Demoxiclave
Generic Name
Amoxicillin and Clavulanic Acid
Manufacturer
Generic Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
demoxiclave 500 mg tablet | ৳ 32.00 | ৳ 224.00 |
Description
Overview of the medicine
Demoxiclave 500 mg Tablet is a combination antibiotic containing Amoxicillin (a penicillin antibiotic) and Clavulanic Acid (a beta-lactamase inhibitor). It is used to treat a wide range of bacterial infections that are resistant to Amoxicillin alone due to beta-lactamase producing bacteria.
Uses & Indications
Dosage
Adults
One Demoxiclave 500 mg/125 mg tablet every 8-12 hours depending on the severity of infection. For severe infections, up to one tablet every 8 hours may be prescribed.
Elderly
No specific dosage adjustment is usually required unless there is significant renal impairment.
Renal_impairment
Dosage should be adjusted based on creatinine clearance. For CrCl 10-30 mL/min, one 500 mg/125 mg tablet every 12 hours. For CrCl <10 mL/min, one 500 mg/125 mg tablet every 24 hours. Hemodialysis patients: one 500 mg/125 mg tablet every 24 hours, with an additional dose during and at the end of dialysis.
How to Take
Take the tablet whole with a glass of water, preferably at the start of a meal to minimize potential gastrointestinal intolerance. Do not crush or chew.
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, a beta-lactamase inhibitor, binds irreversibly to beta-lactamase enzymes produced by bacteria, thereby protecting Amoxicillin from degradation and extending its antibacterial spectrum.
Pharmacokinetics
Onset
Typically, antibacterial effects begin within 1-2 hours of administration.
Excretion
Primarily excreted unchanged by the kidneys (glomerular filtration and tubular secretion) for Amoxicillin. Clavulanic Acid is also excreted renally.
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, with Clavulanic Acid being absorbed more rapidly.
Metabolism
Amoxicillin is partially metabolized (10-25%) to inactive metabolites. Clavulanic Acid is extensively metabolized.
Side Effects
Contraindications
- Hypersensitivity to penicillin or any other beta-lactam antibiotics (e.g., cephalosporins)
- History of cholestatic jaundice or hepatic dysfunction associated with previous Amoxicillin/Clavulanic Acid therapy
- Severe renal impairment (unless dosage is appropriately adjusted)
Drug Interactions
Probenecid
Increases Amoxicillin blood levels by decreasing renal tubular secretion. Concomitant use is not recommended.
Allopurinol
Increased incidence of rash, especially in hyperuricemic patients.
Methotrexate
May increase methotrexate toxicity due to reduced renal excretion.
Oral contraceptives
May reduce the effectiveness of oral contraceptives; advise additional contraceptive methods.
Anticoagulants (e.g., Warfarin)
May prolong prothrombin time. Close monitoring of INR is advised.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose symptoms may include gastrointestinal symptoms (abdominal pain, vomiting, diarrhea) and fluid and electrolyte imbalance. Rarely, renal failure or crystalluria may occur. Treatment is supportive and symptomatic; hemodialysis can remove Amoxicillin and Clavulanic Acid from circulation.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, use during pregnancy only if clearly needed. Both Amoxicillin and Clavulanic Acid are excreted in breast milk; use with caution in breastfeeding mothers due to potential for sensitization, diarrhea, or fungal infection in the infant.
Side Effects
Contraindications
- Hypersensitivity to penicillin or any other beta-lactam antibiotics (e.g., cephalosporins)
- History of cholestatic jaundice or hepatic dysfunction associated with previous Amoxicillin/Clavulanic Acid therapy
- Severe renal impairment (unless dosage is appropriately adjusted)
Drug Interactions
Probenecid
Increases Amoxicillin blood levels by decreasing renal tubular secretion. Concomitant use is not recommended.
Allopurinol
Increased incidence of rash, especially in hyperuricemic patients.
Methotrexate
May increase methotrexate toxicity due to reduced renal excretion.
Oral contraceptives
May reduce the effectiveness of oral contraceptives; advise additional contraceptive methods.
Anticoagulants (e.g., Warfarin)
May prolong prothrombin time. Close monitoring of INR is advised.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose symptoms may include gastrointestinal symptoms (abdominal pain, vomiting, diarrhea) and fluid and electrolyte imbalance. Rarely, renal failure or crystalluria may occur. Treatment is supportive and symptomatic; hemodialysis can remove Amoxicillin and Clavulanic Acid from circulation.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, use during pregnancy only if clearly needed. Both Amoxicillin and Clavulanic Acid are excreted in breast milk; use with caution in breastfeeding mothers due to potential for sensitization, diarrhea, or fungal infection in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA, FDA equivalent)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Extensively studied in numerous clinical trials demonstrating efficacy and safety for bacterial infections. Post-marketing surveillance continues.
Lab Monitoring
- Periodic assessment of renal, hepatic, and hematopoietic function is advisable during prolonged therapy.
Doctor Notes
- Prescribe judiciously to minimize antibiotic resistance.
- Monitor liver function tests in patients with pre-existing hepatic impairment.
- Advise patients on the importance of completing the full course.
Patient Guidelines
- Complete the full course of antibiotic as prescribed by your doctor, even if you feel better.
- Take the medicine with food to reduce stomach upset.
- Inform your doctor if you have a history of allergies to penicillin or other antibiotics.
- Seek medical attention immediately if you experience severe allergic reactions.
Missed Dose Advice
If you miss a dose, 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 take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness in some individuals. If affected, avoid driving or operating machinery.
Lifestyle Advice
- Maintain good hygiene to prevent reinfections. Drink plenty of fluids.
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