ZANITAN DUO 625 625MG TABLET

Indications

• Acute otitis media
• Sinusitis
• Pneumonia

Mechanism of action

Amoxicillin exerts its antibacterial effect by binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, leading to inhibition of peptidoglycan synthesis, which is essential for bacterial cell wall structural integrity. This results in cell lysis and death of the bacteria. Clavulanic acid inhibits beta-lactamase enzymes, which are responsible for the hydrolysis of beta-lactam antibiotics, thus protecting amoxicillin from degradation and allowing it to exert its effect more effectively against beta-lactamase-producing bacteria.

Pharmacodynamics

The pharmacodynamics of amoxiclav is characterized by its time-dependent killing mechanism. The efficacy of amoxicillin is influenced by the duration of time that plasma concentrations remain above the minimum inhibitory concentration (MIC) for the target organism. Clavulanic acid increases the spectrum of activity of amoxicillin, allowing for the treatment of infections caused by organisms that would be resistant to amoxicillin alone. The combination is effective against a wide range of Gram-positive and Gram-negative bacteria.

Pharmacokinetics

Amoxiclav is well absorbed from the gastrointestinal tract, with peak plasma concentrations occurring approximately 1-2 hours after oral administration. It is widely distributed in body tissues and fluids, including the lungs, skin, and urine. The presence of food can affect the absorption of amoxicillin but does not significantly affect clavulanic acid. Both components are primarily eliminated via renal excretion, with approximately 50-70% of a dose excreted unchanged in the urine. The half-life of amoxicillin is about 1 hour, while clavulanic acid has a slightly longer half-life.

Contra-indications

• History of hypersensitivity to amoxicillin, clavulanic acid, or any other component of the formulation
• Severe liver impairment
• History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid

Adverse effects

• Nausea
• Vomiting
• Diarrhea
• Rash
• Allergic reactions
• Hepatic dysfunction
• Clostridium difficile-associated diarrhea
• Anemia
• Thrombocytopenia

Interactions

• Probenecid may increase the plasma concentration of amoxicillin
• Anticoagulants may have enhanced effects when used concurrently
• Methotrexate clearance may be reduced, leading to increased toxicity

Precautions

• Use with caution in patients with renal impairment
• Monitor liver function in patients with a history of liver disease
• Caution in patients with a history of allergy to penicillins or cephalosporins
• Monitor for signs of superinfection with prolonged use

Pregnancy

Amoxiclav is generally considered safe to use during pregnancy. However, it should only be used if clearly needed and after assessment of risks versus benefits.

Breast-feeding

Amoxiclav is excreted in breast milk in small amounts. Caution is advised, and benefits should be weighed against potential risks.

Storage

Store at room temperature away from moisture and heat. Keep out of reach of children.

Formulations

• Tablets
• Oral suspension
• Injection