Urocure SR
Generic Name
Nitrofurantoin (as Macrocrystals) 100 mg Sustained Release Capsule
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
urocure sr 100 mg capsule | ৳ 20.06 | ৳ 200.60 |
Description
Overview of the medicine
Nitrofurantoin is an antibacterial agent specifically used for the treatment and prophylaxis of urinary tract infections. The sustained-release formulation allows for less frequent dosing and improved gastrointestinal tolerability.
Uses & Indications
Dosage
Adults
For acute uncomplicated UTIs: 100 mg (one capsule) orally every 12 hours (twice daily) for 7 days. For prophylaxis of recurrent UTIs: 100 mg orally once daily at bedtime.
Elderly
Similar to adult dosage, but caution with renal function. Contraindicated if creatinine clearance < 60 mL/min.
Renal_impairment
Contraindicated in patients with significant renal impairment (creatinine clearance < 60 mL/min or ESRD) due to increased toxicity and lack of efficacy.
How to Take
Take orally with food (milk or meals) to enhance absorption and reduce gastrointestinal upset. Swallow the capsule whole; do not crush, chew, or open the capsule.
Mechanism of Action
Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates that inactivate or damage bacterial ribosomal proteins, DNA, RNA, and other macromolecules. This leads to the inhibition of vital biochemical processes in the bacterial cell, ultimately resulting in bacterial death.
Pharmacokinetics
Onset
Therapeutic concentrations in urine within 30-60 minutes.
Excretion
Primarily excreted via renal glomerular filtration and tubular secretion. Approximately 40% of the dose is recovered in the urine.
Half life
Plasma half-life is 20-60 minutes, but it is rapidly excreted, leading to high urine concentrations.
Absorption
Well absorbed from the GI tract, especially with food, which increases bioavailability and extends absorption time for SR formulations. Peak plasma concentrations are low due to rapid elimination.
Metabolism
Approximately 50% is metabolized in tissues, but a significant portion is excreted unchanged in the urine.
Side Effects
Contraindications
- Patients with anuria, oliguria, or significant impairment of renal function (creatinine clearance below 60 mL/min or end-stage renal disease).
- Known hypersensitivity to nitrofurantoin.
- Pregnant patients at term (38-42 weeks gestation), during labor and delivery, or when the onset of labor is imminent due to the possibility of hemolytic anemia in the neonate.
- Infants under one month of age.
- Patients with a history of cholestatic jaundice/hepatic dysfunction associated with previous nitrofurantoin use.
- Patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
Drug Interactions
Quinolones
Nitrofurantoin may antagonize the antibacterial effects of quinolone antibiotics.
Probenecid and Sulfinpyrazone
May inhibit renal tubular secretion of nitrofurantoin, leading to decreased urinary concentrations (reducing efficacy) and increased serum levels (potentially increasing toxicity).
Antacids (containing magnesium trisilicate)
May reduce nitrofurantoin absorption, decreasing its effectiveness.
Live bacterial vaccines (e.g., typhoid vaccine)
Antibiotics may reduce the therapeutic effect of live bacterial vaccines.
Storage
Store below 30°C in a dry place, away from direct sunlight. Keep out of reach of children.
Overdose
Symptoms may include vomiting and diarrhea. No specific antidote. Management involves symptomatic and supportive care, increasing fluid intake to promote urinary excretion. Hemodialysis is ineffective.
Pregnancy & Lactation
Pregnancy Category B. Avoid use at term (38-42 weeks gestation) due to risk of hemolytic anemia in neonates. Use during first and second trimesters only if clearly needed and benefits outweigh risks. Excreted in breast milk in small amounts; use with caution during lactation, monitor infant for gastrointestinal upset or hemolytic anemia, especially if infant is G6PD deficient.
Side Effects
Contraindications
- Patients with anuria, oliguria, or significant impairment of renal function (creatinine clearance below 60 mL/min or end-stage renal disease).
- Known hypersensitivity to nitrofurantoin.
- Pregnant patients at term (38-42 weeks gestation), during labor and delivery, or when the onset of labor is imminent due to the possibility of hemolytic anemia in the neonate.
- Infants under one month of age.
- Patients with a history of cholestatic jaundice/hepatic dysfunction associated with previous nitrofurantoin use.
- Patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
Drug Interactions
Quinolones
Nitrofurantoin may antagonize the antibacterial effects of quinolone antibiotics.
Probenecid and Sulfinpyrazone
May inhibit renal tubular secretion of nitrofurantoin, leading to decreased urinary concentrations (reducing efficacy) and increased serum levels (potentially increasing toxicity).
Antacids (containing magnesium trisilicate)
May reduce nitrofurantoin absorption, decreasing its effectiveness.
Live bacterial vaccines (e.g., typhoid vaccine)
Antibiotics may reduce the therapeutic effect of live bacterial vaccines.
Storage
Store below 30°C in a dry place, away from direct sunlight. Keep out of reach of children.
Overdose
Symptoms may include vomiting and diarrhea. No specific antidote. Management involves symptomatic and supportive care, increasing fluid intake to promote urinary excretion. Hemodialysis is ineffective.
Pregnancy & Lactation
Pregnancy Category B. Avoid use at term (38-42 weeks gestation) due to risk of hemolytic anemia in neonates. Use during first and second trimesters only if clearly needed and benefits outweigh risks. Excreted in breast milk in small amounts; use with caution during lactation, monitor infant for gastrointestinal upset or hemolytic anemia, especially if infant is G6PD deficient.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
3 years from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Nitrofurantoin has been extensively studied since its introduction in the 1950s. Clinical trials and real-world data support its efficacy in treating uncomplicated UTIs and for prophylaxis. Sustained-release formulations were developed to improve patient compliance and reduce gastrointestinal side effects compared to immediate-release forms.
Lab Monitoring
- Liver function tests (LFTs) if prolonged treatment or symptoms of liver dysfunction.
- Renal function tests (creatinine clearance) at baseline and periodically, especially in elderly and those with pre-existing renal issues.
- Complete blood count (CBC) if treatment is prolonged or signs of blood dyscrasias appear.
- G6PD screening should be considered for at-risk individuals.
Doctor Notes
- Advise patients about the potential for harmless brownish-yellow urine discoloration.
- Emphasize strict adherence to the full course of treatment to prevent therapeutic failure and resistance.
- Carefully assess renal function (creatinine clearance) before initiating and periodically during treatment, especially in elderly patients.
- Monitor for signs of pulmonary, hepatic, and neurological toxicity, particularly with long-term use.
Patient Guidelines
- Take medicine exactly as prescribed, even if symptoms improve, to ensure complete eradication of infection and prevent recurrence.
- Take with food to avoid stomach upset and improve absorption.
- Drink plenty of fluids unless otherwise advised by your doctor to help flush out the infection.
- Report any unusual side effects, especially difficulty breathing, persistent cough, jaundice, dark urine, numbness/tingling in hands/feet, or severe diarrhea, 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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness or drowsiness in some individuals. Avoid driving or operating heavy machinery until you know how this medicine affects you.
Lifestyle Advice
- Practice good personal hygiene to prevent recurrent UTIs, such as wiping from front to back after bowel movements.
- Empty bladder completely after sexual intercourse.
- Avoid irritating feminine hygiene products.
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