Etifoxine
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 oldcapsuleGeneric· 4 products
from R5.93/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Stresigen 50 Mg | 50 mg | 90 | S5 | R533.27 | R5.93 | R162.91 | 3010608001 |
| Foxistres | 50 mg | 90 | S5 | R617.41 | R6.86 | R175.29 | 3007704001 |
| Stresam | 50 mg | 100 | S5 | R776.65 | R7.77 | R198.72 | 707127002 |
| Stresam | 50 mg | 60 | S5 | R505.60 | R8.43 | R158.84 | 707127001 |
- Stresam
Medical aid coverage
data 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.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.