Rizat Tablet 5 mg

Uses

Rizat Tablet 5 mg is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.

Dosage

Rizat Tablet 5 mg dosage

Dosing Information In Adults: The recommended starting dose of Rizat Tablet 5 mg is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions.Redosing In Adults: Although the effectiveness of a second dose or subsequent doses has not been established in placebocontrolled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.Dosing Information In Pediatric Patients (Age 6 to 17 Years): Dosing in pediatric patients is based on the patient's body weight. The recommended dose of Rizat Tablet 5 mg is 5 mg in patients weighing less than 40 kg, and 10 mg in patients weighing 40 kg or more.The efficacy and safety of treatment with more than one dose of Rizat Tablet 5 mg within 24 hours in pediatric patients 6 to 17 years of age have not been established.Dosage Adjustment For Patients On Propranolol: Sections or subsections omitted from the full prescribing information are not listed. Adult Patients: In adult patients taking propranolol, only the 5-mg dose of Rizat Tablet 5 mg is recommended, up to a maximum of 3 doses in any 24-hour period (15 mg) Pediatric Patients: For pediatric patients weighing 40 kg or more, taking propranolol, only a single 5-mg dose of Rizat Tablet 5 mg is recommended (maximum dose of 5 mg in a 24-hour period). Rizat Tablet 5 mg should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg Administration of Rizat Tablet 5 mg Tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister within an outer aluminum pouch and patients should not remove the blister from the outer pouch until just prior to dosing. The blister pack should then be peeled open with dry hands and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.

Side Effects

The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina Arrhythmias Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure Cerebrovascular Events Other Vasospasm Reactions Medication Overuse Headache Serotonin Syndrome Increase in Blood Pressure

Precaution

Elderly; mild to moderate hepatic or renal impairment; coronary artery disease; pregnancy, lactation. May cause drowsiness. History of seizures. Ensure an interval of at least 24 hr after stopping an ergotamine compound and starting a serotonin (5-HT1) agonist.

Interaction

Propranolol: The dose of Rizatriptan should be adjusted in propranolol-treated patients, as propranolol has been shown 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 ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Rizatriptan within 24 hours is contraindicatedOther 5-HT1 Agonists: Because their vasospastic effects may be additive, co-administration of Rizatriptan and other 5-HT1 agonists within 24 hours of each other is contraindicated SSRIs /SNRIs And Serotonin Syndrome: Cases of serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) Monoamine Oxidase Inhibitors: Rizatriptan is contraindicated in patients taking MAO-A inhibitors and non-selective MAO inhibitors. A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite

Pregnancy & Breastfeeding use

Pregnancy: Inform patients that Rizat Tablet 5 mg should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetusNursing 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 Rizat Tablet 5 mg is administered to a nursing woman. Rizatriptan is extensively excreted in rat milk, with levels in milk at least 5-fold higher than levels in maternal plasma.

Contraindication

Rizat Tablet 5 mg 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 or transient ischemic attack (TIA) Peripheral vascular disease (PVD) Ischemic bowel disease Uncontrolled hypertension Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) Hemiplegic or basilar migraine Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor Hypersensitivity to Rizat Tablet 5 mg (angioedema and anaphylaxisseen)

Special Warning

Pediatric Use: Safety and effectiveness in pediatric patients under 6 years of age have not been established. The efficacy and safety of Rizatriptan in the acute treatment of migraine in patients aged 6 to 17 years was established in an adequate and well-controlled study. The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received Rizatriptan to those who received placebo. The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.Geriatric Use: Clinical studies of Rizatriptan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.Although the pharmacokinetics of rizatriptan were similar in elderly (aged ≥65 years) and in younger adults (n=17), in general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range. This reflects the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.Geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) should have a cardiovascular evaluation prior to receiving RizatriptanRenal Impairment: For mild-moderate impairment, initate with 5 mg. Further dose of 5 mg may be taken after an interval of at least 2 hr. Max: 10 mg/24 hr. Avoid in severe impairment.Hepatic Impairment: For mild-moderate impairment, initate with 5 mg. Further dose of 5 mg may be taken after an interval of at least 2 hr. Max: 10 mg/24 hr. Avoid in severe impairment.

Acute Overdose

May cause hypertension and CV symptoms. Gastric lavage using activated charcoal may be considered. Monitor ECG and clinical status of the patient.

Storage Condition

Store at 15-30° C.

Innovators Monograph

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