Miconazole
Indications
These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product ) specific manufacturer information
Registered South African indications:
- Dermatomycoses
- Tinea pedis (athlete's foot)
- Tinea corporis (tinea circinata)
- Tinea manuum - Tinea cruris due to
- Trichophyton mentagrophytes
- Trichophyton rubrum
- Microsporum audouin
- Epidermophyton floccosum - Candidial infections
- Infections of the skin (.e.g. intertrigo)
- Perianal infections
- Stomatitis angularis (cheilitis, perleche)
- Balanoposthitis
Contraindications (ZA)
Registered South African contraindications
- Hypersensitivity to the active ingredient or any of its excipients
Warnings & precautions
South African recommendations
Caution in the following patient groups
- Pregnancy
- Breastfeeding
- Renal impairment
- Hepatic impairment
- Elderly
Sensitivity or irritation
-
If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued
Contact with eyes
-
Miconazole cream must not come into contact with the eyes
Effects on ability to drive and use machines
-
Not applicable
Adult dosage (ZA)
Forms avail. in SA and covered in this monograph: cre
South African registered indications and dosages
Infections caused by: Fungistatic against all Phycomycetes, Ascomycetes and Adelomycetes tested (e.g. Saprolegnia, Candida, Cryptococcus, Aspergillus, Dermatophytes, Phialophora, Sporotrichum) and fungicidal against Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum, Trichophyton interdigitale and Microsporum canis
Specific doses based on individual indications
Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities
Dermatomycoses
- Tinea corporis (tinea circinata)
- Tinea manuum
Tinea cruris due to
- Trichophyton mentagrophytes
- Trichophyton rubrum
- Microsporum audouin
- Epidermophyton floccosum
Candidial infections
- Infections of the skin (.e.g. intertrigo)
- Perianal infections
- Stomatitis angularis (cheilitis, perleche)
- Balanoposthitis
- Topical (cre): Apply to affected area(s), twice dly (morning and evening); Treatment duration: 2 weeks
Dermatomycoses
- Tinea pedis (athlete's foot)
- Topical (cre): Apply to affected area(s), twice dly (morning and evening); Treatment duration: 1 month
Avoid occlusive dressings when this medication is used in the treatment of conditions caused by Candida albicans as it provides conditions that favour growth of yeast and release of its irritating endotoxins
Continue to apply miconazole cream for the full period of treatment as indicated
Paediatric dosage (ZA)
Forms avail. in SA and covered in this monograph: cre
South African registered indications and dosages
Infections caused by: Fungistatic against all Phycomycetes, Ascomycetes and Adelomycetes tested (e.g. Saprolegnia, Candida, Cryptococcus, Aspergillus, Dermatophytes, Phialophora, Sporotrichum) and fungicidal against Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum, Trichophyton interdigitale and Microsporum canis
Specific doses based on individual indications
Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities
Dermatomycoses
- Tinea corporis (tinea circinata)
- Tinea manuum
Tinea cruris due to
- Trichophyton mentagrophytes
- Trichophyton rubrum
- Microsporum audouin
- Epidermophyton floccosum
Candidial infections
- Infections of the skin (.e.g. intertrigo)
- Perianal infections
- Stomatitis angularis (cheilitis, perleche)
- Balanoposthitis
- See adult dosage
Dermatomycoses
- Tinea pedis (athlete's foot)
- See adult dosage
Avoid occlusive dressings when this medication is used in the treatment of conditions caused by Candida albicans as it provides conditions that favour growth of yeast and release of its irritating endotoxins
Continue to apply miconazole cream for the full period of treatment as indicated
No specific dosages for children provided in South African manufacturer recommendations
Pregnancy & lactation
Pregnancy
South African recommendations
- Caution
- Safety of topical use during pregnancy has not been established
Breastfeeding
South African recommendations
- Caution
- Safety of topical use during breastfeeding has not been established
Fertility
South African recommendations
- No information available
Renal impairment
- Caution; no information available
Hepatic impairment
- Caution; no information available
Elderly
- Caution; no information available
Adverse reactions
Skin and Subcutaneous Tissue Disorders
- Burning sensation
- Skin inflammation
- Skin hypopigmentation
- Angioedema
- Urticaria
- Contact dermatitis
- Rash
- Erythema
- Pruritus
- Application site reactions
- Irritation
- Burning
- Pruritus
- Warmth
Immune, Blood and Lymphatic System Disorders
- Anaphylactic reaction
- Hypersensitivity
Interactions
- Oral anticougulants
- Warfarin
Monitoring
None routine
Mechanism of action
Miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.
