Diprolene Ointment

Diprolene Ointment

WARNINGS

No information provided.

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 (betamethasone dipropionate) 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 (betamethasone dipropionate) 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 (betamethasone dipropionate) 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. (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 Ointment (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 Ointment (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 Ointment (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 Ointment (betamethasone dipropionate) is administered to a nursing woman.

Pediatric Use: Use of DIPROLENE Ointment (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 an 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.

Last reviewed on RxList: 4/19/2006
This monograph has been modified to include the generic and brand name in many instances.

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