Halobetasol Propionate And Tazarotene (Duobrii)

Trade Name : Duobrii

Valeant Pharmaceuticals North America LLC

LOTION

Strength .1.45 mg/gmg/g

HALOBETASOL PROPIONATE; TAZAROTENE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Retinoid [EPC],Retinoids [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Halobetasol Propionate And Tazarotene (Duobrii) which is also known as Duobrii and Manufactured by Valeant Pharmaceuticals North America LLC. It is available in strength of .1; .45 mg/g; mg/g per ml. Read more

Halobetasol Propionate And Tazarotene (Duobrii) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

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. ()

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 . 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.

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

DUOBRII Lotion is contraindicated in pregnancy [n , (, ].
DUOBRII Lotion is contraindicated in pregnancy (, )

No data

Embryofetal risk
Local Adverse Reactions
Photosensitivity and Risk for Sunburn
Ophthalmic Adverse Reactions

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.
In randomized, double-blind, multicenter, vehicle-controlled clinical trials, 410 adults with plaque psoriasis were treated with DUOBRII Lotion or vehicle lotion and had post-baseline safety data. Subjects applied DUOBRII Lotion or vehicle lotion once daily for up to eight weeks. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with DUOBRII Lotion and more frequently than in vehicle-treated subjects.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or n

u2022
6.1

No data

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: CHClFO 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:
Tazarotene:
Molecular Formula: CHNOS 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%.

No data

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate.
A long-term study of tazarotene following oral administration of 0.025, 0.050, and 0.125u00a0mg/kg/day to rats showed no indications of increased carcinogenic risks. Based on pharmacokinetic data from a shorter term study in rats, the highest dose of 0.125 mg/kg/day was anticipated to give systemic exposure in the rat equivalent to 1.4 times the MRHD (based on AUC comparison).
A long-term study with topical application of up to 0.1% of tazarotene in a gel formulation in mice terminated at 88 weeks showed that dose levels of 0.05, 0.125, 0.25, and 1 mg/kg/day (reduced to 0.5 mg/kg/day for males after 41 weeks due to severe dermal irritation) revealed no apparent carcinogenic effects when compared to vehicle control animals. Tazarotenic acid systemic exposures at the highest dose was 35 times the MRHD (based on AUC comparison).
Halobetasol propionate was not genotoxic in the Ames assay, in the sister chromatid exchange test in Chinese hamster somatic cells, in chromosome aberration studies of germinal and somatic cells of rodents, and in a mammalian spot test. Positive mutagenicity effects were observed in a mouse lymphoma gene mutation assay in vitro and in a Chinese hamster micronucleus test.
Tazarotene was non-mutagenic in the Ames assay and did not produce structural chromosomal aberrations in human lymphocytes. Tazarotene was non-mutagenic in the CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in an in vivo mouse micronucleus test.
Studies in rats following oral administration of halobetasol propionate at dose levels up to 0.05 mg/kg/day, approximately 0.53 times the MRHD based on BSA comparisons, indicated no impairment of fertility or general reproductive performance.
No impairment of fertility occurred in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14u00a0days prior to mating and continuing through gestation and lactation with topical doses of a tazarotene gel formulation up to 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure in the rat at the highest dose was 5 times the MRHD (based on AUC comparison).
No impairment of mating performance or fertility was observed in male rats treated for 70 days prior to mating with oral doses of up to 1 mg/kg/day tazarotene, which produced a systemic exposure 17 times the MRHD (based on AUC comparison).
No impairment of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through gestation day 7 with oral doses of tazarotene up to 2 mg/kg/day. However, there was a significant decrease in the number of estrous stages and an increase in developmental effects at that dose, which produced a systemic exposure 30 times the MRHD (based on AUC comparison).

