Almotriptan Malate (Almotriptan Malate)

Trade Name : Almotriptan Malate

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 6.25 mg/1

Storage and handling for Almotriptan Malate

ALMOTRIPTAN MALATE Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Almotriptan Malate (Almotriptan Malate) which is also known as Almotriptan Malate and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 6.25 mg/1 per ml. Read more

Almotriptan Malate (Almotriptan Malate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

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

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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 ()
Patients with hepatic or severe renal impairment: 6.25 mg starting dose; maximum daily dose 12.5 mg (, )

Almotriptan malate tablets are available as white, film-coated, round, convex tablets in the following strengths:
6.25 mg tablet debossed with u201c93u201d on one side and u201cA1u201d on the other side
12.5 mg tablet debossed with u201c93u201d on one side and u201cA2u201d on the other side
Tablets: 6.25 mg and 12.5 mg ()

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Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease ()
Cerebrovascular syndromes (e.g., history of stroke or TIA) ()
Peripheral vascular disease (including ischemic bowel disease) ()
Uncontrolled hypertension ()
Do not use almotriptan malate within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT agonist, e.g., another triptan (, )
Hemiplegic or basilar migraine ()
Known hypersensitivity to almotriptan malate ()

No data

Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm ()
It is strongly recommended that almotriptan malate 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 malate use in the absence of known cardiovascular disease. If almotriptan malate is considered, patients should first have a cardiovascular evaluation. If the evaluation is satisfactory, first dose should take place in a physicianu2019s office setting ()
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 ()
Cerebrovascular events, some fatal ()
Gastrointestinal ischemic events and peripheral vasospastic reactions (e.g., Raynaudu2019s syndrome) ()
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 (, )
Medication overuse headache: Detoxification may be necessary n
Increase in blood pressure, very rarely associated with significant clinical events (, )
Use with caution in patients with a known hypersensitivity to sulfonamides ()

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. 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 malate and 386 adult patients who received placebo. The most common adverse reactions during treatment with almotriptan malate 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 malate and 172 adolescent patients who received placebo. The most common adverse reactions during treatment with almotriptan malate 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 (u2265 1% and greater than placebo) are:
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In adults: nausea, dry mouth and paresthesia ()
In adolescents: dizziness, somnolence, headache, paresthesia, nausea and vomiting ()

No data

Do not use almotriptan malate and ergotamine-containing or ergot-type medications within 24 hours of each other (, )
Do not use almotriptan malate and other 5-HT agonists (e.g., triptans) within 24 hours of each other (, )
SSRI or SNRI: life-threatening serotonin syndrome reported during combined use with triptans (, )
Ketoconazole: use single dose of almotriptan malate 6.25 mg; maximum almotriptan malate daily dose 12.5 mg ()

No data

Pregnancy: based on animal data, may cause fetal harm ()
Nursing mothers: use almotriptan malate with caution (8.3)
Pediatric use: almotriptan malate has not been studied in children under 12 years ()
Geriatric use: insufficient safety and efficacy data; use with caution, usually starting with the 6.25 mg dose ()
Hepatic impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg (, )
Severe renal impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg (, )

No data

Almotriptan malate tablets 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(u00b1)-hydroxybutanedioate (1:1), and its structural formula is:
CHNOS-CHO M.W. 469.56
Almotriptan is a white to off white crystalline powder that is soluble in water. Almotriptan malate tablets for oral administration contain almotriptan malate equivalent to 6.25 mg or 12.5 mg of almotriptan. Each compressed tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, macrogol/PEG 8000, mannitol, microcrystalline cellulose, polydextrose FCC, povidone, sodium stearyl fumarate, titanium dioxide, and triacetin/glycerol triacetate.

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Carcinogenesis
Almotriptan was administered to mice and rats for up to 103 to 104 weeks at oral doses up to 250 mg/kg/day and 75 mg/kg/day, respectively. These doses were associated with plasma exposures (AUC) to parent drug that were approximately 40 and 80 times, in mice and rats respectively, the plasma AUC in humans at the maximum recommended human dose (MRHD) of 25 mg/day. Because of high mortality rates in both studies, which reached statistical significance in high-dose female mice, all female rats, all male mice, and high-dose female mice were terminated between weeks 96 and 98. There was no increase in tumors related to almotriptan administration.
Mutagenesis
Almotriptan was not mutagenic in two gene mutation assays, the Ames test, and the mouse lymphoma tk assay. Almotriptan was not clastogenic in an mouse micronucleus assay.
Impairment of Fertility
When male and female rats received almotriptan (25, 100, or 400 mg/kg/day) orally prior to and during mating and gestation, prolongation of the estrous cycle was observed at the mid-dose and greater, and fertility was impaired at the highest dose. Subsequent mating of treated with untreated animals indicated that the decrease in fertility was due to an effect on females. The no-effect dose for reproductive toxicity in rats (25 mg/kg/day) is approximately 10 times the MRHD on a mg/m basis.

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Almotriptan malate tablets are available as follows:
6.25 mg:
12.5 mg:
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].

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 n .n
Hypersensitivity
Inform patients to tell their physician if they develop a rash, itching, or breathing difficulties after taking almotriptan malate .
Risk of Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, Other Vasospasm-Related Events, and Cerebrovascular Events
Inform patients that almotriptan malate 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, 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 .
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome with the use of almotriptan malate or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
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) n .
Pregnancy
Advise patients to notify their physician if they become pregnant during treatment or intend to become pregnant .
Nursing Mothers
Advise patients to notify their physician if they are breastfeeding or plan to breastfeed .
Ability to Operate Machinery or Vehicles
Counsel patients that almotriptan malate 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 malate to gauge whether it affects their mental or visual performance adversely.
Distributed By:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. C 5/2017

This Patient Information has been approved by the U.S. Food and Drug Administration

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