Baxdela
Generic Name
Delafloxacin 300 mg Injection
Manufacturer
Melinta Therapeutics
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| delaflox 300 mg injection | ৳ 1,500.00 | N/A |
Description
Overview of the medicine
Delafloxacin is a novel fluoroquinolone antibiotic used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults. It has activity against both Gram-positive (including MRSA) and Gram-negative bacteria.
Uses & Indications
Dosage
Adults
300 mg IV every 12 hours. Duration of treatment depends on the type and severity of infection, typically 5 to 14 days.
Elderly
No specific dose adjustment is generally required based on age alone; however, monitor renal function.
Renal_impairment
For severe renal impairment (CrCl < 30 mL/min), including End-Stage Renal Disease (ESRD) on hemodialysis, the recommended dose is 200 mg IV every 12 hours.
How to Take
Administer by intravenous infusion over 60 minutes. Do not administer as a rapid or bolus injection.
Mechanism of Action
Delafloxacin inhibits bacterial DNA gyrase and topoisomerase IV, essential enzymes involved in bacterial DNA replication, transcription, repair, and recombination, leading to bacterial cell death.
Pharmacokinetics
Onset
Rapid, shortly after initiation of infusion.
Excretion
Approximately 65% is excreted renally and 28% is excreted fecally.
Half life
Approximately 8 hours.
Absorption
Administered intravenously, resulting in 100% bioavailability.
Metabolism
Primarily metabolized via glucuronidation. Less than 10% is metabolized by CYP450 enzymes.
Side Effects
Contraindications
- Known hypersensitivity to delafloxacin or other fluoroquinolones.
- History of tendon disorders related to fluoroquinolone use.
Drug Interactions
Warfarin
Potential for increased anticoagulant effect; monitor INR (International Normalized Ratio).
QT-prolonging drugs
Caution advised due to potential for QT prolongation.
Multivalent cations (e.g., antacids, iron supplements)
Less clinically significant interaction for IV administration compared to oral fluoroquinolones, but caution if co-administered orally.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Do not freeze.
Overdose
In case of overdose, symptomatic and supportive treatment is recommended. Hemodialysis is unlikely to be effective in removing delafloxacin.
Pregnancy & Lactation
Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Lactation: Not recommended during breastfeeding as it is excreted in breast milk.
Side Effects
Contraindications
- Known hypersensitivity to delafloxacin or other fluoroquinolones.
- History of tendon disorders related to fluoroquinolone use.
Drug Interactions
Warfarin
Potential for increased anticoagulant effect; monitor INR (International Normalized Ratio).
QT-prolonging drugs
Caution advised due to potential for QT prolongation.
Multivalent cations (e.g., antacids, iron supplements)
Less clinically significant interaction for IV administration compared to oral fluoroquinolones, but caution if co-administered orally.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Do not freeze.
Overdose
In case of overdose, symptomatic and supportive treatment is recommended. Hemodialysis is unlikely to be effective in removing delafloxacin.
Pregnancy & Lactation
Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Lactation: Not recommended during breastfeeding as it is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Refer to the product label for specific shelf life, typically 2-3 years when stored properly.
Availability
Hospitals, Pharmacies
Approval Status
FDA Approved
Patent Status
Patented
Clinical Trials
Delafloxacin has been extensively studied in Phase 3 clinical trials (e.g., PROCEED studies) for the treatment of ABSSSI, demonstrating efficacy and safety.
Lab Monitoring
- Monitor liver function tests (LFTs), renal function, and complete blood count (CBC).
- Monitor for signs and symptoms of C. difficile-associated diarrhea.
Doctor Notes
- Culture and susceptibility testing should be performed to guide therapy where possible.
- Adjust dose for patients with severe renal impairment (CrCl < 30 mL/min).
- Monitor for serious adverse reactions including tendon disorders, CNS effects, and hypersensitivity reactions.
Patient Guidelines
- Complete the full course of treatment as prescribed, even if symptoms improve.
- Report any unusual or severe side effects, especially tendon pain, numbness, or tingling.
- Avoid driving or operating heavy machinery if you experience dizziness or lightheadedness.
Missed Dose Advice
If a dose is missed, administer it as soon as remembered. Do not take a double dose to make up for a missed dose. Continue the regular dosing schedule.
Driving Precautions
This medicine may cause dizziness or lightheadedness, which could impair your ability to drive or operate machinery. Exercise caution.
Lifestyle Advice
- Maintain adequate hydration during treatment.
- Avoid excessive sun exposure; use sunscreen and protective clothing (though photosensitivity is less common with delafloxacin).
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Global Brand Names
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