Amoxicillin + Clavulanic Acid

This is indicated for short-term treatment of bacterial infections at the following sites:

• URTI (including ENT); e.g., tonsillitis, sinusitis, otitis media.
• LRTI; e.g., acute and chronic bronchitis, lobar and bronchopneumonia.
• Genito-urinary tract infections; e.g., cystitis, urethritis, pyelonephritis. SSTI.
• Bone and joint infections; e.g., osteomyelitis.
• Other infections; e.g., septic abortion, puerperal sepsis, intra-abdominal sepsis, etc.

Pharmacodynamic properties: Co-amoxiclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-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 (3-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 this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.

Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.

Dose of Tablets:

Adults and children over 12 years: The usual adult dose is 625 mg Tablet every 12 hours or one 375 mg tablet every 8 hours.

Dose of Powder for Suspensions

Powder for Suspension:

• 1–6 years: 5 ml 3 times daily or 0.25 ml/kg 3 times daily
• 6–12 years: 10 ml 3 times daily

Dose of Injections:

Adults: Usually 1.2 g every 8 hours, increased in more severe infections to 1.2 g every 6 hours.

Prolongation of bleeding time and prothrombin time has been reported in some patients receiving this preparation.

History of Penicillin hypersensitivity.

Urticarial and erythematous rashes sometimes occur. In common with other beta-lactam antibiotics angioedema and anaphylaxis have been reported.

Use in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.

This should be used with care in patients on anti-coagulation therapy or with severe hepatic dysfunction.

Store below 25°C in a cool & dry place. Protect from light. Keep out of reach of children.