Dilarof
Generic Name
Levosulpiride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| dilarof 500 mcg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Dilarof (Levosulpiride) is a prokinetic and antiemetic agent used to treat functional dyspepsia, irritable bowel syndrome, nausea, and vomiting. It acts by selectively blocking D2 dopamine receptors in the gastrointestinal tract.
Uses & Indications
Dosage
Adults
25 mg three times daily, 15-30 minutes before meals. Dosage may be increased to 50 mg three times daily based on response and tolerability.
Elderly
No specific dose adjustment, but use with caution due to potential for increased sensitivity and renal impairment.
Renal_impairment
Dose reduction is recommended. For moderate renal impairment (CrCl 30-60 mL/min), reduce dose by 50%. For severe renal impairment (CrCl <30 mL/min), further reduction may be necessary.
How to Take
Take orally, preferably 15-30 minutes before main meals with a glass of water.
Mechanism of Action
Levosulpiride selectively blocks peripheral D2 dopamine receptors in the gastrointestinal wall, increasing acetylcholine release. This enhances gastrointestinal motility and tone, leading to improved gastric emptying and reduced symptoms of dyspepsia. At higher doses, it may also have central D2 antagonism.
Pharmacokinetics
Onset
Prokinetic effects can be observed within an hour.
Excretion
Mainly excreted unchanged in the urine.
Half life
Approximately 6-7 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations are reached within approximately 3 hours.
Metabolism
Minimally metabolized; primarily excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to levosulpiride or any component of the formulation
- Pheochromocytoma
- Epilepsy or manic states
- Gastrointestinal hemorrhage, mechanical obstruction or perforation
- Prolactin-dependent tumors (e.g., breast cancer)
- Concomitant use with drugs that prolong QT interval
Drug Interactions
Anticholinergics
May antagonize the prokinetic effect of levosulpiride.
Sucralfate or antacids
May reduce absorption of levosulpiride if taken concurrently; administer at least 2 hours apart.
Alcohol & CNS depressants
May enhance sedative effects.
Dopamine agonists (e.g., Bromocriptine)
May reduce their effectiveness.
Drugs that prolong QT interval (e.g., antiarrhythmics, some antipsychotics)
Increased risk of cardiac arrhythmias.
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 sedation, extrapyramidal symptoms (e.g., dystonia, tremor), and hypotension. Management is supportive and symptomatic, including gastric lavage and activated charcoal if appropriate. Anticholinergic agents can be used to manage extrapyramidal symptoms.
Pregnancy & Lactation
Pregnancy Category C: Animal studies have shown adverse effects on the fetus, and there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Lactation: Levosulpiride is excreted in breast milk. Avoid use during lactation or discontinue breastfeeding if use is necessary.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Available in pharmacies and hospitals
Approval Status
Approved in Bangladesh
Patent Status
Off-patent
Clinical Trials
Various clinical trials have been conducted to evaluate the efficacy and safety of levosulpiride in functional dyspepsia, IBS, and other gastrointestinal motility disorders. Studies generally support its effectiveness as a prokinetic agent.
Doctor Notes
- Consider patient's renal function before prescribing and adjust dose accordingly.
- Advise patients about potential for hyperprolactinemia-related side effects and monitor if concerns arise.
- Avoid in patients with a history of seizures or cardiac issues, especially QT prolongation.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Take Dilarof 15-30 minutes before meals for best results.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Report any unusual side effects, especially breast changes or irregular periods, 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 double dose to make up for a missed one.
Driving Precautions
Levosulpiride may cause drowsiness or dizziness. Patients should be advised to exercise caution when driving or operating hazardous machinery until they are reasonably certain that Dilarof does not adversely affect their ability to engage in such activities.
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Global Brand Names
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