Spectrum of activity: Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum audouinii, Candida albicans, Epidermophyton floccosum
Dosage forms
- Cream
Formulation
Cream (per g) 20mg
- Covarex (Meyerall)
- Daktarin (Janssen) originator
- Dermazole (Sandoz)
- Sutharex Cream (MeyerZall Laboratories)
Also available in the following forms: Oral gel, vaginal cream and vaginal tablet.
COMBINATION PREPARATIONS
Hydrocortisone/ Miconazole
Cream (per g) 10mg/20mg
- Daktacort (Specpharm)
- Elozart (LeBasi)
References
1. SAMF_12th Edition_Page 180 2. SmPC: Daktarin 2% Cream, McNeil Products Ltd: Last updated on eMC: 25 Aug 2016; Downloaded online 7 March 2019 [https://www.medicines.org.uk/emc/medicine/22613] 3. https://drive.google.com/drive/folders/0B4_v8Xoq_6PoRE5TNUtIRmxfWjQ (07/2008_Janssen_Daktarin_cream) 4. https://drive.google.com/drive/folders/0B4_v8Xoq_6PoRE5TNUtIRmxfWjQ (06/2015_MeyerZall_Covarex_cream) 5. Standard treatment guidelines and essential medicines list for South Africa, Hospital level, 2017 6. U2D: Miconazole (topical): Drug information; Uptodate; Downloaded online 7 Mar 2019 [https://www.uptodate.com/contents/miconazole-topical-drug-information?search=miconazole&source=panel_search_result&selectedTitle=1~38&usage_type=panel&display_rank=1] 7. NAPOS The Drug Database for Acute Porphyria: D01AC02 Miconazole; Accessed online; 7 Mar 2019 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=D01AC02&l=gbr] 8. South African Institute for Drug-Free Sport: Dermazole; Accessed online; 7 Mar 2019 [http://www.drugfreesport.org.za/online-medication-check/] 9. SmPC: Daktarin 2% Cream, McNeil Products Ltd: Last updated on eMC: 05 Nov 2020; Downloaded online 24 Feb 2021 [https://drive.google.com/drive/folders/1wJmwh1YNMD3YtV7PI79V7vOVzxLxkpjh] 10. PI: Daktarin Cream, Janssen: Date of Registration: 25 July 2008 [https://drive.google.com/drive/folders/1wJmwh1YNMD3YtV7PI79V7vOVzxLxkpjh] 11. PI - COVEREX CREAM PACKAGE INSERT - Glenmark - Date of publication - February 2019 - Downloaded online 03 February 2026.pdf [https://www.sahpra.org.za/wp-content/uploads/2020/02/Daktarin-Cream_PI_Janssen_MCC-format-25-November-2011.pdf] 12. PI - Daktarin-Cream_PI_Janssen_MCC-format-Date of revision of text - 25-November-2011 - Downloaded online 03 February 2026.pdf [https://www.sahpra.org.za/wp-content/uploads/2020/02/Daktarin-Cream_PI_Janssen_MCC-format-25-November-2011.pdf] GHANA REFERENCES GH1. Ministry of Health Ghana National Drugs Programme (GNDP) Standard Treatment Guidelines, 7th Edition, 2017 [https://drive.google.com/drive/folders/1EQKbcrtqOU9qM1DpWgsS35ERYS_WkO_w] GH2. Ministry of Health Ghana National Drugs Programme (GNDP) Essential Medicines List, 7th Edition, 2017 [https://drive.google.com/drive/folders/1EQKbcrtqOU9qM1DpWgsS35ERYS_WkO_w]
Brands & products
7 products · cached snapshot- Covarex
- Daktarin
- Dermazole
- Sutharex Cream
CRECream· 7 products
from R55.59| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Covarex | 2 g/100g | 25 | Meyerzall Laboratories (Pty) Ltd | R55.59 |
| Sutharex Cream | 20 mg/g | 30 | MeyerZall Laboratories (Pty) Ltd | R59.83 |
| Covarex | 2 g/100g | 30 | Meyerzall Laboratories (Pty) Ltd | R66.68 |
| Covarex | 2 g/100g | 40 | Meyerzall Laboratories (Pty) Ltd | R88.87 |
| Dermazole | 20 mg/g | 25 | Sandoz SA (Pty) Ltd | R107.90 |
| Covarex | 2 g/100g | 50 | Meyerzall Laboratories (Pty) Ltd | R111.14 |
| Daktarin Creamdiscontinued | 20 mg/g | 30 | Janssen Pharmaceutica (Pty) Ltd | R357.36 |
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.