Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied/Storage Desoximetasone Topical Spray, 0.25% is a clear colorless liquid supplied in white, opaque bottles with white, opaque screw caps in the following sizes: 30 mL 50 mL 100 mL (2-50 mL bottles) 100 mL (NDC 51672-1396-3) (NDC 51672-1396-4) (NDC 51672-1396-6) (NDC 51672-1396-7) Store at controlled room temperature between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature] Spray is flammable; avoid heat, flame or smoking when using this product. Each unit is co-packaged with a manual spray pump for installation by the pharmacist. 16.2 Instructions for the Pharmacist Remove the spray pump from the wrapper Remove and discard the cap from the bottle Keeping the bottle vertical, insert the spray pump into the bottle and turn clockwise until well-fastened Dispense the bottle with the spray pump inserted Label the bottle with "discard the product 30 days after dispensing"; PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton 100 mL NDC 51672-1396-7 Desoximetasone Topical Spray 0.25% For Topical Use Only NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE Keep this and all medications out of the reach of children. Rx only TARO PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied/Storage Desoximetasone Topical Spray, 0.25% is a clear colorless liquid supplied in white, opaque bottles with white, opaque screw caps in the following sizes: 30 mL 50 mL 100 mL (2-50 mL bottles) 100 mL (NDC 51672-1396-3) (NDC 51672-1396-4) (NDC 51672-1396-6) (NDC 51672-1396-7) Store at controlled room temperature between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature] Spray is flammable; avoid heat, flame or smoking when using this product. Each unit is co-packaged with a manual spray pump for installation by the pharmacist. 16.2 Instructions for the Pharmacist Remove the spray pump from the wrapper Remove and discard the cap from the bottle Keeping the bottle vertical, insert the spray pump into the bottle and turn clockwise until well-fastened Dispense the bottle with the spray pump inserted Label the bottle with "discard the product 30 days after dispensing"
- PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton 100 mL NDC 51672-1396-7 Desoximetasone Topical Spray 0.25% For Topical Use Only NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE Keep this and all medications out of the reach of children. Rx only TARO PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
Overview
Desoximetasone Topical Spray, 0.25% contains desoximetasone as the active ingredient. Desoximetasone is a corticosteroid with the chemical name of pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-, (11β,16α)-. Desoximetasone has the molecular formula of C 22 H 29 FO 4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is: Each gram of Desoximetasone Topical Spray contains 2.5 mg of desoximetasone in a clear, colorless liquid with the following inactive ingredients: glyceryl oleate, isopropyl alcohol (23.4%), isopropyl myristate, L-menthol, and mineral oil. Desoximetasone Topical Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients. Chemical Structure
Indications & Usage
Desoximetasone Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. Desoximetasone Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older ( 1 ).
Dosage & Administration
Apply Desoximetasone Topical Spray as a thin film to the affected skin areas twice daily. Rub in gently. The treated skin area should not be bandaged or otherwise covered or wrapped unless directed by the physician. Desoximetasone Topical Spray should be discontinued when control is achieved. Treatment beyond 4 weeks is not recommended. Do not use if atrophy is present at the treatment site. Avoid use on the face, axilla or groin. Desoximetasone Topical Spray is for external use only. It is not for oral, ophthalmic, or intravaginal use. Apply a thin film to the affected skin areas twice daily. Rub in gently. ( 2 ) Desoximetasone Topical Spray should be discontinued when control is achieved. ( 2 ) Treatment beyond 4 weeks is not recommended. ( 2 ) Do not use if atrophy is present at the treatment site. ( 2 ) Do not use with occlusive dressings, unless directed by the physician ( 2 ) Avoid use on the face, axilla or groin. ( 2 ) Desoximetasone Topical Spray is not for oral, ophthalmic, or intravaginal use. ( 2 )
Warnings & Precautions
Desoximetasone Topical Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. ( 5.1 ) Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. ( 5.1 ) Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. ( 5.1 ) Modify use if HPA axis suppression develops. ( 5.1) High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. ( 5.1 ) Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) Desoximetasone Topical Spray is flammable; keep away from heat or flame. ( 5.5 ) 5.1 Effect on Endocrine System Desoximetasone Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10 to 15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Desoximetasone Topical Spray twice a day for 28 days. [ see Clinical Pharmacology (12.2) ] Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [ see Use in Specific Populations (8.4) ] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. 5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.4 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Desoximetasone Topical Spray should be discontinued until the infection has been adequately treated. 5.5 Flammable Contents Desoximetasone Topical Spray is flammable; keep away from heat or flame.
Contraindications
None None ( 4 )
Adverse Reactions
The most common adverse reactions (≥ 1%) are application site dryness, application site irritation and application site pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals, U.S.A., Inc., at 1-866-923-4914 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 practice. In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied Desoximetasone Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Desoximetasone Topical Spray. Adverse reactions that occurred in ≥ 1% of subjects treated with Desoximetasone Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%). Another less common adverse reaction (<1% but >0.1%) was folliculitis. Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Desoximetasone Topical Spray, 0.25% b.i.d. (N = 149) Vehicle spray b.i.d. (N = 135) Number of Subjects with Adverse Reactions 13 (8.7%) 18 (13.3%) Application site dryness 4 (2.7%) 7 (5.2%) Application site irritation 4 (2.7%) 5 (3.7%) Application site pruritus 3 (2.0%) 5 (3.7%)
Storage & Handling
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature] Spray is flammable; avoid heat, flame or smoking when using this product. Each unit is co-packaged with a manual spray pump for installation by the pharmacist.
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