DUOCLAV TABLETS 1000

Indications

• Bacterial infections of the respiratory tract, such as pneumonia and bronchitis
• Otitis media (middle ear infections)
• Sinusitis
• Skin and soft tissue infections
• Urinary tract infections
• Gonorrhea
• Helicobacter pylori eradication (as part of combination therapy for peptic ulcer disease)

Dosage

Children: Refer to the BNF for Children for appropriate dosing based on the child's age, weight, and clinical condition.

Adults: Refer to specific guidelines or the BNF for appropriate adult dosing based on the indication and severity of the infection.

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 disrupting cell wall synthesis and leading to cell death.

Pharmacodynamics

The pharmacodynamic properties of amoxicillin include its ability to exhibit time-dependent killing, with its efficacy linked to the time that serum concentrations remain above the minimum inhibitory concentration (MIC) for the target organism. Resistance can occur through the production of beta-lactamases, which hydrolyze the beta-lactam ring, rendering the antibiotic ineffective.

Pharmacokinetics

Amoxicillin is well absorbed from the gastrointestinal tract, with bioavailability ranging from 70% to 90%. It is widely distributed in body tissues and fluids, including the lungs, liver, and kidneys. Amoxicillin is minimally metabolized in the liver, with approximately 50-70% of the drug excreted unchanged in the urine. Its half-life is approximately 1 to 1.5 hours, necessitating multiple dosing to maintain effective plasma levels.

Contra-indications

• Hypersensitivity to penicillins
• History of severe allergic reactions to beta-lactam antibiotics

Adverse effects

• Nausea
• Vomiting
• Diarrhea
• Rash
• Allergic reactions
• Anaphylaxis
• Clostridium difficile-associated diarrhea

Interactions

• Probenecid may increase amoxicillin plasma levels
• Oral contraceptives may have reduced efficacy when used with amoxicillin
• Anticoagulants may have increased effects when used with amoxicillin

Precautions

• Use with caution in patients with renal impairment
• Monitor for signs of an allergic reaction
• Consider alternative therapy in patients with a history of gastrointestinal disease

Pregnancy

Amoxicillin is generally considered safe during pregnancy and is often used to treat infections in pregnant women.

Breast-feeding

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

Storage

Store at room temperature, away from moisture and heat. Reconstituted solutions should be refrigerated and used within a specified time frame.

Formulations

• Capsules
• Tablets
• Oral suspension
• Injection

Indications

• Acute bacterial sinusitis
• Acute otitis media
• Community-acquired pneumonia
• Urinary tract infections
• Skin and soft tissue infections
• Bite wounds

Dosage

Adults: Refer to

Mechanism of action

Amoxicillin exerts its antibacterial effect by binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, inhibiting peptidoglycan synthesis which is crucial for bacterial cell wall structural integrity. This ultimately leads to cell lysis and death. Clavulanic acid, on the other hand, binds to and inactivates beta-lactamase enzymes produced by some bacteria, which would otherwise hydrolyze and inactivate amoxicillin. By protecting amoxicillin from these enzymes, clavulanic acid extends its antimicrobial spectrum.

Pharmacodynamics

The pharmacodynamics of clavulanic acid and amoxicillin together provide a synergistic effect against a wide range of gram-positive and gram-negative bacteria. The combination is particularly effective against strains producing beta-lactamase, which are resistant to many other antibiotics. Clavlana is indicated for treating infections like respiratory tract infections, urinary tract infections, skin and soft tissue infections, and certain types of gastrointestinal infections caused by susceptible organisms.

Pharmacokinetics

After oral administration, amoxicillin and clavulanic acid are rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1 to 2 hours. The presence of food may enhance the absorption of clavulanic acid but does not significantly affect amoxicillin. Both components are widely distributed in body tissues and fluids. Amoxicillin is primarily excreted unchanged in the urine, while clavulanic acid undergoes some metabolism before renal excretion. The half-life of amoxicillin is approximately 1 hour, while clavulanic acid has a slightly longer half-life.

Contra-indications

• Hypersensitivity to clavulanic acid or any other component of the formulation
• Severe hepatic impairment
• History of cholestatic jaundice or hepatic dysfunction associated with previous use of amoxicillin-clavulanate

Adverse effects

• Diarrhea
• Nausea
• Vomiting
• Rash
• Hepatotoxicity
• Allergic reactions
• Superinfection
• Abdominal pain

Interactions

• Probenecid may increase the plasma concentrations of clavulanic acid
• Anticoagulants may have their effects altered
• Methotrexate may have increased toxicity

Precautions

• Use with caution in patients with renal impairment
• Monitor liver function during prolonged therapy
• Consider potential for antibiotic resistance with prolonged use

Pregnancy

Clavulanate is generally considered safe to use during pregnancy, but should be prescribed only if clearly needed, as limited data is available.

Breast-feeding

Clavulanate is excreted in breast milk. Caution is advised if used by nursing mothers, especially in infants under two months of age.

Storage

Store at room temperature, protected from light and moisture. Reconstituted solutions should be stored in a refrigerator and used within a specified time frame, usually 7-14 days depending on the formulation.

Formulations

• Oral tablets
• Suspensions
• Injections