Celestone S

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Celestone S uses

Celestone S consists of Betamethasone Sodium Phosphate, Sulfacetamide Sodium.

Betamethasone Sodium Phosphate:



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

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

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

Discontinue Celestone S (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.

Celestone S (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 Celestone S (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)
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3 DOSAGE FORMS AND STRENGTHS

Spray, 0.05% for topical use. Each gram of Celestone S (Betamethasone Sodium Phosphate) Spray contains 0.643 mg Celestone S (Betamethasone Sodium Phosphate) dipropionate USP (equivalent to 0.5 mg Celestone S (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

  • Celestone S 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

Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Celestone S (Betamethasone Sodium Phosphate) 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 Celestone S (Betamethasone Sodium Phosphate) 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.

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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 Celestone S (Betamethasone Sodium Phosphate) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Celestone S (Betamethasone Sodium Phosphate) Spray and 180 subjects applied vehicle spray.

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

Celestone S (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 Celestone S (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

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.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

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

Celestone S (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

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 Celestone S (Betamethasone Sodium Phosphate) Spray is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Celestone S 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 Celestone S (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.

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11 DESCRIPTION

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

The chemical name for Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray contains 0.643 mg of Celestone S (Betamethasone Sodium Phosphate) dipropionate USP (equivalent to 0.5 mg Celestone S (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. Celestone S (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 Celestone S Spray in psoriasis is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray for 15 days. No subjects (0 out of 24) treated with Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) dipropionate, betamethasone-17-propionate, and Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) dipropionate, while the metabolites, betamethasone-17-propionate and Celestone S (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) Celestone S (Betamethasone Sodium Phosphate) Spray b.i.d.

(15 days)

Celestone S (Betamethasone Sodium Phosphate) Spray b.i.d.

(29 days)

Betamethasone-17-propionate 120 ± 127 63.9 ± 52.6
Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) dipropionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of Celestone S (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.

Celestone S (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 Celestone S (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).

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
Celestone S (Betamethasone Sodium Phosphate) Spray

b.i.d.

(N=182)

Vehicle Spray

b.i.d.

(N=95)

Celestone S (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

Celestone S 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 Celestone S (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

Celestone S (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

Celestone S (Betamethasone Sodium Phosphate) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

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

What is Celestone S (Betamethasone Sodium Phosphate) Spray?

  • Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray is safe and effective in children under 18 years of age. Celestone S (Betamethasone Sodium Phosphate) Spray is not recommended for use in patients under 18 years of age.


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

  • are allergic to any of the ingredients in Celestone S (Betamethasone Sodium Phosphate) Spray. See the end of this leaflet for a list of the ingredients in Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Celestone S (Betamethasone Sodium Phosphate) 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 Celestone S (Betamethasone Sodium Phosphate) Spray?

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

  • Use Celestone S (Betamethasone Sodium Phosphate) Spray exactly as your doctor tells you to use it.
  • Your doctor should tell you how much Celestone S (Betamethasone Sodium Phosphate) Spray to use and where to apply it.
  • Apply Celestone S (Betamethasone Sodium Phosphate) Spray 2 times a day.
  • Use Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray. Do not use Celestone S (Betamethasone Sodium Phosphate) Spray for longer than 4 weeks.
  • Wash your hands after applying Celestone S (Betamethasone Sodium Phosphate) Spray.
  • Do not use Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray?

  • Celestone S (Betamethasone Sodium Phosphate) Spray can pass through your skin. Too much Celestone S (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 Celestone S (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 Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray?

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

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


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

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Celestone S (Betamethasone Sodium Phosphate) Spray for a condition for which it was not prescribed. Do not give Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray that is written for health professionals.


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

Active ingredient: Celestone S (Betamethasone Sodium Phosphate) 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

Celestone S (Betamethasone Sodium Phosphate) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

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

Read this “Instructions for Use” before you start using Celestone S (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 Celestone S (Betamethasone Sodium Phosphate) Spray bottle.

Figure A

How to apply Celestone S (Betamethasone Sodium Phosphate) Spray:

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

Figure B

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

Figure C

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

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

Figure D

How should I store Celestone S (Betamethasone Sodium Phosphate) Spray?

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

Keep Celestone S (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

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

Issued: 02/2016

007528

140693

Sulfacetamide Sodium:


DESCRIPTION

Celestone S ® ophthalmic suspension is a sterile, topical anti-inflammatory/anti-infective combination product for ophthalmic use.

Structural Formulas

MW=254.24 C8H9N2NaO3S·H2O MW=402.49 C23H30O6

Structural Formulas

Chemical Names

Celestone S (Sulfacetamide Sodium) sodium: N-sulfanilylacetamide monosodium salt monohydrate.

Prednisolone acetate: 11ß, 17, 21-trihydroxypregna-1, 4-diene-3, 20-dione 21-acetate.

Each mL of Celestone S (Sulfacetamide Sodium) ® ophthalmic suspension contains:

Actives: Celestone S (Sulfacetamide Sodium) sodium 10%, prednisolone acetate (microfine suspension) 0.2%.

Inactives: benzalkonium chloride (0.004%); edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; potassium phosphate, monobasic; purified water; sodium phosphate, dibasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust pH (6.6 to 7.2).

CLINICAL PHARMACOLOGY

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antibacterial drug may be used when this inhibition is considered to be clinically significant in a particular case.

When a decision to administer both a corticosteroid and an antibacterial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained. The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

Microbiology

Celestone S (Sulfacetamide Sodium) sodium exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid required for growth through competition with p-aminobenzoic acid.

