Esomiloc
Generic Name
Esomeprazole + Levosulpiride
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| esomiloc 20 mg tablet | ৳ 6.00 | ৳ 60.00 |
| esomiloc 40 mg tablet | ৳ 8.00 | ৳ 80.00 |
| esomiloc 20 mg capsule | ৳ 8.00 | ৳ 80.00 |
| esomiloc 40 mg capsule | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Esomiloc is a combination medicine containing Esomeprazole (a proton pump inhibitor) and Levosulpiride (a prokinetic agent). It is primarily used to treat gastroesophageal reflux disease (GERD), dyspepsia, and other conditions associated with acid reflux and impaired gastrointestinal motility.
Uses & Indications
Dosage
Adults
One capsule (Esomeprazole 40 mg + Levosulpiride 25 mg) once daily, preferably before breakfast.
Elderly
Dosage adjustment may be required in elderly patients with impaired renal function.
Renal_impairment
Use with caution; dose reduction may be necessary in severe renal impairment (especially for Levosulpiride).
How to Take
Take orally, swallow the capsule whole with water. Do not chew or crush. Best taken before a meal, usually in the morning.
Mechanism of Action
Esomeprazole works by irreversibly blocking the H+/K+-ATPase (proton pump) in gastric parietal cells, thereby reducing gastric acid secretion. Levosulpiride is a selective dopamine D2 receptor antagonist with prokinetic and antiemetic properties. It increases gastric emptying and improves gastrointestinal motility by blocking dopamine receptors in the gut.
Pharmacokinetics
Onset
Symptomatic relief usually occurs within a few days of starting treatment.
Excretion
Esomeprazole metabolites are primarily excreted in the urine (approximately 80%) and feces (approximately 20%). Levosulpiride is primarily excreted unchanged in the urine (approximately 90%).
Half life
Esomeprazole: approximately 1-1.5 hours. Levosulpiride: approximately 6-8 hours.
Absorption
Esomeprazole is rapidly absorbed after oral administration, with peak plasma levels occurring within 1-2 hours. Levosulpiride is also rapidly absorbed, reaching peak plasma concentrations within 2-3 hours.
Metabolism
Esomeprazole is extensively metabolized in the liver via the cytochrome P450 system (CYP2C19 and CYP3A4). Levosulpiride is minimally metabolized and excreted mainly unchanged.
Side Effects
Contraindications
- Hypersensitivity to Esomeprazole, Levosulpiride, or any excipients
- Prolactin-dependent tumors (e.g., pituitary adenoma)
- Gastrointestinal hemorrhage, mechanical obstruction, or perforation
- Patients with epilepsy or manic states due to potential for exacerbation
Drug Interactions
Alcohol
Levosulpiride may potentiate the sedative effects of alcohol.
Antacids
Should not be taken simultaneously as they may reduce Levosulpiride absorption.
Diazepam
Esomeprazole may prolong the elimination of diazepam.
Warfarin
Esomeprazole may increase INR and prothrombin time. Monitor closely.
Phenytoin
Esomeprazole may reduce the metabolism of phenytoin, increasing its levels.
CNS depressants
Additive CNS depression with other CNS depressants.
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 may include drowsiness, disorientation, extrapyramidal symptoms, and hypotension. Treatment is symptomatic and supportive, including gastric lavage and activated charcoal if appropriate.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding due to potential excretion in breast milk (especially Levosulpiride).
Side Effects
Contraindications
- Hypersensitivity to Esomeprazole, Levosulpiride, or any excipients
- Prolactin-dependent tumors (e.g., pituitary adenoma)
- Gastrointestinal hemorrhage, mechanical obstruction, or perforation
- Patients with epilepsy or manic states due to potential for exacerbation
Drug Interactions
Alcohol
Levosulpiride may potentiate the sedative effects of alcohol.
Antacids
Should not be taken simultaneously as they may reduce Levosulpiride absorption.
Diazepam
Esomeprazole may prolong the elimination of diazepam.
Warfarin
Esomeprazole may increase INR and prothrombin time. Monitor closely.
Phenytoin
Esomeprazole may reduce the metabolism of phenytoin, increasing its levels.
CNS depressants
Additive CNS depression with other CNS depressants.
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 may include drowsiness, disorientation, extrapyramidal symptoms, and hypotension. Treatment is symptomatic and supportive, including gastric lavage and activated charcoal if appropriate.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding due to potential excretion in breast milk (especially Levosulpiride).
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Available in pharmacies and hospitals
Approval Status
DGDA approved
Patent Status
Generic available (off-patent)
Clinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of Esomeprazole and Levosulpiride individually and in combination for treating GERD and dyspepsia. Studies typically show significant improvement in symptom scores and healing rates of esophagitis.
Lab Monitoring
- Liver function tests (periodically with long-term use)
- Renal function tests (especially in patients with kidney impairment)
- Serum prolactin levels (if prolactin-related side effects develop)
Doctor Notes
- Assess patients for risk factors of extrapyramidal symptoms and hyperprolactinemia before initiating Levosulpiride.
- Caution in patients with cardiovascular disease due to potential QT prolongation (though less common with Levosulpiride than other antipsychotics).
- Advise patients on lifestyle modifications to complement therapy.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not chew or crush the capsule; swallow it whole.
- It is best to take this medicine before your first meal of the day.
- Report any unusual or severe side effects to your doctor.
Missed Dose Advice
If a dose is missed, 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 double the dose.
Driving Precautions
This medicine may cause dizziness or drowsiness. If you experience these symptoms, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid fatty, spicy, and acidic foods.
- Eat smaller, more frequent meals.
- Avoid lying down immediately after eating.
- Elevate the head of your bed.
- Avoid smoking and excessive alcohol consumption.
- Maintain a healthy weight.
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