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BIORITZ

Quick Overview

Our aim is to reach out to the globe within shortest possible time frame


To promote this objective, not only we distribute and market our CNS  range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Biorotz which contains Rizatriptan……10 mg 


 

BIORITZ-10 TAB

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Details

Each uncoated tablet contains

Rizatriptan Benzoate USP

Equivalent to Rizatriptan…10 mg

Colour: Red Oxide of Iron

CHEMISTRY: 3-[2-(Dimethylamino)ethy1]-5-(1H-1,2,4-triazol-1- ylmethypindole monobenzoate.

CATEGORY: 5-HT1 Agonist Triptan Drug.

PHARMACOLOGY

PHARMACODYNAMICS:

Rizatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Rizatriptan Tablets presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

PHARMACOKINETICS:

Absorption

Rizatriptan is absorbed following oral administration. The mean oral absolute bioavailabiltty of the Rizatriptan is about 45%, and mean peak plasma concentrations (Cm.) are reached in approximately 1-1.5 hours (T). The presence of a migraine headache did not appear to affect the absorption or pharmacoldnelics of rizatriptan. Food has no significant effect on the bioavailabiltty of rizatriptan but delays the li me to reach peak concentration by an hour.

Distribution

The mean volume of distribution is approximately 140 liters in male subjects and 110 liters in female subjects. Rizatriptan is minimally bound (14%) to plasma proteins.

Metabolism

The primary route of rizatriptan metabolism is via oxidative deamination by monoamine wddase-A (MAO-A) to the indole acetic acid metabolite, which is not active at the 5-HT1B/1D receptor. Plasma concentrations of N­monodesmethyl-rizatriptan are approximately 14% of those of parent compound, and it is eliminated at a similar rate.

Elimination

Approximately 14% of an oral dose is excreted in urine as unchanged rizatriptan while 51% is excreted as indole acetic acid metabolite, indicating substantial first pass metabolism. The plasma half-life of rizatriptan in males and females averages 2-3 hours.

INDICATIONS:

Rizatriptan is 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.

DOSAGE AND ADMINISTRATION:

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. 10 mg single dose in patients 40 kg. Adjust dose if co-administered with propranolol.

CONTRAINDICATIONS:

Rizatriptan Tablets is contraindicated in patients with:

  • · Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease.
  • · Coronary artery vasospasm including Prinzmetal's angina.
  • · History of stroke ortransientischemic attack (TIA).
  • · Peripheral vascular disease (PVD).
  • · Ischemic bowel disease.
  • · Uncontrolled hypertension.
  • · Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine­containing medication or ergot-type medication (such as di hyd roergotami ne or methysergide).
  • · Hemiplegic or basilar migraine.
  • · Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor.
  • · Hypersensitivity to Rizatriptan Tablets.

WARNINGS AND PRECAUTIONS:

Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina Rizatriptan Tablets should not be given to patients with ischemic or vasospaslic coronary artery disease. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of Rizatriptan Tablets. Periodic cardiovascular evaluation should be considered in intermittent long-term users of Rizatriptan Tablets who have cardiovascular risk factors.

Arrhythmias

Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue Rizatriptan Tablets if these disturbances occur.

Chest, Throat, Neck andMr Jaw Pain/Tightness/Pressure

As with other 5-HT1 agonists, sensations of lightness, pain, pressure, and heaviness in the precordium, throat, neck and jaw commonly occur after treatment with Rizatriptan Tablets and are usually non-cardiac in origin. However, if a cardiac origin is suspected, patients should be evaluated.

Cerebrovascular Events

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities.

Discontinue Rizatriptan Tablets if a cerebrovascular event occurs. Rizatriptan Tablets should not be administered to patients with a history of stroke or transient ischemic attack.

Other Vasospasm Reactions

5-HT1 agonists, including Rizatriptan Tablets, may cause non-coronary vasospaslic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome.

Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established.

Medication Overuse Headache

Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detwdficalion of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

Serotonin Syndrome

Serotonin syndrome may occur with triptans, including Rizatriptan Tablets particularly during co-administralion with selective serotonin reuptake inhibitors (SSR1s), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Rizatriptan Tablets treatment should be discontinued if serotonin syndrome is suspected.

Increase in Blood Pressure

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients with and without a history of hypertension receiving 5-HT1 agonists, including Rizatriptan Tablets. Rizatriptan Tablets is contraindicated in patients with uncontrolled hypertension.

INTERACTIONS:

Propranolol

The dose of Rizatriptan Tablets should be adjusted in propranolol-treated patients, as propranolol has been reported to increase the plasma AUC of rizatriptan by 70%.

Ergot-Containing Drugs

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine­containing or ergot-type medications (like dihydroergotamine or methysergide) and Rizatriptan Tablets within 24 hours is contraindicated.

Other 5-HT1 Agonists

Because their vasospastic effects may be additive, co-administralion of Rizatriptan Tablets and other 5-HT1 agonists within 24 hours of each other is contraindicated.

PREGNANCY AN LACTATION:

Pregnancy

PregnancyCategoryC

There are no adequate and well-controlled studies in pregnant women. Rizatriptan Tablets should be used during pregnancy only if the potential benefit justifies the potential riskto the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Rizatriptan Tablets is administered to a nursing woman.

USE IN SPECIFIC POPULATION

Pediatric Use

Safety and effectiveness in pediatric patients under 6 years of age have not been established.

Geriatric Use

Reported studies have not identified differences in responses between the elderly and younger patients.

Effect to Drive & Use the Machine: Rizatriptan 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.

ADVERSE DRUG REACTIONS:

MyocardialIschernia, Myocardial Infarction and Prinzmetal's Angina

  • Arrhythmias
  • · Chest and or Throat, Neck and/or Jaw Pain/Tightness/Pressure
  • Cerebrovascular Events
  • Other Vasospasm Reactions
  • Medication Overuse Headache
  • Serotonin Syndrome
  • Increase in Blood Pressure

OVERDOSAGE:

Based on the pharmacology of Rizatriptan 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 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.

PRESENTATION: Blister of 4 Tablets.

STORAGE: Store below 30°C.

Keep out of reach of children.

 

 
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