Rizatriptan Benzoate

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Rizatriptan Benzoate is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.

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Rizatriptan Benzoate 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 Rizatriptan Benzoate (angioedema and anaphylaxisseen)

Rizatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Rizatriptan Benzoate 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.

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

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

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

Pregnancy: Inform patients that Rizatriptan Benzoate 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 Rizatriptan Benzoate 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.

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.

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.