Demoxiclave (125 mg+31.25 mg)/5 ml (Powder for Suspension)

Indications

• Short-term treatment of bacterial infections in upper respiratory tract
• Short-term treatment of bacterial infections in lower respiratory tract
• Genito-urinary tract infections treatment
• Treatment of skin and soft tissue infections
• Treatment of bone and joint infections
• Treatment of other infections like septic abortion, puerperal sepsis, intra-abdominal sepsis

Composition

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

Pharmacology

• Broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms
• Inactivation of a wide range of beta-lactamase enzymes
• Optimized absorption at the start of a meal
• Low levels of serum binding
• Doubling the dosage approximately doubles the serum levels achieved

Dosage

• Specific dosage for adults and children over 12 years
• Different dosage for treatment of more severe infections and infections of the respiratory tract
• Recommended dosage for different age groups
• IV injection dosage for adults and children

Administration

• Oral dosage form to be taken without regard to meals
• Enhanced absorption when administered at the start of a meal
• Instruction for IV injection administration
• Validity period of reconstituted vial

Interaction

• Reported prolongation of bleeding time and prothrombin time
• Reduction in efficacy of oral contraceptives
• Possible concomitant use with allopurinol
• No data on the concomitant use of Co-amoxiclav and allopurinol

Contraindications

• History of Penicillin hypersensitivity
• Possible cross-sensitivity with other beta-lactam antibiotics
• Contraindicated for patients with a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice

Side Effects

• Uncommon and mainly of a mild and transitory nature
• Reported side effects such as diarrhea, pseudomembranous colitis, indigestion, nausea, vomiting, and candidiasis
• Rare occurrences of hepatitis, cholestatic jaundice, urticarial and erythematous rashes
• Reported cases of angioedema and anaphylaxis

Pregnancy & Lactation

• Animal studies showed no teratogenic effect
• Limited use in human pregnancy with no untoward effect
• Not recommended for use during pregnancy unless considered essential by the physician
• Trace quantities detected in breast milk during lactation

Precautions & Warnings

• Use with care in patients on anticoagulation therapy or with severe hepatic dysfunction
• Dosage adjustment in case of moderate or severe renal impairment
• Maintenance of adequate fluid intake and urinary output during high dose administration

Use in Special Populations

• Dose adjustment for patients with renal impairment
• Similar reduction in dosage recommended for children
• Caution and monitoring of hepatic function in case of administration with hepatic impairment

Overdose Effects

• Problems of overdose unlikely to occur
• Possible gastrointestinal symptoms and disturbance of fluid and electrolyte balances
• Potential removal by haemodialysis

Therapeutic Class

• Belongs to the category of broad spectrum penicillins

Reconstitution

• Instruction for reconstitution of IV injection
• Incompatibility with certain solutions for injection
• Administration method in drip tubing of infusion fluids

Storage Conditions

• Recommended storage conditions below 25°C, protected from light and moisture
• Validity period of reconstituted suspension and vial

Related Brands

• Clamox DS (400 mg+57.50 mg)/5 ml (Powder for Suspension) - opsonin-pharma-ltd
• Clamox 500 mg+125 mg (Tablet) - opsonin-pharma-ltd
• Clamox 250 mg+125 mg (Tablet) - opsonin-pharma-ltd
• Clamox 875 mg+125 mg (Tablet) - opsonin-pharma-ltd
• Clamox (125 mg+31.25 mg)/5 ml (Powder for Suspension) - opsonin-pharma-ltd