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

Co-amoxiclav

Pharmaceutical Product

Systemic antibiotic \u2013 penicillin/\u03b2-lactamase inhibitor

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

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.