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Betamethasone cream
Composition
Betamethasone 17-Valerate
equivalent to Betamethasone
0.1%w/w
Pharmacology
Topical corticosteroids, such as betamethasone valerate, are effective in
the treatment of corticosteroid-responsive dermatoses primarily because of
anti-inflammatory, anti-pruritic and vasoconstrictive actions.
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 will increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of
topical corticosteroids.
Once absorbed through the skin topical corticosteroids are handled
through pharmacokinetic pathway similar to systemically administered
asteroids. Corticosteroids are bound to plasma proteins in varying degrees.
Corticosteroids are metabolised 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.
Indications
It is indicated for relief of the inflammatory and pruritic manifestations
of corticosteroid-responsive dermatoses, eg psoriasis and allergic and
inflammatory dermatitis.
Side-effects / Adverse reactions
The following local adverse reactions have been reported with topical
dermatological corticosteroids especially under occlusive dressings:
burning, itching, irritation, dryness, folliculitis, hypertrichosis,
acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact
dermatitis, maceration of the skin, secondary infection, skin atrophy,
striae and miliaria. Systemic absorption of topical corticosteroids has
produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression,
manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some
patients.
Precautions / Warnings
Patients receiving a large dose of a potent topical steroid applied to a
large surface area or prolonged use or under an occlusive dressings should
be evaluated periodically for evidence of HPA axis suppression by using the
urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is
noted, an attempt should be made to withdraw the drug, to reduce the
frequency of application, or to substitute a less potent steroid. Recovery
of HPA axis function is generally prompt and complete upon discontinuation
of the drug. Infrequently, signs and symptoms of steroid withdrawal may
occur, requiring supplemental systemic corticosteroids.
If irritation or sensitization develops, topical corticosteroids should
be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, an appropriate anti-fungal
or antibacterial agent should be instituted. If a favorable response does
not occur promptly, the corticosteroid should be discontinued until the
infections has been adequately controlled. This preparation is for external
use only. Avoid introduction of the cream into the eye. If a reaction
suggesting sensitivity or chemical irritation should occur, use of this
medication should be discontinued.
Use In Pregnancy and Lactation
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.
It is not known whether topical administration of corticosteroids can
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
prescribed for nursing woman.
Use in Children
Paediatric 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.
HPA axis suppression, Cushing's syndrome and intracranial hypertension have
been reported in children receiving topical corticosteroids. Manifestation
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 children 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.
Contraindications
It is contraindicated in patients who are hypersensitive to betamethasone
valerate, or to other corticosteroids, or to any ingredients in this
preparation.
Dosage
A thin film of the cream is applied to the effected skin area one to three
times a day. Dosage once or twice a day is often effective.
Symptoms and treatment for overdosage and antidotes:
Excessive prolonged use of topical corticosteroids can suppress
pituitary-adrenal function resulting in secondary adrenal insufficiency.
Appropriate symptomatic treatment is indicated. Acute hypercorticoid
symptoms are virtually reversible. Treat electrolyte imbalance, if
necessary. In cases of chronic toxicity, slow withdrawal of steroids is
advised.
Storage conditions:
Store at or below 25°C.
Shelf-life: 3 years.
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