Ibuprofen + Paracetamol
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Indications
Approved Indications
- Relief of mild to moderate pain (headache, toothache, menstrual pain, musculoskeletal pain)
- Fever and inflammation
- Post-operative or post-traumatic pain
- Pain associated with osteoarthritis or rheumatoid arthritis
- Cold and flu-related fever and body pain
Off-Label / Clinically Accepted Uses
- Migraine and tension-type headache
- Dental or post-surgical pain
- Musculoskeletal sprains and strains
Dosage & Administration
Adults:
- 1 tablet (Ibuprofen 200–400 mg + Paracetamol 325–500 mg) every 6 hours as needed.
- Maximum: Ibuprofen 1200 mg/day (OTC) or 2400 mg/day (prescription); Paracetamol up to 4000 mg/day.
Children (≥12 years):
- Same as adults, adjusted by weight if needed.
Children (3 months–12 years):
- Ibuprofen: 5–10 mg/kg every 6–8 hr.
- Paracetamol: 10–15 mg/kg every 4–6 hr (max 60 mg/kg/day).
Elderly:
- Use lowest effective dose; monitor renal and hepatic function.
Administration:
Take with or after food, with a full glass of water to minimize gastric irritation.
Mechanism of Action (MOA)
- Ibuprofen: Inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis to relieve pain, fever, and inflammation.
- Paracetamol: Inhibits prostaglandin synthesis in the central nervous system, producing analgesic and antipyretic effects.
- The combination provides faster and longer-lasting pain relief than either agent alone.
Pharmacokinetics
Absorption: Rapidly absorbed after oral intake; peak plasma levels in 1–2 hours.
Distribution: Widely distributed; ibuprofen ~99% protein bound, paracetamol ~25%.
Metabolism: Ibuprofen via hepatic oxidation (CYP2C9); paracetamol by glucuronidation and sulfation (minor CYP2E1 pathway).
Excretion: Both excreted mainly in urine as metabolites; <10% unchanged.
Half-life: Ibuprofen 2–4 hr; Paracetamol 2–3 hr.
Pregnancy Category & Lactation
Pregnancy:
- Paracetamol: Category B – considered safe at therapeutic doses.
- Ibuprofen: Category C (1st–2nd trimester), D (3rd trimester – avoid due to risk of fetal ductus arteriosus closure).
Lactation:
Both drugs pass into breast milk in very small amounts; generally safe when used at recommended doses.
Therapeutic Class
Analgesic, Antipyretic, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Combination.
Contraindications
- Hypersensitivity to ibuprofen, paracetamol, or other NSAIDs.
- Active peptic ulcer or GI bleeding.
- Severe hepatic or renal impairment.
- Last trimester of pregnancy.
Warnings & Precautions
- Avoid prolonged use or overdose (risk of liver damage and GI bleeding).
- Use cautiously in hepatic, renal, or cardiovascular disease.
- Avoid alcohol consumption.
- Monitor liver function in long-term therapy.
Side Effects
Common: Nausea, dyspepsia, abdominal discomfort, dizziness, rash.
Serious / Rare: GI bleeding, ulceration, hepatic injury, hypersensitivity, renal impairment.
Drug Interactions
- Alcohol, hepatotoxic drugs: Increased risk of liver toxicity.
- NSAIDs, corticosteroids: Increased GI risk.
- Anticoagulants, antiplatelets: Increased bleeding tendency.
- Antihypertensives, diuretics: Reduced efficacy.
- Cholestyramine: Delays paracetamol absorption.
Recent Updates / Guidelines
- Combination shown to be more effective than monotherapy for acute pain and fever.
- Recommended for short-term symptomatic relief only.
Storage Conditions
Store below 30°C, protected from light and moisture. Keep out of reach of children.