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Rizatriptan (Rizatriptan)

Trade Name : Rizatriptan

Bryant Ranch Prepack

TABLET, FILM COATED

Strength 10 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 (Rizatriptan) which is also known as Rizatriptan and Manufactured by Bryant Ranch Prepack. It is available in strength of 10 mg/1 per ml. Read more

Rizatriptan (Rizatriptan) 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
  • Ri
  • Limitations of Usen- [see Contraindications ]. n
  • Rizatriptan benzoate 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 n
  • u00a0Limitations of Use:n
  • No data
  • Adults: 5 mg or 10 mg single dose; separate repeat doses by at leastu00a0two hours; maximum dose in a 24-hour period: 30 mgu00a0n
  • Pediatric patients 6 to 17 years: 5 mg single dose in patients less than 40 kg (88 lb); 10 mg single dose in patientsu00a0 40 kg (88 lb) or moreu00a0()
  • Adjust dose if co-administered with propranolol ()
  • Rizatriptan Benzoate Tablets
  • u2022u00a0Rizatriptan Benzoate Tablets: 5 mg and 10 mg n
  • Rizatriptan benzoate tablets are contraindicated in patients with: u2022u00a0Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease u2022u00a0Coronary artery vasospasm including Prinzmetal's angina u2022u00a0History of stroke or transient ischemic attack (TIA) u2022u00a0Peripheral vascular disease (PVD) u2022u00a0Ischemic bowel disease u2022u00a0Uncontrolled hypertension u2022u00a0Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) u2022u00a0Hemiplegic or basilar migraine u00a0. u2022u00a0Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor u2022u00a0Hypersensitivity to rizatriptan or any of the excipients(angioedema and anaphylaxis seen) n
  • u2022u00a0History of ischemic heart disease or coronary artery vasospasm () u2022u00a0History of stroke or transient ischemic attack () u2022u00a0Peripheral vascular disease () u2022u00a0Ischemic bowel disease () u2022u00a0Uncontrolled hypertension () u2022u00a0Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan), or of an ergotamine-containing medicationu00a0() u2022u00a0Hemiplegic or basilar migraineu00a0() u2022u00a0MAO-A inhibitor used in the past 2 weeks () u2022u00a0Hypersensitivity to rizatriptan or any of the excipients()
  • u2022u00a0Myocardial ischemia, myocardial infarction, and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors () u2022u00a0Arrhythmias: Discontinue dosing if occurs () u2022u00a0Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk () u2022u00a0Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occursu00a0() u2022u00a0Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs () u2022u00a0Medication overuse headache: Detoxification may be necessaryu00a0() u2022u00a0Serotonin syndrome: Discontinue dosing if occurs ()
  • The following adverse reactions are discussed in more detail in other sections of the labeling: u2022u00a0Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina u2022u00a0Arrhythmias u2022u00a0Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure u2022u00a0Cerebrovascular Events u2022u00a0Other Vasospasm Reactions u2022u00a0Medication Overuse Headache u2022u00a0Serotonin Syndrome u2022u00a0Increase in Blood Pressure n
  • The most common adverse reactions in adults were (incidence u2265 5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness n n n
  • No data
  • u2022u00a0Pregnancy: Based on animal data, may cause fetal harmu00a0n
  • No overdoses of rizatriptan benzoate were reported during clinical trials in adults.
  • Some adult patients who received 40 mg of rizatriptan benzoate 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 benzoate, 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.u00a0
  • 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 contain 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 molecular formula is CHNCHO, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP 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.
  • Rizatriptan benzoate tablets are available for oral administration in strengths of 5 mg 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 maize starch, ferric oxide (red), and magnesium stearate.
  • No data
  • Carcinogenesisn
  • Mutagenesis
  • in vitro
  • in vivo
  • in vitro
  • in vivo
  • Impairment of Fertilityn
  • No data
  • Product: 71335-1352
  • NDC: 71335-1352-1 10 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-1352-2 6 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-1352-3 90 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-1352-4 9 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-1352-5 30 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-1352-6 18 TABLET, FILM COATED in a BOTTLE
  • NDC: 71335-1352-7 12 TABLET, FILM COATED in a BOTTLE
  • 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 Eventsn- Arrayn- [see Warnings and Precautions (, , , )]
  • Serotonin Syndromen n- [see Warnings and Precautions (), Drug Interactions (), and Clinical Pharmacology ()]
  • Pregnancyn n- [see Use in Specific Populations ()]
  • Lactationn n- [see Use in Specific Populations ()].
  • Ability to Perform Complex Tasksn
  • Medication Overuse Headachen n- [see Warnings and Precautions ()]n- Macleods Pharma USA, Inc.
  • .
  • .
  • RIZATRIPTAN BENZOATE TABLETS
  • u00a0
  • 5 mg and 10 mg
  • Read this Patient Information before you start taking rizatriptan benzoate 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 tablet?
  • u00a0
  • Rizatriptan benzoate tablet is a prescription medicine that belongs to a class of medicines called Triptans.
