Roxiclav
Generic Name
Amoxicillin and Clavulanic Acid
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| roxiclav 250 mg tablet | ৳ 35.00 | ৳ 210.00 |
Description
Overview of the medicine
Roxiclav-250 mg tablet is a broad-spectrum antibiotic combination used to treat various bacterial infections. It contains amoxicillin, a penicillin-type antibiotic, and clavulanic acid, a beta-lactamase inhibitor, which protects amoxicillin from degradation by certain bacterial enzymes.
Uses & Indications
Dosage
Adults
For mild to moderate infections, 250 mg amoxicillin/62.5 mg clavulanic acid tablet three times a day. For more severe infections, dosage may be increased.
Elderly
No specific dose adjustment is usually required unless there is severe renal impairment. Monitor renal function.
Renal_impairment
Dosage adjustment is necessary for patients with creatinine clearance less than 30 mL/min. Consult product leaflet for specific guidelines.
How to Take
Take the tablet orally, preferably at the start of a meal to minimize potential gastrointestinal intolerance. Swallow whole with water.
Mechanism of Action
Amoxicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis. Clavulanic acid is a beta-lactamase inhibitor that irreversibly binds to beta-lactamase enzymes produced by resistant bacteria, thereby preventing the degradation of amoxicillin and extending its antibacterial spectrum.
Pharmacokinetics
Onset
Rapid; typically within 30 minutes to 1 hour.
Excretion
Primarily excreted unchanged in the urine by active tubular secretion and glomerular filtration. Clavulanic acid is excreted in urine and feces.
Half life
Approximately 1-1.5 hours for both amoxicillin and clavulanic acid in individuals with normal renal function.
Absorption
Both amoxicillin and clavulanic acid are well absorbed from the gastrointestinal tract after oral administration. Peak serum concentrations are generally achieved within 1-2 hours.
Metabolism
Amoxicillin is minimally metabolized; clavulanic acid is extensively metabolized.
Side Effects
Contraindications
- Hypersensitivity to penicillin or any beta-lactam antibiotic, or to any component of the formulation.
- History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid therapy.
- History of severe allergic reactions (e.g., anaphylaxis) to other beta-lactam agents.
Drug Interactions
Probenecid
Decreases renal tubular secretion of amoxicillin, leading to increased and prolonged blood levels of amoxicillin. Concomitant use is not recommended.
Allopurinol
Increased incidence of skin rash.
Methotrexate
Amoxicillin may reduce methotrexate excretion, potentially increasing toxicity.
Oral contraceptives
May reduce the efficacy of oral contraceptives; advise additional barrier contraception.
Warfarin and other oral anticoagulants
May prolong prothrombin time; careful monitoring of INR is advised.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) and disturbances of fluid and electrolyte balance. Renal impairment has also been observed. Treatment is symptomatic and supportive, including hemodialysis if severe renal impairment occurs.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Both amoxicillin and clavulanic acid are excreted in breast milk; use with caution in nursing mothers.
Side Effects
Contraindications
- Hypersensitivity to penicillin or any beta-lactam antibiotic, or to any component of the formulation.
- History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid therapy.
- History of severe allergic reactions (e.g., anaphylaxis) to other beta-lactam agents.
Drug Interactions
Probenecid
Decreases renal tubular secretion of amoxicillin, leading to increased and prolonged blood levels of amoxicillin. Concomitant use is not recommended.
Allopurinol
Increased incidence of skin rash.
Methotrexate
Amoxicillin may reduce methotrexate excretion, potentially increasing toxicity.
Oral contraceptives
May reduce the efficacy of oral contraceptives; advise additional barrier contraception.
Warfarin and other oral anticoagulants
May prolong prothrombin time; careful monitoring of INR is advised.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) and disturbances of fluid and electrolyte balance. Renal impairment has also been observed. Treatment is symptomatic and supportive, including hemodialysis if severe renal impairment occurs.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Both amoxicillin and clavulanic acid are excreted in breast milk; use with caution in nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from manufacturing date.
Availability
Pharmacies nationwide
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensively studied in numerous clinical trials for its efficacy and safety in various bacterial infections.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) in patients with hepatic dysfunction or during prolonged therapy.
- Renal function tests (creatinine, BUN) in patients with renal impairment or during prolonged therapy.
- Complete blood count (CBC) during prolonged therapy.
Doctor Notes
- Emphasize importance of completing the full antibiotic course to patients.
- Be mindful of potential hypersensitivity reactions, especially in patients with a history of penicillin allergy.
- Monitor liver function tests in patients with pre-existing hepatic impairment or during prolonged treatment.
Patient Guidelines
- Complete the full course of treatment even if symptoms improve to prevent antibiotic resistance.
- Take the medicine with food to reduce stomach upset.
- Inform your doctor about any allergies or other medications you are taking.
- Seek immediate medical attention if you experience severe allergic reactions (e.g., difficulty breathing, swelling).
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 to catch up.
Driving Precautions
Generally, Roxiclav does not impair the ability to drive or operate machinery. However, if side effects like dizziness or headache occur, avoid such activities.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids.
- Avoid alcohol during treatment, as it may worsen gastrointestinal side effects.
- Maintain good hygiene to prevent further infections.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Roxiclav Brand
Other medicines available under the same brand name
