Aripipracare 20 mg 20 tablets

Aripipracare 20 mg 20 tablets

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.