Clinical medicine profile
Serratiopeptidase /Aceclofenac / Paracetamol
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
- [Serratiopeptidase] Severe active hepatic disease / acute liver failure.
- Hypersensitivity.
- Chronic heavy alcohol use — use reduced maximum daily dose or avoid. [Aceclofenac] 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. [Paracetamol] 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
- Inflammation and pain in rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
- Clinical selection for Serratiopeptidase /Aceclofenac / Paracetamol 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.
Adverse effects
- [Serratiopeptidase] [From component Diclofenac] GIT disturbances, GIT ulceration, headache, dizziness, vertigo, tinnitus, taste alteration, blood dyscrasia, renal, hepatic disorders. [Aceclofenac] Dyspepsia, nausea, fluid retention, raised BP.
- Serious: peptic ulcer/bleed, AKI, heart failure exacerbation, severe skin reactions, bronchospasm, hepatitis (rare). [Paracetamol] Rare at therapeutic doses.
- Serious: acute liver failure in overdose, rare severe skin reactions (SJS/TEN/AGEP).
Drug interactions
Open multi-drug checker ↗- 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.
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
[Serratiopeptidase] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration. [Aceclofenac] Avoid in third trimester. Earlier pregnancy: use only if needed; prefer paracetamol first-line. [Paracetamol] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration.
Compatible with breastfeeding at standard doses.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.