Rizamig Tablet

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

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.

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

Administration of Rizatriptan Benzoate 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.

Propranolol: The dose of Rizamig 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 Rizamig within 24 hours is contraindicated

Other 5-HT1 Agonists: Because their vasospastic effects may be additive, co-administration of Rizamig 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: Rizamig 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

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)

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

Pregnancy: Inform patients that Rizatriptan Benzoate should not be used during pregnancy unless the potential benefit justifies the potential risk to 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 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 Rizamig 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 Rizamig 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 Rizamig 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 Rizamig

Renal 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.

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

5-HT Agonists

Store at 15-30° C.