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INN monograph

Phenobarbitone

Therapeutic agent (verify pharmacological class) · POM

POM

Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Professional class pharmacology (Therapeutic agent (verify pharmacological class))

Class
Therapeutic agent (verify pharmacolo...
Schedule
POM
Route
See product SmPC
Onset
Product-specific
Duration
Product-specific
Pregnancy
Use only if potential be...
Renal
Review renal impairment...
High-alert
No

Kenya market

Wholesale / list prices where loaded

From
KES 226
Median
KES 226
Brands
7

Risk first

Contraindications

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

Precautions

  • hyperthyroidism
  • diabetes mellitus
  • severe anaemia
  • perform periodic laboratory evaluation of organ systems
  • including hepatic, renal, and haemapoetic systems

Point of care

Dosing

Adult

By mouth 60-180mg at night. Child: 5-8mg/kg daily. By 1.V or I.M. 50-200mg repeated after 6 hours when required [max, 600mg daily]. Status epilepticus: 1.V at rate lower than 100mg/min [max. 15mg/kg].All forms of epilepsy except typical absence seizures. By mouth or by I.V injection, neonate, initially 20 mg/kg by slow intravenous injection then 2.55 mg/kg once daily either by slow intravenous injection or by mouth; dose and frequency adjusted according to response. By mouth, Child 1 month12 years initially 11.5 mg/kg twice daily, increased by 2 mg/kg daily as required; usual maintenance dose 2.54 mg/kg once or twice daily; Child 1218 years, 60180 mg once daily.

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

Open checker →
  • 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

  • Exfoliative dermatitis and Stevens-Johnson syndrome
  • severe respiratory depression, apnea, laryngospasm, bronchospasm, or hypoten-sion may occur with intravenous administration
  • prolonged barbiturate therapy may result in osteopenia or rickets
  • barbiturate dependence
  • drowsiness
  • mental depression
  • hyperkinesia in children
  • paradoxical excitement
  • lethargy
  • restless and confusion in elderly.

Use

Indications

  • All forms of epilepsies except absence seizures Clinical selection for Phenobarbitone should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
  • Class context: Therapeutic agent (verify pharmacological class).
  • Confirm site-specific dose, duration and monitoring before prescribing.

Pharmacology

Mode of action

It acts as non-selective depressants CNS.

It acts as non-selective depressants CNS. Its action may be related to its ability t…
Full mechanism text

It acts as non-selective depressants CNS. Its action may be related to its ability to enhance and /or mimic the inhibitory synaptic action of gamma-aminobutyric acid [GABA].

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

7 listed
Brand Company Pack KES
Barbit Incepta Pharma Standard Commercial Pack
Phenbital Dawa Limited Standard Commercial Pack
Phenobarbital, by Cosmos Cosmos Limited. Standard Commercial Pack
Phenobarbitone, by Allied Laboratory & Allied Ltd. Standard Commercial Pack 225.75
Phenobarbitone, by Biodeal Biodeal Laboratories Ltd. Standard Commercial Pack
Satal, Tasa Independent / Registered Supplier Standard Commercial Pack
Satal Forte, Tasa Independent / Registered Supplier 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))

Open source link

Last reviewed: 01 Aug 2026

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

Kenya Verified Health Registry