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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 25C.
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.

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