Roxiclav
Generic Name
Amoxicillin and Clavulanic Acid
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| roxiclav 500 mg tablet | ৳ 55.00 | ৳ 220.00 |
Description
Overview of the medicine
Roxiclav 500 mg Tablet is a broad-spectrum antibiotic composed of amoxicillin, a penicillin-type antibiotic, and clavulanic acid, a beta-lactamase inhibitor. This combination extends the antibacterial spectrum of amoxicillin to include organisms resistant to amoxicillin alone.
Uses & Indications
Dosage
Adults
One 500 mg/125 mg tablet every 8-12 hours for 7-10 days, depending on infection severity.
Elderly
Same as adults, dose adjustment may be necessary in renal impairment.
Renal_impairment
Dose adjustment required based on creatinine clearance. e.g., CrCl 10-30 mL/min: 500 mg/125 mg every 12 hours; CrCl <10 mL/min: 500 mg/125 mg every 24 hours.
How to Take
Administer orally. Can be taken at the start of a meal to minimize potential gastrointestinal intolerance. Swallow the tablet whole with a glass of water.
Mechanism of Action
Amoxicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial cell lysis and death. Clavulanic acid is a beta-lactamase inhibitor that inactivates a wide range of beta-lactamase enzymes produced by bacteria, thereby protecting amoxicillin from degradation and extending its antibacterial spectrum.
Pharmacokinetics
Onset
Within 1 hour
Excretion
Primarily excreted unchanged in urine.
Half life
Amoxicillin: 1-1.5 hours; Clavulanic acid: 1 hour
Absorption
Rapidly and well absorbed from the gastrointestinal tract, improved with food.
Metabolism
Partially metabolized in the liver (clavulanic acid is extensively metabolized).
Side Effects
Contraindications
- Known hypersensitivity to penicillin or other beta-lactam antibiotics
- History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate therapy
- Severe renal impairment (CrCl < 30 mL/min) without dose adjustment
Drug Interactions
Warfarin
Increased INR, monitor coagulation parameters closely.
Probenecid
Increases and prolongs amoxicillin blood levels.
Methotrexate
Increased methotrexate toxicity due to reduced renal tubular secretion.
Oral Contraceptives
May decrease efficacy, advise additional contraceptive methods.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include gastrointestinal symptoms such as nausea, vomiting, and diarrhea, and disturbances of fluid and electrolyte balance. Treatment is symptomatic and supportive; hemodialysis can remove amoxicillin/clavulanate from circulation.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, use during pregnancy should only be when clearly needed. Both amoxicillin and clavulanic acid are excreted in breast milk; use with caution during lactation, monitoring for adverse effects in the infant.
Side Effects
Contraindications
- Known hypersensitivity to penicillin or other beta-lactam antibiotics
- History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate therapy
- Severe renal impairment (CrCl < 30 mL/min) without dose adjustment
Drug Interactions
Warfarin
Increased INR, monitor coagulation parameters closely.
Probenecid
Increases and prolongs amoxicillin blood levels.
Methotrexate
Increased methotrexate toxicity due to reduced renal tubular secretion.
Oral Contraceptives
May decrease efficacy, advise additional contraceptive methods.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include gastrointestinal symptoms such as nausea, vomiting, and diarrhea, and disturbances of fluid and electrolyte balance. Treatment is symptomatic and supportive; hemodialysis can remove amoxicillin/clavulanate from circulation.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, use during pregnancy should only be when clearly needed. Both amoxicillin and clavulanic acid are excreted in breast milk; use with caution during lactation, monitoring for adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date, refer to packaging for exact expiry.
Availability
Available in pharmacies nationwide
Approval Status
Approved
Patent Status
Generic available (original patent expired)
WHO Essential Medicine
YesClinical Trials
Amoxicillin/clavulanic acid has undergone extensive clinical trials demonstrating its efficacy and safety in various bacterial infections since its introduction. Ongoing surveillance for resistance patterns and new formulations continues.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) in patients with hepatic dysfunction history or prolonged treatment
- Renal function tests (creatinine clearance) in patients with renal impairment
- Complete blood count for prolonged therapy
Doctor Notes
- Emphasize adherence to the full course of therapy.
- Counsel patients on potential allergic reactions and liver dysfunction symptoms.
- Monitor renal function in elderly and renally impaired patients.
Patient Guidelines
- Complete the full course of treatment as prescribed, even if symptoms improve.
- Do not share this medicine with others.
- Report any severe or persistent side effects to your doctor.
- Take with food to minimize stomach upset.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause dizziness or headaches in some individuals. Patients should be advised to exercise caution when driving or operating machinery until they know how Roxiclav affects them.
Lifestyle Advice
- Maintain good hydration.
- Avoid alcohol during treatment as it may exacerbate GI upset.
- Follow up with your doctor as advised.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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