The safety and efficacy of once daily use of DUOBRII Lotion for the treatment of moderate to severe plaque psoriasis were assessed in two prospective, multicenter, randomized, double-blind clinical trials (Trial 1 [NCT02462070] and Trial 2 [NCT02462122]). These trials were conducted in 418 subjects 18 years of age and older with moderate to severe plaque psoriasis that covered a body surface area (BSA) between 3% and 12% excluding the face, scalp, palms, soles, axillae, and intertriginous areas. Disease severity was determined by a 5-grade Investigatoru2019s Global Assessment (IGA). Subjects applied DUOBRII Lotion or vehicle to all affected areas once daily for up to 8 weeks. All subjects returned for a 4-week follow-up visit (12-Week visit) where safety and efficacy were evaluated.
The primary efficacy endpoint was the proportion of subjects with u201ctreatment successu201d at Week 8. Treatment success was defined as at least a 2-grade improvement from baseline in the IGA score and an IGA score equating to u201cclearu201d or u201calmost clearu201d. Table 3 lists the primary efficacy results for Trials 1 and 2. The secondary efficacy endpoints evaluated treatment success sequentially at Weeks 12, 6, 4, and 2. Figure 1 shows the primary and secondary efficacy results over time.
Figure : Efficacy Results* over Time

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:
Storage and Handling Conditions
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled RoomTemperature] Protect from freezing.

Advise the patient to read the FDA-approved patient labeling ().
This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all administration instructions or all possible adverse or unintended effects.
Advise patients using DUOBRII Lotion of the following information and instructions:
Important Administration Instructions
If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides [].
Inform patients that total dosage should not exceed 50 grams per week .
Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s), unless directed by physician. Advise patients to avoid use on the face, groin, or axillae .
Inform patients that DUOBRII Lotion is for external use only. Advise patients that DUOBRII Lotion is not for oral, ophthalmic, or intravaginal use n
Fetal risk is associated with DUOBRII Lotion for females of reproductive potential. Advise patients to use an effective method of contraception during treatment to avoid pregnancy. Advise the patient to stop medication if she becomes pregnant and call her doctor [].
Breastfeeding women should not apply DUOBRII Lotion directly to the nipple and areola to avoid directly exposing the infant .
Avoid exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sunlamps. Use sunscreen and protective clothing if exposure to sunlight is unavoidable when using DUOBRII Lotion .
HPA Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects
DUOBRII Lotion may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including DUOBRII Lotion, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids .
Local Adverse Reactions
Inform patients that DUOBRII Lotion may cause local adverse reactions. These reactions may be more likely to occur with occlusive use or use of DUOBRII Lotion. If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides, unless allergic contact dermatitis is identified n
Ophthalmic Adverse Reactions
Advise patients to report any visual symptoms to their healthcare providers.
Manufactured for:n
Bridgewater, NJ 08807 USA
By:
Laval, Quebec H7L 4A8, Canada
U.S. Patent Numbers: 6,517,847; 8,809,307; and 10,251,895
DUOBRII is a trademark of Bausch Health Companies Inc. or its affiliates.
u00a9 2019 Bausch Health Companies Inc. or its affiliates
9645601

PATIENT INFORMATION
DUOBRIIu2122 (DEW-oh-bree)
(halobetasol propionate and tazarotene) lotion, for topical use
Important information: DUOBRII is for use on skin only.
What is the most important information I should know about DUOBRII?
DUOBRII may cause birth defects if used during pregnancy.
What is DUOBRII?
DUOBRII is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis.
It is not known if DUOBRII is safe and effective in children under 18 years of age.
Do not usen- DUOBRII if you:
Before using DUOBRII, tell your healthcare provider about all of your medical conditions, including if you:
What are the possible side effects of DUOBRII?
DUOBRII may cause side effects, including:
The mostn- common side effects of DUOBRII include:
These are not all of the possible side effects of DUOBRII.
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 DUOBRII?
Keep DUOBRII and all medicines out of the reach of children.
General information about the safe and effective use of DUOBRII
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DUOBRII for a condition for which it was not prescribed. Do not give DUOBRII to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about DUOBRII that is written for health professionals.
What are the ingredients in DUOBRII?
Active ingredients:
Inactive ingredients:
Manufactured forn- :
Byn- :
U.S. Patent Numbers: 6,517,847; 8,809,307 and 10,251,895
u00a9 2019 Bausch Health Companies Inc. or its affiliates

NDC
Duobriiu2122(halobetasol propionateand tazarotene) Lotion0.01%/0.045%
Rx onlyNet Wt. 100g
For Topical Use OnlyNot for Eye Use
Ortho Dermatologics

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Halobetasol Propionate And Tazarotene (Duobrii)

Trade Name : Duobrii

LOTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Halobetasol Propionate And Tazarotene (Duobrii)

Trade Name : Duobrii

LOTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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