Ofex
Generic Name
Ofloxacin
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ofex 100 mg suspension | ৳ 210.00 | N/A |
Description
Overview of the medicine
Ofex 100 mg Suspension contains Ofloxacin, a broad-spectrum fluoroquinolone antibiotic used to treat various bacterial infections in children.
Uses & Indications
Dosage
Elderly
Not typically recommended for elderly as a suspension; adult formulations available. Dose adjustment may be needed based on renal function.
Children
Typically 15 mg/kg body weight per day, divided into two doses (every 12 hours) for 5-10 days, depending on the infection. Maximum 400 mg/day.
Renal_impairment
Dosage adjustment is necessary for pediatric patients with renal impairment. Consult a physician for specific guidelines; usually, the dosage interval is extended or the dose reduced.
How to Take
Administer orally with or without food. Shake the bottle well before each use. Use the provided measuring cup or spoon for accurate dosing.
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
Antibacterial effect typically observed within 1-2 hours.
Excretion
Primarily excreted unchanged by the kidneys (70-80% within 24-48 hours). Also excreted in bile and feces to a lesser extent.
Half life
Approximately 4-6 hours, longer in renal impairment.
Absorption
Rapidly and well absorbed after oral administration, bioavailability is approximately 90-100%. Peak plasma concentrations are reached within 1-2 hours.
Metabolism
Minimally metabolized; less than 10% of the dose is metabolized in humans.
Side Effects
Contraindications
- Hypersensitivity to Ofloxacin or other fluoroquinolones
- History of tendon disorders related to quinolone administration
- Epilepsy or other seizure disorders
- Children below 1 year of age
- Pregnancy and lactation (unless benefits outweigh risks)
Drug Interactions
NSAIDs
Concomitant use may increase the risk of CNS stimulation and convulsive seizures.
Warfarin
May enhance the anticoagulant effect of warfarin, requiring INR monitoring.
Theophylline
May increase theophylline levels, potentially leading to toxicity.
Corticosteroids
Increased risk of tendinitis and tendon rupture when co-administered with corticosteroids.
Antacids (containing magnesium/aluminum), Sucralfate, Iron/Zinc supplements
Reduce oral absorption of ofloxacin. Administer ofloxacin at least 2 hours before or 2 hours after these agents.
Storage
Store below 30°C (room temperature). Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
In case of overdose, gastric lavage should be performed to remove unabsorbed drug. Symptomatic and supportive treatment should be initiated. Adequate hydration is important to prevent crystalluria. Monitor ECG for QT prolongation.
Pregnancy & Lactation
Ofloxacin is generally not recommended during pregnancy due to potential risks to fetal cartilage development. It is excreted in breast milk and may cause adverse effects in nursing infants; therefore, it is generally contraindicated during lactation.
Side Effects
Contraindications
- Hypersensitivity to Ofloxacin or other fluoroquinolones
- History of tendon disorders related to quinolone administration
- Epilepsy or other seizure disorders
- Children below 1 year of age
- Pregnancy and lactation (unless benefits outweigh risks)
Drug Interactions
NSAIDs
Concomitant use may increase the risk of CNS stimulation and convulsive seizures.
Warfarin
May enhance the anticoagulant effect of warfarin, requiring INR monitoring.
Theophylline
May increase theophylline levels, potentially leading to toxicity.
Corticosteroids
Increased risk of tendinitis and tendon rupture when co-administered with corticosteroids.
Antacids (containing magnesium/aluminum), Sucralfate, Iron/Zinc supplements
Reduce oral absorption of ofloxacin. Administer ofloxacin at least 2 hours before or 2 hours after these agents.
Storage
Store below 30°C (room temperature). Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
In case of overdose, gastric lavage should be performed to remove unabsorbed drug. Symptomatic and supportive treatment should be initiated. Adequate hydration is important to prevent crystalluria. Monitor ECG for QT prolongation.
Pregnancy & Lactation
Ofloxacin is generally not recommended during pregnancy due to potential risks to fetal cartilage development. It is excreted in breast milk and may cause adverse effects in nursing infants; therefore, it is generally contraindicated during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture, depending on the manufacturer's specification. Check the expiry date on the packaging.
Availability
Available in pharmacies and hospitals in Bangladesh
Approval Status
Approved by DGDA
Patent Status
Generic (Off-patent)
WHO Essential Medicine
YesClinical Trials
Ofloxacin has undergone extensive clinical trials globally to establish its efficacy and safety for various bacterial infections, particularly in pediatric and adult populations. Ongoing surveillance continues for rare adverse events.
Lab Monitoring
- Renal function tests (e.g., creatinine, BUN) for patients with renal impairment or on prolonged therapy.
- Liver function tests (e.g., ALT, AST) if signs of hepatic dysfunction occur.
- Complete blood count for prolonged therapy.
- INR monitoring for patients on warfarin.
- ECG monitoring in patients with risk factors for QT prolongation.
Doctor Notes
- Counsel patients on the importance of completing the full course of therapy, even if symptoms improve.
- Advise parents to report any signs of tendon pain, swelling, or neurological symptoms immediately.
- Be aware of potential drug interactions, especially with antacids, warfarin, and NSAIDs.
- Consider dosage adjustments in patients with renal impairment.
- Monitor for signs of hypersensitivity reactions or severe diarrhea (C. difficile-associated diarrhea).
Patient Guidelines
- Complete the full course of medication, even if symptoms improve, to prevent recurrence and resistance.
- Shake the suspension well before each use and use the provided measuring device for accurate dosing.
- Avoid excessive exposure to direct sunlight or artificial UV light, as it may cause photosensitivity.
- Report any pain, swelling, or inflammation of tendons (especially in the ankle, shoulder, or hand) immediately.
- Do not take antacids, iron, or zinc supplements within 2 hours of taking ofloxacin.
- Consult your doctor if you experience severe diarrhea or any signs of an allergic reaction.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Ofloxacin may cause dizziness, lightheadedness, or visual disturbances. Patients should be advised to know how they react to the medication before driving or operating machinery.
Lifestyle Advice
- Maintain adequate hydration by drinking plenty of fluids.
- Avoid strenuous physical activity that could strain tendons during treatment.
- Wear protective clothing and use sunscreen when outdoors.
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