Betamethasone Dipropionate

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
Rx only

Betamethasone Dipropionate Lotion USP 0.05% (Augmented) 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.

Chemically, betamethasone dipropionate is 9-fluoro-11β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C₂₈H₃₇FO₇, a molecular weight of 504.6 and the following structural formula:

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 Betamethasone Dipropionate Lotion USP 0.05% (Augmented) contains 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in an augmented lotion base of purified water; isopropyl alcohol (30%); hydroxypropyl cellulose; propylene glycol; monobasic sodium phosphate and phosphoric acid used to adjust the pH.

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Betamethasone dipropionate lotion (augmented) 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 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Betamethasone dipropionate lotion (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

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 betamethasone dipropionate lotion (augmented) greater than 50 mL 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 axis suppression.

Betamethasone dipropionate lotion (augmented) was applied once daily at 7 mL per day for 21 days to diseased scalp and body skin in patients with scalp psoriasis to study its effects on the HPA axis. In 2 out of 11 patients, the drug lowered plasma cortisol levels below normal limits. HPA axis suppression in these patients was transient and returned to normal within a week. In one of these patients, plasma cortisol levels returned to normal while treatment continued. 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. (See PRECAUTIONS-Pediatric Use.)

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Betamethasone dipropionate lotion (augmented) should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin or in the axillae.

The local adverse reactions which were reported with betamethasone dipropionate lotion (augmented) during controlled clinical trials were as follows: erythema, folliculitis, pruritus and vesiculation each occurring in less than 1% of patients.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae and miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Topically applied betamethasone dipropionate lotion (augmented) can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Apply a few drops of betamethasone dipropionate lotion (augmented) to the affected skin once or twice daily and massage lightly until the lotion disappears. Betamethasone dipropionate lotion (augmented) is a super-high potency topical corticosteroid. Treatment with betamethasone dipropionate lotion (augmented) should be limited to two weeks, and amounts greater than 50 mL per week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Betamethasone dipropionate lotion (augmented) should not be used with occlusive dressings. Betamethasone dipropionate lotion (augmented) should not be applied to the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

Betamethasone Dipropionate Lotion USP 0.05% (Augmented) is supplied as follows:

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)[see USP Controlled Room Temperature].

E. FOUGERA & CO.
A division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

I2267A
R1/08
#105

Relabeling (Additional barcode label) by:
Physicians Total Care, Inc.
Tulsa, OK         74146

NDC 54868-6288-0

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 ML LABEL

BETAMETHASONE
DIPROPIONATE LOTION
USP, 0.05% (AUGMENTED*)
(Potency expressed as betamethasone)
*Vehicle augments the penetration of the steroid.

For Topical Use Only.
Not for Ophthalmic Use.

Rx Only

DO NOT USE IN EYES

30 mL