Amignul

Uses

Adults: Amignul malate tablets are used for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.

Adolescents Age 12 to 17 Years: Amignul malate tablets are used 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).

Amignul is the only oral triptan approved in the USA for the treatment of migraine in adolescent from 12 to 17 years of age.

Amignul is also used to associated treatment for these conditions: Migraine

How Amignul works

Amignul binds with high affinity to human 5-HT_1B and 5-HT_1D receptors leading to cranial blood vessel constriction.

Dosage

Amignul dosage

The recommended dose of Amignul 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. If the headache is relieved after the initial Amignul (almotriptan malate) dose but returns, the dose may be repeated after 2 hours. 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.

Side Effects

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 (Coronary Artery Disease).

Precaution

Hypersensitivity to the active substance or to any of the excipients. Patients with severe hepatic impairment, with a previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA) Peripheral vascular disease.

Interaction

These drugs have been reported to cause prolonged vasospastic reactions. 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).

Food Interaction

• Take with or without food. The absorption is unaffected by food.

Amignul Cholesterol interaction

[Major] The group of drugs known as 5-hydroxytryptamine1 receptor (5-HT1) agonists can cause vasospastic reactions, including coronary vasospasm, peripheral vascular ischemia, and colonic ischemia.

Rarely, serious adverse cardiac events including acute myocardial infarction, arrhythmia, cardiac arrest, and death have been reported within a few hours following the administration of 5-HT1 agonists, in some cases even in patients with no prior history or findings of coronary artery disease (CAD).

Significant elevation in blood pressure, including hypertensive crisis, has also been reported on rare occasions in patients with and without a history of hypertension, as have transient increases in blood pressure and peripheral vascular resistance.

In general, patients with potentially unrecognized CAD as predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, tobacco use, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) should not be administered 5-HT1 agonists unless a cardiovascular evaluation provides satisfactory clinical evidence indicating the lack of CAD, ischemic heart disease, or other significant underlying cardiovascular disease.

As a precaution, the manufacturers recommend that the first dose be administered under medical surveillance in such patients, and that electrocardiographic monitoring be considered during the interval immediately following administration to help detect any asymptomatic cardiac ischemia that may occur.

Periodic cardiovascular evaluations should be performed during intermittent, long-term use.

Amignul Drug Interaction

Major: duloxetine, duloxetineUnknown: erenumab, erenumab, diphenhydramine, diphenhydramine, onabotulinumtoxinA, onabotulinumtoxinA, galcanezumab, galcanezumab, pregabalin, pregabalin, topiramate, topiramate, cyanocobalamin, cyanocobalamin, cholecalciferol, cholecalciferol, lisdexamfetamine, lisdexamfetamine

Amignul Disease Interaction

Major: CAD risk factors, cardiovascular disease, liver disease, renal dysfunction

Volume of Distribution

• 180 to 200 L

Half Life

3-4 hours

Clearance

• 57 L/h [healthy]
• 34.2 L/h [moderate renal impairment (creatinine clearance between 31 and 71 mL/min)]
• 9.8 L/h [severe renal impairment (creatinine clearance between 10 and 30 mL/min)]

Elimination Route

Amignul is eliminated primarily by renal excretion (about 75% of the oral dose), with approximately 40% of an administered dose excreted unchanged in urine. Approximately 13% of the administered dose is excreted via feces, both unchanged and metabolized.

Pregnancy & Breastfeeding use

Pregnancy Category C. There is no data regarding excretion of almotriptan in human milk.

Contraindication

As with other 5-HT1B/1D receptor agonists, almotriptan should not be used in patients with a history, symptoms or signs of ischaemic heart disease (myocardial infarction, angina pectoris, documented silent ischaemia, Prinzmetal's angina) or severe hypertension and uncontrolled mild or moderate hypertension. Concomitant administration with ergotamine, ergotamine derivatives (including methysergide) and other 5-HT1B/1D agonists is contraindicated.

Special Warning

Hepatic Impairment: The recommended starting dose of almotriptan malate in patients with hepatic impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period

Renal Impairment: The recommended starting dose of almotriptan malate 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

Acute Overdose

No case of overdose has been reported. The most frequently reported adverse event in patients receiving 150 mg (the highest dose administered to patients) was somnolence.

Storage Condition

Keep in a dry place away from light and heat. Keep out of the reach of children.

Innovators Monograph

You find simplified version here Amignul