Dexocort

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Dexocort uses


1 INDICATIONS AND USAGE

Dexocort® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

Dexocort® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older (1).

2 DOSAGE AND ADMINISTRATION

Apply Dexocort® Topical Spray as a thin film to the affected skin areas twice daily. Rub in gently.

The treated skin area should not be bandaged or otherwise covered or wrapped unless directed by the physician.

Dexocort® Topical Spray should be discontinued when control is achieved.

Treatment beyond 4 weeks is not recommended.

Do not use if atrophy is present at the treatment site.

Avoid use on the face, axilla or groin.

Dexocort® Topical Spray is for external use only. It is not for oral, ophthalmic, or intravaginal use.

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3 DOSAGE FORMS AND STRENGTHS

Topical Spray, 0.25%. Each gram of Dexocort® Topical Spray contains 2.5 mg of Dexocort in a clear, colorless liquid.

Spray, 0.25% w/w (3)

4 CONTRAINDICATIONS

None

None (4)

5 WARNINGS AND PRECAUTIONS

5.1 Effect on Endocrine System

Dexocort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10-15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Dexocort® Topical Spray twice a day for 28 days. [see Clinical Pharmacology (12.2) ]

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in Specific Populations (8.4) ]

5.2 Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

5.3 Allergic Contact Dermatitis with Topical Corticosteroids

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

5.4 Concomitant Skin Infections

Concomitant skin infections should be treated with an appropriate antimicrobial agent.

If the infection persists, Dexocort® Topical Spray should be discontinued until the infection has been adequately treated.

5.5 Flammable Contents

Dexocort® Topical Spray is flammable; keep away from heat or flame.

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6 ADVERSE REACTIONS

The most common adverse reactions are application site dryness, application site irritation and application site pruritus. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Taro 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 Dexocort® Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Dexocort® Topical Spray.

Adverse reactions that occurred in ≥ 1% of subjects treated with Dexocort® Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%).

Another less common adverse reaction (<1% but >0.1%) was folliculitis.

Dexocort® 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%)
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Dexocort® Topical Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

Dexocort has been shown to be teratogenic and 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 Dexocort® Topical Spray based on a body surface area comparison.

8.3 Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Dexocort® Topical Spray is administered to a nursing woman.

If used during lactation, Dexocort® Topical Spray should not be applied on the chest to avoid accidental ingestion by the infant.

8.4 Pediatric Use

Safety and effectiveness of Dexocort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. 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 effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. [see Warnings and Precautions ]

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. [see Warnings and Precautions (5.1) ]

8.5 Geriatric Use

Clinical studies of Dexocort® 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.

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10 OVERDOSAGE

Dexocort® Topical Spray can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions (5.1) ]

11 DESCRIPTION

Dexocort® (desoximetasone) Topical Spray, 0.25% contains Dexocort as the active ingredient.

Dexocort is a corticosteroid with the chemical name of pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-, (11β,16α)-.

Dexocort has the molecular formula of C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.

The structural formula is:

Each gram of Dexocort® Topical Spray contains 2.5 mg of Dexocort in a clear, colorless liquid with the following inactive ingredients: glyceryl oleate, isopropyl alcohol (23.4%), isopropyl myristate, L-menthol, and mineral oil. Dexocort® Topical Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

Chemical Structure

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 studies performed with Dexocort® Topical Spray in healthy subjects indicate that it is in the high to super-high range of potency as compared with other topical corticosteroids.

The potential for hypothalamic-pituitary-adrenal axis suppression was evaluated in a study of 24 adult subjects with moderate to severe plaque psoriasis. Dexocort® Topical Spray was applied twice a day for 28 days. Twenty-one 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 this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-min post cosyntropin stimulation. In the 2 subjects with available follow-up values, suppression reversed 28 days after the end of treatment.