  • Rizatriptan benzoate is available as a traditional 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 tablet is not to be used to prevent migraine attacks.
  • Rizatriptan benzoate tablet is not for the treatment of hemiplegic or basilar migraines.
  • It is not known if rizatriptan benzoate tablet is safe and effective for the treatment of cluster headaches.n It is not known if taking more than 1 dose of rizatriptan benzoate tablet in 24 hours is safe and effective in children 6 to 17 years of age.
  • It is not known if rizatriptan benzoate tablet is safe and effective in children under 6 years of age.n n n
  • Do not take rizatriptan benzoate tablets if you:n
  • u2022u00a0have or have had heart problems u2022u00a0have or have had a stroke or a transient ischemic attack (TIA) u2022u00a0have or have had blood vessel problems including ischemic bowel disease u2022u00a0have uncontrolled high blood pressure u2022u00a0have taken other Triptan medicines in the last 24 hours u2022u00a0have taken ergot-containing medicines in the last 24 hours u2022u00a0have hemiplegic or basilar migraines u2022u00a0take monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor within the last 2 weeks u2022u00a0are allergic to rizatriptan benzoate or any of the ingredients in rizatriptan benzoate tablets. See the end of this leaflet for a complete list of ingredients in rizatriptan benzoate tablets.n
  • 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.n n n n tell your doctor if you:n u2022u00a0have or have had heart problems, high blood pressure, chest pain, or shortness of breath u2022u00a0have any risk factors for heart problems or blood vessel problems such as:n ou00a0high blood pressure ou00a0high cholesterol ou00a0smoking ou00a0obesity ou00a0diabetes ou00a0family history of heart problems ou00a0you are post menopausal ou00a0you are a male over 40
  • u2022u00a0have kidney or liver problems u2022u00a0have any other medical condition u2022u00a0are pregnant or plan to become pregnant. It is not known if rizatriptan benzoate tablets will harm your unborn baby. If you become pregnant while taking rizatriptan benzoate tablets, talk to your healthcare provider. u2022u00a0are breastfeeding or plan to breastfeed. It is not known if rizatriptan benzoate passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take rizatriptan benzoate tablets.n n including prescription and nonprescription medicines, vitamins, and herbal supplements.
  • 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.n n u2022u00a0propranolol containing medicines such as Inderal, Inderal LA, or Innopran XLn u2022u00a0medicines used to treat mood disorders, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
  • 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.n n u2022u00a0Take rizatriptan benzoate tablets exactly as your doctor tells you to take it. u2022u00a0Your doctor will tell you how much rizatriptan benzoate to take and when to take it. u2022u00a0If your headache comes back after your first rizatriptan benzoate tablets dose: ou00a0For adults: a second dose may be taken 2 hours after the first dose. Do not take more than 30 mg of rizatriptan benzoate tablets in a 24-hour period (for example, do not take more thanu00a03 10-mg tablets in a 24-hour period). o For children 6 to 17 years of age: It is not known if taking more than 1 dose of rizatriptan benzoate tablets in 24 hours is safe and effective. Talk to your doctor about what to do if your headache does not go away or comes back.
  • u2022u00a0If you take too much rizatriptan benzoate, call your doctor or go to the nearest hospital emergency room right away.n n n
  • 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.n- heart attack.n- stroke.
  • u2022u00a0 Symptoms of blood vessel problems may include: ou00a0stomach pain ou00a0bloody diarrhea ou00a0vision problems ou00a0coldness and numbness of hands and feetn u2022u00a0 A condition called serotonin syndrome can happen when Triptan medicines such as rizatriptan benzoate tablets are taken with certain other medicines. Symptoms of serotonin syndrome may include: ou00a0agitation ou00a0hallucinations ou00a0coma ou00a0fast heartbeat ou00a0fast changes in your blood pressure ou00a0increased body temperature ou00a0muscle spasm ou00a0loss of coordination ou00a0nausea, vomiting or diarrhea
  • u2022u00a0n
  • The most common side effects of rizatriptan benzoate tablets in adults include: u2022u00a0feeling sleepy or tired u2022u00a0pain or pressure in your chest or throat u2022u00a0dizzinessn 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?
  • u2022u00a0Store rizatriptan benzoate tablets at room temperature between 59u00b0F to 86u00b0F (15u00b0C to 30u00b0C). u2022u00a0Safely throw away medicine that is out of date or no longer needed.
  • Keep rizatriptan benzoate tablets and all medicines out of the reach of children.n
  • General Information about the safe and effective use of rizatriptan benzoate tablets
  • For more information, callu00a0 Macleods Pharma USA, Inc at1-888-943-3210 or 1-855-926-3384.
  • What are the ingredients in rizatriptan benzoate tablets? Active ingredient:
  • Inactive ingredients in rizatriptan benzoate tablets:n
  • u00a0n
  • u00ae* The brand names mentioned are registered trademarks of their respective manufacturers.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:
  • Macleods Pharma USA, Inc.n
  • Manufactured by:
  • Macleods Pharmaceutical Ltd.n
  • Revised: 11/ 2019
  • No data

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