pms-Aripiprazole

Each tablet contains 2 mg aripiprazole.

pms-ARIPIPRAZOLE (aripiprazole) is indicated for the treatment of schizophrenia and related psychotic disorders in adults. In controlled clinical trials, aripiprazole was found to improve both positive and negative symptoms.
Aripiprazole has been shown to be more effective than placebo in maintaining clinical improvement for up to 26 weeks in adults.
Pediatrics (<18 years of age): When prescribing to adolescents with schizophrenia (15-17 years of age), clinicians must take into account the safety concerns associated with all antipsychotic drugs which include: weight gain; hyperlipidemia; hyperglycemia; and, extrapyramidal effects which can be more frequent or more severe in this patient population than in adults. pms-ARIPIPRAZOLE should only be prescribed to adolescents with schizophrenia by clinicians who are experienced in the diagnosis and treatment of adolescents with psychiatric illness and who are experienced in the early detection and management of the previously mentioned safety issues associated with this class of drugs.
Schizophrenia: pms-ARIPIPRAZOLE is indicated for the treatment of schizophrenia in adolescents 15-17 years of age.
Safety and efficacy were evaluated in one 6-week clinical trial in adolescents (13-17 years of age) with schizophrenia. pms-ARIPIPRAZOLE is not indicated for the treatment of schizophrenia in adolescents less than 15 years of age due to insufficient safety and efficacy data.
The safety and efficacy of aripiprazole during long-term treatment have not been systematically evaluated in adolescents with schizophrenia. The physician who elects to use pms-ARIPIPRAZOLE for extended periods in adolescents with schizophrenia should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Geriatrics: Geriatrics (≥65 years of age): pms-ARIPIPRAZOLE is not indicated in elderly patients with dementia. The safety and efficacy of aripiprazole in patients 65 years of age or older has not been established. Caution should be used when treating geriatric patients.

Schizophrenia: Adults: Usual Dose: The recommended starting and target dose for pms-ARIPIPRAZOLE is 10 or 15 mg/day administered on a once-a-day schedule. Doses in the range of 10 to 30 mg/day have been established as effective in clinical trials. However, greater efficacy has not been demonstrated at doses higher than 10 mg/day. Dosage increases, if needed, should only be made after 2 weeks, the time needed to achieve steady state. The maximum daily dose should not exceed 30 mg/day.
Patients should be maintained on the lowest effective dose that provides optimal clinical response and tolerability and should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (15-17 years of age): Usual dose: The recommended target dose of pms-ARIPIPRAZOLE is 10 mg/day administered on a once-a-day schedule. The recommended starting daily dose is 2 mg/day, titrated to 5 mg/day after 2 days and to the target dose of 10 mg/day after 2 additional days. Subsequent dose increases should be administered, if needed and as tolerated, in 5 mg/day increments. Both the 10 mg/day and 30 mg/day doses have been shown to be effective in a double-blind, placebo-controlled clinical trial; however, the 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose.
The maximum daily dose should not exceed 30 mg/day. Patients should be maintained on the lowest effective dose that provides optimal clinical response and tolerability.
The safety and efficacy of aripiprazole during long-term treatment have not been systematically evaluated in adolescent patients with schizophrenia. The physician who elects to use pms-ARIPIPRAZOLE for extended periods in adolescent patients with schizophrenia should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Administration: pms-ARIPIPRAZOLE can be taken without regard to meals. Tablets should not be crushed or cut; they should be swallowed whole.
*For doses not multiple of 2 mg, consider using an appropriate strength of other brands in the market.
Switching from Other Antipsychotics: There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to aripiprazole or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.

Pathological Gambling and Other Compulsive Behaviours: Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other compulsive urges, reported less frequently include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviours. Because patients may not recognize these behaviours as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can be associated with the underlying disorder. In some cases, although not all, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviours may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.

Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. pms-Aripiprazole Tablets 2 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Antipsychotics

N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.

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