Diprolene AF

Inform patients of the following:

• Discontinue therapy when control is achieved, unless directed otherwise by the physician.
• Use no more than 50 grams per week.
• Avoid contact with the eyes.
• Avoid use of DIPROLENE AF Cream on the face, underarms, or groin areas unless directed by the physician.
• Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
• Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.

Betamethasone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Betamethasone topical is used to treat the inflammation caused by a number of conditions such as allergic reactions, eczema, and psoriasis. The dental paste form of betamethasone is used to treat mouth ulcers.

Betamethasone topical may also be used for other purposes not listed in this medication guide.

Do not use this medication if you are allergic to betamethasone.

Before using betamethasone topical, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether betamethasone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of betamethasone topical.

Diprolene AF Cream 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Diprolene AF Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can 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 AF Cream is administered to a nursing woman.

Pediatric Use

Use of Diprolene AF Cream in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [see Warnings and Precautions (5.1)].

In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, Diprolene AF Cream 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of Diprolene AF Cream, and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group [see Warnings and Precautions (5.1)].

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids.

Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of Diprolene AF Cream in the treatment of diaper dermatitis.

Geriatric Use

Clinical trials of Diprolene AF Cream included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and 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.

Diprolene AF (augmented betamethasone dipropionate) Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream base. 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:

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of Diprolene AF Cream 0.05% contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a white cream base of carbomer 940; ceteareth-30; chlorocresol; cyclomethicone; glyceryl oleate/propylene glycol; propylene glycol; purified water; sodium hydroxide; sorbitol solution; white petrolatum; and white wax.

Carcinogenesis, Mutagenesis, 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.

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.

The safety and efficacy of Diprolene AF Cream for the treatment of corticosteroid-responsive dermatoses have been established in two randomized and active controlled trials in subjects with chronic plaque psoriasis. A total of 81 subjects who received Diprolene AF Cream were included in these trials. These trials evaluated Diprolene AF Cream applied once or twice daily for 14 and 21 days, respectively, on bilateral paired psoriatic lesions. Diprolene AF Cream was shown to be effective in relieving the signs and symptoms of chronic plaque psoriasis.

Diprolene AF Cream 0.05% is a white cream supplied in 15-g (NDC 0085-0517-01) and 50-g (NDC 0085-0517-04) tubes.

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

Applies to betamethasone topical: topical application cream, topical application lotion, topical application ointment, topical application spray

Other dosage forms:

• topical application cream, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment

Along with its needed effects, betamethasone topical (the active ingredient contained in Diprolene AF) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking betamethasone topical:

• Burning or stinging
• itching at the application site

• Blistering, burning, crusting, dryness, or flaking of the skin
• cracking or tightening of the skin
• dry skin
• flushing or redness of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
• unusually warm skin

• Blistering, peeling, or loosening of the skin

• Redness and scaling around the mouth

Some side effects of betamethasone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Raised, dark red, or wart-like spots on the skin, especially when used on the face

• Burning, itching, and pain in hairy areas, or pus at the root of the hair

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin