Vipsogal

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Vipsogal uses

Vipsogal consists of Betamethasone Dipropionate, Fluocinonide, Gentamicin Sulfate, Salicylic Acid, Vitamin B5 (Panthenol).

Betamethasone Dipropionate:



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

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

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

Discontinue Vipsogal (Betamethasone Dipropionate) 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.

Vipsogal (Betamethasone Dipropionate) 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 Vipsogal (Betamethasone Dipropionate) 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 Vipsogal (Betamethasone Dipropionate) Spray contains 0.643 mg Vipsogal (Betamethasone Dipropionate) USP (equivalent to 0.5 mg 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

  • Vipsogal 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

Vipsogal (Betamethasone Dipropionate) 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 Vipsogal (Betamethasone Dipropionate) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Vipsogal (Betamethasone Dipropionate) 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 Vipsogal (Betamethasone Dipropionate) 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 Vipsogal (Betamethasone Dipropionate) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Vipsogal (Betamethasone Dipropionate) Spray and 180 subjects applied vehicle spray.

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

Vipsogal (Betamethasone Dipropionate) 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 Vipsogal (Betamethasone Dipropionate) 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. Vipsogal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Vipsogal (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 Vipsogal (Betamethasone Dipropionate) Spray is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Vipsogal 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 Vipsogal (Betamethasone Dipropionate) 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

Vipsogal (Betamethasone Dipropionate) Spray contains 0.0643% Vipsogal (Betamethasone Dipropionate) (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid.

The chemical name for Vipsogal (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 Vipsogal (Betamethasone Dipropionate) Spray contains 0.643 mg of Vipsogal (Betamethasone Dipropionate) USP (equivalent to 0.5 mg 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. Vipsogal (Betamethasone Dipropionate) 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 Vipsogal Spray in psoriasis is unknown.

12.2 Pharmacodynamics

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

(15 days)

Vipsogal (Betamethasone Dipropionate) Spray b.i.d.

(29 days)

Betamethasone-17-propionate 120 ± 127 63.9 ± 52.6
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 Vipsogal (Betamethasone Dipropionate).

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

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 Vipsogal (Betamethasone Dipropionate) 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
Vipsogal (Betamethasone Dipropionate) Spray

b.i.d.

(N=182)

Vehicle Spray

b.i.d.

(N=95)

Vipsogal (Betamethasone Dipropionate) 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

Vipsogal 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 Vipsogal (Betamethasone Dipropionate) 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

Vipsogal (Betamethasone Dipropionate) 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

Vipsogal (Betamethasone Dipropionate) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

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

What is Vipsogal (Betamethasone Dipropionate) Spray?

  • Vipsogal (Betamethasone Dipropionate) 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 Vipsogal (Betamethasone Dipropionate) Spray is safe and effective in children under 18 years of age. Vipsogal (Betamethasone Dipropionate) Spray is not recommended for use in patients under 18 years of age.


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

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

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

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

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

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

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

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


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

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


What are the ingredients in Vipsogal (Betamethasone Dipropionate) Spray?

Active ingredient: Vipsogal (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

Vipsogal (Betamethasone Dipropionate) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

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

Read this “Instructions for Use” before you start using Vipsogal (Betamethasone Dipropionate) 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 Vipsogal (Betamethasone Dipropionate) Spray bottle.

Figure A

How to apply Vipsogal (Betamethasone Dipropionate) Spray:

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

Figure B

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

Figure C

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

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

Figure D

How should I store Vipsogal (Betamethasone Dipropionate) Spray?

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

Keep Vipsogal (Betamethasone Dipropionate) 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

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

Issued: 02/2016

007528

140693

Fluocinonide:


1INDICATIONS AND USAGE

Vipsogal Cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1)

Limitation of Use:

  • Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1)
  • Avoid use on the face, groin, or axillae. (1.2)
  • Avoid use in perioral dermatitis or rosacea. (1.2)

1.1 Indications

VANOS® (fluocinonide) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4) ].

1.2 Limitation of Use

Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Vipsogal (Fluocinonide) Cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.

Vipsogal (Fluocinonide) Cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

2DOSAGE AND ADMINISTRATION

For topical use only. Vipsogal (Fluocinonide) Cream is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of Vipsogal (Fluocinonide) Cream once or twice daily to the affected skin areas as directed by a physician. Twice-daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.

