Registered Malawi · PMRA

ZANITIN INJECTION 1.2G INJECTION

CO-AMOXICLAV

PMPB/PL503/52 INJECTION

What it does

Co-amoxiclav is a combination antibiotic used to treat various infections.

Commonly used for: bacterial infections, chest infections (pneumonia), ear infections (otitis media), skin infections …

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
PMPB/PL503/52
Registration date
15/02/2024
Expiry date
31/03/2025
Status
Registered
Active ingredient
CO-AMOXICLAV
Dosage form
INJECTION
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:45 · updated 2026-09-15 04:32:43

Drug Interactions

6
Check interactions

Severe (1)

Penicillins - increases risk of adverse effects

Valproate increases the risk of adverse effects when given with penicillins (pivmecillinam). Avoid.

Severe Anecdotal

Unknown (5)

Penicillins - increases risk of skin rash

Allopurinol increases the risk of skin rash when given with penicillins (amoxicillin, ampicillin).

Unknown Study

Penicillins - increases exposure

Leflunomide is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Theoretical

Penicillins - increases exposure

Nitisinone is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Study

Penicillins - increases exposure

Teriflunomide is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Study

Phenindione - increases risk of bleeding events

Penicillins are predicted to increase the risk of bleeding events when given with phenindione.

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Co-amoxiclav is a combination antibiotic used to treat various infections.

What it treats

  • bacterial infections
  • chest infections (pneumonia)
  • ear infections (otitis media)
  • skin infections
  • urinary tract infections (UTIs)

How it works

It works by stopping the growth of bacteria that cause infections.

Who it's for

It is suitable for adults and children with certain bacterial infections.

Drug class

Penicillins

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Co-amoxiclav

BNF-referenced

Co-amoxiclav is a combination antibiotic that includes amoxicillin and clavulanic acid. It is classified under penicillins and is primarily used to treat infections caused by beta-lactamase-producing organisms where amoxicillin alone would be ineffective. Its broad-spectrum activity makes it suitable for treating a variety of bacterial infections, including respiratory tract infections, skin infections, and mixed infections involving staphylococci.

Indications

  • Infections due to beta-lactamase-producing strains
  • Mixed infections involving respiratory tract
  • Bone and joint infections
  • Genitourinary tract infections
  • Abdominal infections
  • Skin and soft tissue infections

Dosage

Children: For children aged 1

Adults: For oral administration, the usual dose is 500 mg/125 mg every 8 hours, which may be increased to 1 g/125 mg every 8 hours in severe infections. For intravenous administration, the recommended dose is 1.2 g every 8 hours.

Mechanism of action

Amoxicillin exerts its antibacterial effect by inhibiting bacterial cell wall synthesis through binding to penicillin-binding proteins, leading to cell lysis and death. Clavulanic acid acts as a beta-lactamase inhibitor, protecting amoxicillin from degradation by beta-lactamase enzymes produced by resistant bacteria. This combination enhances the efficacy of amoxicillin against resistant strains.

Pharmacodynamics

Co-amoxiclav demonstrates a time-dependent bactericidal effect, with its efficacy linked to the duration of time the drug concentration remains above the minimum inhibitory concentration (MIC) for the target pathogens. Its broad-spectrum activity covers both Gram-positive and Gram-negative bacteria, making it useful in empirical therapy for various infections.

Pharmacokinetics

Co-amoxiclav is well absorbed from the gastrointestinal tract, with peak plasma concentrations occurring approximately 1-2 hours after oral administration. The presence of clavulanic acid does not significantly alter the pharmacokinetics of amoxicillin. It is widely distributed throughout body tissues and fluids, including the lungs, bile, and urine. The half-life of amoxicillin is approximately 1 hour, while clavulanic acid has a similar half-life. Both components are primarily excreted by the kidneys, necessitating dose adjustments in renal impairment.

Contra-indications

  • Hypersensitivity to penicillins or cephalosporins
  • History of jaundice or hepatic dysfunction associated with flucloxacillin
  • Severe renal impairment without appropriate monitoring

Adverse effects

  • Gastrointestinal disturbances
  • Erythema nodosum
  • Bronchospasm
  • Hepatic dysfunction
  • Electrolyte imbalance
  • Eosinophilia
  • Hallucinations
  • Purpura

Interactions

  • Probenecid may increase plasma concentrations of co-amoxiclav
  • Anticoagulants may have their effects altered
  • Other antibiotics may reduce the efficacy of co-amoxiclav

Precautions

  • Caution in patients with a history of allergic reactions to beta-lactam antibiotics
  • Use with caution in patients with hepatic or renal impairment
  • Monitor for signs of superinfection during prolonged therapy

Pregnancy

Co-amoxiclav is generally considered safe during pregnancy, but should be used only if clearly needed.

Breast-feeding

Amoxicillin and clavulanic acid are excreted in breast milk; monitor for potential effects on the infant.

Storage

Store below 25°C. Protect from light. Once reconstituted, use within 24 hours if kept at room temperature.

Formulations

  • Powder for solution for injection
  • Oral suspension 125 mg/125 mg per 5 mL
  • Tablets 250 mg/125 mg and 500 mg/125 mg
BNF 85 (British National Formulary) p.627 BNF for Children 2019-2020 p.376 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Co-amoxiclav

PubChem CID 23665637

Molecular formula: C24H27KN4O10S

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.