DRUGS & SUPPLEMENTS

Celeston

Name: Celeston drug & pharmaceuticals. Celeston available forms, doses, prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Celeston uses

Celeston consists of Betamethasone, Betamethasone Acetate, Betamethasone Sodium Phosphate, Betamethasone Valerate.

Betamethasone:

Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Use in specific populations
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
How supplied/storage and handling
Patient counseling information
Celeston (Betamethasone) reviews

Celeston (Betamethasone) Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Celeston (Betamethasone) Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)

2 DOSAGE AND ADMINISTRATION

Shake well before use.

Apply Celeston (Betamethasone) Spray to the affected skin areas twice daily and rub in gently.

Use Celeston (Betamethasone) Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.

Discontinue Celeston (Betamethasone) Spray when control is achieved.

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

Do not bandage, cover, or wrap the treated skin area unless directed by a physician.

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.

Celeston (Betamethasone) Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Apply to the affected skin areas twice daily. Rub in gently. (2)
Use Celeston (Betamethasone) Spray for up to 4 weeks and not beyond. (2)
Discontinue treatment when control is achieved. (2)
Do not use if atrophy is present at the treatment site. (2)
Do not use with occlusive dressings unless directed by a physician. (2)
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. (2)
Not for oral, ophthalmic, or intravaginal use. (2)

3 DOSAGE FORMS AND STRENGTHS

Spray, 0.05% for topical use. Each gram of Celeston (Betamethasone) Spray contains 0.643 mg Celeston (Betamethasone) dipropionate USP (equivalent to 0.5 mg Celeston (Betamethasone)) in a slightly thickened, white to off-white oil-in-water emulsion.

Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)

4 CONTRAINDICATIONS

None.

None. (4)

5 WARNINGS AND PRECAUTIONS

Celeston Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. (5.1)
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. (5.1)
Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. (5.1)
Modify use if HPA axis suppression develops. (5.1)
High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)
Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects

Celeston (Betamethasone) Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with Celeston (Betamethasone) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Celeston (Betamethasone) Spray twice daily for 29 days .

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required.

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.

Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended .

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of Celeston (Betamethasone) Spray is not recommended in pediatric patients .

5.2 Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.

6 ADVERSE REACTIONS

The most common adverse reactions are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 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 clinical practice.

In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied Celeston (Betamethasone) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Celeston (Betamethasone) Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with Celeston (Betamethasone) Spray for up to 28 days are presented in Table 1.

	Celeston (Betamethasone) Spray b.i.d. (N=352)	Vehicle Spray b.i.d. (N=180)
Application site pruritus	6.0%	9.4%
Application site burning and/or stinging	4.5%	10.0%
Application site pain	2.3%	3.9%
Application site atrophy	1.1%	1.7%

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with Celeston (Betamethasone) spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

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 have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

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

Celeston (Betamethasone) dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

8.3 Nursing Mothers

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

8.4 Pediatric Use

Safety and effectiveness of Celeston 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 greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions (5.1)]

Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

8.5 Geriatric Use

Clinical studies of Celeston (Betamethasone) Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

11 DESCRIPTION

Celeston (Betamethasone) Spray contains 0.0643% Celeston (Betamethasone) dipropionate (equivalent to 0.05% Celeston (Betamethasone)), a synthetic, fluorinated corticosteroid.

The chemical name for Celeston (Betamethasone) dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C₂₈H₃₇FO₇ and the molecular weight is 504.6. The structural formula is shown below.

Each gram of Celeston (Betamethasone) Spray contains 0.643 mg of Celeston (Betamethasone) dipropionate USP (equivalent to 0.5 mg Celeston (Betamethasone)) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients:, butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. Celeston (Betamethasone) Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

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 of Celeston Spray in psoriasis is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with Celeston (Betamethasone) Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

The potential for HPA axis suppression by Celeston (Betamethasone) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Celeston (Betamethasone) Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with Celeston (Betamethasone) Spray for 15 days. No subjects (0 out of 24) treated with Celeston (Betamethasone) Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

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 are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of Celeston (Betamethasone) dipropionate, betamethasone-17-propionate, and Celeston (Betamethasone) were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of Celeston (Betamethasone) dipropionate, while the metabolites, betamethasone-17-propionate and Celeston (Betamethasone), were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

Analyte (pg/mL)	Celeston (Betamethasone) Spray b.i.d. (15 days)	Celeston (Betamethasone) Spray b.i.d. (29 days)
Betamethasone-17-propionate	120 ± 127	63.9 ± 52.6
Celeston (Betamethasone)	119 ± 176	57.6 ± 55.9

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Celeston (Betamethasone) dipropionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of Celeston (Betamethasone) dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen 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 of carcinogenesis.

Celeston (Betamethasone) was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

14 CLINICAL STUDIES

Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied Celeston (Betamethasone) Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).

Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-grade reduction from baseline). Table 3 presents the efficacy results at Day 15 and Day 29.

^a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.
	Study 1		Study 2
	Celeston (Betamethasone) Spray *b.i.d.* (N=182)	Vehicle Spray *b.i.d.* (N=95)	Celeston (Betamethasone) Spray *b.i.d.* (N=174)	Vehicle Spray *b.i.d.* (N=87)
Treatment Success at Day 15	21.5%	7.4%	19.0%	2.3%
Treatment Success at Day 29	42.7%	11.7%	34.5%	13.6%

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied/Storage

Celeston Spray is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes:

60 mL (NDC 67857-808-17)
120 mL (NDC 67857-808-04)

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .

Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

16.2 Handling/Instructions for the Pharmacist

Remove the spray pump from the wrapper.
Remove and discard the cap from the bottle.
Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly.
Dispense the bottle with the spray pump inserted.
Include the date dispensed in the space provided on the carton.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform patients of the following:

Discontinue therapy when control is achieved, unless directed otherwise by the physician.
Do not use for longer than 4 consecutive weeks.
Avoid contact with the eyes.
Avoid use of Celeston (Betamethasone) Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician.
Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Celeston (Betamethasone) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007465

140728

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 02/2016

PATIENT INFORMATION
Celeston (Betamethasone) (ser-ne-vo)
(betamethasone dipropionate)

Spray, 0.05%

Important: Celeston (Betamethasone) Spray is for use on the skin only. Do not get Celeston (Betamethasone) Spray near or in your eyes, mouth, or vagina.

What is Celeston (Betamethasone) Spray?

Celeston (Betamethasone) Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.

It is not known if Celeston (Betamethasone) Spray is safe and effective in children under 18 years of age. Celeston (Betamethasone) Spray is not recommended for use in patients under 18 years of age.

Before you use Celeston (Betamethasone) Spray, tell your doctor about all of your medical conditions, including if you:

are allergic to any of the ingredients in Celeston (Betamethasone) Spray. See the end of this leaflet for a list of the ingredients in Celeston (Betamethasone) Spray.
have thinning of the skin (atrophy) at the treatment site
are pregnant or plan to become pregnant. It is not known if Celeston (Betamethasone) Spray will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Celeston (Betamethasone) Spray passes into breast milk.

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.

How should I use Celeston (Betamethasone) Spray?

See the “Instructions for Use” for detailed information about the right way to apply Celeston (Betamethasone) Spray.

Use Celeston (Betamethasone) Spray exactly as your doctor tells you to use it.
Your doctor should tell you how much Celeston (Betamethasone) Spray to use and where to apply it.
Apply Celeston (Betamethasone) Spray 2 times a day.
Use Celeston (Betamethasone) 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 Celeston (Betamethasone) Spray. Do not use Celeston (Betamethasone) Spray for longer than 4 weeks.
Wash your hands after applying Celeston (Betamethasone) Spray.
Do not use Celeston (Betamethasone) Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.
Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.

What are the possible side effects of Celeston (Betamethasone) Spray?

Celeston (Betamethasone) Spray can pass through your skin. Too much Celeston (Betamethasone) 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 Celeston (Betamethasone) Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.

These are not all the possible side effects of Celeston (Betamethasone) 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 Celeston (Betamethasone) Spray?

Store Celeston (Betamethasone) Spray at room temperature between 68°F to 77°F (20°C to 25°C)
Throw away (discard) any unused Celeston (Betamethasone) Spray after 4 weeks.

Keep Celeston (Betamethasone) Spray and all medicines out of the reach of children.

General information about the safe and effective use of Celeston (Betamethasone) Spray.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Celeston (Betamethasone) Spray for a condition for which it was not prescribed. Do not give Celeston (Betamethasone) Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Celeston (Betamethasone) Spray that is written for health professionals.

What are the ingredients in Celeston (Betamethasone) Spray?

Active ingredient: Celeston (Betamethasone) dipropionate

Inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

007465

140728

Instructions for Use

Celeston (Betamethasone) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

Important: Celeston (Betamethasone) Spray is for use on the skin only. Do not get Celeston (Betamethasone) Spray near or in your eyes, mouth, or vagina.

Read this “Instructions for Use” before you start using Celeston (Betamethasone) 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 treatment.

Parts of the Celeston (Betamethasone) Spray bottle.

Figure A

How to apply Celeston (Betamethasone) Spray:

Step 1: Shake the Celeston (Betamethasone) Spray bottle well. 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 Celeston (Betamethasone) Spray to the affected area as instructed by your doctor. (See Figure B )

Figure B

Step 3: Spray only enough Celeston (Betamethasone) Spray to cover the affected area, for example, the elbow (See Figure C ). Rub in Celeston (Betamethasone) Spray gently.

Figure C

Repeat Steps 2 and 3 to apply Celeston (Betamethasone) Spray to other affected areas as instructed by your doctor.

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

Figure D

How should I store Celeston (Betamethasone) Spray?

Store Celeston (Betamethasone) Spray at room temperature between 68°F to 77°F (20°C to 25°C).
Throw away (discard) any unused Celeston (Betamethasone) Spray after 28 days.

Keep Celeston (Betamethasone) 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.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Celeston (Betamethasone) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007528

140693

Betamethasone Acetate:

Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Use in specific populations
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
How supplied/storage and handling
Patient counseling information
Celeston (Betamethasone Acetate) reviews

Celeston (Betamethasone Acetate) Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Celeston (Betamethasone Acetate) Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)

2 DOSAGE AND ADMINISTRATION

Shake well before use.

Apply Celeston (Betamethasone Acetate) Spray to the affected skin areas twice daily and rub in gently.

Use Celeston (Betamethasone Acetate) Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.

Discontinue Celeston (Betamethasone Acetate) Spray when control is achieved.

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

Do not bandage, cover, or wrap the treated skin area unless directed by a physician.

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.

Celeston (Betamethasone Acetate) Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Apply to the affected skin areas twice daily. Rub in gently. (2)
Use Celeston (Betamethasone Acetate) Spray for up to 4 weeks and not beyond. (2)
Discontinue treatment when control is achieved. (2)
Do not use if atrophy is present at the treatment site. (2)
Do not use with occlusive dressings unless directed by a physician. (2)
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. (2)
Not for oral, ophthalmic, or intravaginal use. (2)

3 DOSAGE FORMS AND STRENGTHS

Spray, 0.05% for topical use. Each gram of Celeston (Betamethasone Acetate) Spray contains 0.643 mg Celeston (Betamethasone Acetate) dipropionate USP (equivalent to 0.5 mg Celeston (Betamethasone Acetate)) in a slightly thickened, white to off-white oil-in-water emulsion.

Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)

4 CONTRAINDICATIONS

None.

None. (4)

5 WARNINGS AND PRECAUTIONS

Celeston Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. (5.1)
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. (5.1)
Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. (5.1)
Modify use if HPA axis suppression develops. (5.1)
High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)
Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects

Celeston (Betamethasone Acetate) Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with Celeston (Betamethasone Acetate) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Celeston (Betamethasone Acetate) Spray twice daily for 29 days .

Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended .

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of Celeston (Betamethasone Acetate) Spray is not recommended in pediatric patients .

5.2 Allergic Contact Dermatitis

6 ADVERSE REACTIONS

The most common adverse reactions are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical Trials Experience

In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied Celeston (Betamethasone Acetate) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Celeston (Betamethasone Acetate) Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with Celeston (Betamethasone Acetate) Spray for up to 28 days are presented in Table 1.

	Celeston (Betamethasone Acetate) Spray b.i.d. (N=352)	Vehicle Spray b.i.d. (N=180)
Application site pruritus	6.0%	9.4%
Application site burning and/or stinging	4.5%	10.0%
Application site pain	2.3%	3.9%
Application site atrophy	1.1%	1.7%

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with Celeston (Betamethasone Acetate) spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

6.2 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

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

Celeston (Betamethasone Acetate) dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

8.3 Nursing Mothers

8.4 Pediatric Use

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

8.5 Geriatric Use

Clinical studies of Celeston (Betamethasone Acetate) Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

11 DESCRIPTION

Celeston (Betamethasone Acetate) Spray contains 0.0643% Celeston (Betamethasone Acetate) dipropionate (equivalent to 0.05% Celeston (Betamethasone Acetate)), a synthetic, fluorinated corticosteroid.

The chemical name for Celeston (Betamethasone Acetate) dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C₂₈H₃₇FO₇ and the molecular weight is 504.6. The structural formula is shown below.

Each gram of Celeston (Betamethasone Acetate) Spray contains 0.643 mg of Celeston (Betamethasone Acetate) dipropionate USP (equivalent to 0.5 mg Celeston (Betamethasone Acetate)) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients:, butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. Celeston (Betamethasone Acetate) Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

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 of Celeston Spray in psoriasis is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with Celeston (Betamethasone Acetate) Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

The potential for HPA axis suppression by Celeston (Betamethasone Acetate) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Celeston (Betamethasone Acetate) Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with Celeston (Betamethasone Acetate) Spray for 15 days. No subjects (0 out of 24) treated with Celeston (Betamethasone Acetate) Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

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 are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of Celeston (Betamethasone Acetate) dipropionate, betamethasone-17-propionate, and Celeston (Betamethasone Acetate) were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of Celeston (Betamethasone Acetate) dipropionate, while the metabolites, betamethasone-17-propionate and Celeston (Betamethasone Acetate), were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

Analyte (pg/mL)	Celeston (Betamethasone Acetate) Spray b.i.d. (15 days)	Celeston (Betamethasone Acetate) Spray b.i.d. (29 days)
Betamethasone-17-propionate	120 ± 127	63.9 ± 52.6
Celeston (Betamethasone Acetate)	119 ± 176	57.6 ± 55.9

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Celeston (Betamethasone Acetate) dipropionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of Celeston (Betamethasone Acetate) dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen 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 of carcinogenesis.

Celeston (Betamethasone Acetate) was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

14 CLINICAL STUDIES

Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied Celeston (Betamethasone Acetate) Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).

^a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.
	Study 1		Study 2
	Celeston (Betamethasone Acetate) Spray *b.i.d.* (N=182)	Vehicle Spray *b.i.d.* (N=95)	Celeston (Betamethasone Acetate) Spray *b.i.d.* (N=174)	Vehicle Spray *b.i.d.* (N=87)
Treatment Success at Day 15	21.5%	7.4%	19.0%	2.3%
Treatment Success at Day 29	42.7%	11.7%	34.5%	13.6%

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied/Storage

60 mL (NDC 67857-808-17)
120 mL (NDC 67857-808-04)

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .

Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

16.2 Handling/Instructions for the Pharmacist

Remove the spray pump from the wrapper.
Remove and discard the cap from the bottle.
Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly.
Dispense the bottle with the spray pump inserted.
Include the date dispensed in the space provided on the carton.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform patients of the following:

Discontinue therapy when control is achieved, unless directed otherwise by the physician.
Do not use for longer than 4 consecutive weeks.
Avoid contact with the eyes.
Avoid use of Celeston (Betamethasone Acetate) Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician.
Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Celeston (Betamethasone Acetate) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007465

140728

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 02/2016

PATIENT INFORMATION
Celeston (Betamethasone Acetate) (ser-ne-vo)
(betamethasone dipropionate)

Spray, 0.05%

Important: Celeston (Betamethasone Acetate) Spray is for use on the skin only. Do not get Celeston (Betamethasone Acetate) Spray near or in your eyes, mouth, or vagina.

What is Celeston (Betamethasone Acetate) Spray?

Celeston (Betamethasone Acetate) Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.

It is not known if Celeston (Betamethasone Acetate) Spray is safe and effective in children under 18 years of age. Celeston (Betamethasone Acetate) Spray is not recommended for use in patients under 18 years of age.

