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INN monograph

N-Acetyl Cysteine

Therapeutic agent (verify pharmacological class) · POM

POM General guidance Grade A-

Review pending · Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Professional class pharmacology (Therapeutic agent (verify pharmacological class))

!

Verify before clinical use

Parts of this page contain general class guidance rather than drug-specific evidence. Confirm dose, contraindications, interactions, and regulatory status against the current SmPC and Kenya STG/EML.

Kenya market

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Risk first

Contraindications

  • Hypersensitivity to the active substance or excipients.
  • Additional absolute contraindications are indication- and product-specific — consult SmPC.

Precautions

  • Obtain allergy and medication history.
  • Adjust for renal/hepatic impairment, pregnancy, lactation, extremes of age and interacting drugs.
  • Use the lowest effective dose for the shortest appropriate duration.
  • Monitor for expected class adverse effects.

Point of care

Dosing

Adult

Adult dose: Initial IV dose: 150mg/kg in 200ml 5% glucose over 15-60 mins. Maintenance dose: IV, 50mg/kg in 500ml of 5% glucose over 4hrs followed by 100mg/kg in 1liter of 5% glucose over 16hrs (total dose over 21hrs: 300mg/kg)Children: Initial IV dose: 150mg/kg in 5ml/kg 5% glucose over 15-60 mins. Maintenance dose: IV, 50mg/kg in 10ml/kg of 5% glucose over 4hrs followed by 100mg/kg in 20ml/kg of 5% glucose over 16hrs.

Paediatric

See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.

Renal

Review renal impairment dosing; many agents need CrCl/eGFR adjustment.

  • CrCl 0–120: Confirm renal dosing in product SmPC / primary label.

Hepatic

Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.

Safety

Drug interactions

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  • Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
  • Document allergy status and key interactions.

Safety

Adverse effects

  • Adverse reactions vary by agent.
  • Counsel on common predictable effects and serious warning symptoms (allergy, severe rash, jaundice, unusual bleeding, severe GI symptoms, neurological changes).
  • Report suspected ADRs via national pharmacovigilance channels.

Use

Indications

  • Therapeutic use is agent- and indication-specific within the class (Therapeutic agent (verify pharmacological class)).
  • Use according to culture results, national guidelines (Kenya STG/EML where applicable) and the current product SmPC.
  • Paracetamol overdose

Pharmacology

Mode of action

About 90% paracetamol is metabolized via phase II pathways by sulphation and glucuronidation while approximately 10% is oxidized via phase I using the cytochrome oxi- dases.

About 90% paracetamol is metabolized via p… The main product of this phase I metabo- l… In case of overdosage quinoneimine toxic m…
Full mechanism text

About 90% paracetamol is metabolized via phase II pathways by sulphation and glucuronidation while approximately 10% is oxidized via phase I using the cytochrome oxi- dases. The main product of this phase I metabo- lism is a chemically reactive quinoneimine toxic metabolite that reacts with glutathione to form a non-toxic metabolite excreted in the urine. In case of overdosage quinoneimine toxic metabolite accumulates. This consumes and depletes of glutathione and in its absence quinoneimine toxic metabolite reacts with nucleophilic sites on critical cellular proteins, interfering with cell function and initiating hepatocellular necrosis. N- acetylcysteine [NAC] replenishes hepatic gluta- thione stores, facilitating quinoneimine toxic metabolite detoxification. NAC therapy is most effective if administered within 8-10 hours of ingestion

ADME

Pharmacokinetics & PD

Onset Product-specific
Duration Product-specific
Route See product SmPC
Elimination are product-specific. Consider food effects, protein binding, hepatic CYP/UGT
Half-life when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Full PK/PD text

Absorption, distribution, metabolism and excretion are product-specific. Consider food effects, protein binding, hepatic CYP/UGT metabolism, renal clearance and half-life when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.

Kenya

Brands & prices

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Special populations

Pregnancy & lactation

Pregnancy

Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist.

Lactation

Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.

Diet

Food & alcohol

  • Food
  • Food

Trust

Sources & disclaimer

Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Professional class pharmacology (Therapeutic agent (verify pharmacological class))

Open source link

Clinical review date not recorded.

Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.

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