Amlevo
Generic Name
Amisulpride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amlevo 25 mg tablet | ৳ 7.00 | ৳ 70.00 |
Description
Overview of the medicine
Amisulpride is an atypical antipsychotic primarily used for the treatment of schizophrenia, including acute and chronic schizophrenic disorders. The 25 mg dose is often used for predominant negative symptoms or as an adjunctive therapy in depression, or very low dose management of psychosis.
Uses & Indications
Dosage
Adults
For negative symptoms: 50 mg to 300 mg daily. For acute psychotic episodes: 400 mg to 800 mg daily, divided into two doses. Doses above 1200 mg daily are not recommended. 25 mg can be a starting dose or for very mild symptoms.
Elderly
Lower doses are recommended for elderly patients, especially due to potential for renal impairment and increased sensitivity to adverse effects. Initiate at a low dose and titrate cautiously.
Renal_impairment
Dose adjustment is required. For creatinine clearance 30-60 mL/min, the dose should be halved. For creatinine clearance 10-30 mL/min, the dose should be reduced to one-third. Not recommended for severe renal impairment (CrCl < 10 mL/min) unless benefits outweigh risks.
How to Take
Amlevo-25-mg-tablet should be taken orally, with or without food. If the daily dose is 300 mg or less, it can be taken once daily. For higher doses, it should be divided into two daily doses.
Mechanism of Action
Amisulpride acts as a selective antagonist of dopamine D2 and D3 receptors. At low doses (like 25 mg), it preferentially blocks presynaptic D2/D3 autoreceptors, which leads to increased dopamine release and may improve negative symptoms and mood. At higher doses, it blocks postsynaptic D2/D3 receptors, which is responsible for its antipsychotic effects.
Pharmacokinetics
Onset
Clinical effects may take several days to weeks to manifest fully, though some symptomatic relief might be noted earlier.
Excretion
Excreted predominantly unchanged in urine via the renal route. Approximately 50% of an intravenous dose is eliminated in urine.
Half life
Approximately 12-13 hours.
Absorption
Amisulpride shows biphasic absorption; a rapid absorption phase with a peak concentration reached in 1 hour and a second slower absorption phase, reaching a second peak between 3 and 4 hours after oral administration. Bioavailability is about 48%.
Metabolism
Amisulpride is minimally metabolized in humans; only two inactive metabolites have been identified.
Side Effects
Contraindications
- Known hypersensitivity to amisulpride or any component of the formulation.
- Prolactin-dependent tumours (e.g., prolactinoma, breast cancer).
- Phaeochromocytoma.
- Children prior to puberty.
- Concomitant use with certain drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, cisapride, sultopride, thioridazine, erythromycin IV, halofantrine, pentamidine, sparfloxacin).
Drug Interactions
Antihypertensive agents
Increased risk of orthostatic hypotension.
Dopamine agonists (e.g., levodopa, bromocriptine)
Mutual antagonism; amisulpride may counteract the effects of dopamine agonists. Concomitant use should be avoided.
Drugs affecting electrolyte balance (e.g., diuretics)
May increase risk of arrhythmias.
CNS Depressants (e.g., opioids, benzodiazepines, alcohol)
May potentiate central nervous system depression, including sedation and respiratory depression.
Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antibiotics, other antipsychotics)
Increased risk of ventricular arrhythmias, including Torsades de Pointes. Concomitant use is contraindicated.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, sedation, hypotension, and extrapyramidal symptoms. Cases of coma have also been reported. ECG monitoring for QT prolongation is crucial. Management is supportive, including maintaining an open airway, providing oxygenation and ventilation, and monitoring cardiovascular parameters. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless the potential benefits justify the potential risks to the fetus. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Amisulpride is excreted into breast milk; therefore, breastfeeding is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture
Availability
Pharmacies, hospitals
Approval Status
Approved in many countries
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established Amisulpride's efficacy in treating schizophrenia, particularly for negative symptoms at lower doses and positive symptoms at higher doses. Ongoing research explores its role in other psychiatric conditions.
Lab Monitoring
- Prolactin levels (especially if symptoms of hyperprolactinemia occur)
- Blood glucose and lipid profile (periodically)
- ECG (before and during treatment, especially in patients with cardiac risk factors)
- Renal function (before and during treatment)
- Complete Blood Count (CBC) (if signs of infection or blood dyscrasias appear)
Doctor Notes
- Initiate Amisulpride at the lowest effective dose and titrate slowly.
- Monitor for extrapyramidal symptoms, particularly at higher doses.
- Regularly assess prolactin levels due to high incidence of hyperprolactinemia.
- Consider ECG monitoring in patients with cardiovascular risk factors or electrolyte disturbances.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Amlevo abruptly, as this can lead to withdrawal symptoms.
- Report any unusual side effects, especially breast changes, menstrual irregularities, or sexual dysfunction, to your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Amlevo may cause drowsiness or blurred vision. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Amlevo therapy does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Avoid alcohol consumption while taking this medication.
- Maintain a healthy diet and exercise to manage potential weight gain.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine
Related
Medicines
Explore similar medicines to find the best option for your healthcare needs.
Avolose
Incepta Pharmaceuticals Ltd.
Avloquin-H
General Pharmaceuticals Ltd.
Azelec
Square Pharmaceuticals Ltd.
Lotenate Plus
General Pharmaceuticals Ltd.
Exib
Incepta Pharmaceuticals Ltd.
Azi S
Square Pharmaceuticals Ltd.
Exalin
Square Pharmaceuticals Ltd.
Timozin
MediCorp Pharma Ltd.
Exopan
Square Pharmaceuticals Ltd.
EuroORS
Euro Pharma Ltd.