Amoxicillin, Sugar Free (Paediatric) 125mg/5ml, 100ml Suspension POM x1
Amoxicillin
Prescription-only medicine (antibiotic)Paediatric sugar-free amoxicillin 125mg/5ml oral suspension (100ml bottle)
Certifications
- Licensed in the UK as a prescription Only medicine (POM) with product licence number PL 43461/0074 for the 125 mg/5 ml sugar Free suspension
- Marketing Authorisation Holder and manufacturer: Flamingo Pharma (UK) Ltd, authorised by the MHRA
- Manufactured in accordance with Good Manufacturing Practice (GMP) and distributed under UK medicines legislation
- Product information (SmPC and PIL) published and regularly updated on the electronic Medicines Compendium (emc) and MHRA databases
- Licensed in the UK as a prescription Only medicine (POM) with product licence number PL 43461/0074 for the 125 mg/5 ml sugar Free suspension
- Marketing Authorisation Holder and manufacturer: Flamingo Pharma (UK) Ltd, authorised by the MHRA
- Manufactured in accordance with Good Manufacturing Practice (GMP) and distributed under UK medicines legislation
- Product information (SmPC and PIL) published and regularly updated on the electronic Medicines Compendium (emc) and MHRA databases
Paediatric sugar-free amoxicillin 125mg/5ml oral suspension (100ml bottle)
Description
Amoxicillin, Sugar-Free (Paediatric) 125mg/5ml, 100ml Suspension POM x1 is a prescription-only oral antibiotic for children, supplied as a 100ml bottle of sugar-free powder for oral suspension. When reconstituted, each 5ml dose contains 125mg of amoxicillin (as amoxicillin trihydrate), a broad-spectrum aminopenicillin. It works by inhibiting bacterial cell wall synthesis, causing susceptible bacteria to rupture and die. This paediatric formulation is indicated for a wide range of infections caused by amoxicillin-sensitive organisms, including infections of the ear, nose and throat, chest, urinary tract, skin and soft tissues, and it may be used in combination with other medicines to treat stomach ulcers caused by Helicobacter pylori. The sugar-free suspension contains sorbitol and other excipients but no sucrose, and is suitable for children where a liquid formulation and sugar-free option are preferred.
Bnefits
- Broad-spectrum activity against many common bacterial pathogens when susceptible, providing versatile treatment for paediatric infections
- Sugar-free oral suspension formulation suitable for children and patients requiring avoidance of sucrose
- Liquid dosage form facilitates accurate weight-based dosing in infants and children who cannot swallow capsules or tablets
- Well-established penicillin-class antibiotic with extensive clinical experience and safety data in paediatric populations
- Can be used, where appropriate, in combination regimens to eradicate Helicobacter pylori in peptic ulcer disease
- Supplied in a 100ml bottle with clear labelling and an accompanying patient information leaflet to support correct use under medical supervision
Indications
- Bacterial infections in different parts of the body caused by organisms susceptible to amoxicillin, in infants and children
- Ear, nose and throat infections such as otitis media, sinusitis, tonsillitis and pharyngitis
- Lower respiratory tract infections including bronchitis and pneumonia where amoxicillin is appropriate
- Urinary tract infections (for example cystitis and pyelonephritis) due to susceptible organisms
- Skin and soft tissue infections, including cellulitis and wound infections
- Dental infections such as dental abscesses, usually in conjunction with dental treatment
- Use in combination with other medicines (such as clarithromycin and a proton pump inhibitor) for the eradication of Helicobacter pylori in patients with stomach or duodenal ulcers, where a paediatric suspension is required
- Other infections in children caused by amoxicillin-sensitive bacteria as described in the licensed product information and local treatment guidelines
Composition
- Active ingredient: Amoxicillin trihydrate BP equivalent to 125 mg amoxicillin per 5 ml of reconstituted suspension
- Each 5 ml dose of the sugar-free suspension contains 0.8 g sorbitol (E420) as a sweetener and excipient
- Excipients include: sodium benzoate (E211), disodium edetate, sodium citrate, citric acid, colloidal anhydrous silica, sorbitol (E420), saccharin sodium, banana flavour, quinoline yellow (E104), xanthan gum
- Free from sucrose (sugar-free formulation), making it suitable for patients requiring sugar-free medicines
Formulation
- Pharmaceutical form: powder for oral suspension (sugar free), reconstituted by the pharmacist to a 100 ml oral suspension
- When reconstituted, the suspension is typically white to pale yellow with a banana flavouring to improve palatability for children
- Strength: 125 mg amoxicillin per 5 ml of reconstituted suspension
- Beta-lactam antibiotic (aminopenicillin) formulation intended for oral administration
Packaging
- Pack size: 100 ml bottle of powder for oral suspension (sugar free), to be reconstituted with water to produce 100 ml of suspension
- Supplied as a single bottle (POM x1) within an outer carton, with a patient information leaflet included
- Bottle is designed to be tightly closed and may be supplied with or used alongside an appropriate measuring device (such as an oral dosing syringe, spoon or cup) for accurate dosing
- Marketed as a pharmaceutical product for paediatric use, with product licence number PL 43461/0074 for the 125 mg/5 ml sugar-free suspension
Usage
- This medicine should only be used when prescribed by a doctor, dentist or other authorised prescriber, following assessment of the child’s condition.
