Aripipracare 20 mg 20 tablets
Multicare
Multicare
Composition
Active ingredient
Each tablet contains Aripiprazole 20 mg.
Excipients
Maize starch, low-substituted hydroxypropyl cellulose E5, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose (Avicel PH 101), and magnesium stearate.
Description
Aripipracare (Aripiprazole) is an atypical antipsychotic with partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.
It restores the balance of dopaminergic and serotonergic neurotransmission in the central nervous system, providing antipsychotic and mood-stabilizing effects.
Aripiprazole reduces positive and negative symptoms of schizophrenia, stabilizes mood, and prevents recurrence of manic episodes in Bipolar I Disorder.
Indications for use
- Schizophrenia in adults and adolescents 15 years and older.
- Treatment of moderate to severe manic episodes in Bipolar I Disorder in adults.
- Prevention of recurrence of manic episodes in adults who have responded to aripiprazole therapy.
- Short-term treatment (up to 12 weeks) of moderate to severe manic episodes in adolescents 13 years and older.
Dosage and administration
Oral use, once daily, with or without food.
Adults
- Schizophrenia: starting and maintenance dose 10-15 mg/day, up to 30 mg/day if necessary.
- Manic episodes: 15 mg/day as monotherapy or adjunctive therapy.
- Recurrence prevention: continue therapy at the effective dose.
Adolescents
- Initiate at 2 mg/day, increasing gradually to 10 mg within 4 days.
- Maximum daily dose: 30 mg, titrated carefully.
- Treatment duration for bipolar disorder should not exceed 12 weeks.
Contraindications
- Hypersensitivity to aripiprazole or any excipient.
- Pregnancy and breastfeeding
- Age under 13 years.
- Caution in patients with cardiovascular disease or severe hepatic impairment.
Precautions
- Use with caution in cardiovascular conditions (ischemic heart disease, heart failure, hypertension, or hypotension).
- Risk of venous thromboembolism in predisposed patients.
- Neuroleptic Malignant Syndrome (NMS) - discontinue immediately if suspected.
- Extrapyramidal symptoms (akathisia, tremor, parkinsonism) may occur, especially in adolescents.
- Discontinue if tardive dyskinesia appears.
- Risk of hyperglycemia or diabetes mellitus.
- Cases of impulse-control disorders (pathological gambling, hypersexuality, binge eating, compulsive shopping) reported.
- Avoid concomitant use with alcohol or other CNS depressants.
- Contains lactose - contraindicated in galactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Side effects
Common
Akathisia, anxiety, insomnia, headache, nausea, tremor, somnolence, dizziness.
Uncommon
Hyperprolactinaemia, hyperglycaemia, depression, hypersexuality, tardive dyskinesia, dystonia, diplopia, tachycardia, orthostatic hypotension, hiccups.
Rare
Seizures, NMS, allergic reactions, arrhythmia, elevated liver enzymes.
Not known
Impulse-control disorders, venous thromboembolism, hyperhidrosis, photosensitivity.
Pregnancy and lactation
- Not recommended during pregnancy. Safety data are limited; potential risks to the fetus exist.
- Neonates exposed to antipsychotics during the third trimester may experience extrapyramidal or withdrawal symptoms.
- Aripiprazole is excreted in breast milk; breastfeeding should be discontinued if treatment is required.
Storage conditions
Store below 30°C, in a dry place, protected from light.
Keep away from reach of children.
Packaging
Carton box containing 2 blisters, each with 10 tablets, and a package insert.