Renal Impairment The recommended starting dose of AXERT in patients with severe

Renal impairment the recommended starting dose of

This preview shows page 56 - 59 out of 96 pages.

Renal Impairment The recommended starting dose of AXERT in patients with severe renal impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY ].
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Dosage Forms And Strengths AXERT (almotriptan malate) Tablets are available as white, coated, circular, biconvex tablets in the following dosage strengths: 6.25 mg tablet with red code imprint “2080” 12.5 mg tablet with blue stylized imprint “A.” AXERT® (almotriptan malate) Tablets are available as follows: 6.25 mg: White, coated, circular, biconvex tablets with red code imprint “2080.” Unit Dose (aluminum blister pack) 6 tablets ............. NDC 0062-2080-06 12.5 mg: White, coated, circular, biconvex tablets with blue stylized imprint “A.” Unit Dose (aluminum blister pack) 12 tablets ............. NDC 0062-2085-12 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled room temperature ]. AXERT Tablets are manufactured by: Janssen-Ortho, LLC Gurabo, Puerto Rico 00778. AXERT Tablets are manufactured for: Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ 08869. Licensed from: Laboratorios Almirall, S.A.
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SIDE EFFECTS Serious cardiac reactions, including myocardial infarction , have occurred following the use of AXERT Tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD . Reactions reported, in association with triptans, have included coronary artery vasospasm, transient myocardial ischemia , myocardial infarction , ventricular tachycardia , and ventricular fibrillation [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS ]. The following adverse reactions are discussed in more detail in other sections of the labeling: Cardiac Events and Fatalities [see WARNINGS AND PRECAUTIONS ] Sensations of Chest Pain and Tightness [see WARNINGS AND PRECAUTIONS ] Cerebrovascular Events and Fatalities [see WARNINGS AND PRECAUTIONS ] Other Vasospasm related Events including Peripheral Vascular Ischemia and Colonic Ischemia [see WARNINGS AND PRECAUTIONS ] Increases in Blood Pressure [see WARNINGS AND PRECAUTIONS ] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS ] Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of AXERT and 386 adult patients who received placebo . The most common adverse events during treatment with AXERT were nausea , somnolence , headache , paresthesia , and dry mouth . In long-term open-label studies where patients were allowed to treat multiple attacks for up to one year, 5% (63 out of 1347 patients) withdrew due to adverse experiences. Adverse events were assessed in controlled clinical trials that included 362 adolescent patients who received AXERT and 172 adolescent patients who received placebo. The most common adverse events during treatment with AXERT were dizziness , somnolence, headache, paresthesia, nausea and vomiting. In a long-term, open-label study where patients were allowed to
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