Before you use Celeston (Betamethasone Acetate) Spray, tell your doctor about all of your medical conditions, including if you:

are allergic to any of the ingredients in Celeston (Betamethasone Acetate) Spray. See the end of this leaflet for a list of the ingredients in Celeston (Betamethasone Acetate) Spray.
have thinning of the skin (atrophy) at the treatment site
are pregnant or plan to become pregnant. It is not known if Celeston (Betamethasone Acetate) Spray will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Celeston (Betamethasone Acetate) Spray passes into breast milk.

How should I use Celeston (Betamethasone Acetate) Spray?

See the “Instructions for Use” for detailed information about the right way to apply Celeston (Betamethasone Acetate) Spray.

Use Celeston (Betamethasone Acetate) Spray exactly as your doctor tells you to use it.
Your doctor should tell you how much Celeston (Betamethasone Acetate) Spray to use and where to apply it.
Apply Celeston (Betamethasone Acetate) Spray 2 times a day.
Use Celeston (Betamethasone Acetate) 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 Celeston (Betamethasone Acetate) Spray. Do not use Celeston (Betamethasone Acetate) Spray for longer than 4 weeks.
Wash your hands after applying Celeston (Betamethasone Acetate) Spray.
Do not use Celeston (Betamethasone Acetate) Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.
Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.

What are the possible side effects of Celeston (Betamethasone Acetate) Spray?

Celeston (Betamethasone Acetate) Spray can pass through your skin. Too much Celeston (Betamethasone Acetate) 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 Celeston (Betamethasone Acetate) Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.

These are not all the possible side effects of Celeston (Betamethasone Acetate) 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 Celeston (Betamethasone Acetate) Spray?

Store Celeston (Betamethasone Acetate) Spray at room temperature between 68°F to 77°F (20°C to 25°C)
Throw away (discard) any unused Celeston (Betamethasone Acetate) Spray after 4 weeks.

Keep Celeston (Betamethasone Acetate) Spray and all medicines out of the reach of children.

General information about the safe and effective use of Celeston (Betamethasone Acetate) Spray.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Celeston (Betamethasone Acetate) Spray for a condition for which it was not prescribed. Do not give Celeston (Betamethasone Acetate) Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Celeston (Betamethasone Acetate) Spray that is written for health professionals.

What are the ingredients in Celeston (Betamethasone Acetate) Spray?

Active ingredient: Celeston (Betamethasone Acetate) dipropionate

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

007465

140728

Instructions for Use

Celeston (Betamethasone Acetate) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

Important: Celeston (Betamethasone Acetate) Spray is for use on the skin only. Do not get Celeston (Betamethasone Acetate) Spray near or in your eyes, mouth, or vagina.

Read this “Instructions for Use” before you start using Celeston (Betamethasone Acetate) 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 treatment.

Parts of the Celeston (Betamethasone Acetate) Spray bottle.

Figure A

How to apply Celeston (Betamethasone Acetate) Spray:

Step 1: Shake the Celeston (Betamethasone Acetate) Spray bottle well. 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 Celeston (Betamethasone Acetate) Spray to the affected area as instructed by your doctor. (See Figure B )

Figure B

Step 3: Spray only enough Celeston (Betamethasone Acetate) Spray to cover the affected area, for example, the elbow (See Figure C ). Rub in Celeston (Betamethasone Acetate) Spray gently.

Figure C

Repeat Steps 2 and 3 to apply Celeston (Betamethasone Acetate) Spray to other affected areas as instructed by your doctor.

Step 4: After applying Celeston (Betamethasone Acetate) Spray, place the cap back onto the pump top. (See Figure D )

Figure D

How should I store Celeston (Betamethasone Acetate) Spray?

Store Celeston (Betamethasone Acetate) Spray at room temperature between 68°F to 77°F (20°C to 25°C).
Throw away (discard) any unused Celeston (Betamethasone Acetate) Spray after 28 days.

Keep Celeston (Betamethasone Acetate) 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.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Celeston (Betamethasone Acetate) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007528

140693

Betamethasone Sodium Phosphate:

Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Use in specific populations
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
How supplied/storage and handling
Patient counseling information
Celeston (Betamethasone Sodium Phosphate) reviews

Celeston (Betamethasone Sodium Phosphate) Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Celeston (Betamethasone Sodium Phosphate) Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)

2 DOSAGE AND ADMINISTRATION

Shake well before use.

Apply Celeston (Betamethasone Sodium Phosphate) Spray to the affected skin areas twice daily and rub in gently.

Use Celeston (Betamethasone Sodium Phosphate) Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.

Discontinue Celeston (Betamethasone Sodium Phosphate) Spray when control is achieved.

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

Do not bandage, cover, or wrap the treated skin area unless directed by a physician.

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.

Celeston (Betamethasone Sodium Phosphate) Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Apply to the affected skin areas twice daily. Rub in gently. (2)
Use Celeston (Betamethasone Sodium Phosphate) Spray for up to 4 weeks and not beyond. (2)
Discontinue treatment when control is achieved. (2)
Do not use if atrophy is present at the treatment site. (2)
Do not use with occlusive dressings unless directed by a physician. (2)
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. (2)
Not for oral, ophthalmic, or intravaginal use. (2)

3 DOSAGE FORMS AND STRENGTHS

Spray, 0.05% for topical use. Each gram of Celeston (Betamethasone Sodium Phosphate) Spray contains 0.643 mg Celeston (Betamethasone Sodium Phosphate) dipropionate USP (equivalent to 0.5 mg Celeston (Betamethasone Sodium Phosphate)) in a slightly thickened, white to off-white oil-in-water emulsion.

Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)

4 CONTRAINDICATIONS

None.

None. (4)

5 WARNINGS AND PRECAUTIONS

Celeston Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. (5.1)
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. (5.1)
Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. (5.1)
Modify use if HPA axis suppression develops. (5.1)
High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)
Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects

Celeston (Betamethasone Sodium Phosphate) Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with Celeston (Betamethasone Sodium Phosphate) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Celeston (Betamethasone Sodium Phosphate) Spray twice daily for 29 days .

Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended .

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of Celeston (Betamethasone Sodium Phosphate) Spray is not recommended in pediatric patients .

5.2 Allergic Contact Dermatitis

6 ADVERSE REACTIONS

The most common adverse reactions are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical Trials Experience

In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied Celeston (Betamethasone Sodium Phosphate) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Celeston (Betamethasone Sodium Phosphate) Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with Celeston (Betamethasone Sodium Phosphate) Spray for up to 28 days are presented in Table 1.

	Celeston (Betamethasone Sodium Phosphate) Spray b.i.d. (N=352)	Vehicle Spray b.i.d. (N=180)
Application site pruritus	6.0%	9.4%
Application site burning and/or stinging	4.5%	10.0%
Application site pain	2.3%	3.9%
Application site atrophy	1.1%	1.7%

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with Celeston (Betamethasone Sodium Phosphate) spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

6.2 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

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

Celeston (Betamethasone Sodium Phosphate) dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

8.3 Nursing Mothers

8.4 Pediatric Use

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

8.5 Geriatric Use

Clinical studies of Celeston (Betamethasone Sodium Phosphate) Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

11 DESCRIPTION

Celeston (Betamethasone Sodium Phosphate) Spray contains 0.0643% Celeston (Betamethasone Sodium Phosphate) dipropionate (equivalent to 0.05% Celeston (Betamethasone Sodium Phosphate)), a synthetic, fluorinated corticosteroid.

The chemical name for Celeston (Betamethasone Sodium Phosphate) dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C₂₈H₃₇FO₇ and the molecular weight is 504.6. The structural formula is shown below.

Each gram of Celeston (Betamethasone Sodium Phosphate) Spray contains 0.643 mg of Celeston (Betamethasone Sodium Phosphate) dipropionate USP (equivalent to 0.5 mg Celeston (Betamethasone Sodium Phosphate)) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients:, butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. Celeston (Betamethasone Sodium Phosphate) Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

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 of Celeston Spray in psoriasis is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with Celeston (Betamethasone Sodium Phosphate) Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

The potential for HPA axis suppression by Celeston (Betamethasone Sodium Phosphate) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Celeston (Betamethasone Sodium Phosphate) Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with Celeston (Betamethasone Sodium Phosphate) Spray for 15 days. No subjects (0 out of 24) treated with Celeston (Betamethasone Sodium Phosphate) Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

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 are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of Celeston (Betamethasone Sodium Phosphate) dipropionate, betamethasone-17-propionate, and Celeston (Betamethasone Sodium Phosphate) were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of Celeston (Betamethasone Sodium Phosphate) dipropionate, while the metabolites, betamethasone-17-propionate and Celeston (Betamethasone Sodium Phosphate), were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

Analyte (pg/mL)	Celeston (Betamethasone Sodium Phosphate) Spray b.i.d. (15 days)	Celeston (Betamethasone Sodium Phosphate) Spray b.i.d. (29 days)
Betamethasone-17-propionate	120 ± 127	63.9 ± 52.6
Celeston (Betamethasone Sodium Phosphate)	119 ± 176	57.6 ± 55.9

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Celeston (Betamethasone Sodium Phosphate) dipropionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of Celeston (Betamethasone Sodium Phosphate) dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen 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 of carcinogenesis.

Celeston (Betamethasone Sodium Phosphate) was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

14 CLINICAL STUDIES

Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied Celeston (Betamethasone Sodium Phosphate) Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).

^a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.
	Study 1		Study 2
	Celeston (Betamethasone Sodium Phosphate) Spray *b.i.d.* (N=182)	Vehicle Spray *b.i.d.* (N=95)	Celeston (Betamethasone Sodium Phosphate) Spray *b.i.d.* (N=174)	Vehicle Spray *b.i.d.* (N=87)
Treatment Success at Day 15	21.5%	7.4%	19.0%	2.3%
Treatment Success at Day 29	42.7%	11.7%	34.5%	13.6%

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied/Storage

60 mL (NDC 67857-808-17)
120 mL (NDC 67857-808-04)

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .

Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

16.2 Handling/Instructions for the Pharmacist

Remove the spray pump from the wrapper.
Remove and discard the cap from the bottle.
Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly.
Dispense the bottle with the spray pump inserted.
Include the date dispensed in the space provided on the carton.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform patients of the following:

Discontinue therapy when control is achieved, unless directed otherwise by the physician.
Do not use for longer than 4 consecutive weeks.
Avoid contact with the eyes.
Avoid use of Celeston (Betamethasone Sodium Phosphate) Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician.
Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Celeston (Betamethasone Sodium Phosphate) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007465

140728

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 02/2016

PATIENT INFORMATION
Celeston (Betamethasone Sodium Phosphate) (ser-ne-vo)
(betamethasone dipropionate)

Spray, 0.05%

Important: Celeston (Betamethasone Sodium Phosphate) Spray is for use on the skin only. Do not get Celeston (Betamethasone Sodium Phosphate) Spray near or in your eyes, mouth, or vagina.

What is Celeston (Betamethasone Sodium Phosphate) Spray?

