INN monograph
Miconazole / Fluocinolone
Antifungal · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Professional class pharmacology (Antifungal)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- Use on rosacea acne, peri-oral dermatitis, scabies, leg ulcers, tuberculous, untreated viral, bacterial or fungal infections, reaction to smallpox vaccination, first three months of pregnancy, continous prophylactic use.
Precautions
- Limit use in children or on face to maximum of 5 days.
- It should be withdrawn gradually following prolonged therapy.
- Unless fully unavoidable, potent corticosteroids should not be used on the face as they may precipitate a rosacea-like disorder and aggravate any pre-existing rosacea, avoid use in an occluded area, near the eye, use in the presence of skin infections without concomitant use of anti-microbial, children under 1yr, on weeping foci.
Point of care
Dosing
Adult
Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.
Paediatric
Paediatric dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
Renal
Fluconazole dose-adjust in CKD; amphotericin nephrotoxicity high-alert.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Monitor LFTs for courses >14 days or higher-risk patients.
Safety
Drug interactions
- [Miconazole] Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Triamcinolone acetonide.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- Local irritation e.g burning sensation and itching, erythema rare, dryness of the skin, aggravation of concurrent untreated infections, thinning of the skin (this may be reversible), loss of skin elasticity, folliculitis, change in skin pigmentation, telangiectasia, purpura and steroid acne, increased growth of hair, severe pituitary-adrenal axis suppression and hypercotism, cushoid state, growth retardation, benign intra-cranial hypertension.
Use
Indications
- Steroid responsive dermatoses complicated or likely to be complicated by fungal infections Clinical selection for Miconazole / Fluocinolone should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Antifungal.
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
Azoles inhibit fungal CYP51 (lanosterol 14α-demethylase), depleting ergosterol and disrupting membrane integrity.
Full mechanism text
Azoles inhibit fungal CYP51 (lanosterol 14α-demethylase), depleting ergosterol and disrupting membrane integrity. Terbinafine inhibits squalene epoxidase. Polyenes bind ergosterol creating membrane pores. Echinocandins inhibit β-glucan synthase (cell wall).
ADME
Pharmacokinetics & PD
| Onset | Days for clinical response (varies) |
|---|---|
| Duration | Days–weeks per indication |
| Route | ORAL / TOPICAL / IV |
| Metabolism | with major interactions. Topicals: minimal systemic |
Full PK/PD text
Fluconazole: excellent bioavailability, renal excretion, CSF penetration. Itraconazole/voriconazole: complex absorption and CYP metabolism with major interactions. Topicals: minimal systemic absorption when intact skin.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
[Miconazole] [From component Triamcinolone acetonide] PREGNANCY CATEGORY C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Lactation
[Miconazole] [From component Triamcinolone acetonide] NURSING MOTHERS It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Professional class pharmacology (Antifungal)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.