Rizamig Tablet

Indication
Rizatriptan Benzoate is indicated for the acute treatment of?ÿmigraine?ÿwith or without aura in adults and in pediatric patients 6 to 17 years old.

Pharmacology
Rizatriptan binds with high?ÿaffinity?ÿto human cloned 5-HT1B/1D receptors. Rizatriptan Benzoate presumably exerts its therapeutic effects in the treatment of?ÿmigraine headache?ÿby binding to 5-HT1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

Dosage
Dosing Information In Adults: The recommended starting dose of Rizatriptan Benzoate 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 Rizatriptan Benzoate 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 Rizatriptan Benzoate 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 Rizatriptan Benzoate 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 Rizatriptan Benzoate is recommended (maximum dose of 5 mg in a 24-hour period). Rizatriptan Benzoate should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg

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%?ÿErgot-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?ÿSSRIs /SNRIs And Serotonin Syndrome: Cases of serotonin syndrome have been reported during co-administration of triptans and selective serotonin?ÿreuptake?ÿinhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)?ÿMonoamine 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

Contradiction
Rizatriptan Benzoate is contraindicated in patients with: Ischemic?ÿcoronary artery disease?ÿ(angina pectoris, history of?ÿmyocardial infarction, or documented silent ischemia), or other significant underlying?ÿcardiovascular disease Coronary artery vasospasm including Prinzmetal's?ÿangina History of?ÿstroke?ÿor?ÿtransient ischemic attack?ÿ(TIA)?ÿ Peripheral vascular disease?ÿ(PVD)?ÿ Ischemic bowel disease?ÿ Uncontrolled hypertension?ÿ Recent use (i.e., within 24 hours) of another 5-HT1?ÿagonist, ergotamine-containing medication, or?ÿergot-type medication (such as dihydroergotamine or methysergide)?ÿ Hemiplegic?ÿor?ÿbasilar?ÿmigraine Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor Hypersensitivity to Rizatriptan Benzoate (angioedema and?ÿanaphylaxisseen)

Side Effect
The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial?ÿIschemia,?ÿMyocardial Infarction, and Prinzmetal's?ÿAngina?ÿ Arrhythmias?ÿ Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure?ÿ Cerebrovascular?ÿEvents?ÿ Other Vasospasm Reactions?ÿ Medication Overuse Headache?ÿ Serotonin?ÿSyndrome?ÿ Increase in Blood Pressure

Pregnancy
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.

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.

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

Storage
Store at 15-30?ø C.