Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3077
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DIPROLENE (Ointment)
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| dailymed-instance:dosage |
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.
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| dailymed-instance:descripti... |
DIPROLENE (augmented betamethasone dipropionate) 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. Chemically, betamethasone dipropionate is 9-fluoro-11��, 17,21-trihydroxy-16��-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula CHFO, 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 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.
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| dailymed-instance:clinicalP... |
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.<br/>Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings . Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids . Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Studies performed with DIPROLENE Ointment indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
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| dailymed-instance:contraind... |
DIPROLENE Ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
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| dailymed-instance:supply |
DIPROLENE Ointment 0.05% is supplied in 15-g (NDC 0085-0575-02) and 50-g (NDC 0085-0575-05) tubes; boxes of one. Store at 25��C (77��F); excursions permitted to 15�����30��C (59�����86��F) [see USP Controlled Room Temperature].
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| dailymed-instance:inactiveI... | |
| dailymed-instance:overdosag... |
Topically applied DIPROLENE Ointment can be absorbed in sufficient amounts to produce systemic effects .
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| dailymed-instance:genericMe... |
betamethasone dipropionate
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| dailymed-instance:fullName |
DIPROLENE (Ointment)
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| dailymed-instance:adverseRe... |
The local adverse reactions which were reported with DIPROLENE Ointment 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.
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| dailymed-instance:indicatio... |
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 of age 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.
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| dailymed-instance:name |
DIPROLENE
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