Amiflox-DS
Generic Name
Ofloxacin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amiflox ds 250 mg suspension | ৳ 85.00 | N/A |
Description
Overview of the medicine
Ofloxacin is a broad-spectrum fluoroquinolone antibiotic used to treat a variety of bacterial infections. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication. It's effective against both Gram-positive and Gram-negative bacteria.
Uses & Indications
Dosage
Adults
400 mg once daily or 200 mg twice daily for most infections. Dosage should be adjusted based on infection and patient's condition.
Elderly
No specific dose adjustment based on age alone, but renal function should be assessed.
Renal_impairment
Reduced dosage is required. For creatinine clearance 20-50 mL/min, 200 mg once every 24 hours; for <20 mL/min, 200 mg once every 48 hours.
How to Take
Oral. Shake the bottle well before use. Can be taken with or without food. Ensure to complete the full course of antibiotics as prescribed.
Mechanism of Action
Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, which are necessary for bacterial DNA replication, transcription, repair, and recombination. This leads to bacterial cell death.
Pharmacokinetics
Onset
Within 1-2 hours for therapeutic effect.
Excretion
Primarily excreted unchanged in the urine (70-80% within 24-48 hours). Also excreted in bile/feces (4-8%).
Half life
Approximately 5-8 hours, slightly prolonged in renal impairment.
Absorption
Rapidly and well absorbed from the gastrointestinal tract. Bioavailability is approximately 98%. Peak plasma concentrations occur 1-2 hours after an oral dose.
Metabolism
Minimally metabolized in the liver; about 5-10% of the dose is metabolized to desmethyl-ofloxacin and ofloxacin N-oxide.
Side Effects
Contraindications
- Hypersensitivity to ofloxacin or other fluoroquinolones
- Patients with a history of tendinitis or tendon rupture associated with fluoroquinolone use
- Epilepsy or other seizure disorders
- Children under 18 years (unless benefits outweigh risks and no alternative treatment is available)
Drug Interactions
NSAIDs
May increase the risk of CNS stimulation and convulsive seizures.
Warfarin
Enhanced anticoagulant effect. Monitor INR.
Theophylline
Increased plasma levels of theophylline, leading to toxicity. Monitor theophylline levels.
Corticosteroids
Increased risk of tendinopathy and tendon rupture.
Antacids (containing Mg/Al), iron, zinc, sucralfate
Reduced absorption of ofloxacin. Take ofloxacin 2 hours before or 2 hours after these agents.
Storage
Store below 30°C in a a dry place, away from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms may include CNS effects (dizziness, confusion, seizures), gastrointestinal reactions (nausea, vomiting), and prolongation of QT interval. Treatment is symptomatic and supportive; gastric lavage and activated charcoal may be used.
Pregnancy & Lactation
Pregnancy: Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: Excreted into breast milk. Should not be used during breastfeeding as it may cause joint problems in the infant.
Side Effects
Contraindications
- Hypersensitivity to ofloxacin or other fluoroquinolones
- Patients with a history of tendinitis or tendon rupture associated with fluoroquinolone use
- Epilepsy or other seizure disorders
- Children under 18 years (unless benefits outweigh risks and no alternative treatment is available)
Drug Interactions
NSAIDs
May increase the risk of CNS stimulation and convulsive seizures.
Warfarin
Enhanced anticoagulant effect. Monitor INR.
Theophylline
Increased plasma levels of theophylline, leading to toxicity. Monitor theophylline levels.
Corticosteroids
Increased risk of tendinopathy and tendon rupture.
Antacids (containing Mg/Al), iron, zinc, sucralfate
Reduced absorption of ofloxacin. Take ofloxacin 2 hours before or 2 hours after these agents.
Storage
Store below 30°C in a a dry place, away from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms may include CNS effects (dizziness, confusion, seizures), gastrointestinal reactions (nausea, vomiting), and prolongation of QT interval. Treatment is symptomatic and supportive; gastric lavage and activated charcoal may be used.
Pregnancy & Lactation
Pregnancy: Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: Excreted into breast milk. Should not be used during breastfeeding as it may cause joint problems in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date, refer to specific product labeling.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of ofloxacin for various bacterial infections. Ongoing post-market surveillance contributes to safety profile monitoring.
Lab Monitoring
- Renal function (especially in elderly or renally impaired patients)
- Liver function tests (periodically)
- Complete blood count (CBC)
- INR for patients on warfarin
- ECG for patients at risk of QT prolongation
Doctor Notes
- Counsel patients on completing the full course and potential for tendon issues, especially if on concomitant corticosteroids.
- Monitor renal function in elderly and those with pre-existing renal impairment; adjust dose accordingly.
- Use in children under 18 years is generally not recommended unless benefits outweigh risks and no safer alternative is available, due to potential for cartilage damage.
- Be aware of potential for serious adverse reactions, including peripheral neuropathy, CNS effects, and tendinopathy.
Patient Guidelines
- Complete the entire course of medication even if symptoms improve.
- Avoid sun exposure or use sunscreen due to photosensitivity.
- Stay well-hydrated.
- Report any tendon pain, numbness, tingling, or severe diarrhea to your doctor immediately.
Missed Dose Advice
Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not double the dose.
Driving Precautions
May cause dizziness, confusion, or visual disturbances. Advise patients to use caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Maintain good hygiene to prevent recurrence of infections.
- Avoid alcohol during treatment as it may exacerbate side effects.
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