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Rizatriptan Benzoate (Maxalt)

Trade Name : MAXALT

Merck Sharp & Dohme Corp.

TABLET

Strength 5 mg/1

RIZATRIPTAN BENZOATE Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]

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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 Rizatriptan Benzoate (Maxalt) which is also known as MAXALT and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 5 mg/1 per ml. Read more

Rizatriptan Benzoate (Maxalt) 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.

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
  • ttMAXALT and MAXALT-MLT are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. tttttt
  • Limitations of Use
  • MAXALT is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age ()
  • Limitations of Use
  • Use only after clear diagnosis of migraine has been established ()
  • Not indicated for the prophylactic therapy of migraine ()
  • Not indicated for the treatment of cluster headache ()
  • No data
  • Adults: 5 or 10 mg single dose; separate repeat doses by at least two hours; maximum dose in a 24-hour period: 30 mg ()
  • Pediatric patients 6 to 17 years: 5 mg single dose in patients less than 40 kg (88 lb); 10 mg single dose in patients 40 kg (88 lb) or more ()
  • Adjust dose if co-administered with propranolol ()
  • No data
  • MAXALT Tablets: 5 and 10 mg ()
  • MAXALT-MLT Orally Disintegrating Tablets: 5 and 10 mg ()
  • MAXALT is contraindicated in patients with:
  • History of ischemic heart disease or coronary artery vasospasm ()
  • History of stroke or transient ischemic attack ()
  • Peripheral vascular disease ()
  • Ischemic bowel disease ()
  • Uncontrolled hypertension ()
  • Recent (within 24 hours) use of another 5-HT agonist (e.g., another triptan), or of an ergotamine-containing medication ()
  • Hemiplegic or basilar migraine ()
  • MAO-A inhibitor used in the past 2 weeks ()
  • Hypersensitivity to rizatriptan or any of the excipients ()
  • No data
  • Myocardial ischemia, myocardial infarction, and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ()
  • Arrhythmias: Discontinue dosing if occurs ()
  • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk ()
  • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs ()
  • Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs ()
  • Medication overuse headache: Detoxification may be necessary ()
  • Serotonin syndrome: Discontinue dosing if occurs ()
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • The most common adverse reactions in adults were (incidence u22655% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()
  • Phenylketonurics: MAXALT-MLT contains phenylalanine ()
  • No overdoses of MAXALT were reported during clinical trials in adults.
  • Some adult patients who received 40 mg of MAXALT either a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence.
  • In a clinical pharmacology study in which 12 adult subjects received MAXALT, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence.
  • In the long-term, open label study, involving 606 treated pediatric migraineurs 12 to 17 years of age (of which 432 were treated for at least 12 months), 151 patients (25%) took two 10-mg doses of MAXALT-MLT within a 24-hour period. Adverse reactions for 3 of these patients included abdominal discomfort, fatigue, and dyspnea.
  • In addition, based on the pharmacology of MAXALT, hypertension or myocardial ischemia could occur after overdosage. Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with MAXALT. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
  • The effects of hemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.
  • MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine(5-HT) receptor agonist.
  • Rizatriptan benzoate is described chemically as: -dimethyl-5-(1-1,2,4-triazol-1-ylmethyl)-1-indole-3-ethanamine monobenzoate and its structural formula is:
  • Its empirical formula is CHNu2022CHO, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25u00b0C.
  • MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate.
  • Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor.
  • No data
  • No data
  • No data
  • No. 3732 u2014 MAXALT Tablets, 5 mg, are pale pink, capsule-shaped, compressed tablets coded MRK on one side and 266 on the other:
  • NDC
  • No. 3733 u2014 MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other:
  • NDC
  • No. 3800 u2014 MAXALT-MLT Orally Disintegrating Tablets, 5 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified triangle on one side, and measuring 10.0-11.5 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows:
  • NDC
  • No. 3801 u2014 MAXALT-MLT Orally Disintegrating Tablets, 10 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows:
  • NDC
  • Storage
  • Store MAXALT Tablets at room temperature, 15u00b0C-30u00b0C (59u00b0F-86u00b0F).
  • Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15u00b0C-30u00b0C (59u00b0F-86u00b0F).
  • tttttttAdvise the patient to read the FDA-approved patient labeling (Patient Information).
  • MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are distributed by:Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 1998-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk0462-t-tol-1910r013
  • Patient Informationn n rizatriptan benzoateTablets and Orally Disintegrating Tablets
  • Read this Patient Information before you start taking MAXALTand each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
  • Unless otherwise stated, the information in this Patient Information leaflet applies to both MAXALT Tablets and to MAXALT-MLT Orally Disintegrating Tablets.
  • What is MAXALT?
