Drug: Diprolene Lotion

DIPROLENE® (augmented betamethasone dipropionate lotion) Lotion 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 DIPROLENE Lotion 0.05% 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; sodium phosphate; phosphoric acid and sodium hydroxide used to adjust the pH.

Source: http://www.rxlist.com

The local adverse reactions which were reported with DIPROLENE Lotion (betamethasone dipropionate) 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. Read the Diprolene Lotion (betamethasone dipropionate) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Apply a few drops of DIPROLENE Lotion (betamethasone dipropionate) to the affected skin once or twice daily and massage lightly until the lotion disappears. DIPROLENE Lotion (betamethasone dipropionate) is a super-high potency topical corticosteroid. Treatment with DIPROLENE Lotion (betamethasone dipropionate) 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. DIPROLENE Lotion (betamethasone dipropionate) should not be used with occlusive dressings. DIPROLENE Lotion (betamethasone dipropionate) should not be applied to the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

Source: http://www.rxlist.com

No information provided. Last reviewed on RxList: 6/2/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

DIPROLENE Lotion (betamethasone dipropionate) 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.

Source: http://www.rxlist.com

DIPROLENE Lotion (betamethasone dipropionate) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Last reviewed on RxList: 6/2/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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

Source: http://www.rxlist.com

DIPROLENE Lotion (betamethasone dipropionate) 0.05% is supplied in 30 mL (29g) (NDC 0085-0962-01), and 60 mL (58g) (NDC 0085-0962-02), plastic squeeze bottles; boxes of one. Store at 25° C (77°F); excursions permitted to 15 - 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Schering Corporation, Kenilworth, NJ 07033 USA. Rev. 10/05 Last reviewed on RxList: 6/2/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 Lotion (betamethasone dipropionate) 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. DIPROLENE Lotion (betamethasone dipropionate) 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. DIPROLENE Lotion (betamethasone dipropionate) 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. Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test
Urinary free cortisol test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in-vitro, human lymphocyte chromosome aberration assay, and equivocal in the in-vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone. Studies in rabbits, mice and rats using intramuscular doses up to 1, 33 and, 2, mg/kg, respectively, resulted in dose related increases in fetal resorptions in rabbits and mice. Pregnancy Teratogenic effects Pregnancy category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 0.2 times the human topical dose of DIPROLENE Lotion (betamethasone dipropionate) in mg/m² of body surface area, assuming 100% absorption and the use in a 60 kg person of 7 g per day. The abnormalities observed included umbilical hernias, cephalocele and cleft palate. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. DIPROLENE Lotion (betamethasone dipropionate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when DIPROLENE Lotion (betamethasone dipropionate) is administered to a nursing woman. Pediatric Use Use of DIPROLENE Lotion (betamethasone dipropionate) , 0.05%, in pediatric patients 12 years of age and younger is not recommended. (See CLINICAL PHARMACOLOGY and ADVERSE REACTIONS sections.) Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Chronic corticosteroid therapy may interfere with the growth and development of children. Geriatric Use Seven clinical studies of DIPROLENE Lotion (betamethasone dipropionate) evaluated 407 subjects of which 56 subjects were 65 years of age and over and 9 subjects were 75 years of age and over. No overall differences in safety or effectiveness were observed in these clinical studies between geriatric subjects and younger subjects. There was a numerical difference for application site reactions (most frequently reported events were burning and stinging) which occurred in 15% (10/65) of geriatric subjects and 11% (38/342) of subjects less than 65 years of age. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Last reviewed on RxList: 6/2/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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