INN monograph
Paracetamol
Analgesic / Antipyretic (non-opioid) · OTC
Review pending · Source: Local active-ingredient clinical extract; WHO Model Formulary / standard SmPC consensus (batch 1 research); Professional class pharmacology (Non-opioid analgesic / antipyretic)
Verify before clinical use
This monograph does not yet include a traceable source link. Confirm dose, contraindications, interactions, and regulatory status against the current SmPC and Kenya STG/EML.
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- Severe active hepatic disease / acute liver failure.
- Hypersensitivity.
- Chronic heavy alcohol use — use reduced maximum daily dose or avoid.
Precautions
- Risk of severe hepatotoxicity in overdose.
- Chronic high-dose use, malnutrition, enzyme-inducing drugs, and alcohol increase risk.
- Check total daily intake from all sources.
Point of care
Dosing
Adult
Orally or as supp: 0.5-1g after 4-6 hours to a max. 4g. Child:<3 months; 10mg/kg 3 months-1 year; 60-120mg, 6-12 years: 250-500mg. Repeated after 4-6 hours to max. of 4 doses in 24 hours. Parenteral: 10mg/kg body weight/dose given IV or deep IM after 4-6 hours to a max. of 5 doses (preferably not for more than 5 consecutive days).
Paediatric
Oral: 10–15 mg/kg/dose every 4–6 hours as needed. Maximum usually 60 mg/kg/day (do not exceed adult max). Use age/weight-appropriate formulations.
Renal
Severe renal impairment (e.g. CrCl <10–30 mL/min): increase dosing interval (e.g. every 6–8 hours) and avoid prolonged high doses; follow local protocol.
- CrCl 30–120: Usual dosing if liver function normal; max 4 g/day adults.
- CrCl 0–29: Consider 500–1000 mg every 6–8 h; avoid prolonged high doses; local protocol.
Hepatic
Avoid or use reduced dose in active liver disease / chronic alcohol use. Absolute caution in severe hepatic impairment — risk of acute liver failure in overdose.
Safety
Drug interactions
- First-line for mild–moderate pain and fever.
- Calculate total daily exposure from all sources.
- In overdose: timed levels + NAC per protocol — do not wait for symptoms.
Safety
Adverse effects
- Rare at therapeutic doses.
- Serious: acute liver failure in overdose, rare severe skin reactions (SJS/TEN/AGEP).
Use
Indications
- Mild to moderate pain (headache, dental pain, musculoskeletal pain, dysmenorrhoea)
- Clinical selection for Paracetamol should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Analgesic / Antipyretic (non-opioid).
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
Inhibitors of cyclo-oxygenase [COX-1 and COX-2] enzyme that catalyzes the conversion of arachidonic acid to PGH2.
Full mechanism text
Inhibitors of cyclo-oxygenase [COX-1 and COX-2] enzyme that catalyzes the conversion of arachidonic acid to PGH2. Paracetamol inhibits central prostaglandin synthesis via effects on cyclo-oxygenase pathways (including COX-2 preferential central effects) and may engage serotonergic descending pathways. Antipyretic effect via hypothalamic heat-regulating centre. Minimal peripheral anti-inflammatory action.
ADME
Pharmacokinetics & PD
| Onset | Oral: ~30–60 minutes |
|---|---|
| Duration | 4–6 hours |
| Route | Oral, Rectal, Intravenous |
| Metabolism | (glucuronidation/sulfation; minor CYP2E1 to NAPQI). |
| Half-life | ~2–3 h (prolonged in overdose/liver disease). |
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| CETAMOL * | DAIMA BIASHARA / Wholesale Import | 60ML C/P NEW PICE | 47.02 |
| CIPLADON | DAIMA BIASHARA / Wholesale Import | 1000MG TABS 8*S | 314.21 |
| CURAMOL | DAIMA BIASHARA / Wholesale Import | 60ML | 27.95 |
| Panadol | P.O. Box 26773 - 00100 Nairobi | Oral Drops, Powder For Suspension 20 | — |
| PANADOL BABY & INFANT | DAIMA BIASHARA / Wholesale Import | 60ML | 229.68 |
| PARAFAST | DAIMA BIASHARA / Wholesale Import | 1GM TABS 8*S | 257.81 |
| PARAFAST ET | DAIMA BIASHARA / Wholesale Import | 500MG TABS 16*S | 279.69 |
| PARAGEN INJECTION | P.O BOX 22953-00100 NAIROBI. | Solution For Injection PARACETAMOL 1000MG/100ML (1%W/V) | — |
| PAROL | DAIMA BIASHARA / Wholesale Import | SYRUP 100ML | 337.50 |
| TOTOMOL | DAIMA BIASHARA / Wholesale Import | 100ML | 40.85 |
Special populations
Pregnancy & lactation
Pregnancy
Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration.
Lactation
Compatible with breastfeeding at standard doses.
Diet
Food & alcohol
- Alcohol Chronic heavy alcohol use increases risk of paracetamol-induced hepatotoxicity. Avoid exceeding recommended doses; counsel high-risk patients.
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; WHO Model Formulary / standard SmPC consensus (batch 1 research); Professional class pharmacology (Non-opioid analgesic / antipyretic)
Clinical review date not recorded.
No traceable source URL is currently attached.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.