Ambozin-SR
Generic Name
Amisulpride Sustained Release
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ambozin sr 75 mg capsule | ৳ 5.00 | N/A |
Description
Overview of the medicine
Ambozin-SR 75 mg Capsule contains Amisulpride, an atypical antipsychotic. At lower doses, it acts as an antidepressant, enhancing dopaminergic transmission in the brain. It is primarily used for the treatment of depressive disorders, dysthymia, and certain anxiety conditions.
Uses & Indications
Dosage
Adults
For depressive disorders, dysthymia, or anxiety: 50-100 mg once daily. Ambozin-SR 75 mg is typically taken as one capsule once daily. Doses should be individualized based on clinical response and tolerability.
Elderly
A reduced dose may be considered for elderly patients, especially those with impaired renal function, starting with 50 mg daily and adjusting carefully.
Renal_impairment
For creatinine clearance (CrCl) 30-60 mL/min, the dose should be halved. For CrCl 10-30 mL/min, the dose should be reduced to one-third. Not recommended for CrCl <10 mL/min due to lack of data.
How to Take
Take the capsule orally, preferably at the same time each day, with or without food. Swallow the capsule whole with water; do not chew or crush it, as this may affect the sustained-release properties.
Mechanism of Action
Amisulpride, at low doses (50-200 mg), selectively blocks presynaptic D2/D3 dopamine autoreceptors, leading to an increase in dopamine release in the synaptic cleft, thus improving mood and reducing depressive symptoms. At higher doses, it blocks postsynaptic D2/D3 receptors, exerting antipsychotic effects.
Pharmacokinetics
Onset
Clinical effects may be observed within a few days to a few weeks, with full therapeutic effect typically seen after 2-4 weeks of consistent use.
Excretion
Approximately 50% of an orally administered dose is excreted unchanged in the urine. Renal clearance is the primary route of elimination.
Half life
The elimination half-life is approximately 12-14 hours, allowing for once or twice daily dosing. Sustained release formulation helps maintain steady plasma levels.
Absorption
Amisulpride is rapidly absorbed after oral administration. It shows two absorption peaks: one rapid (1-4 hours) and a second (3-6 hours). Bioavailability is approximately 48%. Sustained release formulation ensures prolonged absorption.
Metabolism
Amisulpride is minimally metabolized in the liver, with less than 10% undergoing biotransformation to inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to Amisulpride or any component of the formulation
- Phaeochromocytoma (a tumor of the adrenal gland)
- Prolactin-dependent tumors (e.g., pituitary prolactinoma, breast cancer)
- Children under 15 years of age
- Concomitant use with certain drugs that prolong the QT interval or induce torsades de pointes
Drug Interactions
CNS Depressants
Increased sedation and central nervous system depression when co-administered with alcohol, hypnotics, anxiolytics, or other CNS depressants.
Antihypertensives
May cause additive hypotensive effects, leading to orthostatic hypotension.
Dopamine Agonists
Amisulpride may antagonize the effects of dopamine agonists (e.g., levodopa), reducing their efficacy.
QT-prolonging drugs
Increased risk of cardiac arrhythmias, including Torsades de Pointes, with drugs that prolong the QT interval (e.g., certain antiarrhythmics, tricyclic antidepressants, macrolide antibiotics).
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically include somnolence, sedation, hypotension, and extrapyramidal symptoms. Severe overdose may lead to coma. Management involves supportive care, gastric lavage if within a few hours of ingestion, and monitoring of cardiac function (QT prolongation) and vital signs. There is no specific antidote.
Pregnancy & Lactation
Amisulpride is not recommended during pregnancy unless the potential benefit outweighs the risk. Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms. It is excreted in breast milk; therefore, breastfeeding should be avoided during treatment.
Side Effects
Contraindications
- Known hypersensitivity to Amisulpride or any component of the formulation
- Phaeochromocytoma (a tumor of the adrenal gland)
- Prolactin-dependent tumors (e.g., pituitary prolactinoma, breast cancer)
- Children under 15 years of age
- Concomitant use with certain drugs that prolong the QT interval or induce torsades de pointes
Drug Interactions
CNS Depressants
Increased sedation and central nervous system depression when co-administered with alcohol, hypnotics, anxiolytics, or other CNS depressants.
Antihypertensives
May cause additive hypotensive effects, leading to orthostatic hypotension.
Dopamine Agonists
Amisulpride may antagonize the effects of dopamine agonists (e.g., levodopa), reducing their efficacy.
QT-prolonging drugs
Increased risk of cardiac arrhythmias, including Torsades de Pointes, with drugs that prolong the QT interval (e.g., certain antiarrhythmics, tricyclic antidepressants, macrolide antibiotics).
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically include somnolence, sedation, hypotension, and extrapyramidal symptoms. Severe overdose may lead to coma. Management involves supportive care, gastric lavage if within a few hours of ingestion, and monitoring of cardiac function (QT prolongation) and vital signs. There is no specific antidote.
Pregnancy & Lactation
Amisulpride is not recommended during pregnancy unless the potential benefit outweighs the risk. Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms. It is excreted in breast milk; therefore, breastfeeding should be avoided during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date, refer to package for exact expiry.
Availability
Available in pharmacies nationwide in Bangladesh
Approval Status
Approved by DGDA (Drug Administration, Bangladesh)
Patent Status
Generic available, original patent expired
Clinical Trials
Amisulpride has undergone numerous clinical trials demonstrating its efficacy and safety in various psychiatric conditions, including dysthymia, depression, and schizophrenia. Studies support its antidepressant action at lower doses.
Lab Monitoring
- Serum prolactin levels (periodically, especially if symptoms of hyperprolactinemia occur)
- Electrolytes (especially potassium and magnesium, if risk of QT prolongation)
- Liver function tests (baseline and if clinically indicated)
- Renal function (baseline and periodically for dose adjustment)
- ECG (baseline and if cardiac risk factors are present or QT-prolonging drugs are co-administered)
Doctor Notes
- Emphasize gradual titration and discontinuation.
- Monitor for hyperprolactinemia, especially in female patients.
- Assess for cardiovascular risk factors, particularly QT prolongation.
- Educate patients on potential for somnolence and weight gain.
Patient Guidelines
- Take Ambozin-SR 75 mg exactly as prescribed by your doctor.
- Do not stop taking the medicine suddenly, as this may lead to withdrawal symptoms or worsening of your condition. Consult your doctor for gradual dose reduction.
- Report any unusual or severe side effects to your doctor immediately.
- Avoid alcohol while on this medication.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, 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
Ambozin-SR may cause somnolence, dizziness, or blurred vision, especially at the beginning of treatment. Patients should be warned about the risk of drowsiness and advised not to drive or operate machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain a healthy and balanced diet.
- Engage in regular physical activity to support overall well-being and manage weight.
- Practice stress-reducing techniques such as meditation or yoga.
- Ensure adequate sleep (7-8 hours per night).
- Avoid smoking and excessive caffeine intake.
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