INN monograph
Betamethasone Valerate/Gentamycin
Corticosteroid · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Corticosteroid)
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- It should be withdrawn gradually following prolonged therapy.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
DOSAGE AND ADMINISTRATION Apply a thin film of Betamethasone Valerate Cream USP, 0.1% to the affected skin areas one to three times a day. Dosage once or twice a day is often effective.
Paediatric
Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Renal
Fluid retention/hypertension — care in renal disease.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Prednisone needs hepatic activation to prednisolone.
Safety
Drug interactions
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Betamethasone Valerate.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings.
- These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Use
Indications
- INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
- Clinical selection for Betamethasone Valerate/Gentamycin 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.
Pharmacology
Mode of action
Combination product.
Full mechanism text
Combination product. Component mechanism (Betamethasone Valerate): It diffuses across cell membranes and forms a complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus, binds to DNA, and stimulate transcription of messenger RNA [mRNA]. Messenger RNA leads to protein synthesis of various enzymes that are responsible for the effects of systemic corticosteroids. Betamethasone may suppress transcription of mRNA in some cells like lymphocytes.
ADME
Pharmacokinetics & PD
| Onset | Hours–days |
|---|---|
| Duration | Agent and route dependent |
| Route | ORAL / IV / IM / INHALED / TOPICAL / NASAL / OPHTHALMIC |
| Absorption | of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin inc... |
Full PK/PD text
CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Bentogen | Biodeal Laboratories Ltd. | Standard Commercial Pack | — |
| Bentogen Ointment | Biodeal Laboratories Ltd. | Standard Commercial Pack | — |
| Betamix | Sphinx Pharmaceuticals Ltd | Standard Commercial Pack | — |
| Dawavate G | Dawa Limited | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
Pregnancy Teratogenic Effects 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
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; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Corticosteroid)
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.