INN monograph
Naloxone
Therapeutic agent (verify pharmacological class) · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- Hypersensitivity to the active substance or excipients.
- Additional absolute contraindications are indication- and product-specific — consult SmPC.
Precautions
- Acute withdrawal syndrome may arise in opiod dependent patients after rapid reversal
- avoid use in opioid dependent pregnant women as it can cause withdrawal syndrome in fetus.
Point of care
Dosing
Adult
Adult: Initial dose of 0.4-2mg, IV [or IM or SC when IV is not available]. If the desired effects are not attained repeat at 2-3 minute interval [up to 10mg]. Children & neonates: 0.01 mg/kg I.V. A subsequent dose of 0.1 mg/kg may be administered if the response is not satisfactory.
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
- 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
- Complete or partial reversal of opioid depression including respiratory depression
- diagnosis of suspected or known acute opioid overdosage
- as an adjunctive agent to increase blood pressure in the management of septic shock
- reversal of opioid sedation after anaesthesia
- Reversal of sedation and respiratory depression in neonate after maternal exposure to opioids.
Pharmacology
Mode of action
It is known to be an opioid antagonist that competes for the [with greatest affinity], and opiate receptor sites in the CNS.
Full mechanism text
It is known to be an opioid antagonist that competes for the [with greatest affinity], and opiate receptor sites in the CNS. Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
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
| Brand | Company | Pack | KES |
|---|---|---|---|
| Nalotas, Tasa | Independent / Registered Supplier | Standard Commercial Pack | — |
| Naloxone | Rotex Medical | Standard Commercial Pack | — |
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))
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.