Clinical medicine profile
Paracetamol / Diclofenac potassium / Serratiopeptidase
Non-opioid analgesic / antipyretic
- Route
- ORAL / RECTAL / IV
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- [Paracetamol] Severe active hepatic disease / acute liver failure.
- Hypersensitivity.
- Chronic heavy alcohol use — use reduced maximum daily dose or avoid. [Diclofenac] Active peptic ulcer / GI bleeding.
- Severe heart failure.
- NSAID-exacerbated respiratory disease (aspirin-sensitive asthma) for non-selective agents.
- Third trimester pregnancy (ductus arteriosus, oligohydramnios — class warning).
- Severe renal impairment for many agents.
- Hypersensitivity to NSAIDs. [Serratiopeptidase] Severe active hepatic disease / acute liver failure.
- Hypersensitivity.
- Chronic heavy alcohol use — use reduced maximum daily dose or avoid.
Precautions
- [From component Paracetamol] 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.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
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 dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
Generally safe; prolonged high dose rare associations — prefer careful use in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
PRIMARY toxicity organ in overdose; therapeutic doses usually safe if daily limits respected.
Use, effects & interactions
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.
Adverse effects
- [Paracetamol] Rare at therapeutic doses.
- Serious: acute liver failure in overdose, rare severe skin reactions (SJS/TEN/AGEP). [Diclofenac] [From component Diclofenac] GIT disturbances, GIT ulceration, headache, dizziness, vertigo, tinnitus, taste alteration, blood dyscrasia, renal, hepatic disorders. [Serratiopeptidase] [From component Diclofenac] GIT disturbances, GIT ulceration, headache, dizziness, vertigo, tinnitus, taste alteration, blood dyscrasia, renal, hepatic disorders.
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Paracetamol, Diclofenac.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Combination product.
Read complete mechanism
Combination product. Component mechanism (Paracetamol): Inhibitors of cyclo-oxygenase [COX-1 and COX-2] enzyme that catalyzes the conversion of arachidonic acid to PGH2.
30–60 minutes oral
4–6 hours
ORAL / RECTAL / IV
(glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted.
~2–3 h; prolonged in liver disease/overdose.
Pregnancy, lactation & diet
[Paracetamol] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration. [Diclofenac] [Diclofenac] Avoid in third trimester. Earlier pregnancy: use only if needed; prefer paracetamol first-line. [Methyl Salicylate] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist. [Linseed Oil] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist. [Serratiopeptidase] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration.
[Diclofenac] [Diclofenac] Short-course ibuprofen generally acceptable; avoid chronic high-dose/long half-life agents when possible. [Methyl Salicylate] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data. [Linseed Oil] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| LYSOFLAM | DAIMA BIASHARA / Wholesale Import | GEL | KES 154.80Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
| LYSOFLAM TAB 30`S | Not recorded | — | KES 483.75Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.