Paracetamol (Acetaminophen) Dosing Guidelines
Adult Dosing
For adults, the standard dose is 650-1000 mg every 4-6 hours, with a maximum daily limit of 4000 mg, though a more conservative limit of 3000 mg per day is recommended for chronic use to reduce hepatotoxicity risk. 1
Standard Adult Dosing Parameters
- Single dose range: 650-1000 mg every 4-6 hours 1, 2
- Minimum interval between doses: 4 hours 1
- Maximum doses per day: 6 doses in 24 hours 1
- Absolute maximum daily dose: 4000 mg/day 3, 1, 4
- Recommended maximum for chronic use: 3000 mg/day 1
Critical Safety Considerations for Adults
- Patients must be explicitly counseled to avoid all other acetaminophen-containing products, including over-the-counter cold remedies, sleep aids, and opioid combination products 1
- Prescription combination products are limited to ≤325 mg acetaminophen per dosage unit 1
- Repeated supratherapeutic ingestions (doses just above therapeutic range) carry a worse prognosis than acute single overdoses, with approximately 30% of acetaminophen overdose admissions involving repeated supratherapeutic ingestions 1
Special Adult Populations
Elderly Patients (≥60 years)
- Maximum daily dose should be reduced to 3000 mg per day or less 1
- Starting dose should be at the lower end of the dosing range (325 mg per dose) for frail elderly 1
- No evidence supports routine dose reduction for all older people, but dosing should be individualized for those with decompensated cirrhosis or advanced kidney failure 5
Patients with Liver Disease
- Maximum daily dose: 2000-3000 mg per day 1
- Paracetamol is contraindicated in hepatic insufficiency 6
- Hepatotoxicity is rare among adults who use paracetamol as directed, including people with cirrhotic liver disease 5
Chronic Alcohol Users
- Maximum daily dose should be limited to 2000-3000 mg per day 1
- Patients should be advised to avoid concurrent alcohol use 1
Critically Ill Adults
- Recommended dose: 1 gram every 6 hours (IV, oral, or rectal) as an adjunct to opioids 1
- Caution: IV acetaminophen may cause hypotension in up to 50% of patients 1
Pediatric Dosing
Children and Adolescents (≥12 years)
- Dose: 650 mg every 4-6 hours 1
- Maximum: 6 doses in 24 hours, not exceeding 4000 mg total daily 1
- Alternatively: 20.3 mL (650 mg) every 4-6 hours, not to exceed 6 doses in 24 hours 2
Children Under 12 Years
Age-Specific Pediatric Dosing (from FDA labeling)
- Children 6 to under 12 years: 10.15 mL (325 mg) every 4 hours, not to exceed 5 doses in 24 hours 2
- Children 4 to under 6 years: 7.5 mL (240 mg) every 4 hours, not to exceed 5 doses in 24 hours 2
- Children 2 to under 4 years: 5 mL (160 mg) every 4 hours, not to exceed 5 doses in 24 hours 2
- Children under 2 years: Consult a doctor 2
Pediatric Special Considerations
- Use an appropriate measuring device such as a 3-mL or 5-mL oral syringe for accurate measurement in infants and young children 7
- In children with hepatic impairment, doses should be reduced and intervals extended 7
- Chronic exposures greater than 140 mg/kg/day for several days carry a risk of serious liver toxicity and failure 7
Multimodal Approach for Inadequate Pain Relief
When acetaminophen alone provides insufficient pain control, add adjuvant therapies rather than exceeding the 3000 mg daily maximum. 1
Recommended Adjuvants
- Topical lidocaine patches 1
- Regional nerve blocks 1
- NSAIDs (ibuprofen 10 mg/kg every 8 hours in adolescents) 1
- In children, if acetaminophen is ineffective for fever management, ibuprofen may be considered as second-line treatment 7
Common Pitfalls to Avoid
- Failing to recognize acetaminophen in combination products leads to unintentional overdose 1
- Using multiple products simultaneously without monitoring cumulative dose can result in hepatotoxicity 1
- When using combination opioid-acetaminophen products, exercise caution to prevent excess acetaminophen dosing 7
- Overdose can result in liver and kidney failure, particularly with repeated supratherapeutic ingestions 7