Celeston (Betamethasone Sodium Phosphate) Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.

It is not known if Celeston (Betamethasone Sodium Phosphate) Spray is safe and effective in children under 18 years of age. Celeston (Betamethasone Sodium Phosphate) Spray is not recommended for use in patients under 18 years of age.

Before you use Celeston (Betamethasone Sodium Phosphate) Spray, tell your doctor about all of your medical conditions, including if you:

are allergic to any of the ingredients in Celeston (Betamethasone Sodium Phosphate) Spray. See the end of this leaflet for a list of the ingredients in Celeston (Betamethasone Sodium Phosphate) Spray.
have thinning of the skin (atrophy) at the treatment site
are pregnant or plan to become pregnant. It is not known if Celeston (Betamethasone Sodium Phosphate) Spray will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Celeston (Betamethasone Sodium Phosphate) Spray passes into breast milk.

How should I use Celeston (Betamethasone Sodium Phosphate) Spray?

See the “Instructions for Use” for detailed information about the right way to apply Celeston (Betamethasone Sodium Phosphate) Spray.

Use Celeston (Betamethasone Sodium Phosphate) Spray exactly as your doctor tells you to use it.
Your doctor should tell you how much Celeston (Betamethasone Sodium Phosphate) Spray to use and where to apply it.
Apply Celeston (Betamethasone Sodium Phosphate) Spray 2 times a day.
Use Celeston (Betamethasone Sodium Phosphate) 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 Celeston (Betamethasone Sodium Phosphate) Spray. Do not use Celeston (Betamethasone Sodium Phosphate) Spray for longer than 4 weeks.
Wash your hands after applying Celeston (Betamethasone Sodium Phosphate) Spray.
Do not use Celeston (Betamethasone Sodium Phosphate) Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.
Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.

What are the possible side effects of Celeston (Betamethasone Sodium Phosphate) Spray?

Celeston (Betamethasone Sodium Phosphate) Spray can pass through your skin. Too much Celeston (Betamethasone Sodium Phosphate) 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 Celeston (Betamethasone Sodium Phosphate) Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.

These are not all the possible side effects of Celeston (Betamethasone Sodium Phosphate) 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 Celeston (Betamethasone Sodium Phosphate) Spray?

Store Celeston (Betamethasone Sodium Phosphate) Spray at room temperature between 68°F to 77°F (20°C to 25°C)
Throw away (discard) any unused Celeston (Betamethasone Sodium Phosphate) Spray after 4 weeks.

Keep Celeston (Betamethasone Sodium Phosphate) Spray and all medicines out of the reach of children.

General information about the safe and effective use of Celeston (Betamethasone Sodium Phosphate) Spray.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Celeston (Betamethasone Sodium Phosphate) Spray for a condition for which it was not prescribed. Do not give Celeston (Betamethasone Sodium Phosphate) Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Celeston (Betamethasone Sodium Phosphate) Spray that is written for health professionals.

What are the ingredients in Celeston (Betamethasone Sodium Phosphate) Spray?

Active ingredient: Celeston (Betamethasone Sodium Phosphate) dipropionate

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

007465

140728

Instructions for Use

Celeston (Betamethasone Sodium Phosphate) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

Important: Celeston (Betamethasone Sodium Phosphate) Spray is for use on the skin only. Do not get Celeston (Betamethasone Sodium Phosphate) Spray near or in your eyes, mouth, or vagina.

Read this “Instructions for Use” before you start using Celeston (Betamethasone Sodium Phosphate) 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 treatment.

Parts of the Celeston (Betamethasone Sodium Phosphate) Spray bottle.

Figure A

How to apply Celeston (Betamethasone Sodium Phosphate) Spray:

Step 1: Shake the Celeston (Betamethasone Sodium Phosphate) Spray bottle well. 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 Celeston (Betamethasone Sodium Phosphate) Spray to the affected area as instructed by your doctor. (See Figure B )

Figure B

Step 3: Spray only enough Celeston (Betamethasone Sodium Phosphate) Spray to cover the affected area, for example, the elbow (See Figure C ). Rub in Celeston (Betamethasone Sodium Phosphate) Spray gently.

Figure C

Repeat Steps 2 and 3 to apply Celeston (Betamethasone Sodium Phosphate) Spray to other affected areas as instructed by your doctor.

Step 4: After applying Celeston (Betamethasone Sodium Phosphate) Spray, place the cap back onto the pump top. (See Figure D )

Figure D

How should I store Celeston (Betamethasone Sodium Phosphate) Spray?

Store Celeston (Betamethasone Sodium Phosphate) Spray at room temperature between 68°F to 77°F (20°C to 25°C).
Throw away (discard) any unused Celeston (Betamethasone Sodium Phosphate) Spray after 28 days.

Keep Celeston (Betamethasone Sodium Phosphate) 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.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Celeston (Betamethasone Sodium Phosphate) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007528

140693

Betamethasone Valerate:

Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Use in specific populations
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
How supplied/storage and handling
Patient counseling information
Celeston (Betamethasone Valerate) reviews

Celeston (Betamethasone Valerate) Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Celeston (Betamethasone Valerate) Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)

2 DOSAGE AND ADMINISTRATION

Shake well before use.

Apply Celeston (Betamethasone Valerate) Spray to the affected skin areas twice daily and rub in gently.

Use Celeston (Betamethasone Valerate) Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.

Discontinue Celeston (Betamethasone Valerate) Spray when control is achieved.

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

Do not bandage, cover, or wrap the treated skin area unless directed by a physician.

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.

