Bryhali is a high-potency, Class I corticosteroid lotion that may be used by adults to reduce inflammation and itching caused by plaque psoriasis. It contains 0.01% halobetasol propionate.

Bryhali was approved on November 6, 2018. It contains a lower concentration than other halobetasol propionate lotions which limits its risk of side effects.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Bryhali (halobetasol propionate 0.01% lotion) is a highly potent, Class I corticosteroid that can be absorbed through the skin into the bloodstream and cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency, including Cushing’s syndrome, hyperglycemia, and glucosuria. Do not use for longer than 2 weeks and do not exceed the recommended dose. Periodic monitoring for HPA suppression may be required.

Before taking this medicine

You should not use halobetasol topical if you are allergic to it.

Bryhali should not be applied to lesions that are exuding serum or to skin folds (where two areas of skin touch each other).

Tell your doctor if you have ever had:

• any type of skin infection;
• a skin reaction to any steroid medicine;
• liver disease; or
• an adrenal gland disorder.

Topical corticosteroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Children are more susceptible to systemic absorption of topical corticosteroids. Bryhali is not approved for use by anyone younger than 18 years old.

It is not known whether halobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use Bryhali, use only a small amount for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use Bryhali, use only a small amount for the shortest time possible. Do not apply to the breasts.

How do I use Bryhali?

Apply Bryhali exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take it by mouth or use it intravaginally. Topical medicine is for use only on the skin. Do not use on open wounds or sunburned, windburned, dry, or irritated skin. Rinse with water if Bryhali gets in your eyes or mouth.

• Wash your hands before and after using Bryhali, unless you are using this medicine to treat the skin on your hands.
• Apply a thin layer of Bryhali lotion to the affected areas once daily. Rub in gently and completely. Do not apply this medicine over a large area of skin unless your doctor has told you to.

Do not cover the treated skin area with a bandage or other covering unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects.

Bryhali lotion is for short-term use only (up to 8 weeks). Follow your doctor’s dosing instructions very carefully.  Clinical trials have shown Bryhali continues to provide relief from psoriasis for up to 4 weeks after stopping using it.

Call your doctor if your symptoms do not improve after 8 weeks, or if they get worse. Stop using the product if your symptoms improve sooner.

What happens if I miss a dose?

Apply the product as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

High doses or long-term use of Bryhali lotion can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Bryhali?

• Avoid applying Bryhali to your face, scalp, underarms, or groin area. Do not use it to treat any skin condition that has not been checked by your doctor.
• Avoid using other topical steroid medications on the areas you treat with Bryhali unless your doctor tells you to.
• Do not use more than 50 grams per week.

What are the side effects of Bryhali?

Get emergency medical help if you have signs of an allergic reaction to Bryhali such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening of your skin condition;
• redness, warmth, swelling, oozing, or severe irritation of any treated skin;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor; or
• possible signs of absorbing this medicine through your skin – weight gain (especially in your face or your upper back and torso), slow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Common Bryhali side effects may include:

• upper respiratory tract infection
• burning, stinging, itching, or dryness of treated skin
• high blood sugar levels.

Other side effects that may occur with topical corticosteroids include:

• acne
• discoloration of the skin where the tape has been applied
• dryness
• excessive hair growth
• miliaria
• ophthalmic side effects such as cataracts or glaucoma
• perioral dermatitis and allergic contact dermatitis
• redness or crusting around your hair follicles (folliculitis)
• skin thinning
• spider veins
• stretch marks.

Topical corticosteroids can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency.

If you develop a skin infection while using Bryhali your doctor may give you an antimicrobial cream to use as well. If this does not resolve the infection, your doctor may discontinue the tape until the infection has cleared.

Betamethasone is a highly potent steroid that prevents the release of substances in the body that cause inflammation.

Betamethasone topical (for the skin) is used to treat the inflammation and itching caused by a number of skin conditions such as eczema or psoriasis.

Betamethasone topical is available in a cream, gel, ointment, lotion, foam, or spray.

Topical betamethasone formulations are usually formulated with one of two salts: betamethasone dipropionate or betamethasone valerate. The potency of betamethasone formulations can vary depending on which salt is used – dipropionate or valerate.

Betamethasone dipropionate contains two esters – this makes it more fat soluble and increases its ability to penetrate the skin better. This makes it more potent than betamethasone valerate, which only contains one ester.

The absorption and potency of a topical steroid can also vary depending on the vehicle used to deliver the steroid (such as a cream, gel, lotion, or ointment) and if it has been augmented or not. Augmentation refers to enhancing the vehicle with a substance, such as propylene glycol, to allow it to penetrate the skin more quickly and work faster. For example, augmented betamethasone dipropionate 0.05% ointment or gel is a Class 1 (highly potent) topical steroid, but the augmented lotion or cream and regular betamethasone dipropionate ointment is Class 2.

