Clavoxil 250 mg+125 mg (Tablet)

Indications

• Upper respiratory tract infections
• Lower respiratory tract infections
• Genito-urinary tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Septic abortion
• Puerperal sepsis
• Intra-abdominal sepsis

Composition

• 375 mg tablet - Amoxicillin 250 mg as Amoxicillin Trihydrate BP, Clavulanic Acid 125 mg as Diluted Potassium Clavulanate BP
• 625 mg tablet - Amoxicillin 500 mg as Amoxicillin Trihydrate BP, Clavulanic Acid 125 mg as Diluted Potassium Clavulanate BP
• 1 gm tablet - Amoxicillin 875 mg as Amoxicillin Trihydrate BP, Clavulanic Acid 125 mg as Diluted Potassium Clavulanate BP
• Powder for Suspension - Amoxicillin 125 mg as Amoxicillin Trihydrate BP, Clavulanic Acid 31.25 mg as Diluted Potassium Clavulanate BP
• Powder for Suspension (Forte) - Amoxicillin 400 mg as Amoxicillin Trihydrate BP, Clavulanic Acid 57.5 mg as Diluted Potassium Clavulanate BP
• 1.2 gm Injection - Amoxicillin Sodium BP (equivalent to Amoxicillin 1 gm), Clavulanate Potassium USP (equivalent to Clavulanic Acid 200 mg)
• 0.6 gm Injection - Amoxicillin Sodium BP (equivalent to Amoxicillin 500 mg), Clavulanate Potassium USP (equivalent to Clavulanic Acid 100 mg)

Pharmacology

• Broad spectrum bactericidal activity against Gram-positive & Gram-negative microorganisms
• Inactivation of a wide range of beta-lactamase enzymes
• Extended antibiotic spectrum

Dosage

• Adults and children over 12 years
• Tablet - 625 mg every 12 hours, 375 mg every 8 hours
• Suspension - 2 teaspoonful for children 6-12 years, 1 teaspoonful for children 1-6 years, 25 mg/kg/day for children below 1 year
• Forte suspension - 25/3.6 mg/kg/day for mild to moderate infections, 45/6.4 mg/kg/day for serious infections
• IV Injection - 1.2 gm every 8 hours for adults, 30 mg/kg every 8 hours for children 0-3 months

Administration

• Oral dosage form can be taken without regard to meals
• IV injection administered over 2 minutes or slow intravenous infusion over 30 minutes

Interaction

• Prolongation of bleeding time and prothrombin time reported
• Reduced efficacy of oral contraceptives
• Concomitant use of allopurinol may increase allergic skin reactions

Contraindications

• History of Penicillin hypersensitivity
• Cross-sensitivity with other beta-lactam antibiotics
• Previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice

Side Effects

• Diarrhoea
• Pseudomembranous colitis
• Indigestion
• Nausea
• Vomiting
• Candidiasis
• Hepatitis
• Cholestatic jaundice
• Urticarial and erythematous rashes
• Angioedema
• Anaphylaxis

Pregnancy & Lactation

• No teratogenic effect in animal studies
• Limited use in human pregnancy with no untoward effect
• Trace quantities in breast milk

Precautions & Warnings

• Care in patients on anticoagulation therapy
• Dosage adjustment in severe hepatic dysfunction
• Dosage adjustment in moderate or severe renal impairment

Use in Special Populations

• Adjustment in case of renal impairment

Overdose Effects

• Gastrointestinal symptoms
• Disturbance of fluid and electrolyte balances
• Haemodialysis for removal

Therapeutic Class

• Broad spectrum penicillins

Reconstitution

• IV injection reconstituted with Water for Injection BP
• IV injection should not be mixed with certain fluids

Storage Conditions

• Below 25°C
• Protected from light and moisture
• Reconstituted suspension refrigerated and used by 7 days
• Reconstituted vial used within 20 minutes

Related Brands

• Clavoxil 500 mg+125 mg (Tablet) - renata-limited
• Amotid CL (125 mg+31.25 mg)/5 ml (Powder for Suspension) - biopharma-limited
• Amotid CL 500 mg+125 mg (Tablet) - biopharma-limited
• Bioclavid 500 mg+125 mg (Tablet) - sandoz-a-novartis-division
• Bioclavid 875 mg+125 mg (Tablet) - sandoz-a-novartis-division