  • MAXALT is a prescription medicine that belongs to a class of medicines called Triptans. MAXALT is available as a traditional tablet (MAXALT) and as an orally disintegrating tablet (MAXALT-MLT).
  • MAXALT and MAXALT-MLT are used to treat migraine attacks with or without aura in adults and in children 6 to 17 years of age.
  • MAXALT is not to be used to prevent migraine attacks.
  • MAXALT is not for the treatment of hemiplegic or basilar migraines.
  • It is not known if MAXALT is safe and effective for the treatment of cluster headaches.
  • It is not known if taking more than 1 dose of MAXALT in 24 hours is safe and effective in children 6 to 17 years of age.
  • It is not known if MAXALT is safe and effective in children under 6 years of age.
  • Who should not take MAXALT?
  • Do not take MAXALT if you:
  • Talk to your doctor before taking this medicine if you have any of the conditions listed above or if you are not sure if you take any of these medicines.
  • What should I tell my doctor before taking MAXALT?
  • Before you take MAXALT,
  • Tell your doctor about all the medicines you take,
  • MAXALT and other medicines may affect each other causing side effects. MAXALT may affect the way other medicines work, and other medicines may affect how MAXALT works.
  • Especially tell your doctor if you take:
  • 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 and pharmacist when you get a new medicine.
  • How should I take MAXALT?
  • What should I avoid while taking MAXALT?
  • MAXALT may cause dizziness, weakness, or fainting. If you have these symptoms, do not drive a car, use machinery, or do anything that needs you to be alert.
  • What are the possible side effects of MAXALT?
  • MAXALT may cause serious side effects.
  • The most common side effects of MAXALT in adults include:
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • If you take MAXALT too often, this may result in you getting chronic headaches. In such cases, you should contact your doctor, as you may have to stop taking MAXALT.
  • These are not all the possible side effects of MAXALT. For more information, ask your doctor or pharmacist.
  • 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 MAXALT?
  • Keep MAXALT and all medicines out of the reach of children.
  • General Information about the safe and effective use of MAXALT.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MAXALT for a condition for which it was not prescribed. Do not give MAXALT to other people, even if they have the same symptoms that you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about MAXALT. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about MAXALT that is written for health professionals.
  • For more information, go to .
  • What are the ingredients in MAXALT?
  • Active ingredient in MAXALT and MAXALT-MLT orally disintegrating tablets:
  • rizatriptan benzoate.
  • Inactive ingredients in MAXALT:
  • Inactive ingredients in MAXALT-MLT orally disintegrating tablets:
  • MAXALT-MLT orally disintegrating tablets contain aspartame, a source of phenylalanine.
  • Phenylketonurics:
  • MAXALT-MLT orally disintegrating tablets 5-mg contain 1.1 mg of phenylalanine. MAXALT-MLT orally disintegrating tablets 10-mg contain 2.1 mg of phenylalanine.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are distributed by:Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • The brands listed are the trademarks of their respective owners.
  • Copyright u00a9 1998-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • Revised: 10/2019
  • usppi-mk0462-t-tol-1910r013
  • Maxaltn- (rizatriptan benzoate)
  • Arrayn- 5 mgn- Array
  • tttttttNDC 0006-0266-18 tttttt
  • Each tablet contains 7.265 mg of rizatriptan benzoate,equivalent to 5 mg rizatriptan.
  • 18 Tablets
  • USUAL DOSAGE:
  • Rx only
  • Manuf. by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China
  • Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn n Whitehouse Station, NJ 08889, USARizatriptan benzoate (active ingred.) Made in Ireland.Formulated in China.
  • Maxaltn (rizatriptan benzoate)10 mg TABLETS
  • NDC 0006-0267-18
  • Each tablet contains 14.53 mg of rizatriptan benzoate, equivalent to 10 mg rizatriptan.
  • 18 Tablets
  • USUAL DOSAGE:See accompanying circular.
  • Rx only
  • Manuf. by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, China Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889, USARizatriptan benzoate (active ingred.) Made in Ireland.Formulated in China.
  • Maxalt-MLTn- (rizatriptan benzoate)n n
  • Arrayn- 5 mg
  • tttttttNDC 0006-3800-18 tttttt
  • Each tablet contains 7.265 mg of rizatriptan benzoate, equivalent to 5 mg rizatriptan.
  • Phenylketonurics: contains phenylalanine (a component of aspartame) 1.05 mg per 5-mg orally disintegrating tablet.
  • 6 Carrying Cases, Each Containing3 Orally Disintegrating Tablets
  • USUAL DOSAGE
  • Rx only
  • Manuf. by: Catalent UK Swindon, Zydis Ltd.Swindon, Wiltshire, SN5 8RU, UK
  • Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn n Whitehouse Station, NJ 08889, USA
  • Rizatriptan benzoate (active ingred.) Made in Ireland.Formulated in UK.
  • Maxalt-MLTn (rizatriptan benzoate) ORALLY DISINTEGRATING TABLETS10 mg
  • NDC 0006-3801-18
  • Each tablet contains 14.53 mg of rizatriptan benzoate, equivalent to 10 mg rizatriptan.
  • Phenylketonurics: contains phenylalanine (a component of aspartame)2.10 mg per 10-mg orally disintegrating tablet.
  • 6 Carrying Cases, Each Containing3 Orally Disintegrating Tablets
  • USUAL DOSAGE: See accompanying circular.Rx only
  • Manuf. by: Catalent UK Swindon, Zydis Ltd.Swindon, Wiltshire, SN5 8RU, UK
  • Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889, USA
  • Rizatriptan benzoate (active ingred.) Made in Ireland.Formulated in UK.

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