For atopic dermatitis, apply a thin layer of Vipsogal (Fluocinonide) Cream once daily to the affected skin areas as directed by a physician. Once-daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14) ].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Vipsogal (Fluocinonide) Cream once or twice daily to the affected areas as directed by a physician.

For topical use only. Vipsogal (Fluocinonide) Cream is not for ophthalmic, oral, or intravaginal use. (2)

Psoriasis: apply a thin layer once or twice daily to the affected skin areas. (2)

Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. (2)

Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas. (2)

3DOSAGE FORMS AND STRENGTHS

Cream, 0.1%.

Each gram of Vipsogal (Fluocinonide) Cream contains 1 mg of Vipsogal (Fluocinonide) in a white to off-white cream base.

Cream, 0.1% (3)

4CONTRAINDICATIONS

None.

None (4)

5WARNINGS AND PRECAUTIONS

  • Vipsogal Cream has been shown to suppress the HPA axis. Systemic absorption of Vipsogal (Fluocinonide) Cream may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia and unmask latent diabetes. (5.1)
  • Systemic absorption may require evaluation for HPA-axis suppression. (5.1)
  • Modify use should HPA-axis suppression develop. (5.1)
  • Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. (5.3)
  • Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids. (5.3)
  • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

5.1 Effect on Endocrine System

Systemic absorption of topical corticosteroids, including Vipsogal (Fluocinonide) Cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of Vipsogal (Fluocinonide) Cream for longer than 2 weeks may suppress the immune system [see Nonclinical Toxicology (13.1) ].

HPA-axis suppression has been observed with Vipsogal (Fluocinonide) Cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis, and 4 out of 123 pediatric patients with atopic dermatitis [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].

Because of the potential for systemic absorption, use of topical corticosteroids, including Vipsogal (Fluocinonide) Cream, may require that patients be periodically evaluated for HPA-axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA-axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA-axis suppression. If HPA-axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA-axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

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

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

Studies conducted in pediatric patients demonstrated reversible HPA-axis suppression after use of Vipsogal (Fluocinonide) Cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Vipsogal (Fluocinonide) Cream due to their larger skin surface-to-body-mass ratios [see Use in Specific Populations (8.4) ].

5.2 Local Adverse Reactions with Topical Corticosteroids

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

5.3 Concomitant Skin Infections

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Vipsogal Cream should be discontinued until the infection has been adequately controlled.

5.4 Allergic Contact Dermatitis

If irritation develops, Vipsogal (Fluocinonide) Cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

6ADVERSE REACTIONS

The most commonly reported adverse reactions were headache, application site burning, nasopharyngitis, and nasal congestion. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with Vipsogal (Fluocinonide) Cream for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows:

Adverse Reaction Vipsogal (Fluocinonide) Cream,

once daily

(n=216)

Vipsogal (Fluocinonide) Cream,

twice daily

(n=227)

Vehicle Cream,

once or twice daily

(n=211)


Headache


8 (3.7%)


9 (4.0%)


6 (2.8%)


Application Site Burning


5 (2.3%)


4 (1.8%)


14 (6.6%)


Nasopharyngitis


2 (0.9%)


3 (1.3%)


3 (1.4%)


Nasal Congestion


3 (1.4%)


1 (0.4%)


0


Safety in patients 12 to 17 years of age was similar to that observed in adults.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Vipsogal (Fluocinonide) Cream:

Administration Site Conditions: discoloration, erythema, irritation, pruritus, swelling, pain, and condition aggravated.

Immune System Disorders: hypersensitivity.

Nervous System Disorders: headache and dizziness.

Skin and Subcutaneous Tissue Disorders: acne, dry skin, rash, skin exfoliation, and skin tightness.

Because these 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.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

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

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

8.3 Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Safety and efficacy of Vipsogal Cream in pediatric patients younger than 12 years of age have not been established; therefore, use in pediatric patients younger than 12 years of age is not recommended.

