Warnings Precautions warnings Included as part of maxalt maxalt next day the maxalt precautions section. Figure 2: Estimated Probability of women Patients Taking a Second Dose of maxalt Tablets or maxalt Other maxalt Medication for Migraines Over the women 24 Hours Following the women Initial Dose of Study Treatment in women Pooled Studies 1, women 2, 3, and maxalt 4* *This Kaplan-Meier. Pediatric Patients For pediatric patients women weighing 40 kg (88 lb) or women more, taking propranolol, only a single 5-mg dose of maxalt is recommended maxalt (maximum dose of 5 mg in maxalt a 24-hour period). Maxalt Dosage maxalt and Administration, dosing Information in Adults, the recommended starting dose of Maxalt is either 5 mg or 10 mg for the acute treatment of migraines in adults. Food and Drug Administration (FDA) in 1998 and is one of seven triptans, which are a category of medications get maxalt that work similarly to maxalt each other and are approved specifically for treatment of acute migraine episodes. The estimated maxalt probability of achieving an initial headache response within 2 hours following treatment in pooled Studies 1, 2, 3, and 4 women is depicted in Figure. AUC of rizatriptan is approximately 30 higher in females than in males. Have taken a ergot-containing medication or triptan within the 24 hours prior to women migraine. Generic Name: rizatriptan benzoate, dosage Form: tablet, oral ; tablet, orally disintegrating. Dizziness, a severe headache, complications, overuse of Maxalt can cause serious complications, including vascular ischemia, which is diminished blood supply. This is not women a complete list of side effects and others may occur. Headache response, defined as a reduction of moderate or severe headache pain women to women no or mild headache pain, was assessed for up to 2 hours (Study 1) or up to 4 hours after dosing (Studies 2, 3 and 4). How It maxalt Works, maxalt and other triptans are 5-HT (serotonin) receptor maxalt agonists, maxalt which means that they augment the effect of serotonin, a neurotransmitter. Some adult patients who received 40 mg of maxalt either a single dose or as two doses with a 2- hour interdose interval had dizziness and somnolence. The AUC of the active N-monodesmethyl metabolite of rizatriptan was not women affected maxalt by propranolol see women dosage AND administration and drug interactions. Dosage, dosage AND administration, dosing Information In Adults, the recommended starting dose of maxalt is either 5 mg or 10 mg for the acute treatment of migraines in adults. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. You can enroll in this registry by calling. In a separate study, doses.5 mg were not different from placebo. General Information about the safe and effective use of Maxalt. Because the reports include events observed in open studies, the role of maxalt-MLT in their causation cannot be reliably determined. The risk increases if you women are also taking other drugs that increase serotonin, so tell your doctor women or pharmacist of all the drugs you take maxalt (see. Description, maxalt contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Have a history of hemiplegic women or basilar migraine. Keep maxalt and all medicines out of the reach of children. No pharmacokinetic interaction women is anticipated in patients receiving selective MAO-B inhibitors see Contraindications (4) and Drug Interactions (7.5). The percentage of patients achieving the primary efficacy endpoint of no headache pain at 2 hours after treatment was significantly greater in patients who received Maxalt-MLT, compared with those who received placebo (33. Arrhythmias Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. The tablet and the disintegrating forms are both available at 5 mg and 10 mg doses. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Geriatric Use Clinical studies of Maxalt did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More Common, less Common, agitation anxiety blurred vision chills confusion constipation depression diarrhea difficulty with. The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received Maxalt to those who received placebo. The percentage of patients achieving the primary efficacy endpoint of no headache pain at 2 hours after treatment was significantly greater in patients who received maxalt-MLT, compared with those who received placebo (33. Approximately 14 of an oral dose is excreted in urine as unchanged rizatriptan while women 51 is excreted as indole acetic acid metabolite, indicating substantial first pass metabolism. Patients should be apprised of the importance of this follow-up see Warnings and Precautions (5.1,.2,.4,.5). It should be used only if the potential benefit of Maxalt therapy maxalt exceeds risk to the fetus. Patients treated in these maxalt studies were primarily female (88) women and Caucasian (95 with a mean age of 42 years (range 18-72). Symptoms of overuse may need to be treated, and detoxification from migraine medications may be required. Because the reports include events observed in open studies, the role of Maxalt in their causation cannot be reliably determined. General: Allergic conditions including anaphylaxis/anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis see Contraindications (4). Many clinical trials evaluated the safety and efficacy of Maxalt. Maxalt tablets are taken by mouth with water or other liquids. General: Allergic conditions including anaphylaxis /anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis see contraindications. The no-effect dose was 10 mg/kg/day (approximately 15 times the human exposure at the mrdd). In a drug interaction study, when maxalt 10 mg was administered to subjects (n12) receiving concomitant therapy with the selective, reversible MAO-A inhibitor, moclobemide 150.i.d., there were mean increases in rizatriptan AUC and Cmax. 3732 Maxalt Tablets, 5 mg, maxalt are pale pink, capsule-shaped, compressed tablets coded MRK on one side and 266 