Prescription Drug Information: Betamethasone Dipropionate (Page 2 of 3)

11 DESCRIPTION

Betamethasone Dipropionate Cream USP (Augmented), 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-16 β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28 H37 FO7 , a molecular weight of 504.6, and the following structural formula:

chemical-structure
(click image for full-size original)

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

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

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of Betamethasone Dipropionate Cream USP (Augmented), 0.05% in corticosteroid responsive dermatoses is unknown.

12.2 Pharmacodynamics

Vasoconstrictor Assay

Trials performed with betamethasone dipropionate cream (augmented), 0.05% indicate that it is in the high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3 Pharmacokinetics

No pharmacokinetics trials have been conducted with Betamethasone Dipropionate Cream USP (Augmented), 0.05%. 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 [see Dosage and Administration (2) ].

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.

13 NONCLINICAL TOXICOLOGY

13.1 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.

14 CLINICAL STUDIES

The safety and efficacy of betamethasone dipropionate cream (augmented), 0.05% 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 betamethasone dipropionate cream (augmented), 0.05% were included in these trials. These trials evaluated betamethasone dipropionate cream (augmented), 0.05% applied once or twice daily for 14 and 21 days, respectively, on bilateral paired psoriatic lesions. Betamethasone dipropionate cream (augmented), 0.05% was shown to be effective in relieving the signs and symptoms of chronic plaque psoriasis.

16 HOW SUPPLIED/STORAGE AND HANDLING

Betamethasone Dipropionate Cream USP (Augmented), 0.05% is available as follows:

15 g tube (NDC 68788-9219-1)

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information). 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.
Advise patients to report any visual symptoms to their healthcare providers.
Avoid use of Betamethasone Dipropionate Cream USP (Augmented), 0.05% 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.
Advise a woman to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply Betamethasone Dipropionate Cream USP (Augmented), 0.05% directly to the nipple and areola to avoid direct infant exposure.

Manufactured By Perrigo, Bronx, NY 10457

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigorx.com

Rev 07-20 0N200 RC JX3

Patient Information

Betamethasone Dipropionate Cream USP, 0.05% (Augmented)

Important information: Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is for use on skin only. Do not use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in your eyes, mouth, or vagina.

What is Betamethasone Dipropionate Cream USP, 0.05% (Augmented)?

Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is a prescription corticosteroid medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 13 years of age and older.

Betamethasone Dipropionate Cream USP, 0.05% (Augmented) should not be used in children under 13 years of age.

Do not use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) if you are allergic to betamethasone dipropionate or any of the ingredients in Betamethasone Dipropionate Cream USP, 0.05% (Augmented). See the end of this leaflet for a complete list of ingredients in Betamethasone Dipropionate Cream USP, 0.05% (Augmented).

Before using Betamethasone Dipropionate Cream USP, 0.05% (Augmented), tell your healthcare provider about all of your medical conditions, including if you:

have had irritation or other skin reaction to a steroid medicine in the past.
have thinning of the skin (atrophy) at the treatment site.
have diabetes.
have adrenal gland problems.
have liver problems.
have cataracts or glaucoma.
are pregnant or plan to become pregnant. It is not known if Betamethasone Dipropionate Cream USP, 0.05% (Augmented) will harm your unborn baby. If you use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) during pregnancy, use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of the skin and for the shortest time needed.
are breastfeeding or plan to breastfeed. It is not known if Betamethasone Dipropionate Cream USP, 0.05% (Augmented) passes into your breast milk. Breastfeeding women should use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the smallest area of the skin and for the shortest time needed. Do not apply Betamethasone Dipropionate Cream USP, 0.05% (Augmented) directly to the nipple and areola to avoid contact with your baby.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or injection or use other products on your skin or scalp that contain corticosteroids.

Do not use other products containing a steroid medicine with Betamethasone Dipropionate Cream USP, 0.05% (Augmented) without talking to your healthcare provider first.

How should I use Betamethasone Dipropionate Cream USP, 0.05% (Augmented)?

Use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) exactly as your healthcare provider tells you to use it.
Apply a thin layer (film) of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) to the affected skin area 1 or 2 times each day. Do not use more than 50 grams of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in 1 week.
Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.
Betamethasone Dipropionate Cream USP, 0.05% (Augmented) should not be used to treat diaper rash or redness.
Avoid using Betamethasone Dipropionate Cream USP, 0.05% (Augmented) on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site.
Wash your hands after applying Betamethasone Dipropionate Cream USP, 0.05% (Augmented) unless you are using the medicine to treat your hands.

What are the possible side effects of Betamethasone Dipropionate Cream USP, 0.05% (Augmented)?

Betamethasone Dipropionate Cream USP, 0.05% (Augmented) may cause serious side effects, including:

Betamethasone Dipropionate Cream USP, 0.05% (Augmented) can pass through your skin. Too much Betamethasone Dipropionate Cream USP, 0.05% (Augmented) passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.
Cushing’s syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.
High blood sugar (hyperglycemia).
Effects on growth and weight in children.
Vision problems. Topical corticosteroids including Betamethasone Dipropionate Cream USP, 0.05% (Augmented) may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Betamethasone Dipropionate Cream USP, 0.05% (Augmented).
Skin problems.Skin problems including, allergic reactions (contact dermatitis) may happen during treatment with Betamethasone Dipropionate Cream USP, 0.05% (Augmented). Stop using Betamethasone Dipropionate Cream USP, 0.05% (Augmented) and tell your healthcare provider if you develop any skin reactions or have problems with healing during treatment with Betamethasone Dipropionate Cream USP, 0.05% (Augmented).

Your healthcare provider may do certain blood tests to check for side effects.

The most common side effect of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in adults includes stinging.

The most common side effects of Betamethasone Dipropionate Cream USP, 0.05% (Augmented) in children include thinning of the skin (atrophy), tiny red lines or blood vessels showing under the skin (telangiectasia), bruising and shininess.

These are not all of the possible side effects of Betamethasone Dipropionate Cream USP, 0.05% (Augmented). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Betamethasone Dipropionate Cream USP, 0.05% (Augmented)?

Store Betamethasone Dipropionate Cream USP, 0.05% (Augmented) at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Betamethasone Dipropionate Cream USP, 0.05% (Augmented) and all medicines out of the reach of children.

General information about the safe and effective use of Betamethasone Dipropionate Cream USP, 0.05% (Augmented).

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Betamethasone Dipropionate Cream USP, 0.05% (Augmented) for a condition for which it was not prescribed. Do not give Betamethasone Dipropionate Cream USP, 0.05% (Augmented) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Betamethasone Dipropionate Cream USP, 0.05% (Augmented) that is written for health professionals.

What are the ingredients in Betamethasone Dipropionate Cream USP, 0.05% (Augmented)?

Active ingredient: betamethasone dipropionate

Inactive ingredients: carbomer homopolymer type C; ceteareth-30; chlorocresol; cyclomethicone; glyceryl oleate/propylene glycol; propylene glycol; purified water; sodium hydroxide; sorbitol solution; white petrolatum; and white wax.

Manufactured By Perrigo, Bronx, NY 10457

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigorx.com

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 07/2020

Relabeled By: Preferred Pharmaceuticals Inc.

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