New Zealand Data Sheet
New Zealand Data sheet 1 ABILIFYTM TABLETS AbilifyTM 5 mg, 10 mg, 15 mg, 20 mg & 30 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of aripiprazole. Excipient with known effect: Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Abilify (aripiprazole) is available as: 5 mg blue, modified rectangular, shallow convex, bevel-edged, tablets, marked on one side with “A-007” and “5”; 10 mg pink, modified rectangular, shallow convex, bevel-edged, tablets, marked on one side with “A-008” and “10”; 15 mg yellow, round, shallow convex, bevel-edged, tablets, marked on one side with “A-009” and “15”; 20 mg white to pale yellowish white, round, shallow convex, bevel-edged, tablets, marked on one side with “A-010” and “20”; 30 mg pink, round, shallow convex, bevel-edged, tablets, marked on one side with “A-011” and “30”. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Abilify is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. Abilify monotherapy is indicated for acute and maintenance treatment of manic and mixed episodes with Bipolar I Disorder with or without psychotic features. Abilify is indicated as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features. 4.2 Dose and method of administration Recommended Dosage Schizophrenia Adults The recommended starting dose for Abilify is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals.
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