Almotriptan Malate

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Overview

What is Almotriptan Malate?

Almotriptan tablets, USP contain almotriptan malate, a selective 5-hydroxytryptamine (5-HT) 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 CHNOS•CHO, 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.

What does Almotriptan Malate look like?

What are the available doses of Almotriptan Malate?

Tablets: 6.25 mg and 12.5 mg ()

What should I talk to my health care provider before I take Almotriptan Malate?

How should I use Almotriptan Malate?

Almotriptan tablets are a 5HT receptor agonist (triptan) indicated for:

Important Limitations:

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.

What interacts with Almotriptan Malate?

Sorry No Records found

What are the warnings of Almotriptan Malate?

Sorry No Records found

What are the precautions of Almotriptan Malate?

Sorry No Records found

What are the side effects of Almotriptan Malate?

Sorry No records found

What should I look out for while using Almotriptan Malate?

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What might happen if I take too much Almotriptan Malate?

How should I store and handle Almotriptan Malate?

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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5245-85carton 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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5246-85carton 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.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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5245-85carton 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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5246-85carton 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.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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5245-85carton 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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5246-85carton 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.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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5245-85carton 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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5246-85carton 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.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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5245-85carton 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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5246-85carton 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.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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5245-85carton 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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5246-85carton 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.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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5245-85carton 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 on one side of the tablet and on the other side. They are available as follows:NDC 0378-5246-85carton 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.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Almotriptan binds with high affinity to 5-HT, 5-HT, and 5-HT receptors. Almotriptan has weak affinity for 5-HT and 5-HT receptors, but has no significant affinity or pharmacological activity at 5-HT, 5-HT, 5-HT, 5-HT; alpha or beta adrenergic; adenosine (A, A); angiotensin (AT, AT); dopamine (D, D); endothelin (ET, ET); or tachykinin (NK, NK, NK) binding sites.

Non-Clinical Toxicology

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As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see ).

Monoamine Oxidase Inhibitors

(See , , and .)

Serotonergic Drugs

(See and .)

Drugs Affecting Hepatic Metabolism

The metabolism and pharmacokinetics of mirtazapine orally disintegrating tablets may be affected by the induction or inhibition of drug-metabolizing enzymes.

Drugs that are Metabolized by and/or Inhibit Cytochrome P450 Enzymes

Phenytoin In healthy male patients (n=18), phenytoin (200 mg daily) increased mirtazapine (30 mg daily) clearance about 2-fold, resulting in a decrease in average plasma mirtazapine concentrations of 45%. Mirtazapine did not significantly affect the pharmacokinetics of phenytoin.

Carbamazepine In healthy male patients (n=24), carbamazepine (400 mg b.i.d.) increased mirtazapine (15 mg b.i.d.) clearance about 2-fold, resulting in a decrease in average plasma mirtazapine concentrations of 60%.

When phenytoin, carbamazepine, or another inducer of hepatic metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased. If treatment with such a medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose.

Cimetidine In healthy male patients (n=12), when cimetidine, a weak inhibitor of CYP1A2, CYP2D6, and CYP3A4, given at 800 mg b.i.d. at steady state was coadministered with mirtazapine (30 mg daily) at steady state, the Area Under the Curve (AUC) of mirtazapine increased more than 50%. Mirtazapine did not cause relevant changes in the pharmacokinetics of cimetidine. The mirtazapine dose may have to be decreased when concomitant treatment with cimetidine is started, or increased when cimetidine treatment is discontinued.

Ketoconazole: In healthy, male, Caucasian patients (n=24), coadministration of the potent CYP3A4 inhibitor ketoconazole (200 mg b.i.d. for 6.5 days) increased the peak plasma levels and the AUC of a single 30-mg dose of mirtazapine by approximately 40% and 50%, respectively.

Caution should be exercised when coadministering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, or nefazodone.

Paroxetine: In an interaction study in healthy, CYP2D6 extensive metabolizer patients (n=24), mirtazapine (30 mg/day), at steady state, did not cause relevant changes in the pharmacokinetics of steady state paroxetine (40 mg/day), a CYP2D6 inhibitor.

Other Drug-Drug Interactions

Amitriptyline: In healthy, CYP2D6 extensive metabolizer patients (n=32), amitriptyline (75 mg daily), at steady state, did not cause relevant changes to the pharmacokinetics of steady state mirtazapine (30 mg daily); mirtazapine also did not cause relevant changes to the pharmacokinetics of amitriptyline.

Warfarin: In healthy male subjects (n=16), mirtazapine (30 mg daily), at steady state, caused a small (0.2) but statistically significant increase in the International Normalized Ratio (INR) in subjects treated with warfarin. As at a higher dose of mirtazapine, a more pronounced effect can not be excluded, it is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.

Lithium: No relevant clinical effects or significant changes in pharmacokinetics have been observed in healthy male subjects on concurrent treatment with subtherapeutic levels of lithium (600 mg/day for 10 days) at steady state and a single 30 mg dose of mirtazapine. The effects of higher doses of lithium on the pharmacokinetics of mirtazapine are unknown.

Risperidone: In an , nonrandomized, interaction study, subjects (n=6) in need of treatment with an antipsychotic and antidepressant drug, showed that mirtazapine (30 mg daily) at steady state did not influence the pharmacokinetics of risperidone (up to 3 mg b.i.d.).

Alcohol

Concomitant administration of alcohol (equivalent to 60 g) had a minimal effect on plasma levels of mirtazapine (15 mg) in 6 healthy male subjects. However, the impairment of cognitive and motor skills produced by mirtazapine were shown to be additive with those produced by alcohol. Accordingly, patients should be advised to avoid alcohol while taking mirtazapine orally disintegrating tablets.

Diazepam

Concomitant administration of diazepam (15 mg) had a minimal effect on plasma levels of mirtazapine (15 mg) in 12 healthy subjects. However, the impairment of motor skills produced by mirtazapine has been shown to be additive with those caused by diazepam. Accordingly, patients should be advised to avoid diazepam and other similar drugs while taking mirtazapine orally disintegrating tablets.

QTc-Prolonging Drugs

The risk of QT prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes) may be increased with concomitant use of medicines which prolong the QTc interval (e.g., some antipsychotics and antibiotics) and in case of mirtazapine overdose (see and sections).

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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 .

The following adverse reactions are discussed in more detail in other sections of the labeling:

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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