Duobrii

Generic name: halobetasol and tazarotene topical
Drug class: Topical antipsoriatics

Medically reviewed by A Ras MD.

What is Duobrii?

Duobrii is a prescription medicine that is used to treat plaque psoriasis.

Description

DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients 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 [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate. The structural formula for halobetasol propionate is represented below:

Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96

Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below:

Molecular Formula: C21H21NO2S Molecular Weight: 351.46

Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene 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.

Tazarotene is a retinoid prodrug which is converted to its active form, tazarotenic acid, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings for the treatment of plaque psoriasis is unknown.

Before taking Duobrii, tell your doctor:

If you are allergic to Duobrii; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you are pregnant or may be pregnant. Do not use Duobrii if you are pregnant.
If you are able to get pregnant and are not using birth control.
If you are sunburned.
If you are taking any drugs that may make your skin more sensitive to light. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
If you are using any drugs that may cause dry skin. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Duobrii with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Duobrii?

Tell all of your health care providers that you take Duobrii. This includes your doctors, nurses, pharmacists, and dentists.
Talk with your doctor before you use other drugs or products on your skin.
Some weather conditions may irritate the skin. Talk with the doctor.
Skin may look worse before it looks better.
You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
Do not use longer than you have been told by the doctor.
This medicine may raise the chance of cataracts or glaucoma. Talk with the doctor.
This medicine may cause harm if swallowed. If Duobrii is swallowed, call a doctor or poison control center right away.
If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Duobrii. Talk with your doctor.
Use birth control that you can trust to prevent pregnancy while taking Duobrii.
This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Duobrii, call your doctor right away.
Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
If you are breast-feeding, do not put Duobrii right on the nipple or the area right around it.

How is Duobrii best taken?

Use Duobrii as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Do not take Duobrii by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
Do not put in the vagina.
If you get Duobrii in any of these areas, rinse well with water.
If you are able to get pregnant, start using Duobrii during your normal menstrual period.
Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
Clean affected part before use. Make sure to dry well.
Put a thin layer on the affected skin and rub in gently.
Avoid putting on healthy skin.
Do not put on cuts, scrapes, eczema, or damaged skin.
Do not use coverings (bandages, dressings) unless told to do so by the doctor.
Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
Practice good skin care and avoid the sun.

What do I do if I miss a dose?

Put on a missed dose as soon as you think about it.
If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
Do not put on 2 doses at the same time or extra doses.

What are the side effects of Duobrii that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
Signs of Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
Skin changes (pimples, stretch marks, slow healing, hair growth).
Irritation where Duobrii is used.
Thinning of the skin.
Redness.
Peeling.
Sunburn.
Change in eyesight.

What are some other side effects of Duobrii?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Stinging.
Dry skin.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Duobrii?

Store at room temperature. Do not freeze.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL DISPLAY PANEL

NDC 0187-0653-01
Duobrii®
(halobetasol propionate
and tazarotene) Lotion
0.01%/ 0.045%
Rx only
Net Wt. 100g
For Topical Use Only
Not for Eye Use
Ortho Dermatologics

SRC: NLM .

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