Rosebac
Generic Name
Rosebactam 500 mg Injection
Manufacturer
Global Pharma Ltd.
Country
Switzerland
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosebac 500 mg injection | ৳ 700.00 | N/A |
Description
Overview of the medicine
Rosebac 500 mg Injection is a broad-spectrum antibiotic used to treat a wide range of serious bacterial infections, including those resistant to other antibiotics. It belongs to a new class of beta-lactam antibiotics.
Uses & Indications
Dosage
Adults
500 mg IV every 8 hours, infused over 30-60 minutes.
Elderly
No dose adjustment typically required, but monitor renal function.
Renal_impairment
For CrCl 30-50 mL/min: 500 mg IV every 12 hours. For CrCl <30 mL/min: 250 mg IV every 24 hours.
How to Take
For intravenous infusion only. Reconstitute the powder with sterile water for injection, then dilute in 0.9% sodium chloride or 5% dextrose solution. Administer over 30 to 60 minutes.
Mechanism of Action
Rosebactam primarily acts by inhibiting bacterial cell wall synthesis, leading to bacterial cell lysis and death. It has a high affinity for penicillin-binding proteins (PBPs) in susceptible bacteria, thereby interfering with the final stages of peptidoglycan synthesis.
Pharmacokinetics
Onset
Within 15-30 minutes of intravenous administration.
Excretion
Primarily excreted unchanged in the urine (70-80%) within 24 hours via glomerular filtration and tubular secretion.
Half life
Approximately 2-3 hours.
Absorption
Rapid and complete absorption after intravenous administration, reaching peak plasma concentrations within 30 minutes.
Metabolism
Minimal hepatic metabolism; primarily eliminated as unchanged drug.
Side Effects
Contraindications
- Known hypersensitivity to rosebactam or any other carbapenem antibiotics.
- History of severe hypersensitivity reactions to other beta-lactam antibiotics (e.g., penicillin, cephalosporins).
Drug Interactions
Probenecid
Increases plasma concentration and prolongs the half-life of Rosebactam by inhibiting renal tubular secretion.
Aminoglycosides
Synergistic effect against some bacteria, but monitor for increased nephrotoxicity.
Valproic Acid/Sodium Valproate
May reduce valproic acid levels, increasing seizure risk. Co-administration is generally not recommended.
Oral Anticoagulants (e.g., Warfarin)
May enhance the anticoagulant effect; monitor INR closely.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Reconstituted solution should be used immediately or within 6 hours if refrigerated.
Overdose
In case of overdose, discontinue the drug and institute symptomatic and supportive measures. Rosebactam can be removed by hemodialysis.
Pregnancy & Lactation
Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Excreted in breast milk; advise caution or consider alternative feeding during treatment.
Side Effects
Contraindications
- Known hypersensitivity to rosebactam or any other carbapenem antibiotics.
- History of severe hypersensitivity reactions to other beta-lactam antibiotics (e.g., penicillin, cephalosporins).
Drug Interactions
Probenecid
Increases plasma concentration and prolongs the half-life of Rosebactam by inhibiting renal tubular secretion.
Aminoglycosides
Synergistic effect against some bacteria, but monitor for increased nephrotoxicity.
Valproic Acid/Sodium Valproate
May reduce valproic acid levels, increasing seizure risk. Co-administration is generally not recommended.
Oral Anticoagulants (e.g., Warfarin)
May enhance the anticoagulant effect; monitor INR closely.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Reconstituted solution should be used immediately or within 6 hours if refrigerated.
Overdose
In case of overdose, discontinue the drug and institute symptomatic and supportive measures. Rosebactam can be removed by hemodialysis.
Pregnancy & Lactation
Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Excreted in breast milk; advise caution or consider alternative feeding during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date when stored correctly.
Availability
Hospital pharmacies, specialized clinics
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Patented
WHO Essential Medicine
YesClinical Trials
Extensive Phase III trials demonstrated superior efficacy compared to conventional broad-spectrum antibiotics for severe hospital-acquired infections. Post-marketing surveillance is ongoing.
Lab Monitoring
- Renal function (BUN, creatinine)
- Liver function tests (ALT, AST)
- Complete blood count (CBC) with differential, especially platelet count
- Monitoring for signs of superinfection
Doctor Notes
- Consider Rosebac for severe infections resistant to first-line agents.
- Always obtain culture and susceptibility results before initiating or modifying therapy.
- Adjust dose in patients with renal impairment.
Patient Guidelines
- Complete the full course of treatment as prescribed, even if symptoms improve.
- Report any severe or persistent side effects to your doctor immediately.
- Inform your healthcare provider about all medications you are currently taking.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Rosebac may cause dizziness or confusion in some patients. Patients should be advised to exercise caution when driving or operating machinery until they are certain the medication does not adversely affect their ability.
Lifestyle Advice
- Maintain adequate hydration during treatment.
- Avoid alcohol consumption during the course of treatment, as it may exacerbate some side effects.
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