Some strains of these bacteria may be resistant to Celestone S (Sulfacetamide Sodium) or resistant strains may emerge in vivo.

The anti-infective component in these products is included to provide action against specific organisms susceptible to it. Celestone S (Sulfacetamide Sodium) sodium is active in vitro against susceptible strains of the following microorganisms: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens.

INDICATIONS AND USAGE

Celestone S (Sulfacetamide Sodium) ® ophthalmic suspension is a steroid/anti-infective combination drug indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens.

A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

CONTRAINDICATIONS

Celestone S (Sulfacetamide Sodium) ® ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Celestone S (Sulfacetamide Sodium) ® ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids. (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.)

WARNINGS

NOT FOR INJECTION INTO THE EYE.

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.

If the product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids.

In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.

Prolonged use of Celestone S (Sulfacetamide Sodium) ® ophthalmic suspension may suppress the host response and thus increase the hazard of secondary ocular infections.

Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.

A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.

Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered, irrespective of the route of administration.

If signs of hypersensitivity, skin rash, or other serious reactions occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids has been demonstrated.

PRECAUTIONS

General

The initial prescription and renewal of the medication order beyond 20 milliliters of the suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.

Use with caution in patients with severe dry eye.

The p-aminobenzoic acid present in purulent exudates competes with sulfonamides and can reduce their effectiveness.

Information for Patients

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

Contact lenses should not be worn during the use of this product.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the applicator tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Protect from light. Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity. Keep out of the reach of children.

Laboratory Tests

Eyelid cultures and tests to determine the susceptibility of organisms to Celestone S (Sulfacetamide Sodium) may be indicated if signs and symptoms persist or recur in spite of the recommended course of treatment with Celestone S (Sulfacetamide Sodium) ® ophthalmic suspension.

Drug Interactions

Celestone S ® ophthalmic suspension is incompatible with silver preparations. Local anesthetics related to p-aminobenzoic acid may antagonize the action of the sulfonamides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Prednisolone has been reported to be noncarcinogenic. Long-term animal studies for carcinogenic potential have not been performed with Celestone S (Sulfacetamide Sodium).

One author detected chromosomal nondisjunction in the yeast Saccharomyces cerevisiae following application of Celestone S (Sulfacetamide Sodium) sodium. The significance of this finding to topical ophthalmic use of Celestone S (Sulfacetamide Sodium) sodium in the human is unknown.

Mutagenic studies with prednisolone have been negative. Studies on reproduction and fertility have not been performed with Celestone S (Sulfacetamide Sodium). A long-term chronic toxicity study in dogs showed that high oral doses of prednisolone prevented estrus. A decrease in fertility was seen in male and female rats that were mated following oral dosing with another glucocorticosteroid.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with Celestone S sodium. Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been shown to be teratogenic when given in doses 1 to 10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women dosed with corticosteroids.

Kernicterus may be precipitated in infants by sulfonamides being given systemically during the third trimester of pregnancy. It is not known whether Celestone S (Sulfacetamide Sodium) sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.

Celestone S (Sulfacetamide Sodium) ® ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for serious adverse reactions in nursing infants from Celestone S (Sulfacetamide Sodium) sodium and prednisolone acetate ophthalmic suspensions, a decision should be made whether to discontinue nursing or to discontinue the medication.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

ADVERSE REACTIONS

The following adverse reactions have been identified during use of Celestone S (Sulfacetamide Sodium) ® ophthalmic suspension. Because 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.

Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination.

Reactions occurring with Celestone S (Sulfacetamide Sodium) ® ophthalmic suspension include: cataract, dizziness, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, and hypersensitivity including rash, skin pruritus, urticaria, ocular hyperemia, and visual disturbance (blurry vision).

Reactions occurring most often from the presence of the antibacterial ingredient are allergic sensitizations. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.

The reactions due to the corticosteroid component in decreasing order of frequency are: delayed wound healing, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, and posterior subcapsular cataract formation.

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical corticosteroids.

Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriasis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.

Secondary Infection

The development of secondary infection has occurred after use of combinations containing corticosteroids and antibacterials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs.

DOSAGE AND ADMINISTRATION

SHAKE WELL BEFORE USING. Two drops should be instilled into the conjunctival sac every four hours during the day and at bedtime.

Not more than 20 milliliters should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

Celestone S (Sulfacetamide Sodium) ® dosage may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

HOW SUPPLIED

Celestone S (Sulfacetamide Sodium) ® (sulfacetamide sodium–prednisolone acetate ophthalmic suspension, USP) is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with white high impact polystyrene (HIPS) caps as follows:

  • 5 mL in 10 mL bottle - NDC 11980-022-05
  • 10 mL in 15 mL bottle - NDC 11980-022-10

Note: Shake well before using.

Storage: Store at 8°-24°C (46°-75°F) in an upright position. PROTECT FROM LIGHT. Protect from freezing.

Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity.

KEEP OUT OF REACH OF CHILDREN.

Revised: 07/2017

© 2017 Allergan. All rights reserved.

All trademarks are the property of their respective owners.

Irvine, CA 92612

Made in the U.S.A.

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Celestone S 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.


Celestone S 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.


Celestone S 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.


Celestone S 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.


Celestone S pharmaceutical companies:

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


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References

  1. Dailymed."SULFACETAMIDE SODIUM SOLUTION/ DROPS [AKORN, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."SULFACETAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. 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).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Celestone S?

Depending on the reaction of the Celestone S after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Celestone S 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 Celestone S addictive or habit forming?

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

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

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Review

sdrugs.com conducted a study on Celestone S, 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 Celestone S 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.

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

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