Prufit
Generic Name
Prucalopride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| prufit 1 mg tablet | ৳ 14.00 | ৳ 140.00 |
Description
Overview of the medicine
Prufit 1 mg Tablet contains Prucalopride, a selective serotonin 5-HT4 receptor agonist used for the symptomatic treatment of chronic constipation in adults when laxatives fail to provide adequate relief.
Uses & Indications
Dosage
Adults
1 mg once daily. If needed, the dose can be increased to 2 mg once daily.
Elderly
Starting dose 0.5 mg once daily. May be increased to 1 mg once daily if necessary and well tolerated.
Renal_impairment
For severe renal impairment (CrCl <30 mL/min), 0.5 mg once daily. No dosage adjustment needed for mild to moderate renal impairment.
How to Take
Prufit tablet should be taken orally, with or without food, at any time of the day. Swallow the tablet whole with water.
Mechanism of Action
Prucalopride is a selective, high-affinity 5-HT4 receptor agonist that stimulates colonic motility, leading to increased bowel movements and improved stool consistency. It enhances propulsive peristalsis in the colon.
Pharmacokinetics
Onset
Onset of action within 2-4 hours, significant effects seen within 1 week of regular use.
Excretion
Mainly excreted unchanged in urine (about 60%), some via feces.
Half life
Approximately 24-28 hours, allowing for once-daily dosing.
Absorption
Well absorbed orally, bioavailability around 90%. Peak plasma concentration reached within 2-3 hours.
Metabolism
Minimally metabolized; primarily by CYP enzymes to inactive metabolites. About 60% of the dose is excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Intestinal obstruction, intestinal perforation, toxic megacolon/megarectum, inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis).
Drug Interactions
Cyclosporine
Prucalopride is not expected to interact with CYP enzymes, but caution should be exercised with drugs that affect P-glycoprotein.
Erythromycin
May slightly increase Prucalopride levels, but generally not clinically significant.
Ketoconazole
May increase Prucalopride exposure. Dose adjustment may be necessary.
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 headache, nausea, and diarrhea. Treatment is symptomatic and supportive. No specific antidote is available. Gastric lavage and activated charcoal may be considered within the first few hours.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding as it is excreted into breast milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Prucalopride therapy.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Intestinal obstruction, intestinal perforation, toxic megacolon/megarectum, inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis).
Drug Interactions
Cyclosporine
Prucalopride is not expected to interact with CYP enzymes, but caution should be exercised with drugs that affect P-glycoprotein.
Erythromycin
May slightly increase Prucalopride levels, but generally not clinically significant.
Ketoconazole
May increase Prucalopride exposure. Dose adjustment may be necessary.
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 headache, nausea, and diarrhea. Treatment is symptomatic and supportive. No specific antidote is available. Gastric lavage and activated charcoal may be considered within the first few hours.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding as it is excreted into breast milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Prucalopride therapy.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the manufacturing date when stored under recommended conditions.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by FDA (USA) and DGDA (Bangladesh)
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of prucalopride in chronic idiopathic constipation, including placebo-controlled studies supporting its significant improvement in bowel movement frequency and stool consistency compared to placebo.
Lab Monitoring
- No specific routine lab monitoring is required for Prucalopride.
Doctor Notes
- Ensure adequate diagnostic work-up to rule out organic causes of constipation before prescribing prucalopride.
- Monitor for psychiatric symptoms, including depression and suicidal thoughts, especially in patients with a history of such conditions.
- Re-evaluate treatment after 4 weeks if no adequate improvement in symptoms is seen. Consider dose reduction in patients with severe renal impairment.
- Advise patients on lifestyle modifications alongside medication for optimal results.
Patient Guidelines
- Take Prufit 1 mg tablet exactly as prescribed by your doctor.
- Inform your doctor if constipation worsens or new symptoms appear.
- Do not stop taking the medicine without consulting your doctor, even if you feel better.
- Report any unusual mood changes or thoughts to your doctor immediately.
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 continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Prucalopride has negligible influence on the ability to drive and use machines. However, headache and dizziness have been reported. Patients should be advised to be cautious if experiencing these symptoms.
Lifestyle Advice
- Maintain a high-fiber diet.
- Drink plenty of fluids (at least 8 glasses of water daily).
- Engage in regular physical activity.
- Establish a regular bowel habit.
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