Deflox
Generic Name
Ofloxacin 500 mg tablet
Manufacturer
XYZ Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| deflox 500 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Ofloxacin is a synthetic broad-spectrum antibacterial agent of the fluoroquinolone class. It is effective against a wide range of bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and certain sexually transmitted diseases.
Uses & Indications
Dosage
Adults
Dosage varies depending on the type and severity of infection, typically 200 mg to 400 mg orally every 12 hours. For 500 mg strength, regimens like 500 mg orally once daily for certain severe infections or as directed by a physician are possible. Duration of treatment is also condition-specific.
Elderly
No specific dosage adjustment is usually required based solely on age, but dosage should be adjusted for renal impairment, which is more common in elderly patients.
Renal_impairment
Dosage adjustment is necessary in patients with creatinine clearance ≤ 50 mL/min. For creatinine clearance 20-50 mL/min, administer the usual initial dose, then half the recommended dose every 24 hours. For creatinine clearance < 20 mL/min, administer the usual initial dose, then half the recommended dose every 24 hours (or as per specific guidelines for severe impairment).
How to Take
Take orally with a glass of water, with or without food. To ensure optimal absorption, avoid taking antacids, multivitamins containing iron or zinc, or dairy products within 2 hours before or 2 hours after taking Ofloxacin.
Mechanism of Action
Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to disruption of bacterial DNA processes and ultimately bacterial cell death.
Pharmacokinetics
Onset
Significant plasma concentrations are usually achieved within 1-2 hours after oral administration.
Excretion
Primarily excreted unchanged in the urine (70-80% within 24 hours), with a small amount excreted in feces.
Half life
Approximately 4-7 hours; can be prolonged in patients with renal impairment.
Absorption
Rapidly and well absorbed orally, with approximately 98% bioavailability. Peak plasma concentrations are reached within 1-2 hours.
Metabolism
Minimally metabolized in the liver (less than 10% of the dose is metabolized).
Side Effects
Contraindications
- Hypersensitivity to Ofloxacin, other quinolone antibacterials, or any component of the formulation.
- History of epilepsy or other seizure disorders.
- History of tendinitis or tendon rupture associated with fluoroquinolone use.
- Known prolongation of the QT interval or other cardiac arrhythmias.
- Co-administration with Tizanidine.
- Children and adolescents (due to risk of arthropathy and other developmental issues).
Drug Interactions
NSAIDs
Coadministration with NSAIDs may increase the risk of CNS stimulation and convulsive seizures.
Warfarin
May enhance the anticoagulant effects of warfarin, increasing bleeding risk. Monitor INR closely.
Theophylline
May increase theophylline levels, leading to toxicity. Monitor theophylline concentrations.
Corticosteroids
Increased risk of tendinitis and tendon rupture when co-administered with fluoroquinolones.
Antacids (Magnesium, Aluminum), Sucralfate, Iron, Zinc
These can significantly reduce Ofloxacin absorption. Administer Ofloxacin at least 2 hours before or 2 hours after these agents.
Antiarrhythmics (e.g., Quinidine, Procainamide, Amiodarone, Sotalol)
Increased risk of QT interval prolongation.
Storage
Store in a cool, dry place, below 30°C (86°F). Protect from light and moisture. Keep out of reach of children.
Overdose
In case of Ofloxacin overdose, gastric lavage and symptomatic and supportive treatment are recommended. Adequate hydration should be maintained. Monitor ECG for QT prolongation. Hemodialysis or peritoneal dialysis may be helpful in removing the drug from the body.
Pregnancy & Lactation
Ofloxacin is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk and should be avoided during breastfeeding due to potential risk of arthropathy and other serious adverse effects in the infant.
Side Effects
Contraindications
- Hypersensitivity to Ofloxacin, other quinolone antibacterials, or any component of the formulation.
- History of epilepsy or other seizure disorders.
- History of tendinitis or tendon rupture associated with fluoroquinolone use.
- Known prolongation of the QT interval or other cardiac arrhythmias.
- Co-administration with Tizanidine.
- Children and adolescents (due to risk of arthropathy and other developmental issues).
