Desoximetasone 2.5 mg/mL Spray — NDC 68180-944-33 (Billing 68180-0944-33)
This is a package of Desoximetasone 2.5 mg/mL Spray from Lupin Pharmaceuticals, Inc., marketed since Jul 2018 and currently FDA-listed; retail pharmacies pay about $0.5991 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 68180-944-33 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68180 labeler · 944 product · 33 package
- Package marketed since
- Jul 20, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0368180944331
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 070883
- GCN: 34545
- GPI-14 (Medi-Span): 90550040000910
- HICL (First Databank): 003309
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 1376338
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. Creams, gels and ointments calm inflamed, itchy skin from conditions that respond to steroids. The spray is used for plaque psoriasis in adults 18 and ol...
- You put a thin film on the affected skin, usually twice a day, and rub it in gently. Don't cover the spray area with a bandage unless your doctor tells you to. Keep it away from yo...
- Stop when your skin is under control. The label doesn't recommend using the spray beyond 4 weeks. Avoid your face, armpits and groin, and don't use it on skin that has thinned.
- The most common are dryness, irritation and itching where you apply it. Call your doctor if you notice vision changes, thinning skin, stretch marks, or signs of infection.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Desoximetasone — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.599 | $59.91 / 100 ml |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.07 | $107.15 / 100 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Feb 18, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68180-0944-11 68180-944-11 | 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE | — | — | 2018-07-20 | — | Active |
| 68180-0944-22 68180-944-22 | 1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE | — | — | 2018-07-20 | — | Active |
| 68180-0944-33 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE | $0.5991 / mL | $59.91 | 2018-07-20 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Desoximetasone 2.5 mg/mL Spray?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Desoximetasone 2.5 mg/mLthis 68180-0944-33 | Lupin | 1 bottle | $0.599 | AT | FDA listed | — |
| desoximetasone 2.5 mg/mL 45802-0807-98 | Padagis | 1 bottle | $0.648 | AT | Availability likely | +8% |
| Desoximetasone 2.5 mg/mL 51672-1396-03 | Sun | 1 bottle | — | AT | FDA listed | — |
| Topicort 2.5 mg/mL 51672-5281-00 | Sun | 1 bottle | — | AT | FDA listed | — |
| desoximetasone 2.5 mg/mL 63629-8702-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| desoximetasone 2.5 mg/mL 72162-1427-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 18, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Desoximetasone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII P7E6YFV72X
Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII BZ1R15MTK7
Levomenthol is the left-handed form of menthol, a natural cooling compound from mint plants. It's used in medicines as a flavoring agent and to provide a cooling sensation on the skin or mucous membranes.
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UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII 06XEA2VD56
Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Lupin Pharmaceuticals, Inc. labeler code 68180
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- Desoximetasone 2.5 mg/g Ointment NDC 68180-946-01
- Betamethasone dipropionate .5 mg/g Ointment, Augmented NDC 68180-947-01
- Desoximetasone .5 mg/g Ointment NDC 68180-948-01
- Desoximetasone .5 mg/g Cream NDC 68180-949-01
- Desoximetasone 2.5 mg/g Cream NDC 68180-950-01
- Hydrocortisone Butyrate 1 mg/mL Lotion NDC 68180-951-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Desoximetasone topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older ( 1 ). Desoximetasone topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin film to the affected skin areas twice daily. Rub in gently. ( 2 ) Discontinue treatment 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 ) Not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply desoximetasone topical spray, 0.25% as a thin film to the affected skin areas twice daily. Rub in gently.
Do not bandage or otherwise cover or wrap the treated skin unless directed by the physician. Discontinue treatment 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, 0.25% is for external use only.
It is not for oral, ophthalmic, or intravaginal use.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Spray, 0.25% w/w ( 3 ) Topical Spray, 0.25%. Each gram of desoximetasone topical spray contains 2.5 mg of desoximetasone USP in a clear, colorless liquid.
⛔ Contraindications ▾
4 CONTRAINDICATIONS None ( 4 ) None
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Effect on Endocrine System: Desoximetasone topical spray, 0.25% 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.
Safety and effectiveness have not been established in pediatric patients and use in pediatric patients is not recommended. ( 5.1 , 8.4 ) Ophthalmic Adverse Reactions: Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.
( 5.3 .). Flammability: Desoximetasone topical spray, 0.25% is flammable; keep away from heat or flame. ( 5.6 )
5.1Effect on Endocrine System Desoximetasone topical spray, 0.25% 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, 0.25% 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. Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression (the safety and effectiveness of desoximetasone topical spray, 0.25% have not been established in pediatric patients) [see Use in Specific Populations ( 8.4 ) and Clinical Pharmacology ( 12.2 )]
5.2Local 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, fo… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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, 0.25% or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied desoximetasone topical spray, 0.25%.
