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AMISULPRIDE 100MG TABLETS 60`S

Ksh 9,599

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What is Amisulpride and What Is It Used For?

Amisulpride is an atypical antipsychotic medicine that works by selectively blocking dopamine D2 and D3 receptors in the brain. Unlike many other antipsychotics, it has little affinity for histamine, muscarinic, or adrenergic receptors, which gives it a more targeted profile. At low doses, it blocks presynaptic D3 receptors and paradoxically increases dopamine transmission, helping with negative symptoms of schizophrenia.

Amisulpride is indicated for the treatment of: Schizophrenia — including both acute psychotic episodes (positive symptoms: hallucinations, delusions, thought disorder) and chronic schizophrenia with predominantly negative symptoms (social withdrawal, emotional blunting, poverty of speech); Dysthymia (mild chronic depression) — lower doses are used in some clinical guidelines.

Amisulpride should only be initiated under the supervision of a psychiatrist. It is a well-studied atypical antipsychotic with a good evidence base for both positive and negative symptoms of schizophrenia.

 

2. How to Take This Medicine

Acute Psychosis (Positive Symptoms — Schizophrenia)

       400–800 mg/day in two divided doses.

       Maximum dose: 1200 mg/day (specialist use only).

Predominantly Negative Symptoms

       50–300 mg/day as a single daily dose.

Dysthymia

       50 mg once daily.

Take tablets with or without food. If taking once daily, it can be at any time of day. For twice-daily dosing, space doses evenly (e.g., morning and evening).

 

3. Side Effects

Common Side Effects

       Insomnia, agitation, and anxiety.

       Extrapyramidal effects — tremor, stiffness, restlessness (akathisia), slowness of movement — dose-dependent and less common than with typical antipsychotics.

       Raised prolactin — breast enlargement, milky discharge, menstrual irregularities, reduced libido, sexual dysfunction.

       Weight gain (moderate).

       Constipation, nausea.

Serious Side Effects — Seek Medical Attention

       QT prolongation and cardiac arrhythmias — increased risk if taking other QT-prolonging drugs.

       Neuroleptic Malignant Syndrome (NMS) — rare, life-threatening: high fever, severe muscle rigidity, altered consciousness. Seek emergency help immediately.

       Tardive dyskinesia — involuntary repetitive movements (usually with long-term use).

       Seizures — use with caution in epilepsy.

 

4. Contraindications — Who Should NOT Take This Medicine

 

Do not take Amisulpride if you:

       You are allergic to amisulpride or any ingredient in the tablet.

       You have a prolactin-dependent tumour (e.g., pituitary prolactinoma, breast cancer).

       You have phaeochromocytoma (adrenal gland tumour).

       You are taking medicines known to prolong the QT interval (discuss with your doctor).

       You have a severe kidney disease without dose adjustment.

       You are taking levodopa (or other dopamine agonists) — except in Parkinson's disease under specialist guidance.

       Children and adolescents under 18 years (safety not established).

 

5. Safety Warnings and Special Precautions

QT Prolongation and Cardiac Risk

Amisulpride can prolong the QT interval on an ECG (electrocardiogram), which can potentially cause a dangerous heart arrhythmia. An ECG and electrolytes (particularly potassium and magnesium) should be checked before starting treatment, and any abnormalities corrected.

Elderly Patients with Dementia

Antipsychotics including amisulpride should be used with great caution in elderly patients with dementia-related psychosis, as they are associated with an increased risk of stroke and death in this population.

Prolactin Elevation

Amisulpride raises prolactin levels more than most atypical antipsychotics. In patients with breast cancer or prolactinoma, amisulpride should be avoided. Monitor for symptoms of hyperprolactinaemia.

Renal Impairment

Amisulpride is excreted renally. Reduce dose in kidney impairment: CrCl 30–60 mL/min: use half the usual dose; CrCl 10–30 mL/min: use one-third of the usual dose.

 

6. Drug Interactions

       QT-prolonging drugs (antiarrhythmics, tricyclic antidepressants, certain antibiotics like moxifloxacin, methadone) — risk of fatal cardiac arrhythmia; avoid or monitor very carefully with ECG.

       Levodopa and dopamine agonists — mutual antagonism; avoid in Parkinson's disease unless specifically managed by a neurologist.

       Alcohol — enhanced CNS depression and sedation.

       Antihypertensives — increased risk of low blood pressure.

       Lithium — potential for additive neurotoxicity and increased QT risk.

 

7. Storage Instructions

       Store below 25°C, away from moisture and direct light.

       Keep in the original packaging.

       Keep out of reach of children.

 

8. Prescription Status in Kenya

Amisulpride is a prescription-only medicine (POM) in Kenya. It must only be initiated and supervised by a registered psychiatrist or physician with experience in treating psychotic disorders.

 

9. Patient Guidance

 

Important Reminders for Patients

       Take your medication at the same time(s) every day for best results.

       Do not stop taking amisulpride without talking to your psychiatrist — stopping suddenly can cause a relapse of symptoms.

       Limit or avoid alcohol during treatment.

       Tell your doctor if you notice breast changes, milky discharge, missed periods, or sexual difficulties.

       Stand up slowly from lying or sitting down to reduce dizziness from low blood pressure.

       Attend all scheduled psychiatric and monitoring appointments.

 

10. Pharmacist / Prescriber Notes

       Baseline: ECG (QTc interval), FBC, fasting glucose, lipids, prolactin, U&E, LFTs, weight, blood pressure.

       Ongoing: Repeat ECG if dose changes or QT-prolonging drugs added. Monitor weight, glucose, lipids, blood pressure annually or more frequently.

       Renal dose adjustment: CrCl 30–60 mL/min: 50% of normal dose; CrCl 10–30 mL/min: 33% of normal dose; avoid in CrCl <10 mL/min.

       Amisulpride does not undergo significant hepatic metabolism — dose adjustment not required for hepatic impairment.

       Less metabolic risk than olanzapine/clozapine but more prolactin elevation than other atypicals — consider in patient counselling.

 

11. Frequently Asked Questions (FAQs)

What is amisulpride used for?

Amisulpride is an antipsychotic medicine used to treat schizophrenia — both the acute symptoms (hallucinations, delusions) and the chronic negative symptoms (withdrawal, emotional blunting). It is also sometimes used in low doses for dysthymia (chronic mild depression).

Will amisulpride cause weight gain?

Weight gain is possible with amisulpride, but it is generally more moderate than with olanzapine or clozapine. Monitor weight regularly and maintain a healthy diet and physical activity.

Why am I producing breast milk (or having other hormonal side effects)?

Amisulpride increases prolactin levels, which can cause breast milk production, breast enlargement, missed periods, and reduced libido in both men and women. Tell your doctor if these side effects are bothersome.

Can I drink alcohol while taking amisulpride?

Alcohol enhances the sedating and CNS-depressant effects of amisulpride and should be avoided or strictly limited during treatment.

Can I drive while taking amisulpride?

Amisulpride may cause dizziness and slow reactions. Until you know how it affects you, avoid driving, operating machinery, or other tasks requiring alertness.

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