Drug Interactions
NSAIDs
Coadministration with NSAIDs may increase the risk of CNS stimulation and convulsive seizures.
Warfarin
May enhance the anticoagulant effects of warfarin, increasing bleeding risk. Monitor INR closely.
Theophylline
May increase theophylline levels, leading to toxicity. Monitor theophylline concentrations.
Corticosteroids
Increased risk of tendinitis and tendon rupture when co-administered with fluoroquinolones.
Antacids (Magnesium, Aluminum), Sucralfate, Iron, Zinc
These can significantly reduce Ofloxacin absorption. Administer Ofloxacin at least 2 hours before or 2 hours after these agents.
Antiarrhythmics (e.g., Quinidine, Procainamide, Amiodarone, Sotalol)
Increased risk of QT interval prolongation.
Storage
Store in a cool, dry place, below 30°C (86°F). Protect from light and moisture. Keep out of reach of children.
Overdose
In case of Ofloxacin overdose, gastric lavage and symptomatic and supportive treatment are recommended. Adequate hydration should be maintained. Monitor ECG for QT prolongation. Hemodialysis or peritoneal dialysis may be helpful in removing the drug from the body.
Pregnancy & Lactation
Ofloxacin is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk and should be avoided during breastfeeding due to potential risk of arthropathy and other serious adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 2 to 3 years from the date of manufacture, provided proper storage conditions are maintained. Refer to the specific packaging for exact expiry date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by major regulatory bodies globally (e.g., FDA, EMA, DGDA)
Patent Status
Generic available (patent expired for Ofloxacin)
WHO Essential Medicine
YesClinical Trials
Ofloxacin has undergone extensive clinical trials since its development, establishing its efficacy and safety profile for various bacterial infections. Research continues on resistance patterns, optimal dosing, and safety in specific populations. Data from these trials form the basis of its approved indications and safety warnings.
Lab Monitoring
- Renal function tests (e.g., serum creatinine, creatinine clearance) for dose adjustment in impaired renal function.
- Liver function tests (e.g., ALT, AST, bilirubin) in patients with pre-existing hepatic disease or during prolonged therapy.
- Complete Blood Count (CBC) with differential if therapy is prolonged.
- INR (International Normalised Ratio) if co-administered with warfarin.
- Electrocardiogram (ECG) for QT prolongation risk in susceptible patients or with concomitant use of other QT-prolonging drugs.
Doctor Notes
- Emphasize thorough patient counseling on the potential serious adverse reactions associated with fluoroquinolones, including tendinitis/rupture, peripheral neuropathy, and CNS effects. Instruct patients to discontinue the drug immediately and seek medical attention if these symptoms occur.
- Stress the importance of completing the full prescribed course of therapy to minimize the risk of antibiotic resistance and ensure eradication of the infection.
- Advise caution in patients with known or suspected QT prolongation or those taking other QT-prolonging medications.
- Monitor renal function, especially in elderly patients or those with pre-existing renal impairment, and adjust dosage accordingly.
Patient Guidelines
- Complete the full course of antibiotics as prescribed by your doctor, even if symptoms improve, to prevent the development of antibiotic resistance.
- Avoid excessive sunlight exposure or use protective clothing and sunscreen, as Ofloxacin can increase sensitivity to light (photosensitivity).
- Report any pain, swelling, inflammation, or rupture in tendons (especially in the Achilles tendon) immediately to your doctor.
- Do not take antacids, iron supplements, zinc supplements, or dairy products within 2 hours before or 2 hours after taking this medicine.
- Be aware of potential neurological effects such as dizziness, confusion, or unusual thoughts, and report them to your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Ofloxacin may cause dizziness, lightheadedness, vertigo, or visual disturbances. Patients should be advised to know how they react to Ofloxacin before driving or operating machinery. If these side effects occur, avoid such activities.
Lifestyle Advice
- Maintain adequate hydration by drinking plenty of fluids throughout the day while taking this medication.
- Avoid alcohol consumption during treatment, as it may worsen some side effects like dizziness or nausea.
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