Ibuprofen for children

Generic Name: Ibuprofen
Drug Class: Nonsteroidal Anti-inflammatory Drug (NSAID)
Therapeutic Class: Antipyretic, analgesic, anti-inflammatory
Pediatric Formulations: Oral suspension, chewable tablets, suppositories (in some markets)
Common Pediatric Brand Names: Nurofen for Children, Advil Children’s, Motrin Children’s, Brufen Pediatric

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Mechanism of Action

Ibuprofen is a non-selective cyclooxygenase (COX) inhibitor. It inhibits both COX-1 and COX-2 isoenzymes, thereby reducing the synthesis of prostaglandins involved in pain, fever, and inflammation. In children, ibuprofen exerts:

• Antipyretic effects: Acts on the hypothalamic thermoregulatory center to reduce fever

• Analgesic effects: Decreases pain from inflammation or tissue damage

• Anti-inflammatory effects: Alleviates inflammation in soft tissue, joints, or post-surgical conditions

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Approved Pediatric Indications

1. Fever (Antipyresis):

   • Used to reduce temperature in febrile children, including fever caused by infections or post-vaccination reactions.

2. Mild to Moderate Pain:

   • Effective for pain associated with sore throat, toothache, earache, musculoskeletal injuries, headache, and postoperative pain.

3. Inflammatory Conditions (Off-label in some countries):

   • Juvenile idiopathic arthritis (JIA)

   • Minor soft tissue injuries

4. Post-Immunization Reactions:

   • Reduces fever and discomfort following vaccinations.

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Age Recommendations and Dosing

General Pediatric Use:

• Approved for children ≥3 months of age and ≥5–6 kg body weight (region-dependent regulatory status applies).

• Dosing based on weight:
  5–10 mg/kg/dose every 6–8 hours as needed

  • Maximum: 30–40 mg/kg/day (not to exceed 2400 mg/day in adolescents)

Age-Specific Guidelines (common UK/US recommendations):

Age	Single Dose	Frequency
3–5 months	50 mg	Every 6–8 h, max 3 doses/day
6–11 months	50 mg	Every 6–8 h
1–3 years	100 mg	Every 6–8 h
4–6 years	150 mg	Every 6–8 h
7–9 years	200 mg	Every 6–8 h
10–12 years	250–300 mg	Every 6–8 h
>12 years	Adult dose (200–400 mg)	Every 6–8 h

Note: Always use the lowest effective dose for the shortest duration. Accurate weight-based dosing is preferred over age-based.

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Formulations for Children

1. Oral Suspension:

   • Most commonly used in children under 12

   • Strengths: 100 mg/5 mL or 200 mg/5 mL

   • Syringe or spoon provided for precise dosing

2. Chewable Tablets or Meltlets:

   • Suitable for older children who can chew/swallow solid forms

   • Strengths: Typically 100 mg or 200 mg per tablet

3. Suppositories (varies by country):

   • Used when oral route is not feasible (vomiting, NPO status)

4. Effervescent Granules (available in some formulations):

   • Dissolvable in water for children with swallowing difficulties

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Contraindications in Children

• Known hypersensitivity to ibuprofen or other NSAIDs

• History of aspirin-sensitive asthma or NSAID-induced urticaria

• Active gastrointestinal bleeding or peptic ulceration

• Severe hepatic or renal impairment

• Dehydration due to vomiting/diarrhea (increased risk of renal toxicity)

• Congenital bleeding disorders or ongoing anticoagulant therapy

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Cautions and Special Precautions

• Asthma: May exacerbate bronchospasm in aspirin-sensitive individuals

• Renal Impairment: Ibuprofen reduces renal perfusion in volume-depleted states

• Dehydration: Increases risk of nephrotoxicity; avoid during acute gastroenteritis

• Chickenpox (Varicella): Rare but serious skin infections (necrotizing fasciitis) reported with NSAID use; some guidelines advise against use

• Long-term use: Should be avoided unless under specialist guidance (e.g., juvenile arthritis)

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Adverse Effects

Common:

• Gastrointestinal discomfort, nausea, vomiting

• Diarrhea or constipation

• Headache or dizziness

• Rash

Less Common to Rare:

• Gastritis, GI bleeding, ulceration

• Bronchospasm (especially in asthmatic children)

• Hypersensitivity reactions: urticaria, angioedema

• Renal impairment or acute kidney injury (especially with dehydration)

• Elevated liver enzymes (rare)

Severe (Rare):

• Stevens-Johnson syndrome

• Toxic epidermal necrolysis

• Anaphylaxis

• Aseptic meningitis

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Drug Interactions

Avoid co-administration or monitor closely with:

• Other NSAIDs: Increased GI and renal toxicity

• Aspirin: Antagonizes cardioprotective effect of low-dose aspirin

• Corticosteroids: Increased risk of GI ulceration

• Anticoagulants (e.g., warfarin): Increased bleeding risk

• Antihypertensives (ACE inhibitors, ARBs, diuretics): Decreased efficacy and increased renal risk

• Methotrexate: Increased risk of methotrexate toxicity

• SSRIs: Increased risk of gastrointestinal bleeding

• Lithium: Decreased renal clearance and potential lithium toxicity

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Overdose in Children

Symptoms:

• Nausea, vomiting, abdominal pain

• Drowsiness, dizziness

• Ataxia, headache

• Tinnitus

• Rarely: metabolic acidosis, seizures, renal failure

Management:

• Supportive care

• Activated charcoal if ingestion is recent and >200 mg/kg

• IV fluids and monitoring of renal function and acid-base status

• Hospitalization if dose exceeds 400 mg/kg or if symptomatic

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Comparison with Paracetamol (Acetaminophen)

Feature	Ibuprofen	Paracetamol
Action	Antipyretic, analgesic, anti-inflammatory	Antipyretic, analgesic
Onset	30–60 min	30–60 min
Duration	6–8 hours	4–6 hours
Age	≥3 months	≥2 months
GI effects	Higher risk	Minimal
Liver toxicity	Rare	Dose-dependent, common in overdose
Anti-inflammatory	Yes	No

Recommendation: In cases of mild fever or pain, either agent may be used; alternating may be considered for persistent fever under medical advice. Never use both together without clear dosing intervals.

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Patient Counseling for Parents and Caregivers

• Dosing: Use proper measuring devices, never household spoons

• Timing: Space doses at least 6 hours apart

• Duration: Do not exceed 3 days for fever or 5 days for pain without medical review

• Hydration: Ensure adequate fluid intake, especially during fever

• Storage: Keep out of reach of children, store at room temperature

• Allergic signs: Watch for rash, wheezing, or swelling; discontinue and seek medical help

• Avoid in dehydration: If child has persistent vomiting/diarrhea, ibuprofen may not be appropriate

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Clinical Efficacy

Numerous randomized trials confirm that ibuprofen is:

• More effective than paracetamol in reducing high fever

• Equally effective or superior for relief of mild to moderate pain (e.g., dental, ear, musculoskeletal)

• Safe in short-term use when given at appropriate doses and under proper monitoring

• Not recommended for routine use in febrile children solely to reduce temperature without discomfort

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Regulatory and Global Guidance

• UK (BNFc): Licensed from 3 months and ≥5 kg

• US (FDA): OTC use in children ≥6 months

• WHO Essential Medicines List (Children): Included for antipyretic and analgesic indications

• EMA/European guidelines: Support use with standard precautions and dosing

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Storage and Stability

• Oral suspensions should be stored below 25°C

• Discard any remaining suspension after 6 months of opening (unless specified otherwise)

• Check expiry before use; do not freeze liquid forms