625 mg Tablet: Each film coated tablet contains Amoxycillin 500 mg with Clavulanic acid 125 mg.
1 gm Tablet: Each film coated tablet contains Amoxycillin 875 mg with Clavulanic acid 125 mg.
Suspension: Each 5 ml reconstituted suspension contains Amoxycillin 125 mg and Clavulanic acid 31.25 mg.
Forte/BID/DS Suspension: Each 5 ml reconstituted suspension contains Amoxycillin 400 mg and Clavulanic acid 57.50 mg
0.6 gm injection: Sterile powder in vials providing Amoxycillin 500 mg and Clavulanic Acid 100 mg.
1.2 gm injection: Sterile powder in vials providing Amoxycillin 1000 mg and Clavulanic Acid 200 mg.
Amoxycillin & Clavulanic Acid is indicated for short-term treatment of bacterial infections at the following sites:
- Upper respiratory tract infections (including ENT); e.g., tonsillitis, sinusitis, otitis media.
- Lower respiratory tract infections; e.g., acute and chronic bronchitis, lobar and bronchopneumonia.
- Genito-urinary tract infections; e.g., cystitis, urethritis, pyelonephritis.
- Skin and soft tissue infections.
- Bone and joint infections; e.g., osteomyelitis.
- Other infections; e.g., septic abortion, puerperal sepsis, intra-abdominal sepsis, etc.
Amoxycillin & Clavulanic Acidis an antibacterial combination consisting of the antibiotic Amoxicillin and the beta-lactamase inhibitor Clavulanic Acid.
Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by beta-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes.
Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in combination of Amoxicillin and Clavulanic acid protects Amoxicillin from degradation by beta-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.
Dosage & Administration
- Adults and children over 12 years: One 375 mg tablet 3 times a day. In severe infection one 625 mg tablet 3 times a day or one 1 gm tablet two times a day.
- Children of 6-12 years: 2 teaspoonful Powder for Suspension every 8 hours.
- Children of 1 -6 years: 1 teaspoonful Powder for Suspension every 8 hours.
- Children below 1 year: 25 mg/kg/day in divided doses every 8 hours.
- Adults and children over 12 years: 1.2 g every 6-8 hours
- Children up to 3 months: 30 mg/kg every 8 hours (every 12 hours in the perinatal period and in premature infants)
- Child 3 months to 12 years: 30 mg/kg every 6-8 hours.
Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported. If gastrointestinal side effects occur with oral therapy, that may be reduced by taking Amoxycillin & Clavulanic Acid at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur.
Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics angioedema and anaphylaxis have been reported.
Pregnancy & Lactation
Precautions & Warnings
Use in Special Populations
Dosage in renal impairment: The dose should be adjusted in case of patients with renal impairment.
Adults or Children:
- Mild impairment (CrCl > 30 ml/min): No change in dose.
- Moderate impairment (CrCl 10- 30 ml/min): 625 mg tablet 12 hourly.
- Severe impairment (CrCl < 10 ml/min): Not more than one tablet 12 hourly; 625 mg tablet is not recommended.
Dosage in hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.This may be taken without regard to meals; however, absorption of Clavulanate potassium is enhanced when Amoxicillin/Clavulanic acid is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin/Clavulanic acid should be taken at the start of the meal.