Rofecin
Generic Name
rofecin-2-gm-injection
Manufacturer
PharmaCo Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rofecin 2 gm injection | ৳ 682.05 | N/A |
Description
Overview of the medicine
Rofecin 2 gm Injection is a broad-spectrum cephalosporin antibiotic used to treat a wide range of bacterial infections, including severe infections of the respiratory tract, urinary tract, skin and soft tissues, bones and joints, as well as meningitis and septicemia.
Uses & Indications
Dosage
Adults
Usual adult dose is 1-2 gm IV or IM every 12-24 hours, depending on the severity of the infection. In severe cases, up to 4 gm daily in divided doses.
Elderly
No specific dose adjustment is typically required based on age alone, but renal function should be monitored, and dose adjusted if impairment is present.
Renal_impairment
For patients with significant renal impairment (creatinine clearance <10 mL/min), the total daily dose should not exceed 2 gm. Monitoring of plasma concentrations may be beneficial.
How to Take
Rofecin 2 gm Injection can be administered either intravenously (IV) via slow infusion over 30 minutes, or intramuscularly (IM) as a deep injection. For IM administration, it should be reconstituted with an appropriate diluent (e.g., lidocaine 1% for painful IM injections).
Mechanism of Action
Rofecin acts by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located in the bacterial cell wall, thereby disrupting the cross-linking of peptidoglycan chains, leading to cell lysis and bacterial death.
Pharmacokinetics
Onset
Rapid, typically within minutes after IV administration.
Excretion
Excreted primarily through both renal (glomerular filtration) and biliary pathways, with about 50-60% via urine and 40-50% via bile/feces.
Half life
Approximately 6-9 hours in adults, allowing for once- or twice-daily dosing.
Absorption
Intravenous (IV) or Intramuscular (IM) administration provides complete bioavailability. Peak plasma concentrations are achieved rapidly.
Metabolism
Minimal hepatic metabolism; primarily undergoes hydrolysis in plasma.
Side Effects
Contraindications
- Known hypersensitivity to Rofecin, other cephalosporins, or any component of the formulation.
- History of severe hypersensitivity reaction to penicillin or other beta-lactam antibiotics.
- Neonates with hyperbilirubinemia, especially premature infants, due to the risk of bilirubin encephalopathy.
Drug Interactions
Aminoglycosides
Concurrent use may increase the risk of nephrotoxicity, especially in patients with pre-existing renal impairment.
Calcium-containing solutions
Concomitant use with Rofecin is contraindicated in neonates due to the risk of precipitation. In other age groups, administer sequentially with adequate flush.
Oral Anticoagulants (e.g., Warfarin)
May increase the anticoagulant effect, leading to an increased risk of bleeding. Close monitoring of INR is recommended.
Storage
Store below 30°C in a dry place. Protect from light. Keep out of reach of children. Reconstituted solutions should be used immediately or within specified stability periods.
Overdose
In the event of an overdose, symptomatic and supportive treatment should be administered. Rofecin is not significantly removed by hemodialysis or peritoneal dialysis.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown evidence of fetal harm, but adequate and well-controlled studies in pregnant women are lacking. It is excreted in breast milk in small amounts; use with caution in nursing mothers. Consult a doctor before use.
Side Effects
Contraindications
- Known hypersensitivity to Rofecin, other cephalosporins, or any component of the formulation.
- History of severe hypersensitivity reaction to penicillin or other beta-lactam antibiotics.
- Neonates with hyperbilirubinemia, especially premature infants, due to the risk of bilirubin encephalopathy.
Drug Interactions
Aminoglycosides
Concurrent use may increase the risk of nephrotoxicity, especially in patients with pre-existing renal impairment.
Calcium-containing solutions
Concomitant use with Rofecin is contraindicated in neonates due to the risk of precipitation. In other age groups, administer sequentially with adequate flush.
Oral Anticoagulants (e.g., Warfarin)
May increase the anticoagulant effect, leading to an increased risk of bleeding. Close monitoring of INR is recommended.
Storage
Store below 30°C in a dry place. Protect from light. Keep out of reach of children. Reconstituted solutions should be used immediately or within specified stability periods.
Overdose
In the event of an overdose, symptomatic and supportive treatment should be administered. Rofecin is not significantly removed by hemodialysis or peritoneal dialysis.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown evidence of fetal harm, but adequate and well-controlled studies in pregnant women are lacking. It is excreted in breast milk in small amounts; use with caution in nursing mothers. Consult a doctor before use.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture when stored as per instructions.
Availability
Hospitals, Clinics, Pharmacies
Approval Status
Approved by regulatory authorities
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Rofecin has undergone extensive clinical trials to establish its efficacy and safety profile across various bacterial infections in adult and pediatric populations.
Lab Monitoring
- Complete blood count (CBC) for prolonged therapy
- Renal function tests (e.g., serum creatinine, BUN)
- Liver function tests (e.g., AST, ALT, bilirubin) for prolonged therapy or in patients with hepatic impairment
- Coagulation parameters (e.g., INR) in patients on anticoagulants
Doctor Notes
- Confirm bacterial susceptibility before initiating therapy, if possible.
- Monitor for signs of hypersensitivity reactions, especially after the first dose.
- Be aware of potential interactions with calcium-containing solutions, particularly in neonates.
- Adjust dose in severe renal impairment.
Patient Guidelines
- Complete the entire course of medication as prescribed, even if symptoms improve.
- Report any severe or persistent side effects, especially severe diarrhea, to your doctor immediately.
- Inform your healthcare provider about all other medications, supplements, and herbal products you are taking.
- Do not share this medication with others, even if they have similar symptoms.
Missed Dose Advice
If a dose is missed, administer it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Rofecin may cause dizziness or lightheadedness in some individuals. Patients should be cautioned about operating machinery or driving until they know how the medication affects them.
Lifestyle Advice
- Maintain adequate hydration during therapy.
- Follow a balanced diet as advised by your healthcare provider.
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