Logo
Co Amoxiclav 500/125 mg Film Coated Tablets (21)

Co Amoxiclav 500/125 mg Film Coated Tablets (21)

Co-amoxiclav

Pharmaceutical Product
  • UK Licensed prescription Only medicine (POM) with MHRA marketing authorisations for Co Amoxiclav 500/125 mg film Coated tablets
  • Manufactured under EU/UK Good Manufacturing Practice (GMP) and ISO 13485/quality management systems as applicable to the specific MA holder
  • SmPC and PIL approved by the MHRA, consistent with EU core safety and efficacy data for co Amoxiclav
  • Follows official guidance for antibacterial use and resistance stewardship
Systemic antibiotic \u2013 penicillin/\u03b2-lactamase inhibitor

Description

Co-Amoxiclav 500/125 mg film-coated tablets are a prescription-only, broad-spectrum antibiotic combination containing amoxicillin 500 mg and clavulanic acid 125 mg per tablet. Amoxicillin is a β-lactam penicillin that kills susceptible bacteria by inhibiting cell wall synthesis, while clavulanic acid is a β-lactamase inhibitor that protects amoxicillin from enzymatic breakdown. Co-amoxiclav is used in adults and children to treat a range of infections, including respiratory tract infections, ear, nose and throat infections, urinary tract infections, skin and soft-tissue infections (including dental infections), and bone and joint infections. The usual adult dose for this strength is one 500/125 mg tablet three times daily, taken for as long as prescribed by a healthcare professional.

Bnefits

  • Broad-spectrum antibiotic activity against a wide range of β-lactamase–producing and non–β-lactamase–producing bacteria
  • Combination of amoxicillin with clavulanic acid overcomes many forms of β-lactamase–mediated resistance
  • Effective in common community-acquired infections such as sinusitis, otitis media, bronchitis, pneumonia and urinary tract infections
  • Indicated for skin and soft-tissue infections, including dental infections and animal bites
  • Oral film-coated tablet formulation for convenient outpatient therapy
  • Widely used, well-characterised safety and efficacy profile supported by SmPC and regulatory data
  • Available as a standard 500 mg/125 mg strength allowing thrice-daily dosing in adults

Indications

  • Acute bacterial sinusitis (adequately diagnosed)
  • Acute otitis media
  • Acute exacerbations of chronic bronchitis (adequately diagnosed)
  • Community-acquired pneumonia
  • Cystitis and other urinary tract infections
  • Pyelonephritis
  • Skin and soft-tissue infections, particularly cellulitis, animal bites and severe dental abscess with spreading cellulitis
  • Bone and joint infections, particularly osteomyelitis
  • Use should follow official/local guidance on appropriate use of antibacterial agents

Composition

  • Active substances (per film-coated tablet):
  • • Amoxicillin trihydrate equivalent to 500 mg amoxicillin
  • • Potassium clavulanate equivalent to 125 mg clavulanic acid
  • Core excipients (typical SmPC formulation):
  • • Microcrystalline cellulose (E460)
  • • Sodium starch glycolate (Type A)
  • • Colloidal anhydrous silica
  • • Magnesium stearate (E470b)
  • Film-coating excipients (typical SmPC formulation):
  • • Hypromellose (E464)
  • • Macrogol 400
  • • Titanium dioxide (E171)

Formulation

  • Film-coated tablet for oral administration
  • Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate)
  • White or off-white, oval, film-coated tablet (appearance may vary slightly by manufacturer)
  • Prescription-only medicine (POM)

Packaging

  • Blister packs containing 21 film-coated tablets (commonly supplied as 3 blisters × 7 tablets or 3 blisters × 5 tablets plus 1 blister × 6, depending on manufacturer; WMS listing specifies total of 21 tablets)
  • Outer carton labelled with product name, strength, batch number and expiry date

Usage

  • Use only as prescribed by a doctor or other qualified prescriber.
  • Adults and children ≥40 kg: the usual dose for this strength is one 500 mg/125 mg tablet three times a day, with spacing of approximately 8 hours between doses, unless otherwise directed in the SmPC and by the prescriber.
  • Tablets should preferably be taken at the start of a meal to minimise potential gastrointestinal side effects and improve absorption.
  • Tablets should be swallowed whole with a glass of water and should not be divided unless the specific marketed brand provides a functional score line for this purpose (many Co-amoxiclav 500/125 mg tablets are not intended to be split for dosing).
  • Duration of treatment should follow the prescriber’s instructions and relevant guidelines; treatment should not usually exceed 14 days without clinical review.
  • If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next dose. Do not take a double dose to make up for a forgotten dose.
  • Complete the full prescribed course even if symptoms improve early, to reduce the risk of relapse and antibiotic resistance.
  • Children under 40 kg are typically treated with amoxicillin/clavulanic acid oral suspension or paediatric formulations rather than 500/125 mg tablets.

Contraindications

  • Hypersensitivity to amoxicillin, clavulanic acid, any penicillin, or to any of the excipients
  • History of severe immediate or severe delayed hypersensitivity reaction (e.g. anaphylaxis, severe skin reaction) to any other β-lactam antibiotic such as cephalosporins, carbapenems or monobactams
  • History of jaundice or hepatic dysfunction associated with co-amoxiclav or other penicillins
  • Use in patients with infections known to be resistant to amoxicillin/clavulanic acid, where alternative agents are indicated

Adverse Effects

  • Very common and common: diarrhoea, nausea, vomiting, abdominal discomfort, and mild skin rashes
  • Potential for antibiotic-associated colitis, including Clostridioides difficile–associated diarrhoea
  • Allergic reactions ranging from rash and urticaria to anaphylaxis (a medical emergency)
  • Liver-related adverse effects including cholestatic jaundice and hepatitis, usually reversible but sometimes delayed in onset
  • Headache, dizziness and candidiasis (oral or vaginal thrush) have been reported
  • Haematological effects such as reversible thrombocytopenia, leukopenia or eosinophilia may occur
  • As with all antibiotics, prolonged use may lead to overgrowth of non-susceptible organisms

Storage Conditions

  • Store below 25°C (or as per specific brand SmPC) in the original package to protect from moisture.
  • Keep blister strips in the outer carton until use.
  • Do not use after the expiry date stated on the carton and blister.
  • Keep out of the sight and reach of children.

Duration

Typically 5\u201314 days depending on infection type, severity and clinical response; treatment should not usually be extended beyond 14 days without medical review, in line with the SmPC and prescriber guidance.

Onset

Bactericidal activity begins soon after administration; clinical improvement is usually expected within 48\u201372 hours of appropriate therapy, depending on infection and patient factors.

Browse more Pharmaceutical Product

Top Treatments

Top Cities in the UK