Adverse reactions that occurred in ≥ 1% of subjects treated with desoximetasone topical spray, 0.25% are presented in Table 1. Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Another less common adverse reaction (<1% but >0.1%) was folliculitis.
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%) Another less common adverse reaction (<1% but >0.1%) was folliculitis.
6.2Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids included atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria. Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported during use of topical corticosteroids.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on desoximetasone use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids, including Desoximetasone topical spray, 0.25%, may be associated with an increased risk of low birthweight infants (see Data) . Advise pregnant woman that Desoximetasone topical spray, 0.25% may increase the potential risk of low birth weight infants and to use Desoximetasone topical spray, 0.25% on the smallest area of skin and for the shortest duration possible.
Desoximetasone has been shown to cause malformations and be embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Desoximetasone topical spray, 0.25% based on a body surface area comparison. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of high to super-high potency topical corticosteroids exceeded 300g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants.
8.2Lactation Risk Summary There is no information on the presence of topically administered desoximetasone in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for desoximetasone topical spray, 0.25% and any potential adverse effects on the breastfed infant from desoximetasone topical spray, 0.25% or from the underlying maternal condition.
Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use desoximetasone topical spray, 0.25% on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply desoximetasone topical spray, 0.25% directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] .
8.4Pediatric Use The safety and effectiveness of desoximetasone topical spray, 0.25% have not been established in pediatric patients for the treatment of plaque psoriasis. Desoximetasone topical spray, 0.25% is not recommended for use in patients less than 18 years of age due to the high incidence of HPA axis suppression observed [see Warnings and Precautions ( 5.1 )] . Hypothalamic-Pituitary Adrenal (HPA) Axis Suppression The HPA axis suppression potential of desoximetasone topical spray, 0.25% was assessed in an open-label, sequential cohort, safety trial in 129 subjects 2 years to less than 18 years of age with moderate to severe plaque psoriasis defined as a Physician Global Assessment (PGA) score of ≥3 with involvement of at least 10% of their body surface area (excluding the face and scalp).
In total, 100 pediatric subjects were evaluated for HPA axis function via cosyntropin stimulation testing at baseline and following 4 weeks of twice daily application of desoximetasone topical spray, 0.25%. Overall, 36% of pediatric subjects 2 years to less than 18 years of age demonstrated HPA axis suppres… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on desoximetasone use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids, including Desoximetasone topical spray, 0.25%, may be associated with an increased risk of low birthweight infants (see Data) . Advise pregnant woman that Desoximetasone topical spray, 0.25% may increase the potential risk of low birth weight infants and to use Desoximetasone topical spray, 0.25% on the smallest area of skin and for the shortest duration possible.
Desoximetasone has been shown to cause malformations and be embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Desoximetasone topical spray, 0.25% based on a body surface area comparison. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of high to super-high potency topical corticosteroids exceeded 300g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of desoximetasone topical spray, 0.25% have not been established in pediatric patients for the treatment of plaque psoriasis. Desoximetasone topical spray, 0.25% is not recommended for use in patients less than 18 years of age due to the high incidence of HPA axis suppression observed [see Warnings and Precautions ( 5.1 )] . Hypothalamic-Pituitary Adrenal (HPA) Axis Suppression The HPA axis suppression potential of desoximetasone topical spray, 0.25% was assessed in an open-label, sequential cohort, safety trial in 129 subjects 2 years to less than 18 years of age with moderate to severe plaque psoriasis defined as a Physician Global Assessment (PGA) score of ≥3 with involvement of at least 10% of their body surface area (excluding the face and scalp).
In total, 100 pediatric subjects were evaluated for HPA axis function via cosyntropin stimulation testing at baseline and following 4 weeks of twice daily application of desoximetasone topical spray, 0.25%. Overall, 36% of pediatric subjects 2 years to less than 18 years of age demonstrated HPA axis suppression defined as a serum cortisol level ≤ 18 mcg/dL 30-minutes post cosyntropin stimulation. The proportion of subjects demonstrating HPA axis suppression was 35.0% in Cohort 1 (12 years to less than 18 years of age) and 43.3% in Cohort 2 (6 years to less than 12 years of age).
