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New search Medicine profile Betamethasone Valerate/ Neomycin

Clinical medicine profile

Betamethasone Valerate/ Neomycin

Corticosteroid

POM
Evidence state Source-linked Review date not recorded
Route
ORAL / IV / IM / INHALED / TOPICAL / NASAL / OPHTHALMIC
Schedule
POM
ATC
Not assigned
PPB status
registered
Patient advice Check interactions
01 Risk first

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  • It should be withdrawn gradually following prolonged therapy.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.
02 Point of care

Dosing matrix

Population and organ-function guidance, shown together for faster comparison.

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.

03 Clinical use

Use, effects & interactions

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/ Neomycin 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

  • 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.
  • Fixed-dose/multi-ingredient product.
  • Clinical details partially inherited from component monographs: Betamethasone Valerate, Neomycin / Gramicidin / Nystatin / Triamcinolone Acetonide.
  • Confirm combination SmPC for exact dosing.
04 Pharmacology

Mechanism & disposition

Combination product.

Combination product.Component mechanism (Betamethasone Valerat…These complexes then enter the cell nucleu…
Read complete mechanism

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.

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...

05 Special populations

Pregnancy, lactation & diet

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.

06 Kenya market

Brands & loaded prices

From
Median
Listings0
BrandManufacturerPackObserved price
No reviewed brand listings are linked yet.
07 Provenance

Sources & review state

Primary sourceLocal active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Corticosteroid)
Last reviewedNot recorded
EvidenceSource-linked
Open source document ↗

Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.