Because the reports include events observed in open studies, the role of MAXALT-MLT in their causation cannot be reliably determined. A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite [see MAXALT should not be given to patients with ischemic or vasospastic Life-threatening disturbances of cardiac rhythm, including As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HTOveruse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). CC's literal meaning is "carbon copy." AUC of rizatriptan is approximately 30% higher in females than in males. At the mid dose (10 mg/kg/day), which was a no-effect dose for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 15 times that in humans at the maximum recommended human dose (MRHD) of 30 mg/day.
The maximum daily dose should not exceed 30 mg in any 24-hour period. Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Works the same way as email • CX = Correction • CT = Cuttweet. Do not use MAXALT for a condition for which it was not prescribed. ), quantitative estimates of treatment response and the timing of response may be expected to vary considerably from study to study.The estimated probability of achieving an initial headache response within 2 hours following treatment in pooled Studies 1, 2, 3, and 4 is depicted in Figure 1.For patients with migraine-associated photophobia, phonophobia, and nausea at baseline, there was a decreased incidence of these symptoms following administration of MAXALT compared to placebo.Two to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain response in the form of a second dose of study treatment or other medication. Plasma exposure (AUC) at the no-effect dose (2 mg/kg/day) for adverse effects on postnatal development was similar to that in humans at the MRHD.Oral administration of rizatriptan (0, 5, 100, or 250 mg/kg/day) throughout organogenesis and lactation resulted in There are no data on the presence of rizatriptan or any active metabolites in human milk, or on the effects of rizatriptan on the breastfed infant, or on milk production.Rizatriptan was excreted in rat milk, with levels in milk approximately 6 times those in maternal plasma.The developmental and health benefits of breastfeeding should be considered along with the
Patients had to have at least a 6-month history of migraine attacks (with or without aura) usually lasting 3 hours or more (when untreated). The AUC of the active N-monodesmethyl metabolite of rizatriptan was not affected by propranolol [see In a drug interactions study, effects of multiple doses of nadolol 80 mg or metoprolol 100 mg every 12 hours on the pharmacokinetics of a single dose of 10 mg rizatriptan were evaluated in healthy subjects (n=12). 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. Events are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in (>)1/100 pediatric patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 pediatric patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. Maxalt is a prescription medicine used to treat the symptoms of Migraine Headache. Plasma exposure at the no-effect dose (10 mg/kg/day) for reproductive toxicity was approximately 15 times that in humans at the MRHD.Oral administration of rizatriptan (0, 5, 35, or 250 mg/kg/day) to male rats prior to and during mating resulted in no impairment of fertility or reproductive performance. Associated symptoms of nausea, In all studies, the percentage of patients achieving headache response 2 hours after treatment was significantly greater in patients who received either MAXALT 5 or 10 mg compared to those who received placebo. The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions [see Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose.
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