Sandoz Almotriptan

Sandoz Almotriptan Uses, Dosage, Side Effects, Food Interaction and all others data.

Sandoz Almotriptan is a selective and potent serotonin (5 HT1B/1D) agonist. Sandoz Almotriptan binds to specific serotonin receptors on meningeal arteries inhibiting the release of vasoactive peptides and causing constriction of the arteries. It has a limited effect on arteries supplying blood to the brain and little effect on cardiac and pulmonary vessels.

Sandoz Almotriptan is a selective 5-hydroxytryptamine receptor subtype agonist indicated for the acute treatment of migraine attacks with or without aura in adults. Sandoz Almotriptan is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Sandoz Almotriptan is an agonist for a vascular 5-hydroxytryptamine receptor subtype (probably a member of the 5-HT1D family) having only a weak affinity for 5-HT1A, 5-HT5A, and 5-HT7 receptors and no significant affinity or pharmacological activity at 5-HT2, 5-HT3 or 5-HT4 receptor subtypes or at alpha1-, alpha2-, or beta-adrenergic, dopamine1,; dopamine2; muscarinic, or benzodiazepine receptors. This action in humans correlates with the relief of migraine headache. In addition to causing vasoconstriction, experimental data from animal studies show that Sandoz Almotriptan also activates 5-HT1 receptors on peripheral terminals of the trigeminal nerve innervating cranial blood vessels, which may also contribute to the antimigrainous effect of Sandoz Almotriptan in humans.

Trade Name Sandoz Almotriptan
Availability Prescription only
Generic Almotriptan
Almotriptan Other Names Almotriptan
Related Drugs Ubrelvy, Botox, diclofenac, celecoxib, metoclopramide, sumatriptan, Imitrex, Reglan
Type
Formula C17H25N3O2S
Weight Average: 335.464
Monoisotopic: 335.166747749
Protein binding

35%

Groups Approved, Investigational
Therapeutic Class 5-HT Agonists
Manufacturer
Available Country Canada, United States
Last Updated: September 19, 2023 at 7:00 am
Sandoz Almotriptan
Sandoz Almotriptan

Uses

Adults: Sandoz Almotriptan 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: Sandoz Almotriptan 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).

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

Sandoz Almotriptan is also used to associated treatment for these conditions: Migraine

How Sandoz Almotriptan works

Sandoz Almotriptan binds with high affinity to human 5-HT1B and 5-HT1D receptors leading to cranial blood vessel constriction.

Dosage

Sandoz Almotriptan dosage

The recommended dose of Sandoz Almotriptan 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 Sandoz Almotriptan (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.

Sandoz Almotriptan 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.

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

Sandoz Almotriptan 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 Sandoz Almotriptan

Sandoz Almotriptan contains Almotriptan see full prescribing information from innovator Sandoz Almotriptan Monograph, Sandoz Almotriptan MSDS, Sandoz Almotriptan FDA label

*** Taking medicines without doctor's advice can cause long-term problems.
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