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Almotriptan (Almotriptan)

Trade Name : almotriptan

Ajanta Pharma Limited

TABLET, FILM COATED

Strength 6.25 mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Almotriptan (Almotriptan) which is also known as almotriptan and Manufactured by Ajanta Pharma Limited. It is available in strength of 6.25 mg/1 per ml. Read more

Almotriptan (Almotriptan) 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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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.

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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.

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About GNH

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.

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.

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  • No data
  • Almotriptan tablets, USPu00a0are 5HTreceptor agonist (triptan) indicated for:
  • Important limitations:
  • No data
  • 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 tablets, USP are available as white, circular, biconvex, film-coated tablets in the following dosage strengths:
  • 6.25 mg tablet debossed with u2018A1u2019 on one side and plain on other side.
  • 12.5 mg tablet debossed with u2018A2u2019 on one side and plain on other side.
  • Tablets: 6.25 mg and 12.5 mg ()
  • No data
  • 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 tablets 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 tablets ()
  • No data
  • Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm ()
  • It is strongly recommended that almotriptan tablets 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 tablets use in the absence of known cardiovascular disease. If almotriptan tablets are 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 ()
  • 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 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 n
  • The following adverse reactions are discussed in more detail in other sections of the labeling:u00a0
  • Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of almotriptan tablets u00a0and 386 adult patients who received placebo. The most common adverse reactions during treatment with almotriptan tabletswere 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.
  • The most common adverse reactions (u22651% and greater than placebo) are:
  • In adults: nausea, dry mouth and paresthesia ()
  • In adolescents: dizziness, somnolence, headache, paresthesia, nausea and vomiting ()
  • No data
  • Do not use almotriptan tablets and ergotamine-containing or ergot-type medications within 24 hours of each other (, )
  • Do not use almotriptan tablets 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 tablets 6.25 mg; maximum almotriptan tablets daily dose 12.5 mg ()
  • No data
  • Pregnancy: based on animal data, may cause fetal harm ()
  • Nursing mothers: use almotriptan tablets with caution ()
  • Pediatric use: almotriptan tablets have 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 tablets, USP contain almotriptan malate USP, 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:
  • Its empirical formula is CHNOS-CHO, representing a molecular weight of 469.55. Almotriptan is a white to off-white crystalline powder that is soluble in water. Almotriptan tablets, USPu00a0for oral administration contains almotriptan malate equivalent to 6.25 or 12.5 mg of almotriptan. Each compressed tablet contains the following inactive ingredients: mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, sodium stearyl fumarate, polyethylene glycols, titanium dioxide and hypromelloses.
  • No data
  • Carcinogenesis
  • Mutagenesis
  • in vitro
  • in vivo
  • Impairment of Fertility
  • No data
  • Almotriptan tablets, USPu00a0are available as follows:
  • 6.25 mg:
  • Carton of 6 tablets. Single blister of 6 tablets in each carton. NDC 27241-041-11u00a0
  • Blister of 6 tablets NDC 27241-041-68
  • 12.5 mg:
  • Carton of 12 tablets. Two blisters of 6 tablets in each carton. NDC 27241-042-21
  • Blister of 6 tablets NDC 27241-042-68
  • Store at 25u00b0C (77u00b0F); excursions permitted from 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [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 .
  • Hypersensitivity
  • Inform patients to tell their physician if they develop a rash, itching, or breathing difficulties after taking almotriptan tabletsn .
  • Risk of Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, Other Vasospasm-Related Events, and Cerebrovascular Events
  • Inform patients that almotriptan tabletsmay 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, or 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 n
  • Serotonin Syndrome
  • Caution patients about the risk of serotonin syndrome with the use of almotriptan tablets or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) n
  • 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 n- Array
  • 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 tablets 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 tablets to gauge whether it affects their mental or visual performance adversely.
  • Marketed by:
  • Ajanta Pharma USA Inc.
  • Bridgewater, NJ 08807.
  • Made in India.
  • Revised: 12/2017n n
  • PATIENT INFORMATION
  • Almotriptan
  • (al'' moe trip' tan)
  • Tablets, USP
  • What is the most important information I should know about
  • almotriptan tablets?
  • Almotriptan
  • tablets can cause serious side effects, including:
  • Heart attack and other heart problems. Heart problems may lead to death.
  • Stop taking almotriptan tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack:
  • Almotriptan tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem.u00a0 You have a higher risk for heart disease if you:
  • What are
  • almotriptan tablets?
  • Do not take
  • almotriptan tablets if you:
  • Ask your doctor if you are not sure if your medicine is listed above.
  • Before you take almotriptan tablets, tell your doctor about all of your medical conditions, including if you:
  • Tell
  • your doctor about all the medicines you take,
  • Also tell your doctor if you take certain other types of medicines used to treat fungal infection (such as ketoconazole or itraconazole) or to treat HIV/AIDS (such as ritonavir).
  • Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
  • How should I take almotriptan tablets?
  • What should I avoid while taking almotriptan tablets?
  • Almotriptan tablets may cause dizziness, sleepiness, and problems seeing. Do not drive, operate machinery, or do other dangerous activities until you know how almotriptan tablets affects you.
  • What are the possible side effects of almotriptan tablets?
  • Almotriptan tablets may cause serious side effects, including:
  • Symptoms of gastrointestinal and colonic ischemic events include:
  • Symptoms of peripheral vascular ischemia include:
  • The most common side effects of almotriptan tablets in adults are:
  • T
  • he most common side effects of almotriptan tablets in adolescents are:
  • These are not all the possible side effects of almotriptan tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store almotriptan tablets?
  • Keep almotriptan tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of almotriptan tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use almotriptan tablets for a condition for which it was not prescribed. Do not give almotriptan tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about almotriptan tablets that is written for health professionals.
  • What are the ingredients in almotriptan tablets?
  • Active ingredient:
  • Inactive ingredients:
  • Marketed by:
  • Ajanta Pharma USA Inc
  • Bridgewater, NJ 08807.
  • Made in India.
  • This Patient Information has been approved by the U.S. Food and Drug Administration
  • Revised: 12/2017
  • No data
  • NDC 27241-041-11
  • Almotriptan Tablets, USP
  • 6.25 mg 6 Tablets (1x6 unit dose) Rx only
  • Ajanta Pharma Limited
  • NDC 27241-042-21
  • Almotriptan Tablets, USP
  • 12.5 mgu00a0 12 Tablets (2x6 unit dose)
  • Rx only
  • Ajanta Pharma Limited

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