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 Dexocort were measured at two single random time points in the HPA axis suppression trial in 24 subjects with psoriasis [see Clinical Pharmacology (12.2) ]. The mean (% Coefficient of Variation) concentration of Dexocort was 449 pg/mL (86%) at Day 14 and 678 pg/mL (135%) at Day 28. The concentration time profile following application of Dexocort® Topical Spray is not known.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Dexocort® Topical Spray.

In a 13-week repeat-dose toxicity study in rats, topical administration of Dexocort 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.

Dexocort 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 Dexocort doses up to 0.1 mg/kg/day (0.6 mg/m2/day) in Sprague-Dawley rats.

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 Dexocort ® 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.

Parameter Trial 1 Trial 2
Dexocort®

N=59

Vehicle

N=60

Dexocort®

N=60

Vehicle

N=60

Clinical Success 18 (30.5%) 3 (5.0%) 32 (53.3%) 11 (18.3%)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied/Storage

Dexocort® Topical Spray, 0.25% is a clear colorless liquid supplied in white, opaque bottles with white, opaque screw caps in the following sizes:


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). 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

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Inform patients of the following:


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-6681-3 111

Instructions for Use

Dexocort® (Top-i-cort)

(desoximetasone) Topical Spray

Important information: Dexocort® Topical Spray is for use on skin only. Do not get Dexocort® Topical Spray near or in your mouth, eyes or vagina.

Read the Instructions for Use that comes with Dexocort® Topical Spray before you start using it 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 Dexocort® Topical Spray bottle

Figure A

How to apply Dexocort® 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 Dexocort® Topical Spray to the affected area as instructed by your doctor. (See Figure B )

Figure B

Step 3: Spray only enough Dexocort® Topical Spray to cover the affected area, for example, the elbow

(See Figure C ). Rub in Dexocort® Topical Spray gently.

Figure C

Repeat Steps 2 and 3 to apply Dexocort® Topical Spray to other affected areas as instructed by your doctor.

Step 4: After applying Dexocort® Topical Spray, place the cap back onto the pump top. (See Figure D )

Figure D

This Patient Information and Instructions for Use have 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

Dexocort® and TaroPharma® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates.

Issued: 04/2013

PK-7265-0 110

Figure A Figure B Figure C Figure D

PATIENT INFORMATION

Dexocort® (Top-i-cort)

(desoximetasone) Topical Spray

Important information: Dexocort® Topical Spray is for use on skin only. Do not get Dexocort® Topical Spray near or in your eyes, mouth or vagina.

What is Dexocort® Topical Spray?


Before you use Dexocort® Topical Spray, tell your doctor if you:


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.

What should I avoid while using Dexocort® Topical Spray?

Dexocort® Topical Spray is flammable. Avoid heat, flames or smoking while applying Dexocort® Topical Spray to your skin.

How should I use Dexocort® Topical Spray?


See the "Instructions for Use" at the end of the Patient Information for detailed information about the right way to apply Dexocort® Topical Spray.

What are the possible side effects of Dexocort® Topical Spray?

Dexocort® Topical Spray may cause serious side effects, including:


The most common side effects of Dexocort® Topical Spray include dryness, irritation and itching of skin at the treated site.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Dexocort® Topical Spray. For more information, ask your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

How should I store Dexocort® Topical Spray?


General information about the safe and effective use of Dexocort® Topical Spray.


What are the ingredients in Dexocort® Topical Spray?

Active ingredient: Dexocort

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

Issued: 04/2013

PK-7265-0 110

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

NDC 51672-5281-7

100 mL

Rx only

Dexocort ®

(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

Dexocort pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Dexocort available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Dexocort destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Dexocort Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Dexocort pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."TOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."DESOXIMETASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "desoximetasone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Dexocort?

Depending on the reaction of the Dexocort after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dexocort not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Dexocort addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Dexocort, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dexocort consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Dexocort is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Expensive1
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Dexocort drug as prescribed by the doctor?

Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Dexocort is mentioned below.
Visitors%
Once in a day1
100.0%

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Three visitors reported age

Visitors%
46-602
66.7%
30-451
33.3%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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