Trial enrollment in the youngest cohort (2 years to less than 6 years of age) was discontinued early due to high incidence of HPA axis suppression observed in the two oldest cohorts (6 years to less than 18 years of age) [see Clinical Pharmacology ( 12.2 )] . Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore at greater risk of adrenal insufficiency during and/or after withdrawal of treatment.
Adverse reactions including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of desoximetasone topical spray, 0.25% did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE Desoximetasone topical spray, 0.25% can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions ( 5.1 )]
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation and protein regulation; however, the precise mechanism of action in psoriasis is unknown.
12.2Pharmacodynamics Vasoconstrictor Assay Vasoconstrictor studies performed with desoximetasone topical spray, 0.25% in healthy subjects indicate that it is in the high to super-high range of potency as compared with other topical corticosteroids. Hypothalamic-Pituitary Adrenal (HPA) Axis Suppression The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression was evaluated in two trials. Desoximetasone topical spray, 0.25% was applied twice a day for 28 days and HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-min post cosyntropin stimulation.
In the first trial, out of 24 adult subjects with moderate to severe plaque psoriasis, 21. subjects had evaluable serum cortisol levels. The proportion of subjects demonstrating HPA axis suppression was 8.3% (1 out of 12) in subjects having psoriasis involvement of 10-15% of body surface area (BSA), and 22.2% (2 out of 9) in subjects having psoriasis involvement of > 15% of their BSA. In the 2 subjects with available follow-up values, suppression reversed 28 days after the end of treatment.
In another trial, the HPA axis suppression was evaluated in 106 pediatric subjects with moderate to severe plaque psoriasis. One hundred subjects had evaluable serum cortisol levels. The proportion of subjects demonstrating HPA axis suppression was 35.0% (21 out of 60) in Cohort 1 (12 years to less than 18 years of age, with a mean baseline BSA involvement of 16%), and 43.3% (13 out of 30) in Cohort 2 (6 years to less than 12 years of age, with a mean baseline BSA involvement of 19%).
Trial enrollment in the youngest cohort (2 years to less than 6 years of age) was discontinued early due to high incidence of HPA axis suppression observed in the two oldest cohorts (6 years to less than 18 years of age). The overall HPA axis suppression rate was 36% in pediatric subjects 2 years to less than 18 years of age. Due to high incidence of HPA axis suppression observed from this trial, desoximetasone topical spray, 0.25% is not recommended for use in pediatric patients less than 18 years of age [see Use in Specific Populations ( 8.4 )] .
12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.
Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Plasma concentrations of desoximetasone were measured at two single random time points in the HPA axis suppression trial in 24 adult subjects with psoriasis [see Clinical Pharmacology ( 12.2 )] .
The mean (% Coefficient of Variation) concentration of desoximetasone was 449 pg/mL (86%) at Day 14 and 678 pg/mL (135%) at Day 28. The concentration time profile following application of desoximetasone topical spray, 0.25% is not known. In the pediatric HPA axis suppression trial, plasma concentrations of desoximetasone were measured in a subset of subjects in Cohorts 1 and 2 [see Clinical Pharmacology ( 12.2 )] .
High inter subject variability in plasma concentrations was observed in both cohorts. The mean (% Coefficient of Variation) maximum concentration on Day 29 was 188… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation and protein regulation; however, the precise mechanism of action in psoriasis is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How 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 (NDC 68180-944-11) 50 mL (NDC 68180-944-22) 100 mL (NDC 68180-944-33) 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.
16.2Instructions 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"
16.1How 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 (NDC 68180-944-11) 50 mL (NDC 68180-944-22) 100 mL (NDC 68180-944-33) 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.
📋 Description ▾
11 DESCRIPTION Desoximetasone topical spray, 0.25% for dermatologic use 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-, (11ß,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, 0.25% contains 2.5 mg of Desoximetasone USP in a clear, colorless liquid with the following inactive ingredients: butylated hydroxytoluene, citric acid anhydrous, diisopropyl adipate, isopropyl alcohol (23.4%), L-menthol, medium-chain triglycerides, mineral oil and sorbitan monooleate. Desoximetasone topical spray, 0.25% is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) Inform patients of the following: Use this medication as directed by the physician. Do not use this medication for any disorder other than that for which it was prescribed. Desoximetasone topical spray, 0.25% is for external use only.
Avoid contact with eyes and use on the face, axilla or groin. To minimize the risk of adverse reactions: do not bandage or otherwise cover or wrap the treated skin so as to be occlusive. discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact the physician. do not use other corticosteroid-containing products with desoximetasone topical spray, 0.25% without first consulting with the physician.