HPA-axis suppression was studied in four sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area (BSA), treated once daily or twice daily with Vipsogal (Fluocinonide) Cream. The first cohort of 31 patients (mean 36.3% BSA) 12 to <18 years old; the second cohort included 31 patients (mean 39.0% BSA) 6 to <12 years old; the third cohort included 30 patients (mean 34.6% BSA) 2 to <6 years old; the fourth cohort included 31 patients (mean 40.0% BSA) 3 months to <2 years old. Vipsogal (Fluocinonide) Cream caused HPA-axis suppression in 1 patient in the twice-daily group in Cohort 1, 2 patients in the twice-daily group in Cohort 2, and 1 patient in the twice-daily group in Cohort 3. Follow-up testing 14 days after treatment discontinuation, available for all 4 suppressed patients, demonstrated a normally responsive HPA axis. Signs of skin atrophy were present at baseline and severity was not determined, making it difficult to assess local skin safety. Therefore, the safety of Vipsogal (Fluocinonide) Cream in patients younger than 12 years of age has not been demonstrated [see Warnings and Precautions (5.2) ].

HPA-axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA-axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to cosyntropin (ACTH1–24) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5 Geriatric Use

Clinical studies of Vipsogal (Fluocinonide) Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

10OVERDOSAGE

Topically applied Vipsogal (Fluocinonide) Cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ].

11DESCRIPTION

Vipsogal (Fluocinonide) (fluocinonide) Cream, 0.1% contains Vipsogal (Fluocinonide), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Vipsogal (Fluocinonide) has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58.

It has the following chemical structure:

Vipsogal (Fluocinonide) is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol.

Each gram of Vipsogal (Fluocinonide) Cream contains 1 mg micronized Vipsogal (Fluocinonide) in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.

Chemical Structure

12CLINICAL 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 Vipsogal Cream in corticosteroid responsive dermatoses is unknown.

12.2 Pharmacodynamics

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

Application of Vipsogal (Fluocinonide) Cream twice daily for 14 days in 18 adult subjects with plaque-type psoriasis (10–50% BSA, mean 19.6% BSA) and 31 adult subjects (17 treated once daily; 14 treated twice daily) with atopic dermatitis (2–10% BSA, mean 5% BSA) showed demonstrable HPA-axis suppression in 2 subjects with psoriasis (with 12% and 25% BSA) and 1 subject with atopic dermatitis (treated once daily, 4% BSA) where the criterion for HPA-axis suppression is a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (ACTH1–24) [see Warnings and Precautions (5.1) ].

HPA-axis suppression following application of Vipsogal (Fluocinonide) Cream, 0.1% (once or twice daily) was also evaluated in 123 pediatric patients from 3 months to <18 years of age with atopic dermatitis (mean BSA range 34.6%-40.0%). HPA-axis suppression was observed in 4 patients in the twice-daily groups. Follow-up testing 14 days after treatment discontinuation demonstrated a normally responsive HPA axis in all 4 suppressed patients [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ].

12.3Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

13NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Vipsogal (Fluocinonide) Cream because of severe immunosuppression induced in a 13-week dermal rat study. The effects of Vipsogal (Fluocinonide) on fertility have not been evaluated.

Vipsogal (Fluocinonide) revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames test and chromosomal aberration assay using human lymphocytes). However, Vipsogal (Fluocinonide) was positive for clastogenic potential when tested in the in vivo mouse micronucleus assay.

Topical (dermal) application of 0.0003%–0.03% Vipsogal (Fluocinonide) cream to rats once daily for 13 weeks resulted in a toxicity profile generally associated with long-term exposure to corticosteroids including decreased skin thickness, adrenal atrophy, and severe immunosuppression. A NOAEL could not be determined in this study. In addition, topical (dermal) application of 0.1% Vipsogal (Fluocinonide) cream plus ultraviolet radiation (UVR) exposure to hairless mice for 13 weeks and 150–900 mg/kg/day of 0.1% Vipsogal (Fluocinonide) cream to minipigs (a model which more closely approximates human skin) for 13 weeks produced glucocorticoid-related suppression of the HPA axis, with some signs of immunosuppression noted in the dermal minipig study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis.

Topical doses of 0% (fluocinonide cream vehicle), 0.0001%, 0.005%, and 0.001% Vipsogal (Fluocinonide) cream were evaluated in a 52-week dermal photocarcinogenicity study (40 weeks of treatment followed by 12 weeks of observation) conducted in hairless albino mice with concurrent exposure to low level ultraviolet radiation. Topical treatment with increasing concentrations of Vipsogal (Fluocinonide) cream did not have an adverse effect in this study. The results of this study suggest that topical treatment with Vipsogal (Fluocinonide) Cream would not enhance photocarcinogenesis.

