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:
- Vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (Candida candidiasis)
Cautions
Contraindications
- Hypersensitivity to the active ingredient or any of its excipients
- Hypersensitivity to other imidazole derivatives
Cautions
- Pregnancy
- Breastfeeding
- Concomitant use of latex products (condoms or diaphragms)
- Contact with eyes and mucous membranes
Adult dosage
Forms avail. in SA and covered in this monograph: cre, cap
Vaginal candidiasis
- Vaginal (cre): 5g (1 applicator), dly before bed; Treatment duration: 7 days; Repeat course if needed
400mg
- Vaginal (cap): 400mg, dly before bed; Treatment duration: 3 days
AND
100mg/5g
- Topical (cre): Apply to affected area, 12hrly; Treatment duration: 3 days
Paediatric dosage
Paed. forms avail. in SA and covered in this monograph: cre
Vulvovaginitis
- Topical (cre): Apply small quantity to affected area, dly at night; Treatment duration: 7-14 days
Refer to candidiasis, systemic and other: STG, Paed 2017
Special populations
Pregnancy
- Caution
- Although intravaginal absorption is limited, miconazole vaginal cream should be used in the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits outweigh the possible risks
Breastfeeding
- Caution
- It is not known whether miconazole is excreted in human milk. Caution should be exercised when using miconazole vaginal cream during breastfeeding
Renal Impairment
Hepatic Impairment
Elderly
Porphyria Information
Drugs in Sport
- Permitted - No warning
Adverse reactions
Genitourinary Disorders
- Genital pruritus
- Vaginal burning
- Vulvovaginal discomfort
- Dysmenorrhoea
Skin and Subcutaneous Tissue Disorders
- Rash
- Pruritis
- Urticaria
Immune, Blood and Lymphatic System Disorders
- Hypersensitivity reactions
- Angioedema
Interactions
- Latex contraceptive products
- Warfarin
- CYP2C9 substrates
- CYP3A4 subtrates
Monitoring
None routine
Mechanism of action
Miconazole acts by increasing the permeability of the fungal cell membrane through damage caused by inhibiting ergosterol biosynthesis in the fungus. This results in leakage of nutrients and cellular contents from the fungal cell which ultimately causes cell necrosis.
Dosage forms
- Vaginal cream
- Vaginal combination pack
- Vaginal tablet
Formulation
Vaginal cream (per 5g) 100mg
- Gyno-Daktarin VC (Johnson & Johnson) originator
Vaginal capsule 400mg/ Vaginal cream (per 5g) 100mg
- Gyno-Daktarin Combipack (Johnson & Johnson) originator
Also available in the following forms: Oral gel and topical cream
References
1. SAMF_12th Edition_Page 218 2. https://www.medicines.org.uk/emc/medicine/894 (17/12/2015_Janssen_Gyno-Daktarin_vaginal cap) 3. https://www.medicines.org.uk/emc/medicine/6732 (09/11/2018_Janssen_Gyno-Daktarin_cream) 4. https://drive.google.com/drive/folders/0B4_v8Xoq_6PoRE5TNUtIRmxfWjQ (05/2009_Janssen_Gyno-Daktarin VC_cream) 5. https://drive.google.com/drive/folders/0B4_v8Xoq_6PoRE5TNUtIRmxfWjQ (01/09/1995_Janssen_Gyno-Daktarin_cap) 6. https://drive.google.com/drive/folders/0B4_v8Xoq_6PoRE5TNUtIRmxfWjQ (16/09/1994_Janssen_Gyno-Daktarin_Combipak) 7. https://www.uptodate.com/contents/miconazole-topical-drug-information?source=search_result&search=miconazole&selectedTitle=1~36 8. Hardcopy PI_Covarex_cream 9. Standard treatment guidelines and essential medicines list for South Africa, Hospital level, Paediatrics, 2017 10. NAPOS The Drug Database for Acute Porphyria: G01AF04 Miconazole; Accessed online 11 Jan 2019 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=G01AF04&l=gbr] 11. South African Institute for Drug-Free Sport; Gyno-Daktarin; Accessed online 11 Jan 2019 [http://www.drugfreesport.org.za/online-medication-check/] 12. PI - GYNO-DAKTARIN-VC-PI-Signed-March-2021 - Accessed online 08 October 2024.pdf [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2021/09/GYNO-DAKTARIN-VC-PI-Signed-March-2021.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
4 products · cached snapshot- Gyno-Daktarin
VATVaginal tablet· 1 product
from R198.54| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Gyno Daktarin | 1200 mg | 1 | Johnson & Johnson (Pty) Ltd | R198.54 |
VCPVaginal combination pack · 1 product
from R224.73| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Gyno Daktarin Combipack | 0 /5g | 1 | Johnson & Johnson (Pty) Ltd | R224.73 |
VCRVaginal cream· 2 products
from R447.53| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Gyno-Daktarin VCdiscontinued | 20 mg/g | 40 | Janssen Pharmaceutica (Pty) Ltd | R447.53 |
| Gyno-Daktarin VCdiscontinued | 20 mg/g | 78 | Janssen Pharmaceutica (Pty) Ltd | R664.14 |
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.