Advise patients that desoximetasone topical spray, 0.25%, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. [see Warnings and Precautions ( 5.1 )]. Advise women to use desoximetasone topical spray, 0.25% on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding.
Advise breastfeeding woman not to apply desoximetasone topical spray, 0.25% directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations ( 8.1 and 8.2 ]. Report any signs of local or systemic adverse reactions including any visual symptoms to the physician. This medication is flammable; avoid heat, flame, or smoking when applying this product.
Discard this product 30 days after dispensed by pharmacist. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc.
Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) – 454 775 India Revised: October 2024 Image
🍼 Nursing Mothers ▾
8.2Lactation Risk Summary There is no information on the presence of topically administered desoximetasone in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for desoximetasone topical spray, 0.25% and any potential adverse effects on the breastfed infant from desoximetasone topical spray, 0.25% or from the underlying maternal condition.
Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use desoximetasone topical spray, 0.25% on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply desoximetasone topical spray, 0.25% directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] .
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.
Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Plasma concentrations of desoximetasone were measured at two single random time points in the HPA axis suppression trial in 24 adult subjects with psoriasis [see Clinical Pharmacology ( 12.2 )] .
The mean (% Coefficient of Variation) concentration of desoximetasone was 449 pg/mL (86%) at Day 14 and 678 pg/mL (135%) at Day 28. The concentration time profile following application of desoximetasone topical spray, 0.25% is not known. In the pediatric HPA axis suppression trial, plasma concentrations of desoximetasone were measured in a subset of subjects in Cohorts 1 and 2 [see Clinical Pharmacology ( 12.2 )] .
High inter subject variability in plasma concentrations was observed in both cohorts. The mean (% Coefficient of Variation) maximum concentration on Day 29 was 1881 pg/mL (127%) in Cohort 1 (n=11) and 1116 pg/mL (94%) in Cohort 2 (n=8).
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Vasoconstrictor Assay Vasoconstrictor studies performed with desoximetasone topical spray, 0.25% in healthy subjects indicate that it is in the high to super-high range of potency as compared with other topical corticosteroids. Hypothalamic-Pituitary Adrenal (HPA) Axis Suppression The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression was evaluated in two trials. Desoximetasone topical spray, 0.25% was applied twice a day for 28 days and HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-min post cosyntropin stimulation.
In the first trial, out of 24 adult subjects with moderate to severe plaque psoriasis, 21. subjects had evaluable serum cortisol levels. The proportion of subjects demonstrating HPA axis suppression was 8.3% (1 out of 12) in subjects having psoriasis involvement of 10-15% of body surface area (BSA), and 22.2% (2 out of 9) in subjects having psoriasis involvement of > 15% of their BSA. In the 2 subjects with available follow-up values, suppression reversed 28 days after the end of treatment.
In another trial, the HPA axis suppression was evaluated in 106 pediatric subjects with moderate to severe plaque psoriasis. One hundred subjects had evaluable serum cortisol levels. The proportion of subjects demonstrating HPA axis suppression was 35.0% (21 out of 60) in Cohort 1 (12 years to less than 18 years of age, with a mean baseline BSA involvement of 16%), and 43.3% (13 out of 30) in Cohort 2 (6 years to less than 12 years of age, with a mean baseline BSA involvement of 19%).
Trial enrollment in the youngest cohort (2 years to less than 6 years of age) was discontinued early due to high incidence of HPA axis suppression observed in the two oldest cohorts (6 years to less than 18 years of age). The overall HPA axis suppression rate was 36% in pediatric subjects 2 years to less than 18 years of age. Due to high incidence of HPA axis suppression observed from this trial, desoximetasone topical spray, 0.25% is not recommended for use in pediatric patients less than 18 years of age [see Use in Specific Populations ( 8.4 )] .
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Two multi-center, randomized, double-blind, vehicle- controlled clinical trials were conducted in 239 subjects aged 18 years and older with moderate to severe plaque psoriasis of the body. In both trials, randomized subjects applied desoximetasone topical spray, 0.25% or vehicle spray to the affected areas twice daily for 4 weeks. Enrolled subjects had a minimum body surface area of involvement of 10%, and a Physician's Global Assessment score (PGA) of 3 (moderate) or 4 (severe).
Efficacy was assessed at Week 4 as the proportion of subjects who were considered a Clinical Success ("clear" (0) or "almost clear" (1) according to the PGA scale). Table 2 presents the efficacy results. Table 2.
