Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Aripiprazole
Lincoln Pharmaceuticals Limited, INDIA
Antipsychotic drugs
Aripiprazole
10
Oral tablet
Lincoln Pharmaceuticals Limited, INDIA
Physical description: Off white to pink colour with small specks, round shaped, biconvex, plain on both sides of Uncoated tablets.; Local technical representative: Heko Pharmacy Limited (7718)
Registered/Compliant
2022-05-04
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aripiprazole Tablets USP 15 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE DECLARATION Aripiprazole USP QUANTITATIVE DECLARATION Each tablet contains 68.350 mg of Lactose Monohydrate. For full list of Excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Tablet Light yellow colour with small specks, round shaped, flat, breakline on one side and plain on other sides of uncoated tablets. The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS _1._ _THERAPEUTIC INDICATIONS _ It is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years, older, and moderate to severe manic episodes in bipolar I disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. It is also indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar I disorder in adolescents aged 13 years and older. _2._ _POSOLOGY AND METHOD OF ADMINISTRATION _ _ADULTS _ • _SCHIZOPHRENIA:_ starting recommended dose is 10-15 mg/day with a maintenance dose of 15 mg/day. Improved efficacy at doses higher than a daily dose has not been proved although individual patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg. It is effective in a dose range of 10 mg/day to 30 mg/day • MANIC EPISODES IN BIPOLAR I DISORDER: Initially starting dose 15 mg once daily, some patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg. • RECURRENCE PREVENTION OF MANIC EPISODES IN BIPOLAR I DISORDER: for preventing recurrence of manic episodes in patients, who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose. Adjustments of daily dosage, including dose reduction should be considered because of clinical status. _SPECIAL POPULATIONS _ • Read the complete document