Xiclav
Generic Name
Amoxicillin + Clavulanic Acid
Manufacturer
Eskayef Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xiclav 500 mg tablet | ৳ 60.00 | ৳ 420.00 |
Description
Overview of the medicine
Xiclav 500 mg Tablet is a combination antibiotic used to treat a wide range of bacterial infections including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and dental infections. It combines amoxicillin, a penicillin-type antibiotic, with clavulanic acid, a beta-lactamase inhibitor, to overcome bacterial resistance.
Uses & Indications
Dosage
Adults
One 500 mg/125 mg tablet three times a day (every 8 hours), or as directed by a physician. For more severe infections, dosage may be increased.
Elderly
No specific dosage adjustment needed for elderly patients unless renal impairment is present. Renal function should be monitored.
Renal_impairment
Dosage adjustment required based on creatinine clearance. For CrCl between 10-30 mL/min: 500 mg/125 mg every 12 hours. For CrCl less than 10 mL/min: 500 mg/125 mg every 24 hours. Hemodialysis patients: 500 mg/125 mg every 24 hours, with an additional dose during and at the end of dialysis.
How to Take
Xiclav 500 mg Tablet should be taken orally at the start of a meal to optimize absorption and minimize potential gastrointestinal intolerance.
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 prevents bacterial enzymes (beta-lactamases) from inactivating amoxicillin, thereby extending its antibacterial spectrum and efficacy against beta-lactamase producing strains.
Pharmacokinetics
Onset
Rapid, typically within 1 hour.
Excretion
Primarily excreted unchanged in the urine (amoxicillin) or as metabolites (clavulanic acid) via renal and non-renal pathways.
Half life
Amoxicillin: Approximately 1-1.5 hours; Clavulanic Acid: Approximately 1 hour.
Absorption
Both amoxicillin and clavulanic acid are well absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are achieved within approximately 1-2 hours.
Metabolism
Amoxicillin is minimally metabolized; clavulanic acid is extensively metabolized to 2,5-dioxopiperazine and other metabolites.
Side Effects
Contraindications
- Known hypersensitivity to penicillin or any other beta-lactam antibiotics (e.g., cephalosporins) or to any component of Xiclav.
- History of cholestatic jaundice or hepatic dysfunction associated with previous amoxicillin/clavulanate therapy.
Drug Interactions
Probenecid
Increases and prolongs the blood levels of amoxicillin by reducing its renal tubular secretion. Co-administration is not recommended.
Allopurinol
Increased incidence of skin rash when co-administered with amoxicillin.
Methotrexate
Increased methotrexate toxicity due to reduced renal tubular secretion of methotrexate.
Oral Contraceptives
May reduce the efficacy of oral contraceptives. Patients should be advised to use additional non-hormonal contraceptive methods.
Anticoagulants (e.g., Warfarin)
May prolong prothrombin time (INR). Careful monitoring of INR is advised when co-administered.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach and sight of children.
Overdose
Symptoms of overdose typically include gastrointestinal symptoms such as stomach ache, vomiting, and diarrhea. Fluid and electrolyte imbalance may occur. Management involves symptomatic treatment and supportive measures. In cases of significant overdose, hemodialysis can be used to remove amoxicillin/clavulanic acid from circulation.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but adequate and well-controlled studies in pregnant women are lacking. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk. Both amoxicillin and clavulanic acid are excreted into breast milk; therefore, caution should be exercised when Xiclav is administered to a nursing woman, as it may lead to sensitization or gastrointestinal disturbances in the infant.
Side Effects
Contraindications
- Known hypersensitivity to penicillin or any other beta-lactam antibiotics (e.g., cephalosporins) or to any component of Xiclav.
- History of cholestatic jaundice or hepatic dysfunction associated with previous amoxicillin/clavulanate therapy.
Drug Interactions
Probenecid
Increases and prolongs the blood levels of amoxicillin by reducing its renal tubular secretion. Co-administration is not recommended.
Allopurinol
Increased incidence of skin rash when co-administered with amoxicillin.
Methotrexate
Increased methotrexate toxicity due to reduced renal tubular secretion of methotrexate.
Oral Contraceptives
May reduce the efficacy of oral contraceptives. Patients should be advised to use additional non-hormonal contraceptive methods.
Anticoagulants (e.g., Warfarin)
May prolong prothrombin time (INR). Careful monitoring of INR is advised when co-administered.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach and sight of children.
Overdose
Symptoms of overdose typically include gastrointestinal symptoms such as stomach ache, vomiting, and diarrhea. Fluid and electrolyte imbalance may occur. Management involves symptomatic treatment and supportive measures. In cases of significant overdose, hemodialysis can be used to remove amoxicillin/clavulanic acid from circulation.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but adequate and well-controlled studies in pregnant women are lacking. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk. Both amoxicillin and clavulanic acid are excreted into breast milk; therefore, caution should be exercised when Xiclav is administered to a nursing woman, as it may lead to sensitization or gastrointestinal disturbances in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Pharmacies
Approval Status
Approved worldwide
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Amoxicillin/Clavulanic Acid, including generic formulations like Xiclav, has undergone extensive clinical trials demonstrating its efficacy and safety in treating a broad spectrum of bacterial infections. Its effectiveness is well-established through numerous studies over several decades.
Lab Monitoring
- Liver function tests (LFTs) should be performed periodically in patients with hepatic impairment or those receiving prolonged therapy.
- Renal function tests (e.g., creatinine clearance) in patients with renal impairment.
- Complete blood count (CBC) should be monitored during prolonged therapy.
Doctor Notes
- Ensure to counsel patients on the importance of completing the full course of antibiotics to prevent resistance.
- Monitor liver and renal function, especially in patients with pre-existing impairment or during prolonged therapy.
- Advise patients to seek immediate medical attention if signs of severe allergic reaction or C. difficile-associated diarrhea occur.
Patient Guidelines
- Always complete the full course of Xiclav 500 mg as prescribed by your doctor, even if your symptoms improve, to prevent antibiotic resistance and ensure complete eradication of the infection.
- Take the tablet with food to minimize stomach upset and improve absorption.
- Report any severe or persistent diarrhea, skin rash, yellowing of skin or eyes, or any other unusual symptoms to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Xiclav 500 mg may cause dizziness or other central nervous system effects in some individuals. Patients should be cautious when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids during the course of treatment.
- Avoid alcohol consumption during treatment as it may exacerbate gastrointestinal side effects and potentially affect liver function.
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