Bryhali

Generic name: halobetasol topical
Brand names: Bryhali, Lexette, Ultravate, Ultravate X Ointment
Drug class: Topical steroids

Medically reviewed by  A Ras MD.

What is Bryhali?

Bryhali is a prescription corticosteroid medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if Bryhali is safe and effective in children under 18 years of age.

Description

BRYHALI (halobetasol propionate) lotion contains a corticosteroid, halobetasol propionate, as the active ingredient in a white to off-white lotion formulation intended for topical use.

Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20 –dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. The structural formula for halobetasol propionate is represented below:

Each gram of BRYHALI Lotion contains 0.1 mg (0.01%) halobetasol propionate in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%.

 Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.

What is the most important information I should know about Bryhali?

Bryhali is for use on the skin only. Do not apply Bryhali in your mouth, eyes, or vagina.

What should I tell my healthcare provider before using Bryhali?

Before using Bryhali, tell your doctor about all of your medical conditions, including if you:

• have had irritation or other skin reaction to a steroid medicine in the past.
• have a skin infection. You may need medicine to treat the skin infection before using Bryhali.
• have diabetes.
• have adrenal gland problems.
• have liver problems.
• are pregnant or plan to become pregnant. It is not known if Bryhali will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Bryhali passes into your breast milk. If you use Bryhali and breastfeed, do not apply Bryhali to your nipple or areola to avoid getting Bryhali into your baby’s mouth.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroids medicines by mouth, or injection, or use other products on your skin that contain corticosteroids.

How should I use Bryhali?

• Use Bryhali exactly as your doctor tells you to use it.
• Apply a thin layer of Bryhali to the affected areas 1 time each day and rub in gently.
• You should not use more than 50 g of Bryhali in 1 week.
• Do not bandage, wrap, or cover the treated skin area(s) unless your doctor tells you to.
• Avoid using Bryhali on your face, groin, or underarms (armpits).
• Talk to your doctor if your skin does not improve after 8 weeks of treatment with Bryhali.
• You should not use Bryhali longer than 8 weeks unless your doctor tells you to.
• Wash your hands after using Bryhali unless you are using the medicine to treat your hands.

What are the possible side effects of Bryhali?

Bryhali may cause serious side effects, including:

• Bryhali can pass through your skin. Too much Bryhali passing through your skin can cause adrenal glands to stop working.
• Cushing’s syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.
• High blood sugar (hyperglycemia).
• Skin reactions at the treated skin site. Tell your doctor if you get any skin reactions or skin infections.
• Vision problems. Bryhali 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 Bryhali.
• Effects on growth and weight in children.

The most common side effects of Bryhali include burning, stinging, itching, dryness (application site dermatitis), upper respiratory tract infection and high blood sugar (hyperglycemia).

These are not all the possible side effects of Bryhali.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Bryhali

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Bryhali for a condition for which it was not prescribed. Do not give Bryhali to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or doctor for information about Bryhali that is written for health professionals.

How should I store Bryhali?

• Store Bryhali at room temperature between 68° to 77°F (20° to 25°C).
• Protect from freezing.

Keep Bryhali and all medicines out of the reach of children.

What are the ingredients in Bryhali?

Active ingredients: halobetasol propionate

Inactive ingredients: carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 0187-0002-01
• For Topical Use Only
  Not for Eye Use
• BRYHALI®
  (halobetasol propionate) Lotion, 0.01%
• Rx only
• Net Wt. 100 g
• Ortho Dermatologics

SRC: NLM .