Amipride 50 mg 30 tablets
ِAndalous pharmaceutical
ِAndalous pharmaceutical
Composition
Each tablet contains
Amisulpride 52 mg (equivalent to 50 mg amisulpride anhydrous).
Excipients
Lactose monohydrate, microcrystalline cellulose (PH 101), sodium starch glycolate, hypromellose (HPMC E5), magnesium stearate.
Description
Amipride is an antipsychotic (atypical neuroleptic) of the benzamide group with selective antagonism for dopamine D2 and D3 receptors.
It normalizes dopaminergic activity, improving both positive (delusions, hallucinations, suspiciousness) and negative symptoms (emotional withdrawal, apathy, social isolation) of schizophrenia.
It has pronounced antipsychotic and mood-stabilizing effects with minimal sedation and low risk of extrapyramidal side effects at therapeutic doses.
Indications for Use
- Acute and chronic psychotic disorders, including schizophrenia with predominant positive or negative symptoms.
- Treatment of depressive and apathetic states associated with schizophrenia.
Dosage and Administration
- Acute psychotic episodes: 400-800 mg daily, up to 1200 mg/day (in two divided doses).
- Predominant negative symptoms: 50-300 mg once daily.
- Reduce dosage in renal impairment according to creatinine clearance; contraindicated if CrCl <10 mL/min.
- Discontinue gradually.
Tablets should be swallowed whole with water, with or without food.
Contraindications
- Hypersensitivity to amisulpride or excipients.
- Prolactin-dependent tumors (e.g., prolactinoma, breast cancer).
- Phaeochromocytoma.
- Children under 15 years.
- Concomitant use with levodopa or drugs causing torsade de pointes.
Precautions
- Use with caution in Parkinson’s disease, cardiac disorders, electrolyte imbalance, venous thromboembolism risk, and in elderly patients.
- Monitor ECG and electrolytes during therapy.
- May cause hyperprolactinemia, weight gain, or hyperglycemia.
- Discontinue immediately if neuroleptic malignant syndrome, jaundice, seizures, or marked hypotension occur.
Side Effects
Very common : extrapyramidal symptoms (tremor, rigidity, hypokinesia, akathisia, dyskinesia).
Common: somnolence, insomnia, anxiety, dizziness, constipation, nausea, weight gain, elevated prolactin (amenorrhea, galactorrhea, gynecomastia).
Uncommon: leukopenia, hyperglycemia, hyperlipidemia, hyponatremia, orthostatic hypotension. Rare : agranulocytosis, neuroleptic malignant syndrome, QT prolongation, torsade de pointes, photosensitivity.
Pregnancy and Lactation
- Use during pregnancy is not recommended unless clearly necessary.
Amisulpride crosses the placenta and may cause extrapyramidal or withdrawal symptoms in neonates.
- Amisulpride is excreted into breast milk; breastfeeding should be discontinued during treatment.
Storage Conditions
Store below 25 °C in a dry place.
Keep out of reach of children
Packaging
Carton box containing 3 strips of 10 tablets each, with a package leaflet.