Halobetasol Propionate And Tazarotene
Generic Name: halobetasol propionate and tazarotene
Brand Names:
Duobrii
11 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.
Overview
11 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.
Uses
1 INDICATIONS AND USAGE DUOBRII ® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults. DUOBRII Lotion is a combination of halobetasol propionate and tazarotene indicated for the topical treatment of plaque psoriasis in adults. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Apply a thin layer of DUOBRII Lotion once daily to cover only affected areas and rub in gently. If a bath or shower is taken prior to application, the skin should be dry before applying the lotion. The total dosage should not exceed approximately 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.2) ] . Do not use with occlusive dressings unless directed by a physician. Discontinue treatment when control is achieved. Avoid application of DUOBRII Lotion on the face, groin, or in the axillae. DUOBRII Lotion is not for oral, ophthalmic, or intravaginal use. • Apply a thin layer of DUOBRII Lotion to the affected areas once daily.
Side Effects
6 ADVERSE REACTIONS • The most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Warnings
5 WARNINGS AND PRECAUTIONS • Embryofetal risk : DUOBRII Lotion contains tazarotene, which is a teratogenic substance. In females of reproductive potential, obtain a negative pregnancy test within 2 weeks prior to initiating treatment and advise patients to use an effective method of contraception during treatment. (5.1) • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. (5.2) • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. (5.2) • Systemic absorption may require evaluation for HPA axis suppression. 4 CONTRAINDICATIONS DUOBRII Lotion is contraindicated in pregnancy ( 4.1 , 8.1 ) 4.1 Pregnancy DUOBRII Lotion is contraindicated in pregnancy [ see Warnings and Precautions (5.1) , Use in Specific Populations ( 8.1 , 8.3) ].
Pregnancy
8.1 Pregnancy Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, DUOBRII Lotion may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is a white to off-white lotion supplied in a white aluminum tube as follows: • 100 g (NDC 0187-0653-01) Storage and Handling Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Protect from freezing.
Frequently Asked Questions
What is Halobetasol Propionate And Tazarotene used for?▼
1 INDICATIONS AND USAGE DUOBRII ® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults. DUOBRII Lotion is a combination of halobetasol propionate and tazarotene indicated for the topical treatment of plaque psoriasis in adults. ( 1 )
What are the side effects of Halobetasol Propionate And Tazarotene?▼
6 ADVERSE REACTIONS • The most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Can I take Halobetasol Propionate And Tazarotene during pregnancy?▼
8.1 Pregnancy Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, DUOBRII Lotion may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established.
What are the important warnings for Halobetasol Propionate And Tazarotene?▼
5 WARNINGS AND PRECAUTIONS • Embryofetal risk : DUOBRII Lotion contains tazarotene, which is a teratogenic substance. In females of reproductive potential, obtain a negative pregnancy test within 2 weeks prior to initiating treatment and advise patients to use an effective method of contraception during treatment. (5.1) • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. (5.2) • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. (5.2) • Systemic absorption may require evaluation for HPA axis suppression. 4 CONTRAINDICATIONS DUOBRII Lotion is contraindicated in pregnancy ( 4.1 , 8.1 ) 4.1 Pregnancy DUOBRII Lotion is contraindicated in pregnancy [ see Warnings and Precautions (5.1) , Use in Specific Populations ( 8.1 , 8.3) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.