14CLINICAL STUDIES

Two adequate and well-controlled efficacy and safety studies of Vipsogal (Fluocinonide) Cream have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with Vipsogal (Fluocinonide) Cream for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment. The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2.

Vipsogal (Fluocinonide) Cream,

once daily

(n=107)

Vehicle,

once daily

(n=54)

Vipsogal (Fluocinonide) Cream,

twice daily

(n=107)

Vehicle,

twice daily

(n=55)


Subjects cleared


0 (0)


0 (0)


6 (6%)


0 (0)


Subjects achieving treatment successCleared or almost cleared


19 (18%)


4 (7%)


33 (31%)


3 (5%)

Vipsogal (Fluocinonide) Cream,

once daily

(n=109)

Vehicle,

once daily

(n=50)

Vipsogal (Fluocinonide) Cream,

twice daily

(n=102)

Vehicle,

twice daily

(n=52)


Subjects cleared


11 (10%)


0 (0)


17 (17%)


0 (0)


Subjects achieving treatment successCleared or almost cleared


64 (59%)


6 (12%)


58 (57%)


10 (19%)


No efficacy studies have been conducted to compare Vipsogal (Fluocinonide) (fluocinonide) Cream, 0.1% with any other topical corticosteroid product, including Vipsogal (Fluocinonide) cream 0.05%.

16HOW SUPPLIED/STORAGE AND HANDLING

VANOS® (fluocinonide) Cream, 0.1% is white to off-white in color and is supplied in tubes as follows:

  • 30 g NDC 99207-525-30
  • 60 g NDC 99207-525-60
  • 120 g NDC 99207-525-10

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Keep the tube tightly closed.

17PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients using Vipsogal (Fluocinonide) Cream should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects:

  • Vipsogal (Fluocinonide) Cream is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. It should not be used on the face, groin, and underarms.
  • Vipsogal (Fluocinonide) Cream should not be used for any disorder other than that for which it was prescribed.
  • The treated skin area should not be bandaged or otherwise covered or wrapped, so as to be occlusive unless directed by the physician.
  • Patients should report to their physician any signs of local adverse reactions.
  • Other corticosteroid-containing products should not be used with Vipsogal (Fluocinonide) Cream without first talking to the physician.
  • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen in 2 weeks, the patient should be instructed to contact a physician. The safety of the use of Vipsogal (Fluocinonide) Cream for longer than 2 weeks has not been established.
  • Patients should be informed to not use more than 60 g per week of Vipsogal (Fluocinonide) Cream. Do not use more than half of the 120 g tube per week.
  • Patients should inform their physicians that they are using Vipsogal (Fluocinonide) Cream if surgery is contemplated.
  • Patients should wash their hands after applying medication.

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By:

Valeant Pharmaceuticals International, Inc.

Laval, Quebec H7L 4A8, Canada

U.S. Patent Numbers 6,765,001; 7,217,422; 7,220,424; 7,771,733; 7,794,738 and 8,232,264

Vipsogal (Fluocinonide) is a trademark of Valeant Pharmaceuticals

International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

9481801

Patient Information

VANOS® (VAN-ōs) (fluocinonide)

Cream, 0.1%

IMPORTANT: For skin use only. Do not get Vipsogal (Fluocinonide) Cream in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.

Read the Patient Information that comes with Vipsogal (Fluocinonide) Cream before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your condition or treatment.

What is Vipsogal (Fluocinonide) Cream?

Vipsogal (Fluocinonide) Cream is a prescription corticosteroid medicine used on the skin (topical) to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin.

  • You should not use Vipsogal (Fluocinonide) Cream for longer than 2 weeks in a row.
  • You should not use more than 60 grams of Vipsogal (Fluocinonide) Cream or more than half of the 120 gram tube in 1 week.
  • Vipsogal (Fluocinonide) Cream should not be used:
    • if you have skin swelling or redness on the nose or face (rosacea)
    • for a scaly or bumpy rash around your mouth (perioral dermatitis)
    • on your face, underarms, or groin area

It is not known if Vipsogal (Fluocinonide) Cream is safe and effective in children under 12 years of age.

What should I tell my doctor before using Vipsogal (Fluocinonide) Cream?

Before using Vipsogal (Fluocinonide) Cream, tell your doctor if you:

  • have had irritation or other skin reaction to a steroid medicine in the past
  • adrenal gland problems
  • plan to have surgery
  • are pregnant or plan to become pregnant. It is not known if Vipsogal (Fluocinonide) Cream will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breastfeed. It is not known if Vipsogal (Fluocinonide) Cream passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Vipsogal (Fluocinonide) Cream.

