Co Amoxiclav 625 mg (500 mg/125 mg) Tablets x 21
Co-amoxiclav
Pharmaceutical ProductSystemic antibiotic \u2013 penicillin/\u03b2-lactamase inhibitor
Certifications
- UK Licensed prescription Only medicine (POM) with MHRA marketing authorisations for Co Amoxiclav 500 mg/125 mg film Coated tablets or equivalent 625 mg strength
- Manufactured in accordance with EU/UK Good Manufacturing Practice (GMP)
- Quality, safety and efficacy supported by MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
- Listed under national and international guidance as a critically important antibiotic for human medicine, requiring antimicrobial stewardship in use
- UK Licensed prescription Only medicine (POM) with MHRA marketing authorisations for Co Amoxiclav 500 mg/125 mg film Coated tablets or equivalent 625 mg strength
- Manufactured in accordance with EU/UK Good Manufacturing Practice (GMP)
- Quality, safety and efficacy supported by MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
- Listed under national and international guidance as a critically important antibiotic for human medicine, requiring antimicrobial stewardship in use
Systemic antibiotic \u2013 penicillin/\u03b2-lactamase inhibitor
Description
Co-Amoxiclav 625 mg (500 mg/125 mg) tablets are a prescription-only, broad-spectrum antibiotic containing amoxicillin 500 mg and clavulanic acid 125 mg per film-coated tablet. Amoxicillin is a β-lactam penicillin that kills susceptible bacteria by inhibiting bacterial cell wall synthesis, while clavulanic acid is a β-lactamase inhibitor that protects amoxicillin from enzymatic degradation. This combination extends the antibacterial spectrum to include many β-lactamase–producing organisms. The 625 mg strength (expressed as 500 mg + 125 mg) is commonly used in adults and older children for a range of infections such as respiratory, ear, nose and throat, urinary tract, skin and soft tissue, dental, and bone and joint infections, in line with national guidelines and the product SmPC.
Bnefits
- Broad-spectrum antibiotic activity against a wide range of Gram-positive and Gram-negative bacteria, including many β-lactamase–producing strains
- Combination of amoxicillin with clavulanic acid overcomes many mechanisms of β-lactamase–mediated resistance
- Indicated for common community-acquired infections including sinusitis, otitis media, lower respiratory tract infections, urinary tract infections, skin and soft-tissue infections and dental infections
- Useful in bone and joint infections where susceptible organisms are identified
- Oral film-coated tablet formulation allows convenient outpatient and primary-care treatment
- Extensively studied with a long-established efficacy and safety profile, supported by MHRA-approved SmPC and PIL
- 625 mg (500/125 mg) strength suited to thrice-daily adult dosing regimens recommended in UK guidance
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 caused by susceptible organisms
- Pyelonephritis (where appropriate in line with guidelines and susceptibility)
- Skin and soft-tissue infections, including cellulitis, animal bites and severe dental abscess with spreading cellulitis
- Bone and joint infections, including osteomyelitis
- Use should follow official/local antibacterial prescribing guidance and culture/susceptibility data where available
Composition
- Active substances per film-coated tablet:
- • Amoxicillin trihydrate equivalent to 500 mg amoxicillin
- • Potassium clavulanate equivalent to 125 mg clavulanic acid
- Typical core excipients (may vary slightly by MA holder):
- • Microcrystalline cellulose
- • Sodium starch glycolate (Type A or similar disintegrant)
- • Colloidal anhydrous silica
- • Magnesium stearate
- Typical film-coating excipients:
- • Hypromellose
- • Macrogol (polyethylene glycol)
- • Titanium dioxide (E171)
- Tablets are generally free from natural rubber latex; full excipient list is provided in the specific SmPC/PIL for the brand supplied.
Formulation
- Film-coated tablet for oral administration
- Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate), total 625 mg
- White to off-white, oval film-coated tablet (appearance and markings vary by manufacturer)
- Prescription-only medicine (POM)
Packaging
- Blister packs of 21 film-coated tablets (commonly 3 × 7-tablet blisters or equivalent configuration, depending on MA holder)
- Supplied in an outer carton labelled with product name, strength (500 mg/125 mg), quantity (21), batch number and expiry date
- Williams Medical listing: pack size x 21, presentation noted as tablet
Usage
- Use only on the prescription and under the supervision of a suitably qualified prescriber.
- Adults and children weighing 40 kg or more: usual dose for this strength is one 500 mg/125 mg tablet three times daily, adjusted according to infection type, severity and renal function, in line with SmPC and local guidelines.
- Administer at the start of a meal to minimise gastrointestinal intolerance and optimise absorption.
- Swallow tablets whole with a glass of water; if permitted by the specific brand’s PIL, tablets with a score line may be broken in half to aid swallowing, but the full dose must be taken.
- Space doses evenly throughout the day (usually every 8 hours); do not take two doses within 1 hour.
- Do not use for more than 14 days without clinical review; many uncomplicated infections require shorter courses (e.g. 5–7 days) according to guidelines.
- If a dose is missed, take it as soon as remembered unless it is almost time for the next dose; do not double dose to make up for a missed dose.
- Complete the full prescribed course even if symptoms improve early to reduce relapse and resistance risk.
- Children under 40 kg are usually treated with co-amoxiclav oral suspension/paediatric formulations instead of 500/125 mg tablets.
- Dose adjustment or alternative regimens are needed in patients with renal or hepatic impairment; follow SmPC and specialist advice.
Contraindications
- Known hypersensitivity to amoxicillin, clavulanic acid, other penicillins or any excipient in the formulation
- History of severe immediate hypersensitivity reactions (e.g. anaphylaxis) to other β-lactam antibiotics 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 or strongly suspected to be caused by organisms resistant to amoxicillin/clavulanic acid where alternative agents are preferred
Adverse Effects
- Very common or common gastrointestinal effects such as diarrhoea, nausea, vomiting and abdominal discomfort
- Antibiotic-associated colitis including Clostridioides difficile–associated diarrhoea, which may be severe; treatment should be stopped and evaluated if significant diarrhoea occurs
- Hypersensitivity reactions ranging from rash, pruritus and urticaria to angioedema and anaphylaxis (medical emergency)
- Hepatic effects including cholestatic jaundice and hepatitis, usually reversible but sometimes with delayed onset
- Central nervous system effects such as headache and dizziness; convulsions may occur in patients with renal impairment or receiving high doses or concomitant CNS-active drugs
- Mucocutaneous candidiasis (e.g. oral or vaginal thrush) due to alteration of normal flora
- Haematological changes such as reversible thrombocytopenia, leucopenia or eosinophilia
- Prolonged use may result in overgrowth of non-susceptible organisms
Storage Conditions
- Store in the original package in order to protect from moisture.
- Do not store above 25°C (or as stated in the specific brand SmPC).
- Keep blisters in the outer carton until time of use to maintain product integrity.
- Do not use after the expiry date printed on the carton and blister.
- Keep out of the sight and reach of children.
Duration
Typically 5\u201314 days depending on the type and severity of infection and patient response; treatment beyond 14 days should only occur after medical review and in line with the SmPC and local antimicrobial guidance.
Onset
Antibacterial action begins shortly after administration; clinical improvement is usually expected within 48\u201372 hours in appropriately selected and susceptible infections.
