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Diprolene AF 0.05% Cream 15 Gm By Merck & Co.

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Diprolene AF 0.05% Cream 15 Gm By Merck & Co.

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Diprolene AF 0.05% Cream 15 Gm By Merck & Co. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD1432640/RXB10013451
Size : 15 GM
Selling UoM : EA
NDC: 00085-0517-01
UPC Barcode : 300850517018
Supplier: 0050000571 MERCK & CO / USHH PDP
Supplier Material : 051701
Generic Code : 007561 BETAMETHASONE/PROPYLENE GLYC TOPICAL CRE
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

DIPROLENE? (augmented betamethasone dipropionate ointment) Ointment contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.

It is a white to creamy-white, odorless powder insoluble in water freely soluble in acetone and in chloroform sparingly soluble in alcohol.

Each gram of DIPROLENE Ointment 0.05% contains 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a vehicle of propylene glycol, propylene glycol stearate, white wax, and white petrolatum.

INDICATIONS

DIPROLENE Ointment is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. The total dose should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

DOSAGE AND ADMINISTRATION

Apply a thin film of DIPROLENE Ointment to the affected skin once or twice daily. DIPROLENE Ointment is a super-high potency topical corticosteroid. Treatment with DIPROLENE Ointment should be limited to 50 g per week.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

DIPROLENE Ointment should not be used with occlusive dressings. Diprolene Ointment should not be applied to the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

PRECAUTIONS

General: Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. (See DOSAGE AND ADMINISTRATION section.)

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. . If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Patients should not be treated with amounts of DIPROLENE Ointment greater than 50 g per week because of the potential for the drug to suppress HPA axis. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression.

At 14 g per day DIPROLENE Ointment was shown to depress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in patients with psoriasis. These effects were reversible upon discontinuation of treatment. At 7 g per day DIPROLENE Ointment was shown to cause minimal inhibition of the HPA axis when applied 2 times daily for 2 to 3 weeks in healthy patients and in patients with psoriasis and eczematous disorders.

With 6 to 7 g of DIPROLENE Ointment applied once daily for 3 weeks, no significant inhibition of the HPA axis was observed in patients with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.