LOCACORTEN VIOFORM

1 Dosing Considerations • Use of LOCACORTEN VIOFORM under occlusive dressings is not recommended as the resulting humid conditions may promote secondary infection with non-sensitive organisms and also may increase the possibility of elevated protein-bound iodine (PBI).

• If no improvement occurs within 1 week, therapy should be discontinued; it is then advisable to identify and treat the causative pathogens. LOCACORTEN VIOFORM (flumethasone pivalate and clioquinol) Page 5 of 14 • LOCACORTEN VIOFORM may turn yellow when exposed to air and may cause staining of the skin, nails, hair or fabrics.

2 Recommended Dose and Dosage Adjustment LOCACORTEN VIOFORM should be applied to the affected areas in a thin layer 2 to 3 times daily. 3 Pediatrics).

1 Adverse Reaction Overview 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 pivalate. 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. , face, axillae).

General LOCACORTEN VIOFORM should not be used to treat bacterial or mycotic skin diseases in which acute inflammation is not present. Patients should, as a general rule, be advised to inform subsequent physicians of the prior use of corticosteroids.

If, in exceptional cases, LOCACORTEN VIOFORM is applied in large amounts, the patient should be kept under regular medical supervision. 02% flumethasone pivalate and 3% clioquinol Cetyl alcohol, cetyl palmitate, glycerin, petrolatum, phenoxyethanol, sodium lauryl sulfate, stearyl alcohol, water LOCACORTEN VIOFORM (flumethasone pivalate and clioquinol) Page 6 of 14 Ear/Nose/Throat LOCACORTEN VIOFORM should not be used in the external auditory canal if the eardrum is perforated.

Endocrine and Metabolism Adrenal function:

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.

Thyroid function:

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. Hepatic/Biliary/Pancreatic Caution is indicated in patients suffering from hepatic failure.

Renal Caution is indicated in patients suffering from renal failure. Ophthalmologic LOCACORTEN VIOFORM should not be allowed to come into contact with the conjunctiva. 1 Pregnant Women The safety of LOCACORTEN VIOFORM during pregnancy 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. The potential benefit of LOCACORTEN VIOFORM during pregnancy (particularly in the first three months) should be weighed against possible hazard to the fetus.

, chicken pox, skin eruptions following vaccination, herpes simplex, herpes zoster), tuberculosis of the skin, syphilis, rosacea, acne vulgaris and perioral dermatitis. • patients with known hypersensitivity to flumethasone pivalate or to corticosteroids in general, to hydroxyquinolines, clioquinol or other quinoline derivatives, to iodine as well as to any other components of LOCACORTEN VIOFORM, including any non-medicinal ingredient or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • application to ulcerated areas. • application to the eye. • children under 2 years of age.