Fluocinolone
TOPICAL
cream
COMPOSITION PER 100 g:
Fluocinolone Acetonide, 0.2 g.
Excipients: Polyethylene Glycol 4000, Cetyl Alcohol, Glycerin,
Sodium lauryl sulfate, purified water.
ACTIONS
Fluocinolone Acetonide is a synthetic potent glucocorticoid for topical use.
The drug is indicated for the treatment of chronic and acute skin diseases of
different origin, specially those resistant to usual corticosteroids.
INDICATIONS
Local therapeutic of cutaneous affections of inflammatory or pruriginous allergic origin, resistant to lower concentrations of Fluocinolone Acetonide and to other corticosteroids: contact dermatitis, seborroheic dermatitis, neurodermatitis, lupus erythematosus, pustular psoriasis, necrobiosis lipoidica, annular granulation, pretibial myxoedema, etc.
DOSAGE
Apply a small amount of cream and extend over the affected area, two to three times daily.
The dose can be gradually reduced until the complete removal when the patient shows a satisfactory improvement.
DIRECTIONS FOR USE
A small amount should be gently massaged into the affected area, to facilitate the drug penetration. In some cases a previous application of warm damp compresses is recommended to get a better therapeutic effect. When the physician indicates the occlusive technique, a dose greater than 2 g cream daily should not be given.
CONTRAINDICATIONS
As with all topical corticosteroids it is contraindicated in tuberculous cutaneous affections, affections caused by virus, lues, varicella, vaccinal reaction, mycosis and dermatological infections caused by bacteria. Because of its local vasoconstrictive action it should not be used in the treatment of ulcers of the lower extremities.
INCOMPATIBILITIES AND INTERACTIONS
None are known in the topical use of Fluocinolone Acetonide.
WARNING
Sportsmen are advised that this drug contains an ingredient which may lead to a positive result in a doping control.
ADVERSE REACTIONS
No side effects have been observed related to the topical application of Fluocinolone Acetonide. If extensive areas are treated when occlusive technique is used, a small absorption through the skin may occur which should be taken into account.
OVERDOSAGE AND ITS TREATMENT
The risk of toxicity in the topical treatment with Fluocinolone Acetonide, within the low used concentrations, and the recommended application mode is practically inexistent.
In prolonged use under occlusive technique if any corticosteroid like effect is observed, it will be resolved when reducing or discontinuing the treatment.
In case of accidental overdosage, contact the Poison Information Centre. Phone (91) 562 04 20.
HOW SUPPLIED
Tubes of 30 g cream of 0.2% Fluocinolone Acetonide.
AVAILABLE ON PRESCRIPTION ONLY
Drugs should be kept out of children's reach
