|
Dermasole
Cream/Ointment
Betamethasone (as 17-valerate) 0.1%
DESCRIPTION
Pharmaniaga Dermasole cream A white, cream with smooth texture
Pharmaniaga Dermasole ointment A clear translucent ointment
COMPOSITION
Each gram of Dermasole Cream or Ointment contains Betamethasone (as
17-valerate) 1 mg (0.1 % w/w).
ACTION
-
A corticosteroid, which is an isomer of dexamethasone with its hydroxyl
group at position 17, displaced by an ester.
-
This modification increases its glycogenic and anti-inflammatory potencies
by 10 times and cancels out its mineralocorticoid effects.
-
Its principal actions include gluconeogenesis, glycogen deposition, and
protein and calcium metabolism.
PHARMACOKINETICS
-
Absorbed through the skin when applied topically and may enter the systemic
circulation, particularly under an occlusive dressing.
-
Highly bound to plasma proteins (mainly to globulin) in the circulation.
-
Diffuses into tissue fluids and cerebrospinal fluid.
-
Metabolised in the liver and kidney and excreted in the urine.
INDICATIONS
Betamethasone 17-valerate is a potent topical corticosteroid that produces a
satisfactory response in a short time in those inflammatory dermatose that
are normally responsive to topical corticosteroid therapy, and is also
effective in the less responsive conditions such as psoriasis.
Betamethasone
is indicated for the treatment of eczema, including atopic, infantile,
discoid and stasis eczemas and prurigo; psoriasis; neuro dermatoses,
including lichen siraplex; lichen planus; seborrhoeic dermatitis; intertrigo,
contact sensitivity reactions, discoid
lupus erythematosus; generalised erythroderma.
CONTRAINDICATIONS
Rosacea, acne and perioral dermatitis. Skin lesions caused by infection with
viruses (e.g. herpes simplex, chickenpox), fungi (e.g. candidiasis, tinea)
or bacteria (e.g. impetigo).
PRECAUTIONS
Long-term continuous topical therapy should be avoided where possible
particularly in infants and children, as adrenal suppression can occur, even
without occlusion. The least potent corticosteroid which will control the
disease should be selected. The face, more than other areas of the body, may
exhibit atrophic changes after prolonged treatment with potent topical
corticosteroids. This must be borne in mind when treating such conditions as
psoriasis, discoid lupus
erythematosus and severe eczema with betamethasone.
Application to the eyelids may cause glaucoma.
Appropriate chemotherapy should be used whenever infections are present. Any
spread of infection requires withdrawal of topical corticosteroid therapy
and systemic administration of anti-microbial agents. Bacterial infection is
encouraged by the warm, moist conditions induced by occlusive dressings, and
the skin should be cleansed before fresh dressing is applied.
Topical administration of corticosteroids to pregnant animals 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. large amounts or for prolonged periods.
ADVERSE REACTIONS
Prolonged and intensive treatment with highly active corticosteroid
preparations may cause local atrophic changes in the skin such as striae,
thinning, and dilatation of the superficial blood vessels, particularly when
occlusive dressings are used or when skin folds are involved.
As with other topical corticosteroids, prolonged use of large amounts or
treatment of extensive areas, can result in sufficient systemic absorption
to produce the features of hypercorticism. This effect is more likely to
occur in infants and children, and when occlusive dressing are used. In
infants, napkin may act as an occlusive dressing.
In rare instances, treatment of psoriasis with corticosteroids (or its
withdrawal) is thought to have provoked the pustular form of the disease.
DOSAGE AND ADMINISTRATION
A small quantity is applied lightly to the affected area two or three times
daily until improvement by applying once a day or even less often.
Occlusion of the area under treatment with plastic film may be used to
enhance the corticosteroid activity in the more resistant lesions. Overnight
occlusion only is usually adequate to bring about a satisfactory response in
such cases thereafter, improvement can usually be maintained by regular
application without occlusion.
SYMPTOMS AND TREATMENT
OF OVERDOSE
Treatment: As for corticosteroids the adverse effects of corticosteroids are
nearly always due to their use in excess of normal physiological
requirements. They should be treated symptomatically, where possible the
dosage being reduced or drug slowly withdrawn.
STORAGE CONDITIONS
Store below 25°C.
Keep container tightly closed.
Protect from light.
SHELF LIFE
Product should not be used beyond the expiry date imprinted on the product
packaging.
PRESENTATION
Pharmaniaga Dermasole Cream
Tubes of 5g, 15g, 25g and 30g.
In bottle of 500g. (for KKM tender only)
Pharmaniaga Dermasole Ointment
Tubes of 5g, 15g, 25g and 30g.
|
