RxMed: Pharmaceutical Information – LOCACORTEN

LOCACORTEN® VIOFORM®

Novartis Pharmaceuticals

Flumethasone Pivalate – Clioquinol

Topical Corticosteroid – Antibacterial – Antifungal

Action And Clinical Pharmacology: Flumethasone pivalate is a moderately potent difluorinated corticosteroid ester with anti-inflammatory, antipruritic and vasoconstrictive properties. As it is a privalate, its anti-inflammatory action is concentrated at the site of application. This local effect on diseased areas results in a prompt decrease in inflammation, exudation and itching.

Clioquinol, the antimicrobial component of Locacorten Vioform, is active against a broad spectrum of pathogenic microorganisms, including fungi (e.g. Candida, Microsporum, Trichophyton) and gram-positive bacteria (e.g. Staphylococci). Clioquinol has only a slight inhibitory effect on gram-negative bacteria. Clioquinol exerts a bacteriostatic, rather than a bactericidal action.

Locacorten Vioform combines the antifungal and antibacterial effects of clioquinol with the anti-inflammatory and antipruritic effects of flumethasone.

Indications And Clinical Uses: Initial treatment of corticosteroid-responsive inflammatory skin disorders complicated by bacterial and/or fungal infections, with appropriate systemic antibiotics if necessary, such as: seborrheic dermatitis, atopic dermatitis, localized neurodermatitis, contact dermatitis, intertrigo, superficial forms of pyoderma (e.g., impetigo) and of dermatomyocis in which acute inflammation is a prominent feature.

The cream has a slightly drying effect primarily useful for moist, weeping lesions and in intertriginous areas.

Contra-Indications: Viral infections of the skin (e.g., chickenpox, skin eruptions following vaccination, herpes simplex, herpes zoster), tuberculosis of the skin, syphilis, rosacea, acne vulgaris, and perioral dermatitis.

Known hypersensitivity to flumethasone pivalate or to corticosteroids in general, hydroxyquinolines, clioquinol, or other quinoline derivatives, iodine, as well as to any other components of Locacorten Vioform.

Application to ulcerated areas.

Application to the eye.

Children: Children under 2 years of age.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: The safety of Locacorten Vioform during pregnancy or lactation has not been established. Animal studies have shown that corticosteroids may induce fetal abnormalities in pregnant animals. The relevance of this finding to human use has not been elucidated. It is not known whether the active substance passes into the breast milk when applied topically. Therefore, the potential benefit of topical corticosteroids during pregnancy (particularly in the first 3 months), or lactation, should be weighed against possible hazard to the fetus or the nursing infant.

Precautions: Application to relatively large and/or eroded areas, treatment for longer than 1 week, as well as use under occlusive dressings may lead to a marked increase in protein-bound iodine (PBI) and should therefore be avoided.

Provided the preparation is used as recommended, unwanted systemic effects are unlikely to occur. On basic medical grounds, the possibility of a clinically important effect on adrenocortical function should nevertheless be borne in mind, particularly if the preparation is used under occlusion, over large areas of the body, in pediatrics and in patients undergoing prolonged therapy.

If no improvement occurs within 1 week, therapy should be discontinued; it is then advisable to identify and treat the causative pathogens.

Locacorten Vioform should not be used to treat bacterial or mycotic skin diseases in which acute inflammation is not present.

If in exceptional cases Locacorten Vioform is applied in large amounts, the patient should be kept under regular medical supervision.

Patients should, as a general rule, be advised to inform subsequent physicians of the prior use of corticosteroids.

Locacorten Vioform should not be allowed to come into contact with the conjunctiva.

Locacorten Vioform should not be used in the external auditory canal if the ear drum is perforated.

In patients suffering from hepatic and/or renal failure, caution is indicated.

Locacorten Vioform may turn yellow when exposed to air and may cause staining of the skin, nails, hair or fabrics.

Interactions : Topical use of clioquinol, as well as other iodine-containing compounds, may increase the amount of protein-bound iodine (PBI) in patients with normal thyroid function and therefore may interfere with some thyroid function tests (such as PBI, radioactive iodine and butanol-extractable iodine). These tests should not be performed within a period shorter than 1 month following the use of Locacorten Vioform. Other thyroid function tests, such as the T3 resin sponge test or the T4 determination, are unaffected by clioquinol.

The ferric chloride test for phenylketonuria may yield a false-positive result when clioquinol is present in the urine.

Adverse Reactions: Occasionally: signs of irritation such as burning sensation, itching or skin rash at the site of application; hypersensitivity reactions.

Isolated cases: mild skin atrophy due to flumethasone.

If an exacerbation or an allergic type reaction occurs, treatment with Locacorten Vioform should be discontinued.

Local adverse reactions reported during topical treatment with glucocorticoids include contact allergy, changes in skin pigmentation, and secondary infections. Topically applied glucocorticoids may give rise to striae rubrae distensae, telangiectasia, purpura, skin atrophy or steroid acne, especially if applied for prolonged periods of time, under occlusive dressings, to large areas or to permeable areas (e.g., face, axillae).

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Application to extensive or eroded areas of skin may lead to increased PBI values within 1 week. Elevated PBI values may also occur where relatively small areas of skin are treated for more than 1 week. If signs and symptoms resembling those of thyrotoxicosis occur, the preparation should be withdrawn at once. tag_DosageDosage

Dosage And Administration: Should be applied to the affected areas in a thin layer 2 to 3 times daily.

Use of Locacorten Vioform under occlusive dressings is not recommended as the resulting humid conditions may promote secondary infection with nonsensitive organisms and also may increase the possibility of elevated PBI.

Availability And Storage: Each tube of off-white water soluble cream contains: flumethasone pivalate 0.02% and clioquinol 3%. Nonmedicinal ingredients: cetyl alcohol, cetyl palmitate, glycerin, petrolatum, phenoxyethanol, sodium lauryl sulfate, stearyl alcohol and water. Tubes of 15 and 50 g. Protect from heat (store between 15 and 30°C) and freezing.

LOCACORTEN® VIOFORM® Novartis Pharmaceuticals Flumethasone Pivalate – Clioquinol Topical Corticosteroid – Antibacterial – Antifungal