BRIXY-CV 1000 TABLETS (Each film-coated tablet contains Amoxicillin trihydrate BP 875mg/ Clavulanic Acid 125mg)

Indications

• Infections caused by beta-lactamase-producing bacteria
• Acute bacterial sinusitis
• Acute otitis media
• Lower respiratory tract infections
• Urinary tract infections

Dosage

Children: Refer to the BNF for Children for specific dosing according to age and weight; adjustments may be necessary based on the clinical scenario.

Adults: Refer to specific product guidelines for dosing; typical regimens depend on the combination antibiotic used and the severity of the infection.

Mechanism of action

Clavulanic acid works by irreversibly binding to the active site of beta-lactamase enzymes that are produced by certain bacteria to inactivate beta-lactam antibiotics. By inhibiting these enzymes, clavulanic acid protects the penicillin antibiotic from degradation, allowing it to exert its antibacterial effects.

Pharmacodynamics

Clavulanic acid has a synergistic effect when combined with other antibiotics, particularly amoxicillin. The presence of clavulanic acid allows for the effective treatment of infections caused by bacteria that would otherwise be resistant to penicillins. Its antibacterial activity is generally weak on its own but significantly enhances the efficacy of other beta-lactam antibiotics.

Pharmacokinetics

Clavulanic acid is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1 hour. It is widely distributed throughout the body and has a half-life of approximately 1 hour. The drug is primarily excreted unchanged in the urine. In the presence of renal impairment, dosage adjustment may be necessary, as the elimination of clavulanic acid can be affected.

Contra-indications

• Hypersensitivity to clavulanic acid or any of the excipients
• History of jaundice or hepatic impairment associated with previous use of penicillins or beta-lactam antibiotics

Adverse effects

• Nausea
• Diarrhea
• Rash
• Elevated liver enzymes
• Allergic reactions including anaphylaxis
• Superinfection

Interactions

• May enhance the effects of anticoagulants such as warfarin
• Probenecid may increase plasma concentrations of clavulanic acid
• May reduce the efficacy of oral contraceptives

Precautions

• Caution in patients with renal impairment
• Monitor liver function in patients receiving prolonged therapy
• Use with caution in patients with a history of allergic reactions to beta-lactams

Pregnancy

Clavulanic acid is categorized as pregnancy category B. Animal studies have not shown any harm to the fetus, but there are no adequate and well-controlled studies in pregnant women.

Breast-feeding

Clavulanic acid is excreted in breast milk, but it is generally considered safe for use during breastfeeding. Monitor for potential effects in the infant.

Storage

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

Formulations

• Oral tablets
• Oral suspension
• Injectable forms

Indications

• Bacterial infections
• Respiratory tract infections
• Otitis media
• Skin and soft tissue infections
• Urinary tract infections

Dosage

Children: Refer to the BNF for Children for specific dosing based on age and weight.

Adults: Refer to appropriate guidelines for specific dosing based on infection type and severity.

Mechanism of action

Moxicillin exerts its bactericidal effect primarily by binding to penicillin-binding proteins (PBPs) located on the inner membrane of the bacterial cell wall. This binding inhibits the transpeptidation enzyme, which is critical for cross-linking peptidoglycan layers in the bacterial cell wall, thus disrupting cell wall synthesis and leading to osmotic instability and cell lysis.

Pharmacodynamics

Moxicillin demonstrates time-dependent killing, meaning that its efficacy is related to the duration of time that the drug concentration remains above the minimum inhibitory concentration (MIC) for the target organism. It has a relatively high tissue penetration and is effective against a range of bacteria, including Streptococcus pneumoniae and Haemophilus influenzae. Resistance may develop through the production of beta-lactamase enzymes by certain bacteria.

Pharmacokinetics

Moxicillin is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1-2 hours. It is approximately 20-30% protein-bound, and its volume of distribution is approximately 0.3-0.4 L/kg. Moxicillin is metabolized in the liver and primarily excreted by the kidneys, with 50% of the drug eliminated unchanged in the urine. The half-life of moxicillin is approximately 1 hour, but it may be prolonged in patients with renal impairment.

Contra-indications

• Hypersensitivity to amoxicillin or any component of the formulation
• History of severe allergic reactions to penicillins or cephalosporins

Adverse effects

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

Interactions

• Probenecid may increase amoxicillin levels
• Allopurinol may increase the risk of skin reactions
• Anticoagulants may have increased effects with amoxicillin

Precautions

• Use with caution in patients with a history of gastrointestinal disease, particularly colitis
• Monitor renal function in patients with renal impairment
• Caution in patients with a history of allergy to beta-lactam antibiotics

Pregnancy

Amoxicillin is generally considered safe to use during pregnancy. However, it should only be used if clearly needed.

Breast-feeding

Amoxicillin is excreted in breast milk, but it is typically considered safe for use during breastfeeding.

Storage

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

Formulations

• Oral capsules
• Oral tablets
• Oral suspension
• Injectable formulations