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Indications

This Lotion is a combination of halobetasol propionate and tazarotene indicated for the topical treatment of plaque psoriasis in adults.

Pharmacology

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 convert d 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.

A vasoconstrictor assay in healthy subjects with this lotion indicated that it is in the high to super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression was evaluated in a study in adult subjects with moderate to severe plaque psoriasis. A median dose of 8.2 grams this lotion was applied once daily for 8 weeks and 20 subjects were assessed for HPA axis suppression at Weeks 4 and 8. HPA axis suppression was observed in 3 out of 20 (15%) subjects at Week 4. None of the 20 (0%) subjects had HPA axis suppression at Week 8. In this study, the criteria for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone).

Dosage & Administration

Apply a thin layer of this 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 the application of this lotion on the face, groin, or in the axillae. This lotion is not for oral, ophthalmic, or intravaginal use.

Contraindications

This lotion is contraindicated in pregnancy.

Side Effects

The most common side effects are redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.

Pregnancy & Lactation

Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, This Lotion may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. There are no data on the presence of tazarotene, halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after treatment with This Lotion.

Precautions & Warnings

  • This 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.
  • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment.
  • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
  • Systemic absorption may require evaluation for HPA axis suppression.
  • Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
  • Local Adverse Reactions: Local adverse reactions may include atrophy, striae, telangiectasias, and folliculitis. If these effects occur, discontinue at least until the integrity of the skin has been restored. DUOBRII Lotion should not be used on eczematous skin, as it may cause severe irritation.
  • Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. DUOBRII Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers.
  • Ophthalmic Adverse Reactions: Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist

Use in Special Populations

Safety and effectiveness of this lotion in pediatric patients under the age of 18 years have not been evaluated.

Therapeutic Class

Other Topical corticosteroids

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.