INN monograph
Paracetamol B.P 125mg Phenylephrine HCL B.P 1mg Chlorpheniramine Maleate B.P 2mg per 5mL
Non-opioid analgesic / antipyretic · POM
Review pending · Source: Local active-ingredient clinical extract; 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
- 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
- Therapeutic use is agent- and indication-specific within the class (Non-opioid analgesic / antipyretic).
- Use according to culture results, national guidelines (Kenya STG/EML where applicable) and the current product SmPC.
- Relief of cold & flu
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 |
|---|---|---|---|
| FLUCOLDEX E | DAIMA BIASHARA / Wholesale Import | SYRUP 100ML | 107.26 |
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; 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.