Celeston (Betamethasone Valerate) Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Apply to the affected skin areas twice daily. Rub in gently. (2)
Use Celeston (Betamethasone Valerate) Spray for up to 4 weeks and not beyond. (2)
Discontinue treatment when control is achieved. (2)
Do not use if atrophy is present at the treatment site. (2)
Do not use with occlusive dressings unless directed by a physician. (2)
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. (2)
Not for oral, ophthalmic, or intravaginal use. (2)

3 DOSAGE FORMS AND STRENGTHS

Spray, 0.05% for topical use. Each gram of Celeston (Betamethasone Valerate) Spray contains 0.643 mg Celeston (Betamethasone Valerate) dipropionate USP (equivalent to 0.5 mg Celeston (Betamethasone Valerate)) in a slightly thickened, white to off-white oil-in-water emulsion.

Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)

4 CONTRAINDICATIONS

None.

None. (4)

5 WARNINGS AND PRECAUTIONS

Celeston Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. (5.1)
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. (5.1)
Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. (5.1)
Modify use if HPA axis suppression develops. (5.1)
High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)
Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects

Celeston (Betamethasone Valerate) Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with Celeston (Betamethasone Valerate) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Celeston (Betamethasone Valerate) Spray twice daily for 29 days .

Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended .

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of Celeston (Betamethasone Valerate) Spray is not recommended in pediatric patients .

5.2 Allergic Contact Dermatitis

6 ADVERSE REACTIONS

The most common adverse reactions are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical Trials Experience

In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied Celeston (Betamethasone Valerate) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Celeston (Betamethasone Valerate) Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with Celeston (Betamethasone Valerate) Spray for up to 28 days are presented in Table 1.

	Celeston (Betamethasone Valerate) Spray b.i.d. (N=352)	Vehicle Spray b.i.d. (N=180)
Application site pruritus	6.0%	9.4%
Application site burning and/or stinging	4.5%	10.0%
Application site pain	2.3%	3.9%
Application site atrophy	1.1%	1.7%

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with Celeston (Betamethasone Valerate) spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

6.2 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

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

Celeston (Betamethasone Valerate) dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

8.3 Nursing Mothers

8.4 Pediatric Use

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

8.5 Geriatric Use

Clinical studies of Celeston (Betamethasone Valerate) Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

11 DESCRIPTION

Celeston (Betamethasone Valerate) Spray contains 0.0643% Celeston (Betamethasone Valerate) dipropionate (equivalent to 0.05% Celeston (Betamethasone Valerate)), a synthetic, fluorinated corticosteroid.

The chemical name for Celeston (Betamethasone Valerate) dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C₂₈H₃₇FO₇ and the molecular weight is 504.6. The structural formula is shown below.

Each gram of Celeston (Betamethasone Valerate) Spray contains 0.643 mg of Celeston (Betamethasone Valerate) dipropionate USP (equivalent to 0.5 mg Celeston (Betamethasone Valerate)) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients:, butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. Celeston (Betamethasone Valerate) Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

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 of Celeston Spray in psoriasis is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with Celeston (Betamethasone Valerate) Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

The potential for HPA axis suppression by Celeston (Betamethasone Valerate) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Celeston (Betamethasone Valerate) Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with Celeston (Betamethasone Valerate) Spray for 15 days. No subjects (0 out of 24) treated with Celeston (Betamethasone Valerate) Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

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 are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of Celeston (Betamethasone Valerate) dipropionate, betamethasone-17-propionate, and Celeston (Betamethasone Valerate) were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of Celeston (Betamethasone Valerate) dipropionate, while the metabolites, betamethasone-17-propionate and Celeston (Betamethasone Valerate), were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

Analyte (pg/mL)	Celeston (Betamethasone Valerate) Spray b.i.d. (15 days)	Celeston (Betamethasone Valerate) Spray b.i.d. (29 days)
Betamethasone-17-propionate	120 ± 127	63.9 ± 52.6
Celeston (Betamethasone Valerate)	119 ± 176	57.6 ± 55.9

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Celeston (Betamethasone Valerate) dipropionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of Celeston (Betamethasone Valerate) dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen 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 of carcinogenesis.

Celeston (Betamethasone Valerate) was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

14 CLINICAL STUDIES

Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied Celeston (Betamethasone Valerate) Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).

^a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.
	Study 1		Study 2
	Celeston (Betamethasone Valerate) Spray *b.i.d.* (N=182)	Vehicle Spray *b.i.d.* (N=95)	Celeston (Betamethasone Valerate) Spray *b.i.d.* (N=174)	Vehicle Spray *b.i.d.* (N=87)
Treatment Success at Day 15	21.5%	7.4%	19.0%	2.3%
Treatment Success at Day 29	42.7%	11.7%	34.5%	13.6%

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied/Storage

60 mL (NDC 67857-808-17)
120 mL (NDC 67857-808-04)

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .

Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

16.2 Handling/Instructions for the Pharmacist

Remove the spray pump from the wrapper.
Remove and discard the cap from the bottle.
Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly.
Dispense the bottle with the spray pump inserted.
Include the date dispensed in the space provided on the carton.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform patients of the following:

Discontinue therapy when control is achieved, unless directed otherwise by the physician.
Do not use for longer than 4 consecutive weeks.
Avoid contact with the eyes.
Avoid use of Celeston (Betamethasone Valerate) Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician.
Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Celeston (Betamethasone Valerate) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007465

140728

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 02/2016

PATIENT INFORMATION
Celeston (Betamethasone Valerate) (ser-ne-vo)
(betamethasone dipropionate)

Spray, 0.05%

Important: Celeston (Betamethasone Valerate) Spray is for use on the skin only. Do not get Celeston (Betamethasone Valerate) Spray near or in your eyes, mouth, or vagina.

