) Puerto Rico: Almotriptan | Axert;
  • (PT) Portugal: Almogran;
  • (SE) Sweden: Almogran | Almotriptan 2care4 | Almotriptan orifarm
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  23. Refer to manufacturer's labeling.
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