Number of Subjects (%) with Clinical Success (scored as clear or almost clear) at Week 4. Paramete r Trial 1 Trial 2 Desoximetasone Topical Spray, 0.25% N=59 Vehicle N=60 Desoximetasone Topical Spray, 0.25% N=60 Vehicle N=60 Clinical Success 18 (30.5%) 3 (5.0%) 32 (53.3%) 11 (18.3%)
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of desoximetasone topical spray, 0.25%. In a 13-week repeat-dose toxicity study in rats, topical administration of desoximetasone spray at concentrations of 0.001, 0.005 and 0.02% BID (which corresponds to dose levels of 0.01, 0.05, or 0.2 mg/kg/dose BID, respectively) resulted in a toxicity profile consistent with long-term exposure to corticosteroids, including adrenal atrophy and histopathological changes in several organ systems indicative of severe immune suppression.
A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis. Desoximetasone revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster ovary cell chromosome aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay).
No evidence of impairment of male or female fertility was observed at subcutaneous desoximetasone doses up to 0.1 mg/kg/day (0.6 mg/m 2 /day) in Sprague-Dawley rats.
📄 Patient Package Insert ▾
PATIENT INFORMATION Desoximetasone Topical Spray, 0.25% (des-OX-i-MET-a-sone) Important information: Desoximetasone topical spray, 0.25% is for use on skin (topical) only . Do not get desoximetasone topical spray, 0.25% near or in your mouth, eyes or vagina. What is Desoximetasone Topical Spray, 0.25%?
Desoximetasone topical spray, 0.25% is a prescription corticosteroid medicine used to treat plaque psoriasis of the body in people 18 years of age and older. It is not known if desoximetasone topical spray, 0.25% is safe and effective in children under 18 years of age. Desoximetasone topical spray, 0.25% is not recommended for use in children under 18 years of age.
Before you use Desoximetasone Topical Spray, 0.25%, tell your doctor about all of your medical conditions, including if you: have had irritation or other skin reaction to a steroid medicine in the past. have a skin infection. You may need medicine to treat the skin infection before you use desoximetasone topical spray, 0.25%. have thinning of the skin (atrophy) at the treatment site have adrenal gland problems have diabetes liver problems are pregnant or plan to become pregnant. It is not known if desoximetasone topical spray, 0.25% will harm your unborn baby.
Desoximetasone topical spray, 0.25%. may increase your chance of having a low birthweight baby. If you use desoximetasone topical spray, 0.25%. during pregnancy, use desoximetasone topical spray, 0.25%. on the smallest area of the skin and for the shortest time needed. are breastfeeding or plan to breastfeed. It is not known if desoximetasone passes into your breast milk.
If you use desoximetasone topical spray, 0.25% and breastfeed, use desoximetasone topical spray, 0.25% on the smallest area of the skin and for the shortest time needed. Do not apply desoximetasone topical spray, 0.25% directly to the nipple and areola to avoid contact with your baby. Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements.
Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Do not use other products containing a corticosteroid medicine while using desoximetasone topical spray, 0.25% without talking to your doctor first. What should I avoid while using Desoximetasone Topical Spray, 0.25%?
Desoximetasone Topical Spray, 0.25% is flammable. Avoid heat, flames or smoking while applying desoximetasone topical spray, 0.25% to your skin. How should I use Desoximetasone Topical Spray, 0.25%?
See the "Instructions for Use" for detailed information about the right way to apply desoximetasone topical spray, 0.25%. Use desoximetasone topical spray, 0.25% exactly as your doctor tells you to use it. Your doctor should tell you how much desoximetasone topical spray, 0.25% to use and where to use it.
Apply desoximetasone topical spray, 0.25% to the affected skin areas 2 times a day and rub it in gently. Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to. Use Desoximetasone topical spray, 0.25% for the shortest amount of time needed to treat your plaque psoriasis.
Tell your doctor if your skin condition is not getting better after 4 weeks of using desoximetasone topical spray, 0.25%. You should not use desoximetasone topical spray, 0.25% for longer than 4 weeks. Do not use desoximetasone topical spray, 0.25% on your face, armpits or groin.
Do not use desoximetasone topical spray, 0.25% if you have thinning of your skin (atrophy) at the treatment site. Wash your hands after applying desoximetasone topical spray, 0.25%. What are the possible side effects of Desoximetasone Topical Spray, 0.25%?
Desoximetasone topical spray, 0.25% may cause serious side effects, including: Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment with desoximetas… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Desoximetasone Topical Spray, 0.25% 100 mL Bottle Carton NDC 68180-944-33 Rx only For Topical Use Only Not For Oral, Ophthalmic, or Intravaginal Use 100 ml container carton 100 ml