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Rizatriptan Benzoate (Rizatriptan Benzoate)

Trade Name : Rizatriptan Benzoate

Teva Pharmaceuticals USA, Inc.

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 (Rizatriptan Benzoate) which is also known as Rizatriptan Benzoate and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 5 mg/1 per ml. Read more

Rizatriptan Benzoate (Rizatriptan Benzoate) 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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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
  • Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
  • Limitations of Use
  • Rizatriptan benzoate tablets are a serotonin (5-HT) 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 < 40 kg (88 lbs); 10 mg single dose in patients 40 kg (88 lbs) or more ()
  • Adjust dose if coadministered with propranolol ()
  • Rizatriptan Benzoate Tablets: 5 mg and 10 mg ()
  • Rizatriptan benzoate tablets are 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 excipientsu00a0()
  • 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 u2265 5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness ()
  • To report SUSPECTED ADVERSE REACTIONS, u00a0at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()
  • No overdoses of rizatriptan benzoate were reported during clinical trials in adults.
  • Some adult patients who received 40 mg of rizatriptan 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 rizatriptan, 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 rizatriptan benzoate orally disintegrating tablets 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 rizatriptan benzoate, 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 rizatriptan benzoate. 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.
  • Rizatriptan Benzoate Tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine (5-HT) receptor agonist.
  • Rizatriptan benzoate, USP is described chemically as: ,-dimethyl-5-(1-1,2,4-triazol-1-ylmethyl)-1-indole-3-ethanamine monobenzoate and its structural formula is:
  • CHNu2022CHO M.W. 391.47
  • The molecular weight of the free base is 269.4. Rizatriptan benzoate, USP is a white to almost white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25u00b0C.
  • Rizatriptan Benzoate Tablets USP 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, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.
  • No data
  • Carcinogenesis
  • Oral carcinogenicity studies of rizatriptan were conducted in mice (100 weeks) and rats (106 weeks) at doses of up to 125 mg/kg/day. There was no evidence of an increase in tumor incidence related to rizatriptan in either species. Plasma exposures (AUC) at the highest dose tested were approximately 150 (mice) and 240 times (rats) that in humans at the maximum recommended human dose (MRHD) of 30 mg/day.
  • Mutagenesis
  • Rizatriptan was neither mutagenic nor clastogenic in a battery of and genetic toxicity studies, including: the microbial mutagenesis (Ames) assay, mammalian cell mutagenesis and chromosomal aberration assays, and the chromosomal aberration assay in mouse.
  • Impairment of Fertility
  • Oral administration of rizatriptan (0, 2, 10, or 100 mg/kg/day) to female rats prior to and during mating and continuing throughout gestation and lactation resulted in no effect on fertility; however, altered estrous cyclicity and delays in time to mating were observed at the highest dose tested. Plasma exposure at the no-effect dose (10 mg/kg/day) for reproductive toxicity was approximately 15 times that in humans at the MRHD.
  • Oral administration of rizatriptan (0, 5, 35, or 250 mg/kg/day) to male rats prior to and during mating resulted in no impairment of fertility or reproductive performance. Plasma exposure (AUC) at the highest dose tested was approximately 550 times that in humans at the MRHD.
  • No data
  • Rizatriptan Benzoate Tablets USP are supplied as follows:
  • 5 mg (base) u2013 white to off-white, unscored, capsule-shaped tablets, one side of the tablet debossed with the number u201c93u201d, the other side debossed with the number u201c7471u201d, in unit dose boxes of 18 (6x3), NDC 0093-7471-43.
  • 10 mg (base) u2013 white to off-white, unscored, capsule-shaped tablets, one side of the tablet debossed with the number u201c93u201d, the other side debossed with the number u201c7472u201d, in unit dose boxes of 18 (6x3), NDC 0093-7472-43.
  • Storage
  • 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).
  • Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-Related Events, and Cerebrovascular Events
  • Inform patients that rizatriptan benzoate tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke. 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 sign or symptoms. Patients should be apprised of the importance of this follow-up [].
  • Serotonin Syndrome
  • Patients should be cautioned about the risk of serotonin syndrome with the use of rizatriptan benzoate tablets or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [].
  • Pregnancy
  • Inform patients that rizatriptan benzoate tablets should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [].
  • Arrayn- Lactation
  • Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [].
  • Ability To Perform Complex Tasks
  • Since migraines or treatment with rizatriptan benzoate tablets may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of rizatriptan benzoate tablets.
  • 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) [].
  • Manufactured In Canada By:
  • Arrayn- Teva Canada Limited
  • Toronto, Canada M1B 2K9
  • Manufactured For:
  • Arrayn- Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. F 10/2019
  • Arrayn- Rizatriptan Benzoate (RYE-za-TRIP-tan BEN-zo-ATE) Tablets USP
  • Read this Patient Information before you start taking rizatriptan benzoate tablets and 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.
  • What is rizatriptan benzoate?
  • Rizatriptan benzoate is a prescription medicine that belongs to a class of medicines called Triptans. Rizatriptan benzoate is available as a tablet.
  • Rizatriptan benzoate tablets are used to treat migraine attacks with or without aura in adults and in children 6 to 17 years of age.
  • Rizatriptan benzoate is not to be used to prevent migraine attacks.
  • Rizatriptan benzoate is not for the treatment of hemiplegic or basilar migraines.
  • It is not known if rizatriptan benzoate is safe and effective for the treatment of cluster headaches.
  • It is not known if taking more than 1 dose of rizatriptan benzoate in 24 hours is safe and effective in children 6 to 17 years of age.
  • It is not known if rizatriptan benzoate is safe and effective in children under 6 years of age.
  • Who should not take rizatriptan benzoate tablets?
  • Do not take rizatriptan benzoate tablets 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 rizatriptan benzoate tablets?
  • Before you take rizatriptan benzoate tablets,
  • Tell your doctor about all the medicines you take,
  • Rizatriptan benzoate tablets and other medicines may affect each other causing side effects. Rizatriptan benzoate tablets may affect the way other medicines work, and other medicines may affect how rizatriptan benzoate tablets work.u00a0
  • 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 rizatriptan benzoate tablets?
  • What should I avoid while taking rizatriptan benzoate tablets?
  • Rizatriptan benzoate tablets 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 rizatriptan benzoate tablets?
  • Rizatriptan benzoate tablets may cause serious side effects.
  • The most common side effects of rizatriptan benzoate tablets in adults include:
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • If you take rizatriptan benzoate tablets 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 rizatriptan benzoate tablets.
  • These are not all the possible side effects of rizatriptan benzoate tablets. 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 rizatriptan benzoate tablets?
  • Keep rizatriptan benzoate tablets and all medicines out of the reach of children.
  • General Information about the safe and effective use of rizatriptan benzoate tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use rizatriptan benzoate tablets for a condition for which they were not prescribed. Do not give rizatriptan benzoate tablets to other people, even if they have the same symptoms that you have. They may harm them.
  • This Patient Information leaflet summarizes the most important information about rizatriptan benzoate tablets. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about rizatriptan benzoate tablets that is written for health professionals.
  • For more information, call 1-888-838-2872.
  • What are the ingredients in rizatriptan benzoate tablets?
  • Active ingredient:
  • Inactive ingredients:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured In Canada By:
  • Arrayn- Teva Canada Limited
  • Toronto, Canada M1B 2K9
  • Manufactured For:
  • Arrayn- Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. D 10/2019
  • No data
  • No data

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