Sepra-S
Generic Name
Ofloxacin
Manufacturer
Acme Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sepra s 125 mg suspension | ৳ 86.00 | N/A |
Description
Overview of the medicine
Ofloxacin is a broad-spectrum fluoroquinolone antibiotic used to treat various bacterial infections. This suspension form is particularly suitable for pediatric use.
Uses & Indications
Dosage
Adults
Varies by infection type and severity. Typically 200-400 mg orally twice daily, or as directed by physician. For suspension, dosage should be calculated based on required mg and suspension concentration.
Elderly
Dose adjustment may be needed based on renal function. Initiate at the lower end of the dosing range.
Renal_impairment
Dose reduction is required for patients with creatinine clearance <50 mL/min. Consult product leaflet or physician for specific guidelines.
How to Take
Administer orally, with or without food. Shake the bottle well before each use. Use a calibrated measuring device to ensure accurate dosing.
Mechanism of Action
Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication, transcription, repair, and recombination, leading to bacterial cell death.
Pharmacokinetics
Onset
1-2 hours
Excretion
Primarily excreted unchanged in urine (approximately 65-80% of dose) within 48 hours.
Half life
4-7 hours
Absorption
Rapid and complete oral absorption, with bioavailability of approximately 98%. Peak plasma concentrations achieved within 1-2 hours.
Metabolism
Minimally metabolized in the liver (less than 10% of dose).
Side Effects
Contraindications
- Hypersensitivity to ofloxacin, other fluoroquinolones, or any component of the formulation.
- History of tendinitis or tendon rupture associated with fluoroquinolone use.
- Epilepsy or other seizure disorders.
- Children under 1 year of age (use in children <18 years requires careful consideration due to potential for cartilage damage).
Drug Interactions
NSAIDs
May increase the risk of CNS stimulation and convulsive seizures when co-administered with fluoroquinolones.
Warfarin
Potentiation of anticoagulant effect, increasing bleeding risk. Monitor INR/PT.
Theophylline
Increased plasma levels of Theophylline, leading to increased risk of toxicity. Monitor Theophylline levels.
Corticosteroids
Increased risk of tendinitis and tendon rupture when co-administered with fluoroquinolones.
Antacids (containing Mg/Al), Iron, Zinc, Sucralfate
May significantly reduce oral absorption of Ofloxacin. Administer Ofloxacin at least 2 hours before or 2 hours after these agents.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, abdominal pain, diarrhea, dizziness, confusion, seizures. Management involves gastric lavage, symptomatic and supportive care, and maintaining adequate hydration.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for cartilage damage in the fetus. Excreted into breast milk; therefore, not recommended during lactation unless the potential benefit justifies the potential risk to the infant.
Side Effects
Contraindications
- Hypersensitivity to ofloxacin, other fluoroquinolones, or any component of the formulation.
- History of tendinitis or tendon rupture associated with fluoroquinolone use.
- Epilepsy or other seizure disorders.
- Children under 1 year of age (use in children <18 years requires careful consideration due to potential for cartilage damage).
Drug Interactions
NSAIDs
May increase the risk of CNS stimulation and convulsive seizures when co-administered with fluoroquinolones.
Warfarin
Potentiation of anticoagulant effect, increasing bleeding risk. Monitor INR/PT.
Theophylline
Increased plasma levels of Theophylline, leading to increased risk of toxicity. Monitor Theophylline levels.
Corticosteroids
Increased risk of tendinitis and tendon rupture when co-administered with fluoroquinolones.
Antacids (containing Mg/Al), Iron, Zinc, Sucralfate
May significantly reduce oral absorption of Ofloxacin. Administer Ofloxacin at least 2 hours before or 2 hours after these agents.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, abdominal pain, diarrhea, dizziness, confusion, seizures. Management involves gastric lavage, symptomatic and supportive care, and maintaining adequate hydration.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for cartilage damage in the fetus. Excreted into breast milk; therefore, not recommended during lactation unless the potential benefit justifies the potential risk to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, depending on the manufacturer's specifications.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established Ofloxacin's efficacy and safety for various bacterial infections across different age groups, leading to its widespread approval and use.
Lab Monitoring
- Renal function (creatinine clearance) in patients with kidney impairment.
- Liver function tests (ALT, AST) if liver dysfunction is suspected or on long-term therapy.
- Complete Blood Count (CBC) in prolonged therapy.
Doctor Notes
- Counsel patients on the black box warnings associated with fluoroquinolones, particularly regarding tendinitis/tendon rupture and neurological adverse effects.
- Consider alternative antibiotics for pediatric patients where possible, weighing risks vs. benefits.
- Monitor renal function in elderly and renally impaired patients.
Patient Guidelines
- Complete the full course of treatment even if symptoms improve.
- Avoid excessive exposure to direct sunlight and artificial UV light (e.g., sunlamps).
- Report any tendon pain, numbness, tingling, or weakness immediately to your doctor.
- Do not take Ofloxacin with antacids or iron/zinc supplements; separate by at least 2 hours.
Missed Dose Advice
If a dose is missed, 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 double the dose.
Driving Precautions
May cause dizziness, lightheadedness, or visual disturbances. Patients should be cautioned against driving or operating machinery until they know how Ofloxacin affects them.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids.
- Avoid alcohol consumption during treatment as it may exacerbate side effects like dizziness.
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