- The powder is reconstituted by the pharmacist to 100 ml with potable water according to the manufacturer’s instructions before dispensing.
- Shake the bottle well before each dose to ensure the suspension is evenly mixed.
- Doses for children are calculated by the prescriber based on body weight (commonly 40–90 mg/kg/day in two or three divided doses, up to a maximum of 100 mg/kg/day), and will be communicated on the prescription label.
- Doses should be spaced evenly throughout the day, usually at least 4 hours apart, and given using an appropriate oral dosing syringe, spoon or cup to ensure accuracy.
- The suspension can generally be taken with or without food; taking with food may help reduce gastrointestinal upset in some children.
- Caregivers should continue to give the medicine for as long as prescribed, even if the child begins to feel better earlier, to help ensure complete eradication of the infection and reduce the risk of antibiotic resistance.
- If a dose is missed, it should be given as soon as remembered unless it is nearly time for the next dose; a double dose should not be given to make up for a missed dose.
- Caregivers should read the patient information leaflet in full before use and contact a healthcare professional if they have questions about dosing, side effects or interactions.
Contraindications
- Hypersensitivity to amoxicillin trihydrate, any penicillin, or any of the excipients in the formulation (including sorbitol or sodium benzoate)
- History of a severe immediate hypersensitivity reaction (for example anaphylaxis) to any beta-lactam antibiotic, including cephalosporins, carbapenems or monobactams
- Use is contraindicated in patients with known hereditary fructose intolerance (HFI) or certain sugar intolerances without appropriate medical advice, due to sorbitol content
- Any additional contraindications or cautions listed in the current Summary of Product Characteristics (SmPC) and patient information leaflet should be observed
Adverse Effects
- Common side effects include nausea, diarrhoea and skin rash
- Vomiting may occur in some patients
- Overgrowth of non-susceptible organisms such as Candida (for example oral or nappy-area thrush) with prolonged use
- Allergic reactions ranging from mild skin rash or urticaria to severe reactions such as anaphylaxis, angioedema, erythema multiforme, severe bullous skin reactions (including Stevens–Johnson syndrome and toxic epidermal necrolysis), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Blood and lymphatic system disorders such as haemolytic anaemia, thrombocytopenia or leucopenia (generally reversible) have been reported rarely
- Liver-related effects including hepatitis and cholestatic jaundice, particularly with prolonged treatment; changes in liver enzymes may occur
- Clostridioides difficile-associated diarrhoea and colitis, which may present with severe or persistent diarrhoea and abdominal pain
- Crystalluria and renal effects (including acute kidney injury) have been reported, particularly with high doses or inadequate hydration
- Additional adverse effects and their frequencies are detailed in the current patient information leaflet; caregivers should seek medical advice if any severe, unusual or persistent symptoms occur
Storage Conditions
- Dry powder (unreconstituted): store below 25°C, keep the bottle tightly closed and in the original carton until use.
- Reconstituted suspension: store in a refrigerator at 2–8°C and use within 7 days of preparation; any unused sugar-free suspension after this time should be returned to a pharmacist for safe disposal.
- Keep out of the sight and reach of children at all times.
- Do not use after the expiry date printed on the carton and bottle label; the expiry date refers to the last day of the month.
- Medicines should not be disposed of via wastewater or household waste; unused or expired product should be returned to a pharmacy.
Duration
The duration of treatment is determined by the prescriber according to the type and severity of infection and the child\u2019s clinical response. Many common paediatric infections are treated for around 5 to 10 days, while certain conditions (for example some respiratory or Helicobacter pylori-related infections) may require different or longer regimens as recommended in guidelines.
Onset
Clinical improvement is often seen within a few days of starting appropriate therapy, although the full course should always be completed as prescribed, even if symptoms improve earlier.
