Amipride 200 mg 30 tablets

Amipride 200 mg 30 tablets

Composition:
Each tablet contains:
Amisulpride - 200 mg.
Excipients:
Lactose monohydrate SD, Microcrystalline cellulose PH 101, Hydroxypropyl methylcellulose E5, Sodium starch glycolate, Magnesium stearate, Polyethylene glycol 6000, Purified talc, Titanium dioxide, Purified water.
Description:
Amipride (amisulpride) is an atypical antipsychotic from the benzamide class with selective antagonism for dopamine D₂/D₃ receptors.
It is effective in the management of acute and chronic schizophrenia, addressing both positive symptoms (hallucinations, delusions, thought disorders) and negative symptoms (emotional blunting, social withdrawal, lack of motivation).
The medicine provides antipsychotic stabilization, reduction of agitation, and improvement of cognitive and affective symptoms.
Indications for Use:
- Acute schizophrenia
- Chronic schizophrenia
- Predominantly positive symptoms
- Predominantly negative symptoms
- Mixed symptomatology
- Long-term maintenance therapy.
Dosage and Method of Administration:
Acute psychotic episodes:
- 400-800 mg/day
- Up to 1200 mg/day in selected cases (Doses >1200 mg/day are not recommended).
Predominantly negative symptoms:
- 50-300 mg/day.
Mixed symptoms:
- Individual dose adjustment using the lowest effective dose.
Administration:
- Up to 300 mg/day - once daily
- 300 mg/day - divided into two doses.
Special populations:
- Elderly: use with caution
- Children: contraindicated before puberty; not recommended up to 18 years.
Contraindications:
- Hypersensitivity to amisulpride
- Prolactin-dependent tumors (prolactinoma, breast cancer)
- Pheochromocytoma
- Children before puberty
- Concomitant therapy with levodopa
- Drugs inducing torsades de pointes (Class IA and III antiarrhythmics, cisapride, sultopride, IV erythromycin, halofantrine, pentamidine, sparfloxacin).
Precautions:
- Risk of Neuroleptic Malignant Syndrome
- Risk of hyperglycemia; monitor diabetics
- May lower seizure threshold
- Increased prolactin levels - monitor patients at risk
- Risk of venous thromboembolism
- QT prolongation - ECG monitoring required
- Increased mortality in elderly with dementia - not indicated
- Use with caution in renal impairment.
Side Effects:
Very common:
- Extrapyramidal symptoms (tremor, rigidity, hypokinesia, hypersalivation, akathisia).
Common:
- Somnolence
- Acute dystonia
- Constipation, nausea
- Weight gain
- Anxiety, insomnia, sexual dysfunction.
Uncommon:
- Seizures
- Hyperprolactinemia
- Hyperglycemia
- Hypotension
- Leukopenia, neutropenia.
Rare:
- Agranulocytosis
- QT prolongation, ventricular arrhythmias
- Anaphylaxis
- Urticaria, angioedema
- Neuroleptic Malignant Syndrome.
Frequency unknown:
- Photosensitivity
- Neonatal withdrawal symptoms (with 3rd trimester exposure).
Pregnancy and Breastfeeding:
Pregnancy:
Limited human data.
Neonatal EPS or withdrawal possible.
Not recommended unless benefit outweighs risk
Breastfeeding:
Excreted in breast milk.
Discontinue breastfeeding or stop treatment.
Storage Conditions:
Store below 30°C, in a dry place.
Keep away from the reach of children.
Packaging
Carton box containing 3 blisters Each blister contains 10 tablets and leaflet.