Diprolene Glycol (Betamethasone Dipropionate)

DIPROLENE™ GLYCOL

Schering

Betamethasone Dipropionate

Topical Corticosteroid

Action And Clinical Pharmacology: Anti-inflammatory, antipruritic and vasoconstrictive. The propylene glycol components of the vehicle increase penetration and enhance the local effectiveness of betamethasone.

Indications And Clinical Uses: For the relief of the inflammatory manifestations of resistant or severe psoriasis and corticosteroid-responsive dermatoses.

Contra-Indications: In viral diseases including vaccinia, varicella, herpes simplex, and fungal infections; also, tuberculosis of the skin. Hypersensitivity to any of its components.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.

Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. This drug should not be used in or near the eyes since this product is not formulated for ophthalmic use. This product should not be used under an occlusive dressing.

Children: This product is not recommended for use in children under 12 years of age.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema.

The lotion contains isopropyl alcohol and may cause stinging or burning upon application to abraded or sun-burned skin. Do not use in or near the eyes.

Precautions: Suitable precautions should be taken in using topical glucocorticoids in patients with stasis dermatitis and other skin diseases with impaired circulation; hypersensitive subjects and in patients with glaucoma.

Patients should be advised to inform subsequent physicians of the prior use of glucocorticoids.

If irritation, sensitization, excessive dryness develop with its use, treatment should be discontinued.

Application of corticosteroids over extensive lesions, or failure to follow dosage schedule may result in significant systemic absorption producing hypercortisonism manifesting itself by adrenal suppression, moon facies, striae and suppression of growth.

During the use of topical corticosteroids, infections may occur.

If an overt infection is present, appropriate antimicrobial treatment is indicated.

If symptomatic response is not noted within a few days to a week, the local application of corticosteroids should be discontinued and the patient re-evaluated.

Prolonged use of corticosteroid preparations may produce striae or atrophy of the skin or s.c. tissues. It this occurs, treatment should be discontinued.

Diprolene lotion has been shown to suppress the hypothalamic-pituitary adrenal (HPA) axis with repeated application of 7 mL/day.

Therefore, patients receiving large doses of potent topical corticosteroids, applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute with a less potent corticosteroid agent.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroid therapy.

Adverse Reactions: The following adverse reactions were reported with this product: mild to moderate transient folliculitis, increased redness of lesions, increased erythema, itching and vesiculation, perilesional scaling, telangiectasia, dryness, stinging, burning, skin atrophy, local irritation, urticaria. Subnormal plasma cortisol levels were also reported.

The following local adverse skin reactions have been reported with the use of topical steroids: striae, hypertrichosis, change in pigmentation, secondary infection, perioral dermatitis, allergic contact dermatitis, maceration of the skin, acneiform eruptions and miliaria.

Adrenal suppression has also been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids.

Overdose: Symptoms: Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary-adrenal insufficiency.Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary, in case of chronic toxicity, slow withdrawal of corticosteroids is advised.

Dosage And Administration: Cream and Ointment: A thin film of cream or ointment should be applied to cover completely the affected area once daily, in the morning. It may also be applied twice daily, in the morning and at night or as directed by the physician. Treatment should be discontinued when the dermatologic disorder is controlled. According to clinical response, duration of therapy may vary from a few days to a longer period of time. However, treatment should not be continued for more than 4 weeks without patient re-evaluation.

Lotion: A few drops of lotion should be applied to cover completely the affected area and a gentle massage should be effected until the lotion disappears. Once a day for 3 weeks, is the usual frequency of application.

The cream, lotion and ointment should not be used under an occlusive dressing.

Availability And Storage: Cream: Each g of cream contains: betamethasone 0.5 mg (as dipropionate USP, micronized). Nonmedicinal ingredients: carbomer 940, propylene glycol, sodium hydro-xide, titanium dioxide and water. Aluminum tubes of 15 and 50 g.

Lotion: Each g of lotion contains: betamethasone 0.5 mg (as dipropionate USP). Nonmedicinal ingredients: carbomer 940, isopropyl alcohol, propylene glycol, sodium hydroxide and water. Bottles of 30 and 60 mL.

Ointment: Each g of ointment contains: betamethasone 0.5 mg (as dipropionate USP, micronized). Nonmedicinal ingredients: propylene glycol monostearate USP, propylene glycol USP, white wax and white petrolatum. Aluminum tubes of 15 and 50 g.

Store at 2 to 30°C.

DIPROLENEÂ GLYCOL Schering Betamethasone Dipropionate Topical Corticosteroid

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