Other countries may have different regulatory requirements and review practices that may require referencing different information.
Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.
In clinical trials, MAXALT was administered without regard to food.The bioavailability and Cmax of rizatriptan were similar following administration of MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets, but the rate of absorption is somewhat slower with MAXALT-MLT, with Tmax delayed by up to 0.7 hour. Study 7 results are summarized in Table 4.The observed percentage of pediatric patients achieving no headache pain within 2 hours following initial treatment with MAXALT-MLT is shown in Figure 5.The prevalence of the exploratory endpoints of absence of migraine-associated symptoms (nausea, photophobia, and phonophobia) at 2 hours after taking the dose was not statistically significantly different between patients who received MAXALT-MLT and those who received placebo.Read this Patient Information before you start taking MAXALTUnless otherwise stated, the information in this Patient Information leaflet applies to both MAXALT Tablets and to MAXALT-MLTMAXALT is a prescription medicine that belongs to a class of medicines called Triptans.
Maxalt is a prescription medicine that belongs to a class of medicines called Triptans. The most common adverse reactions during treatment with MAXALT (≥5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation and dizziness. You can ask your pharmacist or doctor for information about MAXALT that is written for health professionals.MAXALT-MLT orally disintegrating tablets contain aspartame, a source of phenylalanine.MAXALT-MLT orally disintegrating tablets 5-mg contain 1.1 mg of phenylalanine. Call your doctor for medical advice about side effects. No accumulation occurred on multiple dosing.The mean volume of distribution is approximately 140 liters in male subjects and 110 liters in female subjects.
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