Maxalt-Mlt (rizatriptan benzoate)

Dosage of rizatriptan benzoate is expressed in terms of rizatriptan.

Rizatriptan benzoate is administered orally as conventional or orally disintegrating tablets without regard to meals.

Rizatriptan is also commercially available in fixed combination with meloxicam. Consult the prescribing information for additional information on this combination product.

The rizatriptan orally disintegrating tablet is packaged in a blister in an outer aluminum pouch. The blister should not be removed from the aluminum pouch until just prior to administration. With dry hands, the blister package should be peeled open and the tablet placed on the tongue to dissolve and be swallowed with saliva. Administration with liquid is not necessary.

Rizatriptan tablets and orally disintegrating tablets should be stored at 15-30degreesC.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia), coronary artery vasospasm (e.g., Prinzmetal variant angina), uncontrolled hypertension, or other serious underlying cardiovascular disease.

*History of cerebrovascular syndromes (e.g., stroke of any type, transient ischemic attack).

*Peripheral vascular disease or ischemic bowel disease.

*Hemiplegic or basilar migraine.

*Recent (i.e., 24 hours or less) treatment with another 5-HT1 receptor agonist or an ergotamine-containing or ergot-type drug.

*Concurrent administration or recent discontinuation (i.e. within 2 weeks) of a monoamine oxidase (MAO) type A inhibitor.

*Known hypersensitivity to rizatriptan or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >=5% and greater than placebo) with rizatriptan include asthenia/fatigue, somnolence, pain/pressure sensation, and dizziness.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy have not been established in pediatric patients younger than 6 years of age. The efficacy and safety of rizatriptan for the acute treatment of migraine in pediatric patients 6 to 17 years of age were established in a controlled trial. Adverse effects in pediatric patients are expected to be similar to those reported in adults.

Human data are insufficient to draw conclusions regarding the risk of rizatriptan for major birth defects and miscarriage. In animal studies, developmental toxicity (e.g., decreased fetal body weight, increased mortality, neurobehavioral impairment) was seen following rizatriptan administration during pregnancy or throughout pregnancy and lactation at maternal plasma exposures greater than that expected at therapeutic doses in humans.

Results from an evaluation of pregnancy registry data (1998 to 2018) did not reveal any pattern of congenital anomalies or other adverse birth outcomes with rizatriptan use. However, the number of prospective reports in this registry with outcome information was low. In addition, a significant number of patients were lost to follow-up.

In another study involving data from the Swedish Medical Birth Register, 7 infants were born with malformations among 157 births with maternal first trimester exposure to rizatriptan. In an evaluation of data from the Medical Birth Registry of Norway, 10 infants had major congenital malformations among 310 women who filled rizatriptan prescriptions during the first trimester of pregnancy and 12 infants had major congenital malformation among 271 women who filled rizatriptan prescriptions, before, but not during pregnancy.

There are no data on the presence of rizatriptan or its metabolites in human milk; its effects on the breastfed infant and on milk production are also unknown. Rizatriptan is reported to be present in rat milk, with levels approximately 6 times those seen in maternal plasma.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for rizatriptan and any potential adverse effects on the breastfed infant from rizatriptan or the underlying maternal condition.

Dosage selection for geriatric patients should be cautious, usually starting at the low end of the dosage range, and reflect the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in such patients.

Pharmacokinetic profile is similar to that in younger adults. Clinical studies of rizatriptan did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently than younger patients. While other clinical experience has not revealed age-related differences in response, dosage should be selected with caution in geriatric patients starting at the low end of the dosage range.

Geriatric patients with other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) should have a cardiovascular evaluation prior to rizatriptan administration.