Infrequent were tachycardia, cold extremities, and bradycardia.Digestive: Frequent were diarrhea and vomiting. Rizatriptan benzoate is minimally bound (14%) to plasma proteins.The primary route of rizatriptan benzoate metabolism is via oxidative deamination by monoamine oxidase-A (MAO-A) to the indole acetic acid metabolite, which is not active at the 5-HT1B/1D receptor. The observed percentage of pediatric patients achieving no headache pain within 2 hours following initial treatment with rizatriptan benzoate orally disintegrating tablets is shown in Figure 5.Figure 5: Observed Percentage of Patients Reporting No Headache Pain by 2 Hours Post-Dose in Study 7The 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 rizatriptan benzoate orally disintegrating tablets and those who received placebo.Rizatriptan benzoate tablets, USP 5 mg, are pink, oval-shaped tablets debossed with '462'on one side and "IG" on the other side:Rizatriptan benzoate tablets, USP 10 mg, are pink, oval-shaped tablets, debossed with '463' on one side and "IG" on the other side:Store rizatriptan benzoate tablets at 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST: Dispense a Patient Information Leaflet with each prescription.Read this Patient Information before you start taking rizatriptan benzoate tablets and each time you get a refill. The results from the four controlled studies are summarized in Table 2.Table 2: Response Rates 2 Hours Following Treatment of Initial Headache in Studies 1, 2, 3, and 4Comparisons of drug performance based upon results obtained in different clinical trials may not be reliable. A second dose of rizatriptan benzoate tablets was allowed 2 to 24 hours after dosing for treatment of recurrent headache in Studies 1 and 2. There were no other fertility-related effects in the female rats. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.Using this medicine with any of the following medicines is not recommended. There may be new information. Infrequent were dyspepsia, tongue edema and abdominal distention.Musculoskeletal: Infrequent were muscle weakness, stiffness, myalgia and muscle cramp/spasm.Neurological/Psychiatric: Frequent were hypoesthesia, euphoria and tremor. Our general interest e-newsletter keeps you up to date on a wide variety of health topics. What Is Maxalt? There was no impairment of fertility or reproductive performance in male rats treated with up to 250 mg/kg/day (approximately 550 times the human exposure at the MRDD).The efficacy of rizatriptan benzoate tablets was established in four multicenter, randomized, placebo-controlled trials.
In these cases, your doctor may want to change the dose, or other precautions may be necessary. With doses of 100 mg/kg/day and 250 mg/kg/day, the decreases in average weight of both the male and female offspring persisted into adulthood. Rizatriptan benzoate tablets may affect the way other medicines work, and other medicines may affect how rizatriptan benzoate tablets work.propranolol containing medicines such as Inderal®, Inderal®LA, or Innopran®XL Brands. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.Adverse reactions to rizatriptan benzoate were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of rizatriptan benzoate tablets. The averages displayed are based on pooled data from 4 placebo-controlled, outpatient trials providing evidence of efficacy (Studies 1, 2, 3, and 4). It is often used in infection. Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch (corn starch), pregelatinized starch ( maize), colloidal silicon dioxide, ferric oxide (red), and magnesium stearate.Rizatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.Rizatriptan benzoate tablets and other medicines may affect each other causing side effects.
Other Events Observed in Association with the Administration of Rizatriptan Benzoate in AdultsIn the following section, the frequencies of less commonly reported adverse events are presented that were not reported in other sections of the labeling. RESET. The onset of symptoms can occur within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks.
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