Cream & Ointment
Cream : A white cream
containing Betamethasone Valerate 0.12% w/w (equivalent to Betamethasone
0.1%) with Methyl Paraben 0.08% w/w and Propyl Paraben 0.02% w/w as
Ointment : A white
ointment containing Betamethasone Valerate 0.12% w/w (equivalent to
Betamethasone Valerate is a
corticosteroid for topical application and is available as a cream or
ointment. The affected area of skin is treated once or twice daily. The
anti-inflammatory effect is enhanced by covering with an occlusive dressing,
but if large areas are treated in this way, sufficient amount of the drug
may be absorbed to give rise to systemic effects..
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 corticosteroid can be absorbed from normal
intact skin. Inflammation and/or other disease processes in the skin
increase percutaneous absorption. 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.
For the relief of the
inflammatory manifestations of corticosteroid-responsive dermatoses eg.
eczema (atopic, infantile, nummular), contact dermatitis, seborrhoeic
dermatitis, neurodermatitis, solar dermatitis, exfoliative dermatitis,
stasis dermatitis, dermatitis due to radiation, intertrigo, otitis externa,
psoriasis and anogenital and senile pruritus.
Topical corticosteroids are
contraindicated in those patients with a history of hypersensitivity to any
of the components of the preparation; infants under one year-old; infection
at treatment site; skin atrophy, pre-existing acne vulgaris; perioral
dermatitis; primary cutaneous viral infection (eg. herpes simplex, chicken
pox); tuberculosis of the skin, vaccinia, varicella and rosacea.
The following local adverse
reactions have been rarely reported with the use of topical
corticosteroids-burning, irritation, dryness, folliculitis, hypertrichosis,
acneiform eruptions and hypopigmentation. The following may occur more
frequently with occlusive dressings-maceration of the skin, secondary
infection, skin atropy, striae and miliria. Systemic side effects may also
occur such as hyperglycemia, glycosuria and HPA axis suppression. Treatment
of psoriasis may provoke the pustular form of the disease.
preparations are usually well tolerated, but if signs of hypersensitivity
appear, application should be discontinued immediately. Failure to control
infection and any extension of ulceration are also indications for
discontinuation of treatment. When extensive areas are treated, sufficient
systemic absorption may occur to produce the features of hypercorticism.
this effect is more likely to result if occlusive dressings are used, or if
treatment is prolonged. In children, long term topical therapy should be
avoided where possible as adrenal suppression can occur even without
The least potent corticosteroid
which will control the disease should be selected. Rarely, local atropy or
striae may occur after prolonged treatment under occlusion. Corticosteroids
should never be used in the presence of infection except in conjunction with
effective chemotherapy. Unless there is a specific indication, it is
recommended that Betamethasone valerate should not be used on the face.
In pregnant animals,
administration of corticosteroids can cause abnormalities of foetal
development. The relevance of this finding to human beings has not been
established. However, topical steroids should not be used extensively in
pregnancy, i.e. in large amounts or for long periods.
Adult - apply a thin film to the
affected area 1-3 times daily.
Children - apply a thin film to
the affected area once daily.
SYMPTOMS AND TREATMENT FOR
OVERDOSE AND ANTIDOTE(S)
Topically applied corticosteroids
can be absorbed in sufficient amounts to produce systemic effect. Acute
overdosage is very unlikely to occur, however, in the case of chronic
overdosage or misuse, the features of hypercorticism may appear and in this
situation topical steroids should be discontinued.
450g jar and 15g aluminium tubes.
Protect from strong light.
Store below 30°C.
For external use only.
Recommended shelf-life : 3 years