Betamethasone Dipropionate

Betamethasone dipropionate spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Shake well before use.

Apply betamethasone dipropionate spray to the affected skin areas twice daily and rub in gently.

Use betamethasone dipropionate spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.

Discontinue betamethasone dipropionate spray when control is achieved.

Do not use if atrophy is present at the treatment site.

Do not bandage, cover, or wrap the treated skin area unless directed by a physician.

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.

Betamethasone dipropionate spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Spray, 0.05% for topical use. Each gram of betamethasone dipropionate spray contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white oil-in-water emulsion.

There are no available data on betamethasone dipropionate spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate spray may increase the risk of having a low birthweight infant and to use betamethasone dipropionate spray on the smallest area of skin and for the shortest duration possible.

In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis (

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

• Betamethasone dipropionate spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. High Potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and use in pediatric patients may predispose to HPA axis suppression. Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. (
  
  
  5.1 Effects on Endocrine System

  Betamethasone dipropionate spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

  Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

  In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with betamethasone dipropionate spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with betamethasone dipropionate spray twice daily for 29 days

  [see Clinical Pharmacology (12.2)].

  If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required.

  Systemic effects of topical corticosteroids may also manifest as Cushing's syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.

  Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended

  [see Dosage and Administration (2)]

  .

  Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of betamethasone dipropionate spray is not recommended in pediatric patients

  [see Use in Specific Populations (8.4)].
  )
  
• Topical corticosteroids may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (
  
  
  5.2 Ophthalmic Adverse Reactions

  Use of topical corticosteroids, including betamethasone dipropionate spray, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including betamethasone dipropionate

  [see Adverse Reactions (6.2)]

  .

  Avoid contact of betamethasone dipropionate spray with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
  )