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| Product NDC Code | 51672-5281 | ||||||||||||
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| Drug Name | Topicort |
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| Type | Brand | ||||||||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | SPRAY | ||||||||||||
| RxCUI drug identifier | 1376338, 1376340 |
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| Application Number | NDA204141 | ||||||||||||
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. | ||||||||||||
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Overdosage of Topicort
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Topicort Topical Spray can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ] .
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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 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 Topicort Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Topicort Topical Spray. Adverse reactions that occurred in ≥ 1% of subjects treated with Topicort Topical Spray are presented in Table 1. Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Topicort 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. 6.2 Postmarketing 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.
| Topicort Topical Spray, 0.25% | Vehicle spray | |
|---|---|---|
| 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%) |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism 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. 12.2 Pharmacodynamics Vasoconstrictor Assay Vasoconstrictor studies performed with Topicort Topical Spray 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. Topicort Topical Spray 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, Topicort Topical Spray is not recommended for use in pediatric patients less than 18 years of age [see Use in Specific Populations (8.4) ]. 12.3 Pharmacokinetics 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 Topicort Topical Spray 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).
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism 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.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics Vasoconstrictor Assay Vasoconstrictor studies performed with Topicort Topical Spray 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. Topicort Topical Spray 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, Topicort Topical Spray is not recommended for use in pediatric patients less than 18 years of age [see Use in Specific Populations (8.4) ].
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics 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 Topicort Topical Spray 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).
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS None None ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION Topicort ® (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-, (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 Topicort ® 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. Topicort ® Topical Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Apply Topicort Topical Spray 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. Topicort 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 ) 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 )
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Topical Spray, 0.25%. Each gram of Topicort Topical Spray contains 2.5 mg of desoximetasone in a clear, colorless liquid. Spray, 0.25% w/w ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Topicort ® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. Topicort ® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older ( 1 ).
Spl product data elements
Usually a list of ingredients in a drug product.Topicort Desoximetasone Desoximetasone Desoximetasone glyceryl oleate isopropyl alcohol isopropyl myristate Levomenthol mineral oil
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of Topicort Topical Spray. 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.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of Topicort Topical Spray. 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.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton NDC 51672-5281-7 100 mL Rx only Topicort ® (desoximetasone) Topical Spray, 0.25% 0.25% SPRAY For Topical Use Only Not For Oral, Ophthalmic, or Intravaginal Use TaroPharma ® PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: TaroPharma ® a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: September 2021 PK-6681-4 113
Topicort: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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. Topicort Topical Spray 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 Topicort Topical Spray without first consulting with the physician. Advise patients that Topicort Topical Spray 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 Topicort Topical Spray on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply Topicort Topical Spray 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.
Instructions for use
Information about safe handling and use of the drug product.Instructions for Use TOPICORT ® (Top-i-cort) (desoximetasone) topical spray Important information: Topicort Topical Spray is for use on skin (topical) only. Do not get Topicort Topical Spray near or in your mouth, eyes or vagina. Read the Instructions for Use before you start using Topicort Topical Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. Parts of Topicort Topical Spray bottle (See Figure A ). Figure A How to apply Topicort Topical Spray: Step 1: Remove the cap from the pump top. Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply Topicort Topical Spray to the affected area as instructed by your doctor. (See Figure B ). Figure B Step 3: Spray only enough Topicort Topical Spray to cover the affected area, for example, the elbow ( See Figure C ). Rub in Topicort Topical Spray gently to the affected area. Figure C Repeat Steps 2 and 3 to apply Topicort Topical Spray to other affected areas as instructed by your doctor. Step 4: After applying Topicort Topical Spray, place the cap back onto the pump top (See Figure D ). Figure D How should I store Topicort Topical Spray? Store Topicort Topical Spray at room temperature between 68˚F to 77˚F (20˚C to 25˚C). Throw away (discard) unused Topicort Topical Spray 30 days after it has been opened. Topicort Topical Spray is flammable. Keep away from heat, flames or smoke. Keep Topicort Topical Spray and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Topicort ® and TaroPharma ® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates. Revised: September 2021 PK-7265-0 110 Figure A Figure B Figure C Figure D