Tell your doctor about all the medicine you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a corticosteroid medicine by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

How should I use Vipsogal (Fluocinonide) Cream?

  • See "What is Vipsogal (Fluocinonide) Cream?"
  • Use Vipsogal (Fluocinonide) Cream exactly as your doctor tells you.
  • This medicine is for use on the skin only. Do not use Vipsogal (Fluocinonide) Cream in your eyes, mouth, or vagina.
  • Wash your hands after you use Vipsogal (Fluocinonide) Cream.
  • Do not use Vipsogal (Fluocinonide) Cream for longer than 2 weeks in a row.
  • Talk to your doctor if your skin does not get better after 2 weeks of treatment with Vipsogal (Fluocinonide) Cream.
  • Do not bandage or cover the skin treated with Vipsogal (Fluocinonide) Cream unless your doctor tells you to.

What are the possible side effects with Vipsogal (Fluocinonide) Cream?

Vipsogal (Fluocinonide) Cream may cause side effects, including:

  • Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Your doctor may do blood tests to check you for adrenal insufficiency while you are using Vipsogal (Fluocinonide) Cream. Tell your doctor if you have any of these symptoms of adrenal insufficiency:
    • tiredness that worsens and does not go away
    • nausea or vomiting
    • dizziness or fainting
    • muscle weakness
    • irritability and depression
    • loss of appetite
    • weight loss
  • Cushing's syndrome, when the body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this. Symptoms can include:
    • weight gain, especially around your upper back and midsection
    • slow healing of cuts, insect bites, and infections
    • tiredness and muscle weakness
    • depression, anxiety, and irritability
    • roundness of your face (moon face)
    • new or worsening high blood pressure

The most common side effect of Vipsogal (Fluocinonide) Cream is burning of your skin treated with Vipsogal (Fluocinonide) Cream.

Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with Vipsogal (Fluocinonide) Cream. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Valeant Pharmaceuticals North America LLC at 1-800-321-4576.

How should I store Vipsogal (Fluocinonide) Cream?

  • Store Vipsogal (Fluocinonide) Cream at room temperature, between 59° to 86°F (15° to 30°C).
  • Keep the tube tightly closed.

Keep Vipsogal (Fluocinonide) Cream and all medicines out of reach of children.

General information about Vipsogal (Fluocinonide) Cream

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Vipsogal (Fluocinonide) Cream for a condition for which it was not prescribed. Do not give Vipsogal (Fluocinonide) Cream to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Vipsogal (Fluocinonide) Cream. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Vipsogal (Fluocinonide) Cream that is written for healthcare professionals.

What are the ingredients in Vipsogal (Fluocinonide) Cream?

Active ingredient: Vipsogal (Fluocinonide) 0.1%

Inactive ingredients: anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.

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

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By:

Valeant Pharmaceuticals International, Inc.

Laval, Quebec H7L 4A8, Canada

U.S. Patent Numbers 6,765,001; 7,217,422; 7,220,424; 7,771,733; 7,794,738 and 8,232,264

Vipsogal (Fluocinonide) is a trademark of Valeant Pharmaceuticals

International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

Rev. 05/2017

9481801

Gentamicin Sulfate:



F-27078915

NADA #141-177, Approved by FDA.

PRODUCT

INFORMATION

VETERINARY

For Otic Use in Dogs Only

CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Keep this and all drugs out of the reach of children.

DESCRIPTION Each gram of Vipsogal (Gentamicin Sulfate) Otic Suspension contains Vipsogal (Gentamicin Sulfate) sulfate, USP equivalent to 3 mg Vipsogal (Gentamicin Sulfate) base; mometasone furoate monohydrate equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oilbased system containing a plasticized hydrocarbon gel.

PHARMACOLOGY

Vipsogal (Gentamicin Sulfate): Vipsogal (Gentamicin Sulfate) sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and grampositive bacteria. In vitro tests have determined that Vipsogal (Gentamicin Sulfate) is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, Vipsogal (Gentamicin Sulfate) was shown to have a range of activity against the following organisms commonly isolated from infected canine ears:

Pseudomonas spp. (including P. aeruginosa), coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.

Mometasone: Mometasone furoate monohydrate is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.

Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms.

In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor, and swelling.

In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.

Gentamicin-Mometasone-Clotrimazole: By virtue of its three active ingredients, Vipsogal (Gentamicin Sulfate) Otic Suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, Vipsogal (Gentamicin Sulfate) Otic Suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Vipsogal (Gentamicin Sulfate) Otic Suspension reduced discomfort, redness, swelling, exudate, and odor.

INDICATIONS Vipsogal (Gentamicin Sulfate) Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

CONTRAINDICATIONS If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

WARNINGS The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Vipsogal (Gentamicin Sulfate) Otic Suspension immediately and flush the ear canal thoroughly with a nonototoxic solution.

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.

Field and experimental data have demonstrated that corticostroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

PRECAUTIONS Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.

Administration of recommended doses of Vipsogal (Gentamicin Sulfate) Otic Suspension beyond 7 days may result in delayed wound healing. If overgrowth of nonsusceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.

Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

TOXICOLOGY Field and safety studies with Vipsogal (Gentamicin Sulfate) Otic Suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS ).

ADVERSE REACTIONS

Vipsogal (Gentamicin Sulfate): While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.

Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.

Vipsogal (Gentamicin Sulfate) Otic Suspension: In field studies following once daily teatment with Vipsogal (Gentamicin Sulfate) Otic Suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with Vipsogal (Gentamicin Sulfate) Otic Suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.

DOSAGE AND ADMINISTRATION

The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g, 15 g, and 30 g bottles (2 drops from the 215 g bottle) of Vipsogal (Gentamicin Sulfate) Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g, 15 g, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.

HOW SUPPLIED Vipsogal (Gentamicin Sulfate) Otic Suspension is available in 7.5 g (NDC 14043-120-75), 15 g (NDC 14043-120-15), 30 g (NDC 14043-120-30), and 215 g (NDC 14043-120-21) plastic bottles.

Store between 2° and 25°C (36° and 77°F). Shake well before use.

U.S. Patent No. 6,127,353.

Distributed by

PATTERSON VETERINARY

137 Barnum Road, Devens, MA 01434

www.pattersonvet.com

Made in Canada.

9/15

85239791

Salicylic Acid:


Pharmacological action

Vipsogal is pharmaceytical active ingredient for topical use. Inhibits the secretion of the sebaceous and sweat glands. At low concentrations it has keratoplastic and in high doses keratolytic effect. Vipsogal (Salicylic Acid) has a weak antimicrobial activity.

Why is Vipsogal (Salicylic Acid) prescribed?

Monotherapy with Vipsogal (Salicylic Acid) and as part of combination therapies for inflammatory, infectious and other skin lesions, including burns, psoriasis, eczema, dyskeratosis, ichthyosis, acne vulgaris, warts, hyperkeratosis, corn, callus, oily seborrhea, scaly skin disease, hair loss, sweating feet.

Dosage and administration

Vipsogal is applied to the skin surface 2-3 times / day.

Vipsogal (Salicylic Acid) side effects, adverse reactions

Rarely: local reactions such as itching, burning, skin rashes, allergic reactions.

Vipsogal contraindications

Hypersensitivity to Vipsogal (Salicylic Acid), renal failure, infancy.

Special instructions

The composition of the solution for topical use include ethanol.

Vipsogal drug interactions

Vipsogal (Salicylic Acid) is pharmaceutically not compatible with resorcinol (forms melted mixture) and zinc oxide (forms insoluble forms of zinc salicylate).

Vipsogal 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.


Vipsogal 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.


Vipsogal 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.


Vipsogal 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.


Vipsogal 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."GENTAMICIN PIGLET (GENTAMICIN SULFATE) INJECTION [SPARHAWK LABORATORIES, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."VANOS (FLUOCINONIDE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."NEUTROGENA RAPID CLEAR 7 DAY ACNE INTERVENTION (SALICYLIC ACID) KIT [NEUTROGENA CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Vipsogal?

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

One visitor reported useful

How is the drug Vipsogal useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Useful1
100.0%

Visitor reported side effects

No survey data has been collected yet

One visitor reported price estimates

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

Visitor reported frequency of use

No survey data has been collected yet

One visitor reported doses

What is the dose of Vipsogal drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg1
100.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

One visitor reported age

Visitors%
16-291
100.0%

Visitor reviews


There are no reviews yet. Be the first to write one!


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

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