Rizatriptan Benzoate (Rizatriptan Benzoate)

Trade Name

Rizatriptan Benzoate

Active Ingredient

Power

5 mg/1

Type / form

Tablets

Status

Manufacturer

Mylan Pharmaceuticals Inc.

Storage and handling for Rizatriptan Benzoate

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

Disclaimer

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 Mylan Pharmaceuticals 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

About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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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:
  • No data
  • Rizatriptan Benzoate Tablets:
  • u2022
  • 3
  • Rizatriptan benzoate tablets are contraindicated in patients with:
  • No data
  • 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 ()
  • No data
  • No data
  • u2022
  • 8.1
  • No overdoses of rizatriptan benzoate tablets were reported during clinical trials in adults.
  • Some adult patients who received 40 mg of rizatriptan benzoate tablets 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 tablets, at total cumulative doses of 80 mg (given within 4 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 tablets, 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 tablets. 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 is described chemically as: 3-[2-(Dimethylamino)ethyl]-5-(1H-1,2,4-triazol-1-ylmethyl)indole monobenzoate and its structural formula is:
  • Its molecular formula is CHNu2022CHO, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a cream to white powder 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 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 starch (corn) and red iron oxide.
  • No data
  • No data
  • No data
  • Rizatriptan Benzoate Tablets, USP are available containing 7.265 mg or 14.53 mg of rizatriptan benzoate, USP equivalent to 5 mg or 10 mg of rizatriptan, respectively.
  • The 5 mg tablets are light pink, oval, unscored tablets debossed with on one side of the tablet and plain on the other side. They are available as follows:
  • NDC 0378-1403-96bottles of 12 tablets
  • The 10 mg tablets are light pink, oval, unscored tablets debossed with on one side of the tablet and plain on the other side. They are available as follows:
  • NDC 0378-1404-96bottles of 12 tablets
  • Storage: Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Risk of Myocardial Ischemia and/or Infarction, Prinzmetalu2019s Angina, Other Vasospasm-Related Events, and Cerebrovascular Events:u00a0n- [see , , , ]
  • Serotonin Syndrome:u00a0n- [see , , and ]
  • Pregnancy:u00a0n- [see ]
  • Lactation:u00a0n- [see ]
  • Ability to Perform Complex Tasks:u00a0
  • Medication Overuse Headache:u00a0n- [see ]
  • Rizatriptan Benzoate Tablets, USP(ryeu2033 za tripu2032 tan benu2032 zoe ate)
  • 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.
  • Unless otherwise stated, the information in this Patient Information leaflet applies to both rizatriptan benzoate tablets and to rizatriptan benzoate orally disintegrating tablets.
  • 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 traditional tablet and as an orally disintegrating tablet.
  • Rizatriptan benzoate tablets and rizatriptan benzoate orally disintegrating 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.
  • 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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
  • What are the ingredients in rizatriptan benzoate tablets?
  • Active ingredient in rizatriptan benzoate tablets:
  • Inactive ingredients in rizatriptan benzoate tablets:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • The brands listed are trademarks of their respective owners.
  • Manufactured for:n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n Hyderabad u2014 500 096, India
  • 75070485
  • Revised: 11/2019MX:RZTP:R3
  • NDC 0378-1403-96
  • Rizatriptann- Benzoaten- Tablets, USPn- 5 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a012 Tablets
  • Each tablet contains7.265 mg of rizatriptan benzoate, USPequivalent to 5 mg of rizatriptan.
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX1403ES1
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89
  • NDC 0378-1404-96
  • Rizatriptann- Benzoaten- Tablets, USPn- 10 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a012 Tablets
  • Each tablet contains14.53 mg of rizatriptan benzoate, USPequivalent to 10 mg of rizatriptan.
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX1404ES1
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89

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