Finished product reference
Co-amoxiclav
Powder, for Suspension · Oral · 200 mg/28.5 mg/5 mL · 100 mL
- List code
- 2205
- Pharmacologic class
- Aminopenicillin with beta-lactamase inhibitor (amoxicillin / clavulanic acid)
What it is and how it works
Amoxicillin is a bactericidal broad-spectrum penicillin that inhibits cell-wall synthesis. Clavulanic acid irreversibly inhibits many bacterial beta-lactamases, protecting amoxicillin from hydrolysis and extending its spectrum to beta-lactamase-producing strains of Staphylococcus aureus (methicillin-susceptible), Haemophilus influenzae, Moraxella catarrhalis, Enterobacterales and anaerobes such as Bacteroides.
Indications
Infections caused by susceptible organisms, including acute bacterial sinusitis, otitis media, exacerbations of chronic bronchitis, community-acquired pneumonia, urinary tract infections, skin and soft-tissue infections including animal bites, dental infections, bone and joint infections and intra-abdominal infections; surgical prophylaxis (intravenous).
Dosage and administration (summary)
Oral (adults, expressed as amoxicillin/clavulanic acid): 500/125 mg three times daily, or 875/125 mg two to three times daily, taken at the start of a meal. Intravenous: 1.2 g (1 g/200 mg) every 8 hours by slow injection or infusion. Doses are adjusted in renal impairment; paediatric doses are weight-based.
Contraindications
Hypersensitivity to penicillins; history of severe immediate hypersensitivity to other beta-lactams; previous jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid.
Warnings and precautions
Hypersensitivity reactions including anaphylaxis and severe cutaneous reactions may occur. Cholestatic jaundice and hepatitis, more common in older adults, men and with treatment beyond 14 days, may appear during or after therapy. Clostridioides difficile-associated diarrhoea may occur; maculopapular rash is common in infectious mononucleosis; may increase INR with oral anticoagulants.
Pregnancy
May be used in pregnancy when needed; avoid in women at risk of preterm rupture of membranes (association with necrotising enterocolitis in neonates).
Storage and supply
Store tablets and powder below 25 °C in the original package, protected from moisture; reconstituted oral suspension at 2–8 °C, use within 7 days; reconstitute injection immediately before use.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
- Injection, Powder, for Solution · Parenteral · 1000 mg/200 mg51302
- Powder, for Suspension · Oral · 125 mg/31.25 mg1754
- Powder, for Suspension · Oral · 125 mg/31.25 mg/5mL · 100 mL335
- Powder, for Suspension · Oral · 200 mg/28.5 mg/5 mL · 30 mL53057
- Powder, for Suspension · Oral · 250 mg/62.5 mg52224
- Powder, for Suspension · Oral · 250 mg/62.5 mg/5mL · 100 mL1440
- Powder, for Suspension · Oral · 400 mg/57 mg/5 mL · 100 mL2206
- Powder, for Suspension · Oral · 400 mg/57 mg/5 mL · 30 mL53056
- Powder, for Suspension · Oral · 600 mg/42.9 mg/5mL · 100 mL52270
- Powder, for Suspension · Oral · 600 mg/42.9 mg/5mL · 75 mL20307
- Tablet · Oral · 250 mg/125 mg337
- Tablet · Oral · 500 mg/125 mg338
- Tablet · Oral · 875 mg/125 mg52802
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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