Topicort Spray

• It is used to treat skin rashes.
• It is used to treat psoriasis.

Use Topicort Spray as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• This medicine may catch on fire. Do not use near an open flame or while smoking.
• Do not put on the face, underarms, or the groin area. Do not put on skin that is thinning.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

None

Effect on Endocrine System

Topicort® 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 Topicort® 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)]

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.

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.

Concomitant Skin Infections

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

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

Flammable Contents

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

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

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.

The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression was evaluated in a study of 24 adult subjects with moderate to severe plaque psoriasis. Topicort® 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.

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 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.

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/m2/day) in Sprague-Dawley rats.

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

Inform patients of the following:

• Use this medication as directed by the physician.
• Topicort® Topical Spray is for external use only. Avoid use on the face, axilla or groin.
• Do not to use this medication for any disorder other than that for which it was prescribed.
• Do not bandage or otherwise cover or wrap the treated skin so as to be occlusive.
• Report any signs of local or systemic adverse reactions to the physician.
• Do not use other corticosteroid-containing products with Topicort® Topical Spray without first consulting with the physician.
• Discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact the physician.
• This medication is flammable; avoid heat, flame, or smoking when applying this product.
• Discard this product 30 days after dispensed by pharmacist.

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
TOPICORT® (Top-i-cort)
(desoximetasone) Topical Spray

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

Read the Instructions for Use that comes with Topicort® 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 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.

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

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

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

Issued: 04/2013
PK-7265-0   110

PATIENT INFORMATION
TOPICORT® (Top-i-cort)
(desoximetasone) Topical Spray

Important information: Topicort® Topical Spray is for use on skin only. Do not get Topicort® Topical Spray near or in your eyes, mouth 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.
• You should not use Topicort® Topical Spray on your face, underarms (armpits), or groin areas.
• It is not known if Topicort® Topical Spray is safe and effective in children under 18 years of age. Topicort® Topical Spray should not be used in children under 18 years of age.

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

• are allergic to any of the ingredients in Topicort® Topical Spray. See the end of this leaflet for a list of the ingredients in Topicort® Topical Spray.
• 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 any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Topicort® Topical Spray will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Topicort® Topical Spray passes into your breast milk. Do not apply Topicort® Topical Spray to your chest area if you are breastfeeding. This will help to prevent your baby from accidentally getting Topicort® Topical Spray into the mouth.

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 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?

• Use Topicort® Topical Spray exactly as your doctor tells you to use it.
• Apply Topicort® Topical Spray 2 times a day.
• Do not bandage, cover, or wrap the treated skin area.
• Topicort® Topical Spray should be used 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.
• Wash your hands after applying Topicort® Topical Spray.
• Safely throw away (discard) any unused Topicort® Topical Spray after 30 days.

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

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

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

• Topicort® Topical Spray can pass through your skin. Too much Topicort® Topical Spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.

The most common side effects of Topicort® 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 Topicort® 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 Topicort® Topical Spray?

• Store Topicort® Topical Spray at room temperature between 68°F to 77°F (20°C to 25°C).
• 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.

• Do not use Topicort® Topical Spray for a condition for which it was not prescribed. If you would like more information, talk with your doctor. 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

Issued: 04/2013
PK-7265-0   110

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®