DIPROSONE

1 Dosing Considerations  For some patients adequate maintenance therapy may be achieved with less frequent application. 2 Administration A thin film of DIPROSONE® should be applied to completely cover the affected area. The preparation should be massaged gently and thoroughly into the skin.

The usual frequency of application is twice daily. 4 MISSED DOSE If a dose is missed, the patient can resume treatment with the next scheduled application.

1 Adverse Reaction Overview The following local adverse skin reactions have been reported rarely with the use of topical steroids: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis.

The following may occur more 7 frequently with occlusive dressing: maceration of the skin, secondary infection, skin atrophy, striae, miliaria. Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.

General If a symptomatic response is not noted within a few days to a week, the local applications of DIPROSONE® should be discontinued until the infection is brought under control. Significant systemic absorption may occur when steroids are applied over large areas of the body, especially under occlusive dressings.

To minimize this possibility, when long term therapy is anticipated, interrupt treatment periodically or treat one area of the body at a time. Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

Occlusive dressings should not be applied if there is an elevation of body temperature. Driving and Operating Machinery Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery. Immune In cases of bacterial or fungal infections of the skin, appropriate antimicrobial agents should be used as primary therapy.

If it is considered necessary, DIPROSONE® may be used as an adjunct to control inflammation, erythema, and itching. Ophthalmologic DIPROSONE® is not for ophthalmic use. Do not use in or near the eyes. Topical corticosteroids should be used with caution on lesions close to the eye.

Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Sensitivity/Resistance Although hypersensitivity reactions have been rare with topically applied steroids, the drug should be discontinued, and appropriate therapy initiated if there are signs of sensitivity or irritation. Skin The lotion contains isopropyl alcohol and may cause stinging upon application to abraded or sun- burned skin.

DIPROSONE® (betamethasone dipropionate) is contraindicated in:  patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.

 untreated bacterial, tubercular and fungal infections involving the skin, and in certain viral diseases such as herpes simplex, chicken pox, and vaccinia.  hypersensitivity to any of the components.