Polycef
Generic Name
polycef-125-mg-pediatric-drop
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
polycef 125 mg pediatric drop | ৳ 62.00 | N/A |
Description
Overview of the medicine
Polycef-125 mg Pediatric Drop contains Cefradine, which is a first-generation cephalosporin antibiotic. It is used to treat a wide range of bacterial infections in infants and young children, primarily those affecting the respiratory tract, urinary tract, skin, and middle ear.
Uses & Indications
Dosage
Adults
Not applicable for this pediatric drop formulation. For adult cefradine formulations, typical doses are 250-500 mg every 6 hours or 500 mg-1g every 12 hours, up to 4g daily.
Elderly
Not applicable for this pediatric drop formulation. For elderly patients, adult doses may need adjustment based on renal function.
Renal_impairment
Dosage adjustment is necessary for patients with renal impairment (creatinine clearance < 50 mL/min). Doses should be reduced and/or interval prolonged. Consult physician.
How to Take
For oral administration. The dry powder should be reconstituted with boiled and cooled water according to the manufacturer's instructions. Shake the bottle well before each use. Administer the prescribed dose using the provided calibrated dropper, with or without food.
Mechanism of Action
Cefradine acts by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located in the bacterial cell wall, which prevents the cross-linking of peptidoglycan chains, leading to a defective and unstable cell wall, ultimately resulting in bacterial cell lysis and death.
Pharmacokinetics
Onset
Onset of antibacterial action is rapid, typically within 1 hour after oral administration.
Excretion
Primarily excreted by the kidneys through glomerular filtration and tubular secretion. Over 80-90% of the dose is excreted unchanged in the urine within 6 hours.
Half life
The plasma elimination half-life is approximately 0.7 to 1.5 hours in adults with normal renal function. It may be prolonged in neonates and patients with renal impairment.
Absorption
Cefradine is well absorbed orally, even in the presence of food, although peak concentrations may be slightly delayed. Peak plasma concentrations are usually achieved within 1 to 2 hours after administration.
Metabolism
Cefradine is minimally metabolized in the body; a large proportion of the administered dose is excreted as unchanged drug.
Side Effects
Contraindications
- Known hypersensitivity to cefradine, other cephalosporins, or to any component of the formulation.
- History of severe hypersensitivity reactions (e.g., anaphylaxis) to penicillins or other beta-lactam antibiotics.
Drug Interactions
Probenecid
Concomitant administration of probenecid decreases the renal tubular secretion of cefradine, resulting in increased and prolonged plasma concentrations of cefradine.
Oral Anticoagulants (e.g., Warfarin)
Cephalosporins may enhance the anticoagulant effect of warfarin, requiring careful monitoring of INR.
Nephrotoxic drugs (e.g., Aminoglycosides, Furosemide)
Concomitant use with nephrotoxic drugs may increase the risk of renal toxicity, although this is less common with cefradine compared to other cephalosporins.
Storage
Store the dry powder below 30°C in a cool, dry place, protected from light and moisture. Store the reconstituted suspension in a refrigerator (2-8°C). Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, diarrhea, epigastric distress, and occasionally convulsions (especially in patients with renal impairment). Management involves symptomatic and supportive care. Hemodialysis may be useful in accelerating the removal of cefradine from the blood.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Small amounts of cefradine are excreted in human milk. Caution should be exercised when cefradine is administered to a nursing woman.
Side Effects
Contraindications
- Known hypersensitivity to cefradine, other cephalosporins, or to any component of the formulation.
- History of severe hypersensitivity reactions (e.g., anaphylaxis) to penicillins or other beta-lactam antibiotics.
Drug Interactions
Probenecid
Concomitant administration of probenecid decreases the renal tubular secretion of cefradine, resulting in increased and prolonged plasma concentrations of cefradine.
Oral Anticoagulants (e.g., Warfarin)
Cephalosporins may enhance the anticoagulant effect of warfarin, requiring careful monitoring of INR.
Nephrotoxic drugs (e.g., Aminoglycosides, Furosemide)
Concomitant use with nephrotoxic drugs may increase the risk of renal toxicity, although this is less common with cefradine compared to other cephalosporins.
Storage
Store the dry powder below 30°C in a cool, dry place, protected from light and moisture. Store the reconstituted suspension in a refrigerator (2-8°C). Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, diarrhea, epigastric distress, and occasionally convulsions (especially in patients with renal impairment). Management involves symptomatic and supportive care. Hemodialysis may be useful in accelerating the removal of cefradine from the blood.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Small amounts of cefradine are excreted in human milk. Caution should be exercised when cefradine is administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Dry powder: 2-3 years from manufacturing date. Reconstituted suspension: 7-14 days when stored in a refrigerator (2-8°C), depending on manufacturer.
Availability
Pharmacies, Hospitals
Approval Status
Approved (for Cefradine)
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Cefradine has been extensively studied since its introduction, with numerous clinical trials confirming its efficacy and safety in various bacterial infections, including pediatric populations. Modern clinical trials may focus on new formulations or specific resistance patterns.
Lab Monitoring
- Renal function tests (e.g., creatinine clearance) should be monitored in patients with pre-existing renal impairment and during prolonged high-dose therapy.
- Complete blood count (CBC) should be monitored during prolonged therapy.
- Liver function tests may be monitored if clinically indicated.
Doctor Notes
- Crucial to educate parents/caregivers on proper reconstitution technique, accurate dosing with the provided dropper, and the importance of completing the full prescribed course to ensure therapeutic efficacy and minimize antibiotic resistance.
- Advise monitoring for signs of hypersensitivity reactions, especially in children with a history of penicillin allergy, due to potential cross-reactivity.
- Consider renal function for appropriate dosing, particularly in neonates or children with suspected kidney impairment.
Patient Guidelines
- Ensure the full course of antibiotics is completed as prescribed, even if symptoms improve, to prevent resistance and recurrence.
- Shake the bottle well before each administration to ensure uniform dispersion of the medicine.
- Use the provided measuring dropper or syringe accurately to ensure the correct dose is given to the child.
- Store the reconstituted suspension in the refrigerator (2-8°C) and discard any unused portion after the period specified by the manufacturer (usually 7-14 days).
- Report any unusual side effects or signs of allergic reaction to a healthcare professional immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medication is primarily for pediatric use. In adults taking cefradine, it is generally not expected to impair the ability to drive or operate machinery. However, if dizziness or other central nervous system effects occur, caution should be advised.
Lifestyle Advice
- Encourage good hygiene practices to prevent the spread of infection.
- Ensure the child maintains adequate hydration by drinking plenty of fluids, especially if experiencing diarrhea.
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