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 2 mg tablet | ৳ 24.00 | ৳ 240.00 |
Description
Overview of the medicine
Prufit 2 mg Tablet contains Prucalopride, a medication used to treat chronic idiopathic constipation in adults for whom laxatives have failed to provide adequate relief.
Uses & Indications
Dosage
Adults
The recommended dose is 2 mg once daily, taken with or without food, at any time of day.
Elderly
No specific dose adjustment is required for elderly patients (≥65 years).
Renal_impairment
For severe renal impairment (creatinine clearance < 30 mL/min), the initial dose is 1 mg once daily. For mild to moderate impairment, no dose adjustment is needed.
How to Take
Oral use. Can be taken with or without food, at any time of day.
Mechanism of Action
Prucalopride is a selective, high-affinity 5-HT4 receptor agonist that stimulates colonic motility and accelerates colonic transit, thereby relieving constipation.
Pharmacokinetics
Onset
Clinical effects usually seen within 2-4 days of consistent use, with significant improvement in bowel movement frequency.
Excretion
Primarily excreted unchanged via urine (approximately 60%) and feces (approximately 25%).
Half life
Approximately 24 hours.
Absorption
Well absorbed orally; absolute bioavailability > 90%. Peak plasma concentrations within 2-3 hours.
Metabolism
Minimally metabolized (less than 10%). Primarily excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Intestinal perforation or obstruction, inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), toxic megacolon/megarectum.
Drug Interactions
Rifampicin
Co-administration with rifampicin (a strong CYP3A4 inducer) reduced prucalopride exposure by 40%.
Ketoconazole
Co-administration with ketoconazole (a strong CYP3A4 inhibitor) increased prucalopride exposure by 40%, but no dose adjustment is generally required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include headache, nausea, and diarrhea. Management is symptomatic and supportive. There is no specific antidote for prucalopride.
Pregnancy & Lactation
Not recommended during pregnancy unless clearly necessary. Should be avoided during breastfeeding as prucalopride is excreted in milk.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Intestinal perforation or obstruction, inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), toxic megacolon/megarectum.
Drug Interactions
Rifampicin
Co-administration with rifampicin (a strong CYP3A4 inducer) reduced prucalopride exposure by 40%.
Ketoconazole
Co-administration with ketoconazole (a strong CYP3A4 inhibitor) increased prucalopride exposure by 40%, but no dose adjustment is generally required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include headache, nausea, and diarrhea. Management is symptomatic and supportive. There is no specific antidote for prucalopride.
Pregnancy & Lactation
Not recommended during pregnancy unless clearly necessary. Should be avoided during breastfeeding as prucalopride is excreted in milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Extensive clinical trials (e.g., studies PRU-USA-30, PRU-INT-31) have demonstrated the efficacy and safety of prucalopride in patients with chronic idiopathic constipation over periods up to 12 weeks, and in long-term safety studies up to 12 months.
Lab Monitoring
- Generally not required. However, monitor renal function in patients with severe renal impairment.
- Monitor for signs of depression or suicidal ideation, especially if there is a history of mental health issues.
Doctor Notes
- Assess patient for underlying causes of constipation, including structural, metabolic, and neurological disorders, before initiating prucalopride.
- Caution in patients with a history of serious cardiovascular disease or severe depression/suicidal ideation, although no direct causal link established from clinical trials.
- Monitor for changes in mood or behavior, particularly in susceptible individuals.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, usually once daily.
- Do not exceed the recommended dose of 2 mg per day.
- Continue use for several weeks for the full therapeutic effect, as improvement may not be immediate.
- Inform your doctor if you experience severe diarrhea or abdominal cramps.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to compensate for a missed one.
Driving Precautions
May cause dizziness and fatigue; caution is advised when driving or operating machinery until you know how Prufit affects you.
Lifestyle Advice
- Maintain adequate fluid intake and a fiber-rich diet to help manage constipation.
- Engage in regular physical activity to promote bowel regularity.
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