Amoxicillin, Sugar Free 250mg/5ml, 100ml Suspension POM x1
Amoxicillin
Prescription-only medicine (antibiotic)Adult/paediatric sugar-free amoxicillin 250mg/5ml oral suspension (100ml bottle)
Certifications
- Licensed in the UK under marketing authorisation (Product Licence) PL 43461/0047 for the 250 mg/5 ml sugar Free suspension by Flamingo Pharma (UK) Ltd
- Manufactured in compliance with Good Manufacturing Practice (GMP) standards and UK medicines legislation
- Packaged and distributed by registered wholesalers/pharmacies under MHRA supervision
- Licensed in the UK under marketing authorisation (Product Licence) PL 43461/0047 for the 250 mg/5 ml sugar Free suspension by Flamingo Pharma (UK) Ltd
- Manufactured in compliance with Good Manufacturing Practice (GMP) standards and UK medicines legislation
- Packaged and distributed by registered wholesalers/pharmacies under MHRA supervision
Adult/paediatric sugar-free amoxicillin 250mg/5ml oral suspension (100ml bottle)
Description
Amoxicillin, Sugar-Free 250mg/5ml, 100ml Suspension POM x1 is a prescription-only oral antibiotic suspension intended for patients who require a sugar-free liquid formulation. When reconstituted, each 5 ml of suspension delivers 250 mg of amoxicillin (as amoxicillin trihydrate), making it suitable for adult dosing and patients unable to swallow tablets or capsules. As with other amoxicillin formulations, it acts by inhibiting bacterial cell wall synthesis, leading to bacterial death in susceptible organisms. It is indicated for a range of infections where amoxicillin sensitivity is established, including respiratory, urinary, ear, skin, soft tissue and dental infections.
Bnefits
- Sugar-free oral suspension suitable for patients sensitive to sugars or requiring liquid formulations
- Convenient dosing for adults and children unable to swallow solid dosage forms
- Broad-spectrum antibiotic coverage when used against amoxicillin-sensitive pathogens
- Flexible dosing via oral suspension allowing body-weight or body-surface-based prescriptions
- Well-established safety profile and broad clinical experience
- Useful in outpatient or ambulatory care settings where oral administration is preferred over injectable forms
Indications
- Bacterial infections of the ear, nose and throat (e.g. sinusitis, otitis media, tonsillitis, pharyngitis) when pathogens are susceptible
- Lower and upper respiratory tract infections including bronchitis and community-acquired pneumonia (where indicated)
- Urinary tract infections caused by susceptible bacteria (e.g. cystitis, pyelonephritis)
- Skin and soft tissue infections including cellulitis, wound infections
- Dental infections including dental abscesses when indicated
- Infections by Helicobacter pylori (as part of combination therapy over multiple agents) in conditions requiring oral liquid therapy
- Other infections in which amoxicillin-sensitive organisms are documented or strongly suspected, per local treatment guidelines and prescriber discretion
Composition
- Active: Amoxicillin trihydrate equivalent to 250 mg amoxicillin per 5 ml of reconstituted suspension
- Excipients: Sorbitol (E420) as sweetener (sugar-free), sodium benzoate (E211) preservative, disodium edetate, sodium citrate, citric acid, flavouring agents (e.g. banana flavour), colloidal anhydrous silica, xanthan gum and other excipients typical of oral suspensions
- Free from sucrose, making it suitable for patients requiring sugar-free medications or with dietary sugar restrictions
Formulation
- Powder for oral suspension, to be reconstituted with potable water to 100 ml
- Sugar-free suspension formulation ideal for patients with sugar intolerance, diabetes, or dietary restrictions
- Beta-lactam aminopenicillin antibiotic (oral suspension) intended for systemic antibacterial therapy
Packaging
- One 100 ml bottle of powder for oral suspension supplied per pack (POM x1)
- Bottle packaged in an outer carton including the patient information leaflet (PIL)
- After reconstitution by a pharmacist, the bottle is labelled with reconstitution date, expiry date (usually 7–14 days post-reconstitution) and dosing instructions
Usage
- To be dispensed and reconstituted by a pharmacist according to the manufacturer’s instructions before first use.
- Shake well before each dose to ensure uniform suspension.
- Doses are calculated by prescriber based on infection type, patient’s age/weight and renal function.
- Take with or without food; taking with food may reduce gastrointestinal discomfort in some patients.
- Administer using a marked oral dosing syringe or measuring spoon for accuracy.
- Complete the full prescribed course even if symptoms improve earlier, to reduce risk of relapse and antibiotic resistance.
- If you forget a dose, take it as soon as remembered unless it's close to the next scheduled dose—do not double the dose.
- Read the patient information leaflet carefully and consult your prescriber or pharmacist with any questions or concerns.
Contraindications
- Known hypersensitivity to amoxicillin, any penicillin or any component of the formulation (including sorbitol or preservatives)
- History of a severe immediate hypersensitivity reaction to a beta-lactam antibiotic (e.g. anaphylaxis, angioedema)
- Inherited fructose intolerance or other conditions contraindicating sorbitol-containing medicines
- Known bacterial resistance to amoxicillin in the infecting organism or where susceptibility is unknown and alternative antibiotics are indicated
- Patients with a history of penicillin-associated severe skin reactions (e.g. Stevens–Johnson syndrome, toxic epidermal necrolysis)
- Caution in patients with significant renal impairment; dose adjustments may be needed
- Any contraindications detailed in the specific product’s Summary of Product Characteristics
Adverse Effects
- Common: gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal discomfort
- Skin reactions: rash, urticaria, pruritus
- Hypersensitivity reactions: possible serious allergic reactions including anaphylaxis, angioedema, serum sickness-like reactions, severe skin reactions (e.g. Stevens–Johnson syndrome, toxic epidermal necrolysis)
- Hepatic effects: transient liver enzyme elevations, cholestatic jaundice or hepatitis (rare)
- Haematological effects: rarely reversible blood dyscrasias such as anaemia, thrombocytopenia, leucopenia
- Overgrowth of non-susceptible organisms (e.g. Candida) especially on prolonged therapy
- Clostridioides difficile-associated diarrhoea/colitis, especially with prolonged or repeated use
- Renal effects: risk of crystalluria or kidney injury, particularly with high doses or predisposing conditions
- Serious or persistent adverse reactions should prompt immediate medical evaluation
Storage Conditions
- Store powder below 25 °C in the original bottle and carton until reconstitution.
- After reconstitution, store the suspension in a refrigerator (2–8 °C) and use within 7–14 days (depending on manufacturer instructions).
- Keep out of the sight and reach of children.
- Do not use after the expiry date on the label or if the bottle shows signs of damage or contamination.
- Return any unused or expired medicine to a pharmacy for safe disposal; do not dispose via household waste or wastewater.
Duration
Determined by the prescriber based on the infection type and severity; commonly 5\u201310 days for acute infections but may vary according to local guidelines or combination therapy requirements.
Onset
Improvement in symptoms such as fever, pain or inflammation often begins within 24-72 hours of starting an effective course but full therapeutic benefit depends on completing the prescribed course.
