XOMOX CV 1 GM

Indications

• Bacterial infections of the respiratory tract
• Acute otitis media
• Sinusitis
• Urinary tract infections
• Skin and soft tissue infections
• Helicobacter pylori eradication
• Prophylaxis for endocarditis

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations.

Adults: Refer to the BNF for specific dosing recommendations.

Mechanism of action

Amoxicillin exerts its antibacterial effect by binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall. This binding inhibits the transpeptidation enzyme necessary for cross-linking peptidoglycan layers, ultimately preventing cell wall synthesis and resulting in cell lysis and death.

Pharmacodynamics

The pharmacodynamics of amoxicillin involve its ability to inhibit bacterial growth and replication. It is generally bactericidal, meaning it kills bacteria rather than merely inhibiting their growth. The effectiveness of amoxicillin is influenced by factors such as the type of bacteria, the presence of beta-lactamase enzymes that can inactivate the drug, and the concentration of the antibiotic in relation to the Minimum Inhibitory Concentration (MIC) of the target organism.

Pharmacokinetics

Amoxicillin is well-absorbed from the gastrointestinal tract and reaches peak plasma concentrations within 1 to 2 hours after oral administration. It is widely distributed throughout the body, including in the lungs, kidneys, and middle ear, and can cross the placenta. Approximately 20% of the drug is protein-bound. Amoxicillin is primarily excreted unchanged in the urine, with a half-life of about 1 hour in healthy individuals, which may be prolonged in cases of renal impairment.

Contra-indications

• Hypersensitivity to amoxicillin or other penicillins
• History of severe allergic reactions (e.g. anaphylaxis) to beta-lactam antibiotics

Adverse effects

• Diarrhea
• Nausea
• Vomiting
• Rash
• Allergic reactions (including urticaria and anaphylaxis)
• Hepatotoxicity
• Renal impairment

Interactions

• Probenecid may increase plasma levels of amoxicillin
• Allopurinol may increase the incidence of skin rashes
• Anticoagulants may have increased effects

Precautions

• Use with caution in patients with renal impairment
• Monitor for signs of anaphylaxis in patients with a history of allergies
• Assess liver function regularly in patients on prolonged therapy

Pregnancy

Amoxicillin is generally considered safe to use during pregnancy. It is categorized as pregnancy category B by the FDA, indicating no evidence of risk in human studies.

Breast-feeding

Amoxicillin is excreted in breast milk. While it is generally considered safe for use during breastfeeding, monitoring for any adverse effects in the infant is recommended.

Storage

Store at room temperature, away from moisture and heat. Reconstituted solutions should be refrigerated and used within a specified period as per product guidelines.

Formulations

• Capsules (250 mg, 500 mg)
• Tablets (500 mg, 875 mg)
• Oral suspension (125 mg/5 mL, 250 mg/5 mL)
• Injectable forms (500 mg, 1 g)

Indications

• Bacterial infections caused by beta-lactamase producing organisms
• Community-acquired pneumonia
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections

Dosage

Children: Paediatric dosing of clavulanate should be determined based on the specific indication and the formulation used. Refer to the BNF for

Adults: The usual adult dose of clavulanate varies depending on the specific antibiotic it is combined with, generally ranging from 125 mg to 250 mg, taken every 8 hours when combined with amoxicillin.

Mechanism of action

Clavulanate works by irreversibly binding to the active site of beta-lactamase enzymes. By inhibiting these enzymes, clavulanate protects beta-lactam antibiotics from degradation, allowing them to exert their antibacterial effects effectively. This mechanism enhances the spectrum of activity of the co-administered antibiotic, thereby improving clinical outcomes in infections caused by beta-lactamase producing organisms.

Pharmacodynamics

Clavulanate exhibits a time-dependent antibacterial effect, characterized by its ability to maintain effective concentrations against beta-lactamase producing bacteria. Its pharmacodynamic properties are mainly influenced by its interaction with beta-lactam antibiotics, enhancing their efficacy in treating infections. The overall effect is a synergistic relationship that increases the potency of the antibiotic treatment.

Pharmacokinetics

Clavulanate is usually administered orally or parenterally, and it is rapidly absorbed from the gastrointestinal tract. It reaches peak plasma concentrations within 1 to 2 hours after administration. The drug is widely distributed in body tissues, with a volume of distribution indicative of good tissue penetration. Clavulanate undergoes hepatic metabolism, primarily by conjugation, and is excreted largely in the urine as metabolites. The elimination half-life is approximately 1 hour, necessitating frequent dosing for optimal therapeutic effect.

Contra-indications

• Hypersensitivity to clavulanate or any component of the formulation
• History of jaundice or hepatic impairment related to previous use of beta-lactam antibiotics

Adverse effects

• Diarrhea
• Nausea
• Vomiting
• Rash
• Hepatic dysfunction
• Allergic reactions

Interactions

• Probenecid may increase concentrations of clavulanate
• Anticoagulants may have altered effects due to changes in gut flora

Precautions

• Monitor liver function during prolonged therapy
• Use cautiously in patients with renal impairment
• Assess for history of allergy to penicillins or cephalosporins

Pregnancy

Clavulanate is classified as category B. Animal studies have not shown teratogenic effects, but adequate and well-controlled studies in pregnant women are lacking.

Breast-feeding

Clavulanate is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place away from direct light. Keep out of reach of children.

Formulations

• Clavulanate potassium 125 mg/5 mL
• Clavulanate potassium 250 mg/5 mL