Clinical medicine profile
Miconazole/ Hydrocortisone
Corticosteroid
- Route
- ORAL / IV / IM / INHALED / TOPICAL / NASAL / OPHTHALMIC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
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- It should be withdrawn gradually following prolonged therapy.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.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
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 dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
Fluid retention/hypertension — care in renal disease.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Prednisone needs hepatic activation to prednisolone.
Use, effects & interactions
Indications
- Steroid responsive dermatoses complicated or likely to be complicated by fungal infections Clinical selection for Miconazole/ Hydrocortisone should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Corticosteroid.
- Confirm site-specific dose, duration and monitoring before prescribing.
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.
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Hydrocortisone / Neomycin ear /eye drop.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Corticosteroids bind intracellular glucocorticoid receptors, modulating gene transcription to suppress inflammatory cytokines, inhibit phospholipase A2 via lipocortins, reduce leukocyte migration and stabilise membranes — potent anti-inflammatory and immunosuppressive effects.
Read complete mechanism
Corticosteroids bind intracellular glucocorticoid receptors, modulating gene transcription to suppress inflammatory cytokines, inhibit phospholipase A2 via lipocortins, reduce leukocyte migration and stabilise membranes — potent anti-inflammatory and immunosuppressive effects. Mineralocorticoid activity varies by agent.
Hours–days
Agent and route dependent
ORAL / IV / IM / INHALED / TOPICAL / NASAL / OPHTHALMIC
Pregnancy, lactation & diet
[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. [Hydrocortisone] Used when maternal benefit clear; prefer agents with better obstetric data (e.g. prednisolone). Document risk–benefit.
[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. [Hydrocortisone] Low-dose systemic often compatible; time feeds if high dose — agent-specific.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| Gentamicin / Miconazole/ | Afya Index product / manufacturer unverified | tabs 20g | Unavailable |
| XtradermOchoa | 0.1%/1%/0.1% | tabs 20gm | Unavailable |
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.