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DrugsLevel 4 LocalisationS5CAPEML

Etifoxine

Benzodiazepine analogueAnxiolytic

Indications

Registered South African indications:

  • Anxiety

Cautions

Contraindications

  • Hypersensitivity to the active ingredient or any of its excipients
  • Severe renal impairment
  • Severe hepatic impairment
  • States of shock
  • Myasthenia gravis
  • Galactosaemia

Cautions

  • Pregnancy
  • Breastfeeding
  • Mild to moderate renal impairment
  • Mild to moderate hepatic impairment
  • Elderly
  • Glucose-galactose malabsorption
  • Lactase deficit
  • May impair ability to drive and operate machinery

Adult dosage

Forms avail. in SA and covered in this monograph: cap

Psychosomatic manifestations of anxiety

  • Oral (cap): 150-200mg/day, in 2-3 divided doses; Max duration: 8 weeks

Swallow the capsules with a little amount of water

Paediatric dosage

No information available

Special populations

Pregnancy

  • Caution
  • Taking into account the data available, it is preferable as a safety measure to avoid using etifoxine during pregnancy. Etifoxine crosses the placental barrier

Breastfeeding

  • Caution; not recommended
  • Taking into account the data available, it is preferable as a safety measure to avoid using etifoxine during breastfeeding

Renal Impairment

Hepatic Impairment

Elderly

Porphyria Information

Drugs in Sport

  • Permitted - No warnings

Adverse reactions

Central Nervous System Disorders

  • Drowsiness

Skin and Subcutaneous Tissue Disorders

  • Rash

Immune, Blood and Lymphatic System Disorders

  • Allergic reactions
    - Angioedema
    - Urticaria

Interactions

  • Central nervous system depressants
  • Morphine
  • Morphine derivatives
  • Benzodiazepines
  • Sedative antihistamines
  • Sedative antidepressants
  • Central antihypertensives
  • Baclofen
  • Thalidomide
  • Analegsics
  • Antitussives
  • Narcotic substitutes
  • Hypnotics
  • Neuroleptics
  • Alcohol

Monitoring

None routine

Mechanism of action

Etifoxine hydrochloride belongs to the class of benzoxazine chemicals. It exerts its regulatory action on the autonomic nervous system, antagonises the behaviour, physiological and biochemical effects of anxiogenic stress without demonstrable dependence and a withdrawal syndrome.

Dosage forms

  • Capsule

Formulation

Capsule 50mg

  • Stresam (Adcock Ingram) originator

References

1. SAMF_12th Edition_Page 490 2. https://drive.google.com/drive/folders/12a8M7cLYeFHB6GMg4ieSdSqVKE0OD8CM (07/07/2006_Adcock_Stresam_50mg caps) 3. NAPOS The Drug Database for Acute Porphyria: N05BX03 Etifoxine; Accessed online 11 Dec 2018 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=N05BX03] 4. South African Institute for Drug-Free Sport; Etifoxine; Accessed online 11 Dec 2018 [http://www.drugfreesport.org.za/online-medication-check/] 5. Clinical Pharmacologist: A/Prof(Dr). M Irhuma 5.1. (1) 01 July 2010 : STRESAM Etifoxine hydrochloride 50mg Capsules (BIOCODEX) - SmPC ** No SPC available**No U2D

Brands & products

4 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days old

capsuleGeneric· 4 products

from R5.93/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Stresigen 50 Mg50 mg90S5R533.27R5.93R162.913010608001
Foxistres 50 mg90S5R617.41R6.86R175.293007704001
Stresam50 mg100S5R776.65R7.77R198.72707127002
Stresam50 mg60S5R505.60R8.43R158.84707127001
Trade names (1)
  • Stresam

Medical aid coverage

data not yet integrated
Discovery Health
not yet integrated
  • Comprehensive Series—
  • Executive Plan—
  • KeyCare Series—
  • Priority Series—
  • Saver Series—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Interacts with 3 known drugs

Check against other drugs →
NeoHealth® ID 15114 · updated 12/20/2022