on the other: NDC, carton of 18 tablets. It is not known maxalt if Maxalt is safe and effective in children under 6 years of age. Feeling hot or cold in the extremities. Maxalt-MLT orally disintegrating tablets contain phenylalanine. Maxalt 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. This Patient Information leaflet summarizes the most important information about maxalt. quantitative estimates of treatment response and the timing of response may be expected to vary considerably from study to study. Distribution The mean volume of distribution is approximately 140 liters in male subjects and 110 liters in female subjects. Talk to your doctor before taking this medicine if you have any of the conditions listed above or if you are not sure if you take any of these medicines. Even though it is fast acting, it is best to take Maxalt at the onset of a migraine so that you can avert the maximal pain and other symptoms of your migraine. Figure 1: Estimated Probability of Achieving an Initial Headache Response by 2 Hours in Pooled Studies 1, 2, 3, and 4 For patients with migraine-associated photophobia, phonophobia, and nausea at baseline, there was a decreased incidence of these symptoms following. Other Events Observed In Association With The Administration Of maxalt In Adults In the following section, the frequencies of less commonly reported adverse events are presented that were not reported in other sections of the labeling. Special maxalt Senses: Infrequent were blurred vision and tinnitus. Peel open the blister pack with dry hands and place the maxalt-MLT orally disintegrating tablet on your tongue. The mean oral absolute bioavailability of the maxalt Tablet is about 45, and mean peak plasma concentrations (Cmax) are reached in approximately 1-1.5 hours (Tmax). Renal impairment: In patients with renal impairment (creatinine clearance 10-60 mL/min/1.73 m2 the AUC0- of rizatriptan was not significantly different from that in subjects with normal renal function. If you notice other effects not listed above, contact your doctor or pharmacist. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, women hallucinations, coma autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Maxalt is contraindicated in patients with uncontrolled hypertension see Contraindications (4). Know the medicines you take. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and maxalt within 24 hours is contraindicated see contraindications. Pediatric: The pharmacokinetics of rizatriptan was determined in pediatric migraineurs 6 to 17 years of age. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Maxalt will not prevent maxalt maxalt headaches or reduce the number of attacks. All reported events occurred at an incidence 1, or are believed to be reasonably associated with the use of the drug. Not for use in the prevention of migraine or the treatment of cluster headaches. By: Zhejiang Huahai Pharmaceutical., Ltd. Call your doctor or go to the nearest hospital emergency room right away if you think you are having any of the serious side effects of Maxalt including: heart attack. Do not push the Maxalt-MLT orally disintegrating tablet through the blister. It is not known if taking more than 1 dose of Maxalt in 24 hours is safe and effective in children 6 to 17 years of age. What should I avoid while taking maxalt? Triptans also induce vasoconstriction (narrowing of the blood vessels) in the brain. Overuse is considered dosing on more than 10 days per month. Store maxalt-MLT Orally Disintegrating Tablets at room temperature, 59-86F (15-30C). Monoamine Oxidase Inhibitors maxalt is contraindicated in patients taking MAO-A inhibitors and non-selective MAO inhibitors. 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. N-monodesmethyl-rizatriptan, a metabolite with activity similar to that of parent compound at the 5-HT1B/1D receptor, is formed to a minor degree. Other 5-HT1 Agonists Because their vasospastic effects may be additive, co-administration of maxalt and other 5-HT1 agonists within 24 hours of each other is contraindicated see contraindications. Patients with sensations of chest pain/pressure/tightness or symptoms suggestive of angina following dosing should be evaluated for coronary artery disease or Prinzmetals angina before administering additional doses; monitor with ECG if dosing is resumed and similar symptoms occur. Skin and Skin Appendage: Frequent was flushing. Dosage Adjustment For Patients On maxalt Propranolol Sections or subsections omitted from the full prescribing information are not listed. The interaction would be expected to be greater with irreversible women MAO inhibitors. The adverse reaction profile seen with maxalt-MLT Orally Disintegrating Tablets was similar to that seen with maxalt Tablets. These women combinations can cause can cause a rare but serious condition called serotonin syndrome, which manifests with anxiety, fevers, jerking movements, tremors, women and muscle rigidity. Infrequent were tachycardia, cold extremities, and bradycardia. Event frequencies are calculated as the number of pediatric patients 6 to 17 years of age who used maxalt-MLT and reported an event divided by the total number of patients exposed to maxaltmlt (N1068). Phenylketonurics: contains phenylalanine (a component of aspartame).10 mg per 10-mg orally disintegrating tablet. Increases of approximately 2 to 3 mmHg have been observed in healthy subjects receiving 10 mg of this drug every 2 hours for 3 doses. A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite see contraindications and clinical pharmacology. Unless otherwise stated, the information in this Patient Information leaflet applies to both maxalt Tablets and to maxalt-MLT Orally Disintegrating Tablets. Maxalt was approved by the.S. How should I take maxalt? Safety and effectiveness of maxalt have not been established for cluster headache. 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.7 hour.
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