Potency of betamethasone preparations

Class 1 (highly potent)

• Augmented betamethasone dipropionate 0.05% ointment
• Augmented betamethasone dipropionate 0.05% gel

Class 2 (potent)

• Augmented betamethasone dipropionate 0.05% lotion
• Augmented betamethasone dipropionate 0.05% cream (0.05%)
• Regular betamethasone dipropionate 0.05% ointment

Class 3 (upper medium potency)

• Regular betamethasone dipropionate cream 0.05%

Class 4 and 5 (medium potency)

• Betamethasone valerate foam 0.12%
• Regular betamethasone dipropionate spray 0.05%

Warnings

Do not use betamethasone longer than you have been told to by your doctor. Use care when using on a large part of the skin. Talk with your doctor.

Do not use to treat diaper rash or redness. Avoid applying betamethasone cream, gel, ointment, lotion, foam, or spray to the diaper area.

Different brands of betamethasone may be for use in different ages of children. Talk with the doctor before using betamethasone cream, gel, ointment, lotion, foam, or spray on a child.

If you are breastfeeding, do not apply betamethasone cream, gel, ointment, lotion, foam, or spray to the nipple or the area around it.

Betamethasone may raise the chance of cataracts or glaucoma. Talk to your doctor.

Before taking this medicine

You should not use betamethasone if you are allergic to it.

To make sure betamethasone is safe for you, tell your doctor if you have ever had:

• skin irritation after using steroid medicine;
• thinning of the skin where you will apply betamethasone;
• cataracts or glaucoma;
• diabetes;
• liver disease;
• adrenal gland problems; or
• any type of skin infection.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks. If you apply betamethasone to your chest, avoid areas that may come into contact with the baby’s mouth.

Do not use betamethasone on a child without a doctor’s advice. Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

Diprolene is not approved for use by anyone younger than 13 years old. Sernivo and Luxiq are not approved for anyone younger than 18 years old.

How should I use betamethasone ?

Use betamethasone cream, gel, ointment, lotion, foam, or spray exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or on sunburned, windburned, dry, or irritated skin. Rinse with water if this medicine gets in your eyes or mouth.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after using this medicine, unless you are using the medicine to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not apply betamethasone cream, gel, ointment, lotion, foam, or spray over a large area of skin.

Do not cover the treated skin area unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects.

Use betamethasone regularly to get the most benefit. Stop using the medicine once your symptoms clear up.

Call your doctor if your skin condition does not improve after 2 weeks, or if it gets worse.

Do not use Diprolene for longer than 2 weeks in a row. Do not use Sernivo or Luxiq for longer than 4 weeks.

Store at room temperature away from moisture and heat.

The foam is flammable. Do not use near high heat or open flame. Do not smoke until the foam has completely dried on your skin.

Dosing information

Usual Adult Dose for Dermatitis:

Cream, gel, ointment:

• Apply a thin film topically to the affected area 1 or 2 times a day
• Foam, lotion: Apply topically twice a day (morning and night)

Comments:

• Treatment should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment may be necessary.
• Occlusive dressings should not be used unless directed by a healthcare provider.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Adult Dose for Plaque Psoriasis:

Spray:

• Apply topically to affected skin areas twice a day; rub in gently
• Duration of Treatment: Up to 4 weeks

Comments:

• Discontinue therapy when control is achieved; treatment beyond 4 weeks is not recommended.

Use: For the treatment of mild to moderate plaque psoriasis.

Usual Pediatric Dose for Dermatitis:

12 years or older:

• Cream, gel, ointment: Apply a thin film topically to the affected area 1 or 2 times a day
  Foam, lotion: Apply topically twice a day (morning and night)

Comments:

• Treatment should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment may be necessary.
• Occlusive dressings should not be used unless directed by a healthcare provider.
• Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

What other drugs will affect betamethasone?

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

What happens if I miss a dose?

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

Long term use of high doses can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using betamethasone?

Do not get betamethasone topical in your eyes. If contact does occur, rinse with water.

Avoid applying betamethasone to the skin of your face, underarms, or groin area without your doctor’s instruction.

Do not use betamethasone to treat any condition that has not been checked by your doctor.

Betamethasone side effects

Get emergency medical help if you have signs of an allergic reaction to betamethasone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using betamethasone and call your doctor at once if you have:

• severe skin irritation where the medicine was applied; or
• signs of skin infection (swelling, redness, warmth, oozing).

Your skin can absorb topical steroid medicine, which may cause steroid side effects throughout the body. Stop using betamethasone and call your doctor if you have:

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• slow wound healing, thinning skin, increased body hair;
• increased thirst or urination, dry mouth, fruity breath odor;
• weight gain, puffiness in your face; or
• muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common betamethasone side effects may include:

• itching, redness, burning, stinging, or blistering of treated skin;
• skin bruising or shiny appearance; or
• folliculitis (redness or crusting around your hair follicles).