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.PATIENT INFORMATION TOPICORT ® (Top-i-cort) (desoximetasone) topical spray This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: September 2021 Important information: Topicort Topical Spray is for use on skin (topical) only . Do not get Topicort Topical Spray near or in your mouth, eyes or vagina. What is Topicort Topical Spray? Topicort Topical Spray 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 Topicort Topical Spray is safe and effective in children under 18 years of age. Topicort Topical Spray is not recommended for use in children under 18 years of age. Before you use Topicort Topical Spray, 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 Topicort Topical Spray. 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 Topicort Topical Spray will harm your unborn baby. Topicort Topical Spray may increase your chance of having a low birthweight baby. If you use Topicort Topical Spray during pregnancy, use Topicort Topical Spray on the smallest area of the skin and for the shortest time needed. are breastfeeding or plan to breastfeed. It is not known if Topicort Topical Spray passes into your breast milk. If you use Topicort Topical Spray and breastfeed, use Topicort Topical Spray on the smallest area of the skin and for the shortest time needed. Do not apply Topicort Topical spray 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 Topicort Topical Spray without talking to your doctor first. What should I avoid while using Topicort Topical Spray? Topicort Topical Spray is flammable. Avoid heat, flames or smoking while applying Topicort Topical Spray to your skin. How should I use Topicort Topical Spray? See the " Instructions for Use " for detailed information about the right way to apply Topicort Topical Spray. Use Topicort Topical Spray exactly as your doctor tells you to use it. Your doctor should tell you how much Topicort Topical Spray to use and where to use it. Apply Topicort Topical Spray 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 Topicort Topical Spray 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 Topicort Topical Spray. You should not use Topicort Topical Spray for longer than 4 weeks. Do not use Topicort Topical Spray on your face, armpits or groin. Do not use Topicort Topical Spray if you have thinning of your skin (atrophy) at the treatment site. Wash your hands after applying Topicort Topical Spray. What are the possible side effects of Topicort Topical Spray? Topicort Topical Spray 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 Topicort Topical Spray . Your doctor may do blood tests to check for adrenal gland problems. Cushing's syndrome , a condition that happens when your body is exposed to large amounts of the hormone cortisol. Your doctor may do tests to check for this. High blood sugar (hyperglycemia) or diabetes mellitus that has not been diagnosed can happen when treated with Topicort Topical Spray. Your doctor may do tests to check for this . Skin reactions at the treated skin site. Tell your doctor if you get any skin reactions or skin infections. Eye problems. Using Topicort Topical Spray may increase your chance of getting cataracts and glaucoma. Do not get Topicort Topical Spray in your eyes because it may cause eye irritation. Tell your doctor if you have blurred vision or other vision problems during treatment with Topicort Topical Spray. The most common side effects of Topicort Topical Spray include dryness, irritation and itching of skin at the treated site. These are not all of the possible side effects of Topicort Topical Spray. 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 Topicort Topical Spray? Store Topicort Topical Spray at room temperature between 68˚F to 77˚F (20˚C to 25˚C). Throw away (discard) unused Topicort Topical Spray after 30 days. Keep Topicort Topical Spray and all medicines out of the reach of children. General information about the safe and effective use of Topicort Topical Spray. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Topicort Topical Spray for a condition for which it was not prescribed. Do not give Topicort Topical Spray to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about Topicort Topical Spray that is written for health professionals. What are the ingredients in Topicort Topical Spray? Active ingredient: desoximetasone Inactive ingredients: glyceryl oleate, isopropyl alcohol, isopropyl myristate, L-menthol, and mineral oil Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 PK-7265-0 110
| PATIENT INFORMATION TOPICORT® (Top-i-cort) (desoximetasone) topical spray |
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| This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: September 2021 |
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Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.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 Topicort Topical Spray 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. Parameter Trial 1 Trial 2 Topicort N=59 Vehicle N=60 Topicort N=60 Vehicle N=60 Clinical Success 18 (30.5%) 3 (5.0%) 32 (53.3%) 11 (18.3%)
| Parameter | Trial 1 | Trial 2 | ||
|---|---|---|---|---|
| Topicort N=59 | Vehicle N=60 | Topicort N=60 | Vehicle N=60 | |
| 18 (30.5%) | 3 (5.0%) | 32 (53.3%) | 11 (18.3%) | |
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Clinical studies of Topicort Topical Spray 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.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use The safety and effectiveness of Topicort Topical Spray have not been established in pediatric patients for the treatment of plaque psoriasis. Topicort Topical Spray 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 Topicort Topical Spray 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 Topicort Topical Spray. 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.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy 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 Topicort Topical Spray, may be associated with an increased risk of low birthweight infants (see Data ). Advise pregnant woman that Topicort Topical Spray may increase the potential risk of low birth weight infants and to use Topicort Topical Spray 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 Topicort Topical Spray 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.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 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 Topicort Topical Spray, may be associated with an increased risk of low birthweight infants (see Data ). Advise pregnant woman that Topicort Topical Spray may increase the potential risk of low birth weight infants and to use Topicort Topical Spray 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 Topicort Topical Spray 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. 8.2 Lactation 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 Topicort Topical Spray and any potential adverse effects on the breastfed infant from Topicort Topical Spray or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use Topicort Topical Spray on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Topicort Topical Spray directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ]. 8.4 Pediatric Use The safety and effectiveness of Topicort Topical Spray have not been established in pediatric patients for the treatment of plaque psoriasis. Topicort Topical Spray 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 Topicort Topical Spray 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 Topicort Topical Spray. 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. 8.5 Geriatric Use Clinical studies of Topicort Topical Spray 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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied/Storage Topicort ® (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 51672-5281-3) 50 mL (NDC 51672-5281-4) 100 mL (2- 50mL bottles) (NDC 51672-5281-6) 100 mL (NDC 51672-5281-7) 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"
Storage and handling
Information about safe storage and handling of the drug product.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API