Siaby

Siaby

aripiprazole

Manufacturer:

Mersifarma TM
Full Prescribing Info
Contents
Aripiprazole.
Description
Each orally disintegrating tablet contains 10 mg aripiprazole.
Each mL of oral solution contains 1 mg aripiprazole.
Indications/Uses
Orally disintegrating tablet: Treatment of schizophrenia in adults; bipolar I disorders, for acute treatment of manic and mixed episodes in adults; adjunctive therapy of Major Depression Disorders (MDD) in adults.
Oral solution: Adjunct therapy for treatment of any form of parkinsonisms. To control extrapyramidal disorders caused by CNS drugs.
Dosage/Direction for Use
Orally disintegrating tablet: Schizophrenia: Adults: Initially 10-15 mg/day.
Recommended dose: 10-15 mg/day; Maximum: 30 mg/day.
Adolescents: Initially 2 mg/day.
Recommended dose: 10 mg/day; Maximum: 30 mg/day.
Bipolar mania: Adults: Monotherapy: Initially 15 mg.
Recommended dose: 15 mg/day; Maximum: 30 mg/day.
Adjunct therapy to lithium or valproate: Adults: 10-15 mg/day.
Recommended dose: 15 mg/day; Maximum: 30 mg/day.
Monotherapy or adjunct therapy to lithium or valproate: Children: Initially 2 mg/day.
Recommended dose: 10 mg/day; Maximum: 30 mg/day.
Major depressive disorders: Adults: Adjunct therapy to antidepressants: Initially 2-5 mg/day.
Recommended dose: 5-10 mg/day; Maximum: 15 mg/day.
Irritability related to autism disorders: Children: Initially 2 mg/day.
Recommended dose: 5-10 mg/day; Maximum: 15 mg/day.
Tourette's disorders: Patients <50 kg: Initially 2 mg/day.
Recommended dose: 5 mg/day; Maximum: 10 mg/day.
Patients ≥50 kg: Initially 2 mg/day.
Recommended dose: 10 mg/day; Maximum: 20 mg/day.
Oral solution: Idiopathic & post-encephalitic parkinsonism: Initially 1 mg/day on day 1, then increase to 2 mg 2-3 times daily for 3-5 days.
Post-encephalitis: 12-15 mg daily.
Drug-induced parkinsonism (extrapyramidal effects): Adults: Initially 1 mg, may be increased until the symptoms subsides. Total daily dose: 5-15 mg.
Special Precautions
Orally disintegrating tablet: A history of cardiovascular disease, diabetes, seizure, suicide thought. Hypersensitivity.
Oral solution: Gonioscopic evaluation & intraocular pressure monitoring should be performed. Patients with coronary heart disease, liver and kidney disease, hypertension, male patients with a potency of prostate hypertrophy. Discontinue if tardive dyskinesia occur in long-term treatment.
Adverse Reactions
Orally disintegrating tablet: Nausea, vomiting, constipation headache, dizziness, insomnia; neuroleptic malignant syndrome, tardive dyskinesia, potency of metabolism changes.
Oral solution: Dry mouth, blurred vision, dizziness, mild nausea, anxiety, constipation, urinary retention, tachycardia, dilated pupils, increased intraocular pressure, headache.
Drug Interactions
Orally disintegrating tablet: Concomitant use with CNS depressants, drugs interfere with CYP3A4 or CYP2D6 enzymes, anti-hypertensive drugs.
Oral solution: Antagonized with chlorhydria (Glutamic acid, betazole). Potentiate adrenergic agents.
MIMS Class
Antipsychotics
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Siaby oral soln 1 mg/mL
Packing/Price
150 mL x 1's
Form
Siaby OD tab 10 mg
Packing/Price
1 × 10's
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