Flugal
Generic Name
Flugeliximab
Manufacturer
Global Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| flugal 200 mg injection | ৳ 200.00 | N/A |
Description
Overview of the medicine
Flugal 200 mg Injection is a broad-spectrum synthetic antibacterial agent belonging to the new generation fluoroquinolone class. It is effective against a wide range of gram-positive and gram-negative bacteria and is indicated for the treatment of various severe bacterial infections.
Uses & Indications
Dosage
Adults
200 mg intravenously once daily, infused over 60 minutes for 7-14 days depending on the infection type and severity.
Elderly
No specific dose adjustment required based on age alone; monitor renal function.
Renal_impairment
For Creatinine Clearance (CrCl) 30-50 mL/min: 100 mg once daily. For CrCl < 30 mL/min: 100 mg every 48 hours.
How to Take
Administer Flugal 200 mg Injection intravenously only. The solution should be infused slowly over a period of 60 minutes. Do not administer as a rapid bolus injection. Ensure the patient is well-hydrated.
Mechanism of Action
Flugeliximab inhibits bacterial DNA gyrase and topoisomerase IV, essential enzymes involved in bacterial DNA replication, transcription, repair, and recombination. This leads to disruption of bacterial DNA, ultimately resulting in bacterial cell death.
Pharmacokinetics
Onset
Clinical effects typically observed within 24-48 hours of initiation.
Excretion
Primarily excreted unchanged in the urine (renal excretion), with a small portion excreted in feces.
Half life
Approximately 6-8 hours, allowing for once-daily dosing.
Absorption
Rapid and complete absorption after intravenous administration, reaching peak plasma concentrations within 1-2 hours.
Metabolism
Minimally metabolized in the liver; primary elimination is via the kidneys.
Side Effects
Contraindications
- Known hypersensitivity to flugeliximab, other fluoroquinolones, or any component of the formulation.
- History of tendinitis or tendon rupture associated with fluoroquinolone use.
- Patients with myasthenia gravis, due to potential exacerbation of muscle weakness.
Drug Interactions
Warfarin
Fluoroquinolones may enhance the anticoagulant effects of warfarin, requiring close monitoring of INR.
Corticosteroids
Increased risk of tendinitis and tendon rupture when co-administered with fluoroquinolones.
Antiarrhythmics (Class IA and Class III)
Increased risk of QT prolongation when co-administered; use with caution.
Sucralfate, Antacids containing Magnesium/Aluminum, Iron, Zinc
These agents can decrease the oral absorption of fluoroquinolones (though less relevant for IV form, caution if other oral fluoroquinolones are used).
Storage
Store below 30°C. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
In the event of an overdose, discontinue Flugal and initiate symptomatic and supportive treatment. Monitor ECG for QT prolongation. Hemodialysis or peritoneal dialysis is not effective in removing flugeliximab from the body.
Pregnancy & Lactation
Flugeliximab is generally not recommended during pregnancy or lactation due to potential risks to the fetus/infant based on animal studies. Use only if the potential benefit justifies the potential risk, and after consulting with a healthcare professional.
Side Effects
Contraindications
- Known hypersensitivity to flugeliximab, other fluoroquinolones, or any component of the formulation.
- History of tendinitis or tendon rupture associated with fluoroquinolone use.
- Patients with myasthenia gravis, due to potential exacerbation of muscle weakness.
Drug Interactions
Warfarin
Fluoroquinolones may enhance the anticoagulant effects of warfarin, requiring close monitoring of INR.
Corticosteroids
Increased risk of tendinitis and tendon rupture when co-administered with fluoroquinolones.
Antiarrhythmics (Class IA and Class III)
Increased risk of QT prolongation when co-administered; use with caution.
Sucralfate, Antacids containing Magnesium/Aluminum, Iron, Zinc
These agents can decrease the oral absorption of fluoroquinolones (though less relevant for IV form, caution if other oral fluoroquinolones are used).
Storage
Store below 30°C. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
In the event of an overdose, discontinue Flugal and initiate symptomatic and supportive treatment. Monitor ECG for QT prolongation. Hemodialysis or peritoneal dialysis is not effective in removing flugeliximab from the body.
Pregnancy & Lactation
Flugeliximab is generally not recommended during pregnancy or lactation due to potential risks to the fetus/infant based on animal studies. Use only if the potential benefit justifies the potential risk, and after consulting with a healthcare professional.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture when stored under recommended conditions.
Availability
Hospitals, Clinics, and Retail Pharmacies
Approval Status
Approved by national regulatory authorities
Patent Status
Under patent protection
Clinical Trials
Extensive Phase I, II, and III clinical trials have demonstrated the efficacy and safety of flugeliximab across various bacterial infections, including specific studies on complicated urinary tract infections and hospital-acquired pneumonia. Post-marketing surveillance continues to monitor for rare adverse events.
Lab Monitoring
- Renal function tests (creatinine, BUN, CrCl) at baseline and periodically, especially in patients with pre-existing renal impairment.
- Liver function tests (ALT, AST, ALP, bilirubin) if hepatic dysfunction is suspected.
- ECG monitoring in patients at risk for QT prolongation.
Doctor Notes
- Prioritize alternative antibiotics in patients with a history of severe adverse reactions to fluoroquinolones.
- Carefully monitor renal function, especially in elderly patients or those with pre-existing kidney impairment, to ensure appropriate dose adjustment.
- Educate patients on the signs and symptoms of tendinitis/tendon rupture and the importance of immediate discontinuation and medical consultation if such symptoms occur.
Patient Guidelines
- Complete the full prescribed course of treatment, even if symptoms improve, to prevent the development of drug-resistant bacteria.
- Report any pain, swelling, or inflammation of tendons, especially in the ankle, shoulder, or hand, immediately to your doctor.
- Avoid excessive exposure to sunlight and artificial UV light during treatment, as fluoroquinolones can increase sensitivity to light.
Missed Dose Advice
If a dose of Flugal is missed, administer it as soon as possible. If it is almost time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Flugal may cause dizziness, lightheadedness, or visual disturbances. Patients should be advised to assess their reaction to the drug before driving or operating machinery.
Lifestyle Advice
- Maintain adequate hydration by drinking plenty of fluids throughout the treatment period.
- Avoid strenuous physical activity or exercise that might put excessive strain on your tendons during treatment.
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