Paracetamol for children

Generic Name: Paracetamol
International Names: Acetaminophen (USA/Canada), Paracetamol (UK, EU, Asia)

Common Brand Names for Children:

• Calpol (UK)

• Panadol Baby & Infant

• Tylenol Children’s (USA)

• Tempra
  Drug Class: Analgesic (pain reliever) and Antipyretic (fever reducer)
  Pharmaceutical Category: Non-opioid analgesic
  Formulations for Children:

• Oral suspension (liquid syrup)

• Suppositories

• Dispersible tablets

• Chewable tablets

• Drops for infants

Route of Administration:

• Oral (most common for children)

• Rectal (in case of vomiting or difficulty swallowing)

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1. Mechanism of Action

Paracetamol acts primarily in the central nervous system (CNS) by inhibiting the cyclooxygenase (COX) enzymes, especially COX-2, leading to decreased prostaglandin synthesis. This results in:

• Reduction of fever via action on the hypothalamic heat-regulating center

• Analgesic effects without significant anti-inflammatory properties

Unlike NSAIDs, paracetamol has minimal peripheral anti-inflammatory action and does not affect platelet function or gastric mucosa, making it safer in pediatric populations.

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2. Therapeutic Indications in Children

• Fever reduction due to infections, post-immunization fever

• Mild to moderate pain, including:

  • Teething

  • Sore throat

  • Earache

  • Headache

  • Minor injuries

  • Post-operative pain

• Post-vaccination fever or discomfort

It is considered the first-line analgesic/antipyretic in pediatrics due to its safety profile.

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3. Dosage and Administration

Dosing is weight-based, not age-based

Recommended dose:

• 15 mg/kg per dose, every 4–6 hours as needed

• Maximum frequency: No more than 4 doses in 24 hours

• Maximum daily dose: 60 mg/kg to 75 mg/kg/day (depending on guidelines)

General Guidance:

Weight (kg)	Approx. Age	Single Dose (mg)	Suspension Dose (120 mg/5 mL)
4–5 kg	~0–3 months	60–75 mg	2.5 mL (half teaspoon)
6–7 kg	~3–6 months	90–105 mg	3.75–4.5 mL
8–9 kg	~6–12 months	120–135 mg	5 mL (1 teaspoon)
10–14 kg	~1–3 years	150–210 mg	6.25–8.75 mL
15–20 kg	~4–6 years	225–300 mg	9.5–12.5 mL
21–25 kg	~6–9 years	315–375 mg	~13–15.5 mL
26–40 kg	~10–12 years	390–600 mg	~16–25 mL

Important: Always verify actual body weight before dosing. Never exceed the maximum of 4 doses in 24 hours.

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4. Formulation-Specific Instructions

Oral Suspension (e.g., Calpol 120 mg/5 mL or 250 mg/5 mL)

• Shake well before use

• Use oral dosing syringe or dosing spoon provided

• Do not dilute with water or mix with food unless prescribed

Suppositories

• Used when oral route is not possible

• Insert rectally; dosage typically mirrors oral dosing (mg/kg)

• Onset may be slightly slower

Chewable or Dispersible Tablets

• For older children (>6 years)

• Ensure child can chew or swallow safely

• Can be dispersed in water if needed

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5. Pharmacokinetics in Children

• Absorption: Rapid via GI tract

• Peak plasma levels: 30–60 minutes after oral intake

• Metabolism: Primarily hepatic via glucuronidation and sulfation

• Half-life: Shorter in children (1.5–2.5 hours) than adults

• Excretion: Renal (metabolites)

Neonates have immature liver enzymes, which may delay clearance; hence dosing intervals may be extended in infants under 3 months.

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6. Contraindications

• Hypersensitivity to paracetamol

• Severe liver impairment

• Hepatitis or acute liver injury

• Children who have received maximum number of doses in 24 hours

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7. Warnings and Precautions

• Liver toxicity is the primary concern in overdose

• Use with caution in children with:

  • Liver disease

  • Dehydration or poor oral intake

  • Poor nutritional status (e.g., malnourishment)

Paracetamol does not treat underlying infection—used only for symptom relief.

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8. Adverse Effects

Paracetamol is generally well-tolerated when used correctly. Side effects are rare.

Common

• None (when used within recommended dosage)

Uncommon to Rare

• Rash or urticaria (allergic reaction)

• Nausea or mild GI upset

• Liver toxicity in overdose

• Blood disorders (e.g., thrombocytopenia, very rare)

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9. Overdose and Toxicity

Paracetamol is the leading cause of drug-induced liver failure worldwide due to unintentional or intentional overdose.

Toxic Dose in Children:

• 150 mg/kg in a single ingestion

• 75 mg/kg/day for multiple consecutive days

Signs of Overdose (early and delayed):

• Nausea, vomiting

• Abdominal pain

• Lethargy

• Elevated liver enzymes → hepatic necrosis

• Jaundice, confusion, hepatic failure (after 24–72 hrs)

Antidote:

• N-acetylcysteine (NAC)

• Most effective when administered within 8 hours of ingestion

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10. Drug Interactions

Generally safe with most pediatric medications, but:

• Enzyme-inducing antiepileptics (e.g., carbamazepine, phenytoin): ↑ risk of hepatotoxicity

• Isoniazid: ↑ hepatotoxic risk

• Warfarin: Long-term use may enhance anticoagulant effects

• Alcohol (if relevant): potentiates liver toxicity, though rarely applicable in pediatric context

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11. Use in Neonates and Infants

• Use with caution in <3 months

• Generally restricted to treatment of post-immunization fever or medically assessed pain/fever

• Dosing interval may be every 6–8 hours

• Liver metabolism is immature → reduced clearance

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12. Guidance for Caregivers

• Always measure using the proper dosing device

• Do not use kitchen spoons

• Avoid duplicate use of other medications containing paracetamol

• Keep a written record of doses and timing

• Store safely, away from children’s reach

• Do not exceed 4 doses in 24 hours

• Do not use for more than 3 consecutive days without medical review

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13. Clinical Pearls

• First-line for fever and pain in most pediatric conditions

• Safer alternative to ibuprofen in children with asthma, dehydration, or gastritis

• Less likely to cause gastric irritation

• Fast onset of action (30–60 minutes)

• Best to avoid routine prophylactic use (e.g., during vaccinations unless fever develops)