Product Description

Amisulpride Tablets IP 100 mg is an atypical antipsychotic medication primarily used for the treatment of schizophrenia, particularly targeting negative symptoms such as emotional and social withdrawal. It is also used in acute psychotic episodes, depressive symptoms associated with schizophrenia, and in some countries for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults. Amisulpride acts as a selective dopamine D2 and D3 receptor antagonist with dose-dependent effects.

Uses

• Treatment of schizophrenia, especially the negative symptoms

• Management of acute psychotic episodes

• Treatment of depressive symptoms associated with schizophrenia

• Prevention and treatment of postoperative nausea and vomiting (PONV) in adults (in some regions)
  

How it works

Amisulpride’s mechanism of action is dose-dependent:

• Low doses (50–300 mg/day): Preferentially block presynaptic dopamine D2 and D3 autoreceptors, increasing dopamine release in certain brain areas, which improves negative symptoms such as apathy and social withdrawal.

• High doses (>400 mg/day): Block postsynaptic dopamine D2 and D3 receptors, particularly in the limbic system, thereby reducing dopamine activity and alleviating positive symptoms, such as hallucinations and delusions.

• This dual action makes amisulpride effective for both negative and positive symptoms of schizophrenia.

Benefits

Effective in improving negative symptoms of schizophrenia, which are often resistant to treatment.

• Lower risk of extrapyramidal side effects (movement disorders) compared to typical antipsychotics.

• May cause less weight gain than some other atypical antipsychotics, such as risperidone.

• Can improve depressive symptoms associated with schizophrenia, enhancing overall quality of life.

How to use

Swallow the tablet whole with water; do not crush, chew, or break.

• Take regularly at the same time each day to maintain consistent blood levels.

• Any dose adjustments or discontinuation should be done only under medical supervision.

• Do not double the dose if a dose is missed; take it as soon as remembered unless it is near the time for the next dose.
  

Side Effects

Common side effects include:

• Insomnia (difficulty sleeping)

• Anxiety or agitation

• Gastrointestinal disturbances: constipation, nausea, vomiting

• Dry mouth

• Weight gain

• Hypotension (low blood pressure), which may cause dizziness

• Blurred vision

Serious side effects (require immediate medical attention):

• Prolonged QT interval or cardiac arrhythmias (especially in patients with heart conditions)

• Seizures (amisulpride lowers seizure threshold)

• Hyperprolactinemia (may cause galactorrhea, gynecomastia, menstrual irregularities)

• Neuroleptic malignant syndrome (rare but life-threatening)

Safety Advice

Inform your doctor if you have a history of cardiovascular disease, arrhythmias, prolonged QT interval, or electrolyte imbalances (low potassium or magnesium).

• Monitor blood sugar regularly if diabetic, as amisulpride can increase glucose levels.

• Use caution in patients with kidney or liver impairment; dose adjustments may be necessary.

• Avoid alcohol during treatment as it can increase sedation and dizziness.

• Not recommended for elderly patients with dementia-related psychosis due to increased risk of stroke and mortality.

• Contraindicated in patients with prolactin-dependent tumors (e.g., breast or pituitary tumors).

• Use caution in patients with Parkinson’s disease, as symptoms may worsen.

Storage Conditions

Store at a temperature below 30°C (86°F) in a cool, dry place

FAQs

When to take this medication? 

The specific time to take Amisulpride can vary. Some doctors may advise taking it at bedtime to minimize daytime drowsiness, while others may recommend a different schedule. Always follow your doctor's instructions for the correct timing and dosage.

How long does it take to see the effects? 

The time it takes for Amisulpride to work can vary. Some patients may notice an improvement in symptoms within a few days, while others might not see the full effects for several weeks. Consistent use as prescribed is important for effectiveness.

Can Amisulpride be stopped abruptly? 

No, you should never stop taking Amisulpride suddenly without consulting your doctor. Abrupt discontinuation can lead to withdrawal symptoms and a relapse of your condition. Your doctor will create a plan for gradually reducing the dose when it's appropriate.

Does Amisulpride cause weight gain? 

Weight gain is a possible side effect of Amisulpride. An increase in appetite can contribute to this. You can help manage weight by monitoring food intake and incorporating a healthy diet and regular exercise into your routine.

What if a dose is missed? 

If a dose is missed, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed one and continue the regular dosing schedule. Never take a double dose to make up for a missed one.

Is it safe to drive or operate machinery? 

Amisulpride can cause dizziness and drowsiness, especially when first taking it. Driving or operating heavy machinery should be avoided until the medication's effects and its impact on your ability to concentrate are known.

Can alcohol be consumed while on Amisulpride? 

You should avoid consuming alcohol while taking Amisulpride. Alcohol can increase the risk of drowsiness, dizziness, and other side effects.