Panadol Baby

Panadol Baby pack shot

Acts** on fever and pain,1 gentle1,3,d on the child

Formulated for children from 2 months+, Panadol Baby contains paracetamol, which is recommended as first-line treatment for fever and mild-to-moderate pain in children.2-4 It starts to relieve fever within 15 minutes of dosing.1,5-7

Chart adapted from the World Health Organization guidelines on fever management in children

The World Health Organization guidelines on fever management state that when a child presents with fever, danger signs should be looked for. These include an inability to drink, persistent vomiting, convulsions, lethargy or unconsciousness, stridor in a calm child or severe malnutrition. If these signs are present, the patient must be referred immediately for specialist management.8

The symptomatic fever, associated with distress due to non-specific respiratory infections, diarrhoea and other infections, is managed with paracetamol.2

Chart showing reduction of temperature after paracetamol. Adapted from Wong et al. 2001.

This was a randomised, double-blind multicentre trial involving febrile children aged 6 months to 6 years who were given a dose of paracetamol (acetaminophen) 12 mg/kg (n=210). A downward slope in temperature was seen at the 15-minute time point. Maximal rate of temperature reduction was reached at 60 minutes in the paracetamol group.6

As effective as ibuprofen at doses of 10 mg/kg9

Chart showing the reduction of temperature in children given paracetamol 10 mg/kg or ibuprofen 10 mg/kg. Adapted from Vauzelle et al. 1997

This was a randomised, double blind, multicentre trial with 116 children aged 4.1 years (± 2.6 years) with a fever related to an infectious disease and a mean baseline temperature of 39°C (± 0.5°C), who were treated with either single doses of ibuprofen 10.3 mg/kg (± 1.9 mg/kg) or paracetamol 9.8 mg/kg (± 1.9 mg/kg). The children’s rectal temperature was regularly monitored for 6 hours. Tmax is the time that elapsed between first dose of drug administration and lowest temperature observed between the 0-6 hours.9

When given to children with fever, both paracetamol 10 mg/kg and ibuprofen 10 mg/kg were similar in reduction of temperature in the time between dosing and achieving lowest temperature during 0-6 hours.9

Chart showing the reduction of temperature in children given paracetamol 15 mg/kg or ibuprofen 10 mg/kg. Adapted from Autret-Leca et al. 2007

A randomised, single-dose, double-blind study in children from 3 months to 12 years old (N = 301) with non-serious fever received either paracetamol 15 mg/kg or ibuprofen 10 mg/kg. Mean temperature in both groups were 38.9°C at baseline. Primary outcome was tympanic temperature reduction over the following 8 hours post first dose administration.

Both paracetamol 15 mg/kg and ibuprofen 10 mg/kg had similar (not significant) reductions in temperature. The mean area under the curve (AUC) was -7.66°C and -7.77°C, respectively.10

Effective pain-relief in children11

Chart showing significant pain relief from paracetamol vs. placebo as assessed by children and their parents. Adapted from Schactel et al. 1993.

This was a randomised, single-dose, double-blind, placebo-controlled study in children aged 2-12 years with acute sore throat treated with paracetamol 15 mg/kg, ibuprofen 10 mg/kg or placebo. Paracetamol showed significant pain relief vs. placebo from 1-hour post dose, which was sustained until 4 hours after dosing based on the children’s assessment of their pain.The parents’ assessment of changes in pain intensity seen in their children reflected the same.11

An unsurpassed tolerability profile among children’s over-the counter analgesics/antipyretics3,12

Happy child with his mother

When compared to non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen, paracetamol is preferred because it is gentle on tiny tummies,1,3 has a lower risk of bleeding complications in certain vector-borne diseases like dengue2 may be suitable for children with dehydration12 and does not interact with as many other medicines like ibuprofen does.2

In a literature review of 23 clinical studies of paracetamol involving children, the safety data showed that paracetamol had comparable safety to ibuprofen and ketoprofen in short-term treatment of fever.3

What can Panadol for children do for Ollie?

Baby smiling

Ollie’s got a fever

Ollie’s 1 years old and has been having a fever for the past two days. His mum is worried because he’s been fussy and not eating well. She wants something to help him get relief from the fever and at the same time, something that is suitable for him.

Panadol Baby 120mg/5ml Oral Suspension is suitable from 2 months+ and would help Ollie feel better by reducing his fever effectively and safely.

Panadol Baby product details

  • Product Information

    Product Information: Please consult the summary of product characteristics for full product information. Panadol Baby 120mg/5ml Oral Suspension (paracetamol). Indications: Relief of pains of teething, toothache and sore throats, reducing fever associated with colds, flu and childhood infections such as chicken pox, whooping cough, measles and mumps. Dosage: Do not give to babies under 2 months. 2-3 months: post vaccination fever. (Other indications only if >4kg and >37 weeks gestation): 2.5mL. Max 2 doses in 24 hours at least 4-6 hours apart. 3-6 months: 2.5mL dose up to 4 times in 24 hours.6-24 months: 5mL dose up to 4 times in 24 hours. 2-4 years: 7.5 mL dose up to 4 times in 24 hours. 4-8 years: 10mL dose up to 4 times in 24 hours. 8-10 years: 15 mL dose up to 4 times in 24 hours. 10-12 years: 20mL dose up to 4 times in 24 hours. Minimum dosing interval: 4 hours.The lowest dose necessary to achieve efficacy should be used. Max duration of use without medical advice: 3 days. Contraindications: Hypersensitivity to paracetamol or any other ingredients. Precautions: Do not use with any other paracetamol containing products. The concomitant use with other products containing paracetamol may lead to an overdose.Paracetamol overdose may cause liver failure, which can lead to liver transplant or death. Patients with depleted glutathione levels/ glutathione depleted states. Liver or kidney impairment, premature babies <3 months old, non-cirrhotic alcoholic liver disease. Caution, due to paracetamol, if administered with flucloxacillin due to increased risk of high anion gap metabolic acidosis.Do not exceed the stated dose. Contains parahydroxybenzoates (E216 and E218) which may cause allergic reactions (possibly delayed). Consult a doctor prior to use if the child has a known intolerance to some sugars as this product contains maltitol syrup and sorbitol. May have a mild laxative effect and cause gastrointestinal discomfort. Side Effects: Very rare cases of serious skin reactions have been reported.All very rare: Hypersensitivity reactions including anaphylaxis and skin rash, thrombocytopenia, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, bronchospasm, hepatic dysfunction.Legal Category: GSL (60mL), Pharmacy only (100mL). MA Number: PA 678/39/3. MA Holder: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24. Text Prepared: December 2022. Further information available on request.Contains Paracetamol. Always read the label/leaflet.

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