Ofex
Generic Name
Ofloxacin 400 mg capsule
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ofex 400 mg capsule | ৳ 50.00 | ৳ 200.00 |
Description
Overview of the medicine
Ofex 400 mg capsule contains Ofloxacin, a broad-spectrum fluoroquinolone antibiotic used to treat various bacterial infections including urinary tract, respiratory tract, skin and soft tissue, and sexually transmitted infections.
Uses & Indications
Dosage
Adults
Typically 400 mg once daily or 200 mg twice daily, depending on the severity and type of infection. Duration varies from 3 to 10 days.
Elderly
Dose adjustment may be necessary based on renal function (creatinine clearance).
Renal_impairment
Dosage reduction is required for patients with impaired renal function (creatinine clearance < 50 mL/min). Consult a physician for specific dosage.
How to Take
Take the capsule orally with a glass of water, with or without food. Avoid taking it with dairy products or antacids containing magnesium or aluminum.
Mechanism of Action
Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination, leading to bacterial cell death.
Pharmacokinetics
Onset
Rapid onset of action due to quick absorption.
Excretion
Primarily excreted unchanged by the kidneys (70-80% within 24-48 hours). Also excreted in bile and feces.
Half life
Elimination half-life typically ranges from 4 to 7 hours.
Absorption
Well absorbed orally, with peak plasma concentrations occurring 1-2 hours after administration. Bioavailability is approximately 98%.
Metabolism
Minimally metabolized in the liver; approximately 5% of the dose is metabolized.
Side Effects
Contraindications
- Hypersensitivity to ofloxacin, other quinolones, or any excipients of the product
- History of tendon disorders related to fluoroquinolone administration
- Epilepsy or other seizure disorders
- Children and adolescents during the growth phase (due to risk of cartilage damage)
Drug Interactions
Warfarin
Enhanced anticoagulant effect. Monitor INR/PT.
Theophylline
Increased plasma levels of theophylline, requiring dosage adjustment.
Corticosteroids
Increased risk of tendon rupture.
Antacids, Iron, Zinc Supplements
Reduced absorption of ofloxacin. Administer at least 2 hours before or after.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
Increased risk of CNS stimulation and convulsions.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include central nervous system symptoms (confusion, hallucinations, tremors, convulsions) and gastrointestinal reactions. Management involves symptomatic and supportive treatment, including gastric lavage and adequate hydration.
Pregnancy & Lactation
Pregnancy Category C. Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted into breast milk and therefore contraindicated during lactation.
Side Effects
Contraindications
- Hypersensitivity to ofloxacin, other quinolones, or any excipients of the product
- History of tendon disorders related to fluoroquinolone administration
- Epilepsy or other seizure disorders
- Children and adolescents during the growth phase (due to risk of cartilage damage)
Drug Interactions
Warfarin
Enhanced anticoagulant effect. Monitor INR/PT.
Theophylline
Increased plasma levels of theophylline, requiring dosage adjustment.
Corticosteroids
Increased risk of tendon rupture.
Antacids, Iron, Zinc Supplements
Reduced absorption of ofloxacin. Administer at least 2 hours before or after.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
Increased risk of CNS stimulation and convulsions.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include central nervous system symptoms (confusion, hallucinations, tremors, convulsions) and gastrointestinal reactions. Management involves symptomatic and supportive treatment, including gastric lavage and adequate hydration.
Pregnancy & Lactation
Pregnancy Category C. Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted into breast milk and therefore contraindicated during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture
Availability
Pharmacies, Hospitals
Approval Status
Generally approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have evaluated Ofloxacin's efficacy and safety in various bacterial infections, demonstrating its broad-spectrum activity. Post-marketing surveillance continues to monitor long-term safety.
Lab Monitoring
- Renal function (creatinine clearance) for patients with kidney impairment
- Liver function tests in patients with hepatic impairment
- Blood counts (rarely, in prolonged therapy)
- ECG monitoring for patients at risk of QT prolongation
Doctor Notes
- Emphasize the black box warning regarding tendon rupture, peripheral neuropathy, and CNS effects to patients.
- Advise careful consideration of risk-benefit in elderly patients or those with pre-existing cardiovascular conditions due to QT prolongation risk.
- Educate patients on proper administration to avoid interactions with antacids/minerals and complete the full course to prevent resistance.
Patient Guidelines
- Complete the full course of antibiotics, even if symptoms improve, to prevent resistance.
- Avoid exposure to strong sunlight or artificial UV light as photosensitivity may occur.
- Report any tendon pain, swelling, or inflammation immediately to your doctor.
- Do not take antacids, sucralfate, didanosine (chewable/buffered tablets or pediatric powder), or products containing iron or zinc within 2 hours of taking ofloxacin.
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 resume your regular dosing schedule. Do not double a dose to make up for a missed one.
Driving Precautions
Ofloxacin may cause dizziness, lightheadedness, or visual disturbances. Patients should be advised to know how they react to ofloxacin before driving or operating machinery.
Lifestyle Advice
- Stay well-hydrated by drinking plenty of fluids.
- Avoid driving or operating machinery if you experience dizziness or visual disturbances.
- Avoid alcohol consumption during treatment as it may exacerbate CNS side effects.
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