Prucon
Generic Name
Prucalopride
Manufacturer
Hypothetical Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
prucon 1 mg tablet | ৳ 13.00 | ৳ 130.00 |
Description
Overview of the medicine
Prucalopride is a selective, high-affinity 5-HT4 receptor agonist indicated for the symptomatic treatment of chronic idiopathic constipation in adults for whom laxatives fail to provide adequate relief. It helps to restore normal bowel function by increasing bowel motility.
Uses & Indications
Dosage
Adults
2 mg once daily. For severe renal impairment (CrCl < 30 mL/min), 1 mg once daily.
Elderly
Initially 1 mg once daily, may be increased to 2 mg if needed after consultation.
Renal_impairment
Severe renal impairment (CrCl < 30 mL/min): 1 mg once daily. No dosage adjustment needed for mild to moderate renal impairment.
How to Take
Prucalopride tablets should be taken orally with or without food, at any time of day.
Mechanism of Action
Prucalopride selectively stimulates the 5-HT4 receptors of the enteric nervous system, leading to the release of acetylcholine and other neurotransmitters. This enhances colonic motility, propulsive contractions, and gastrointestinal transit, thereby alleviating constipation.
Pharmacokinetics
Onset
Clinical effects observed within 1 week; some patients may experience relief within 1-2 days.
Excretion
Primarily excreted unchanged via urine (approximately 60%) and feces (approximately 39%).
Half life
Approximately 24 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations are reached within 2-3 hours. Absolute bioavailability is >90%.
Metabolism
Minimal metabolism; primarily excreted unchanged. Not significantly metabolized by CYP450 enzymes.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Intestinal perforation or obstruction.
- Obstructive ileus.
- Severe inflammatory conditions of the intestinal tract (e.g., Crohn's disease, ulcerative colitis, toxic megacolon).
Drug Interactions
Warfarin
No clinically relevant interaction observed.
Erythromycin
Small increase in prucalopride plasma concentrations, not clinically significant.
Ketoconazole
Increases prucalopride exposure, but not considered clinically relevant.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include headache, nausea, and diarrhea. Treatment is symptomatic and supportive. No specific antidote is available.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy. Use only if potential benefit justifies the potential risk to the fetus. Lactation: Prucalopride is excreted into breast milk. Should not be used during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Intestinal perforation or obstruction.
- Obstructive ileus.
- Severe inflammatory conditions of the intestinal tract (e.g., Crohn's disease, ulcerative colitis, toxic megacolon).
Drug Interactions
Warfarin
No clinically relevant interaction observed.
Erythromycin
Small increase in prucalopride plasma concentrations, not clinically significant.
Ketoconazole
Increases prucalopride exposure, but not considered clinically relevant.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include headache, nausea, and diarrhea. Treatment is symptomatic and supportive. No specific antidote is available.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy. Use only if potential benefit justifies the potential risk to the fetus. Lactation: Prucalopride is excreted into breast milk. Should not be used during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory bodies (e.g., EMA, FDA)
Patent Status
Generic versions available, original patent expired in many regions
Clinical Trials
Prucalopride has been extensively studied in several phase III clinical trials demonstrating its efficacy and safety in chronic constipation. Studies consistently showed an increase in spontaneous complete bowel movements compared to placebo, with good tolerability.
Lab Monitoring
- No routine laboratory monitoring is required for prucalopride. Monitor renal function in elderly patients or those with pre-existing renal impairment.
Doctor Notes
- Assess renal function before initiating treatment, especially in elderly patients.
- Re-evaluate patient response after 4 weeks; if no clinical benefit, consider discontinuing treatment.
- Counsel patients on adherence and lifestyle modifications (diet, fluid intake, exercise) for optimal results.
- Be aware of potential, though rare, psychological adverse events.
Patient Guidelines
- Take the tablet whole with water.
- Do not crush or chew the tablet.
- Continue taking the medicine as prescribed, even if you feel better.
- Inform your doctor if you experience severe diarrhea, worsening abdominal pain, or new psychological symptoms.
- Maintain adequate fluid intake.
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 the dose.
Driving Precautions
Prucalopride is unlikely to affect the ability to drive or use machines. However, if you experience dizziness or fatigue, avoid driving or operating machinery.
Lifestyle Advice
- Increase dietary fiber intake.
- Engage in regular physical activity.
- Ensure adequate hydration throughout the day.
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Global Brand Names
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