What is Celeston (Betamethasone Valerate) Spray?

Celeston (Betamethasone Valerate) Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.

It is not known if Celeston (Betamethasone Valerate) Spray is safe and effective in children under 18 years of age. Celeston (Betamethasone Valerate) Spray is not recommended for use in patients under 18 years of age.

Before you use Celeston (Betamethasone Valerate) Spray, tell your doctor about all of your medical conditions, including if you:

are allergic to any of the ingredients in Celeston (Betamethasone Valerate) Spray. See the end of this leaflet for a list of the ingredients in Celeston (Betamethasone Valerate) Spray.
have thinning of the skin (atrophy) at the treatment site
are pregnant or plan to become pregnant. It is not known if Celeston (Betamethasone Valerate) Spray will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Celeston (Betamethasone Valerate) Spray passes into breast milk.

How should I use Celeston (Betamethasone Valerate) Spray?

See the “Instructions for Use” for detailed information about the right way to apply Celeston (Betamethasone Valerate) Spray.

Use Celeston (Betamethasone Valerate) Spray exactly as your doctor tells you to use it.
Your doctor should tell you how much Celeston (Betamethasone Valerate) Spray to use and where to apply it.
Apply Celeston (Betamethasone Valerate) Spray 2 times a day.
Use Celeston (Betamethasone Valerate) 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 Celeston (Betamethasone Valerate) Spray. Do not use Celeston (Betamethasone Valerate) Spray for longer than 4 weeks.
Wash your hands after applying Celeston (Betamethasone Valerate) Spray.
Do not use Celeston (Betamethasone Valerate) Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.
Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.

What are the possible side effects of Celeston (Betamethasone Valerate) Spray?

Celeston (Betamethasone Valerate) Spray can pass through your skin. Too much Celeston (Betamethasone Valerate) 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 Celeston (Betamethasone Valerate) Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.

These are not all the possible side effects of Celeston (Betamethasone Valerate) 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 Celeston (Betamethasone Valerate) Spray?

Store Celeston (Betamethasone Valerate) Spray at room temperature between 68°F to 77°F (20°C to 25°C)
Throw away (discard) any unused Celeston (Betamethasone Valerate) Spray after 4 weeks.

Keep Celeston (Betamethasone Valerate) Spray and all medicines out of the reach of children.

General information about the safe and effective use of Celeston (Betamethasone Valerate) Spray.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Celeston (Betamethasone Valerate) Spray for a condition for which it was not prescribed. Do not give Celeston (Betamethasone Valerate) Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Celeston (Betamethasone Valerate) Spray that is written for health professionals.

What are the ingredients in Celeston (Betamethasone Valerate) Spray?

Active ingredient: Celeston (Betamethasone Valerate) dipropionate

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

007465

140728

Instructions for Use

Celeston (Betamethasone Valerate) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

Important: Celeston (Betamethasone Valerate) Spray is for use on the skin only. Do not get Celeston (Betamethasone Valerate) Spray near or in your eyes, mouth, or vagina.

Read this “Instructions for Use” before you start using Celeston (Betamethasone Valerate) 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 treatment.

Parts of the Celeston (Betamethasone Valerate) Spray bottle.

Figure A

How to apply Celeston (Betamethasone Valerate) Spray:

Step 1: Shake the Celeston (Betamethasone Valerate) Spray bottle well. 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 Celeston (Betamethasone Valerate) Spray to the affected area as instructed by your doctor. (See Figure B )

Figure B

Step 3: Spray only enough Celeston (Betamethasone Valerate) Spray to cover the affected area, for example, the elbow (See Figure C ). Rub in Celeston (Betamethasone Valerate) Spray gently.

Figure C

Repeat Steps 2 and 3 to apply Celeston (Betamethasone Valerate) Spray to other affected areas as instructed by your doctor.

Step 4: After applying Celeston (Betamethasone Valerate) Spray, place the cap back onto the pump top. (See Figure D )

Figure D

How should I store Celeston (Betamethasone Valerate) Spray?

Store Celeston (Betamethasone Valerate) Spray at room temperature between 68°F to 77°F (20°C to 25°C).
Throw away (discard) any unused Celeston (Betamethasone Valerate) Spray after 28 days.

Keep Celeston (Betamethasone Valerate) 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.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Celeston (Betamethasone Valerate) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007528

140693

Celeston 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.

Celeston 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.

Cream; Topical; Betamethasone Valerate 0.2%
Emulsion; Topical; Betamethasone Valerate 0.2%
Injectable; Injection; Betamethasone Acetate 3 mg; Betamethasone Sodium Phosphate 3 mg / ml
Ointment; Topical; Betamethasone Valerate 0.2%
Syrup; Oral; Betamethasone Sodium Phosphate 0.6 mg / 5 ml
Tablets; Oral; Betamethasone 0.6 mg

Celeston 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.

Human:
Adrenals
Anti-inflammatory agents

Celeston 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.

H02AB01 - Betamethasone

Celeston 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.

References

Dailymed."LUXIQ (BETAMETHASONE VALERATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."BETAMETHASONE: 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).
"betamethasone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Celeston?

Depending on the reaction of the Celeston after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Celeston 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 Celeston 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.

Review

sdrugs.com conducted a study on Celeston, 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 Celeston 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

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Visitor reported side effects

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Visitor reported price estimates

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Visitor reported frequency of use

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Visitor reported doses

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Visitor reported time for results

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Visitor reported administration

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One visitor reported age

	Visitors		%
16-29	1		100.0%

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

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