INN monograph
Paracetamol 500mg, Phenylephrine HCL 10mg, Chlorpheniramine Maleate 2mg, Caffeine 30mg
Non-opioid analgesic / antipyretic · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Professional class pharmacology (Non-opioid analgesic / antipyretic)
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
- Do not exceed 4 g/day in adults (lower in malnutrition, alcohol, elderly, liver disease — often ≤2–3 g).
- Account for combination products (cold remedies).
- Overdose is a medical emergency (NAC protocol).
Point of care
Dosing
Adult
Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.
Paediatric
Paediatric dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
Renal
Generally safe; prolonged high dose rare associations — prefer careful use in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
PRIMARY toxicity organ in overdose; therapeutic doses usually safe if daily limits respected.
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
- Relief of nasal and sinus congestion, sinus pain and headache Clinical selection for Paracetamol 500mg, Phenylephrine HCL 10mg, Chlorpheniramine Maleate 2mg, Caffeine 30mg should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Non-opioid analgesic / antipyretic.
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
Paracetamol inhibits central prostaglandin synthesis via effects on cyclo-oxygenase pathways (including COX-2 preferential central effects) and may engage serotonergic descending pathways.
Full mechanism text
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 | 30–60 minutes oral |
|---|---|
| Duration | 4–6 hours |
| Route | ORAL / RECTAL / IV |
| Metabolism | (glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted. |
| Half-life | ~2–3 h; prolonged in liver disease/overdose. |
Full PK/PD text
Rapid oral absorption. Hepatic metabolism (glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted. Half-life ~2–3 h; prolonged in liver disease/overdose.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
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
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Professional class pharmacology (Non-opioid analgesic / antipyretic)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.