Toplevo
Generic Name
Levofloxacin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
toplevo 500 mg tablet | ৳ 16.00 | ৳ 160.00 |
Description
Overview of the medicine
Levofloxacin is a synthetic broad-spectrum antibacterial agent from the fluoroquinolone class. It is used to treat various bacterial infections.
Uses & Indications
Dosage
Adults
Typical dosage is 500 mg orally once daily for 7 to 14 days, depending on the infection type and severity.
Elderly
Dosage adjustment may be necessary based on renal function, not solely due to age.
Renal_impairment
Dose reduction required based on creatinine clearance (e.g., CrCl 20-49 mL/min: 250 mg every 24 hours; CrCl 10-19 mL/min: 250 mg every 48 hours).
How to Take
Toplevo tablets should be taken orally, with or without food. It should be taken with plenty of water. Do not crush or chew the tablet.
Mechanism of Action
Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to bacterial cell death.
Pharmacokinetics
Onset
Antibacterial effect typically observed within hours of first dose.
Excretion
Primarily renal excretion, with about 87% of an oral dose excreted unchanged in urine within 48 hours.
Half life
Plasma elimination half-life is approximately 6-8 hours.
Absorption
Rapid and nearly complete oral absorption. Peak plasma concentrations are achieved within 1-2 hours. Bioavailability is approximately 99%.
Metabolism
Minimally metabolized in the liver; approximately 5% of a dose is metabolized.
Side Effects
Contraindications
- Hypersensitivity to levofloxacin or other fluoroquinolones.
- History of tendinitis or tendon rupture associated with fluoroquinolone use.
- Epilepsy.
- Children and adolescents (under 18 years of age), except in specific life-threatening situations where benefit outweighs risk.
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin, requiring INR monitoring.
Corticosteroids
Increased risk of tendon rupture when co-administered with fluoroquinolones.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May increase the risk of CNS stimulation and convulsive seizures when co-administered with fluoroquinolones.
Antacids (containing magnesium or aluminum), Sucralfate, Metal cations (iron, zinc)
May reduce the absorption of levofloxacin. Take levofloxacin at least 2 hours before or 2 hours after these agents.
Storage
Store in a cool, dry place below 30°C. Protect from moisture and direct light. Keep out of reach of children.
Overdose
In case of overdose, symptoms may include CNS effects (confusion, hallucinations, tremors, convulsive seizures), QT prolongation. Treatment involves gastric emptying, supportive care, and symptomatic treatment. Hemodialysis or peritoneal dialysis is not effective in removing levofloxacin.
Pregnancy & Lactation
Pregnancy Category C. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human breast milk; therefore, use with caution or avoid during lactation.
Side Effects
Contraindications
- Hypersensitivity to levofloxacin or other fluoroquinolones.
- History of tendinitis or tendon rupture associated with fluoroquinolone use.
- Epilepsy.
- Children and adolescents (under 18 years of age), except in specific life-threatening situations where benefit outweighs risk.
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin, requiring INR monitoring.
Corticosteroids
Increased risk of tendon rupture when co-administered with fluoroquinolones.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May increase the risk of CNS stimulation and convulsive seizures when co-administered with fluoroquinolones.
Antacids (containing magnesium or aluminum), Sucralfate, Metal cations (iron, zinc)
May reduce the absorption of levofloxacin. Take levofloxacin at least 2 hours before or 2 hours after these agents.
Storage
Store in a cool, dry place below 30°C. Protect from moisture and direct light. Keep out of reach of children.
Overdose
In case of overdose, symptoms may include CNS effects (confusion, hallucinations, tremors, convulsive seizures), QT prolongation. Treatment involves gastric emptying, supportive care, and symptomatic treatment. Hemodialysis or peritoneal dialysis is not effective in removing levofloxacin.
Pregnancy & Lactation
Pregnancy Category C. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human breast milk; therefore, use with caution or avoid during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the manufacturing date, consult package for exact date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by health authorities worldwide (e.g., FDA, DGDA)
Patent Status
Generic available, patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of levofloxacin in treating various bacterial infections. Ongoing post-marketing surveillance continues to monitor for rare adverse events.
Lab Monitoring
- Renal function tests (creatinine clearance) in elderly patients or those with pre-existing renal impairment.
- Liver function tests if there are signs of hepatic dysfunction.
- Complete Blood Count (CBC) if prolonged use is anticipated.
- ECG monitoring in patients at risk for QT prolongation.
Doctor Notes
- Thoroughly review patient history for risk factors of tendon disorders, QT prolongation, and CNS disorders before prescribing.
- Educate patients on black box warnings, particularly regarding tendinitis, tendon rupture, and peripheral neuropathy, and advise them to seek immediate medical attention for related symptoms.
- Adjust dosage for renal impairment. Avoid in pediatric patients unless absolutely necessary for specific severe infections.
Patient Guidelines
- Complete the full course of treatment as prescribed, even if you feel better.
- Avoid excessive exposure to sunlight or artificial UV light while taking this medicine and for several days afterwards.
- Report any new or worsening symptoms, especially tendon pain, swelling, numbness, or tingling.
- Stay well-hydrated during treatment.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your 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
Toplevo may cause dizziness, lightheadedness, or visual disturbances. Patients should exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Avoid alcohol if it worsens any side effects like dizziness.
- Maintain good personal hygiene to prevent secondary infections.
- Avoid strenuous exercise that puts stress on tendons during treatment.
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