Betamethasone Valerate

Taro Pharmaceuticals U.s.a., Inc.
Human Prescription Drug
NDC 51672-4188

Betamethasone Valerate is a human prescription drug labeled by 'Taro Pharmaceuticals U.s.a., Inc.'. National Drug Code (NDC) number for Betamethasone Valerate is 51672-4188. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Betamethasone Valerate drug includes Betamethasone Valerate - 1.2 mg/g . The currest status of Betamethasone Valerate drug is Active.

Drug Information:

Drug NDC:	51672-4188
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Betamethasone Valerate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Betamethasone Valerate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Taro Pharmaceuticals U.s.a., Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Aerosol, Foam
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	BETAMETHASONE VALERATE - 1.2 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	24 May, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA208204
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Taro Pharmaceuticals U.S.A., Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1244634
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	9IFA5XM7R2
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
51672-4188-3	1 CAN in 1 CARTON (51672-4188-3) / 50 g in 1 CAN	24 May, 2017	N/A	No
51672-4188-7	1 CAN in 1 CARTON (51672-4188-7) / 100 g in 1 CAN	24 May, 2017	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Betamethasone Valerate

Aerosol, Foam
Mylan Pharmaceuticals Inc.
NDC: 0378-8180

Betamethasone Valerate

Ointment
Preferred Pharmaceuticals, Inc.
NDC: 68788-7827

Luxiq

Product Elements:

Betamethasone valerate betamethasone valerate betamethasone valerate betamethasone alcohol cetyl alcohol anhydrous citric acid polysorbate 60 potassium citrate propylene glycol water stearyl alcohol

Indications and Usage:

Indications and usage betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.

Warnings:

Warning flammable. avoid fire, flame or smoking during and immediately following application. keep out of reach of children. contents under pressure. do not puncture or incinerate container. do not expose to heat or store at temperatures above 120Â°f (49Â°c).

General Precautions:

General systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (hpa) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. manifestations of cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of hpa axis suppression. if hpa axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. recovery of hpa axis function is generally prompt upon discontinuation of topical cortico Read more...

steroids. infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. for information on systemic supplementation, see prescribing information for those products. pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (see precautions-pediatric use . ) if irritation develops, betamethasone valerate foam, 0.12% should be discontinued and appropriate therapy instituted. allergic contact dermatitis with corticosteroids is usually diagnosed by observing a 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. in the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. if a favorable response does not occur promptly, use of betamethasone valerate foam, 0.12% should be discontinued until the infection has been adequately controlled.

Dosage and Administration:

Dosage and administration note: for proper dispensing of foam, can must be inverted. for application to the scalp invert can and dispense a small amount of betamethasone valerate foam, 0.12% onto a saucer or other cool surface. do not dispense directly onto hands as foam will begin to melt immediately upon contact with warm skin. pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. repeat until entire affected scalp area is treated. apply twice daily, once in the morning and once at night. as with other corticosteroids, therapy should be discontinued when control is achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. betamethasone valerate foam, 0.12% should not be used with occlusive dressings unless directed by a physician.

Contraindications:

Contraindications betamethasone valerate foam, 0.12% is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

Adverse Reactions:

Adverse reactions the most frequent adverse event was burning/itching/stinging at the application site; the incidence and severity of this event were as follows: incidence and severity of burning/itching/stinging maximum severity product total incidence mild moderate severe betamethasone valerate foam n=63 34 (54%) 28 (44%) 5 (8%) 1 (2%) betamethasone valerate lotion n=63 33 (52%) 26 (41%) 6 (10%) 1 (2%) placebo foam n=32 24 (75%) 13 (41%) 7 (22%) 4 (12%) placebo lotion n=30 20 (67%) 12 (40%) 5 (17%) 3 (10%) other adverse events which were considered to be possibly, probably, or definitely related to betamethasone valerate foam, 0.12% occurred in 1 patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis. the following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. these reactions are listed in an approximately decreasing order of occurrence: irritation Read more...

; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria. systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (hpa) axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Adverse Reactions Table:

Incidence and severity of burning/itching/stinging
		Maximum severity
Product	Total incidence	Mild	Moderate	Severe
Betamethasone Valerate Foam n=63	34 (54%)	28 (44%)	5 (8%)	1 (2%)
Betamethasone valerate lotion n=63	33 (52%)	26 (41%)	6 (10%)	1 (2%)
Placebo Foam n=32	24 (75%)	13 (41%)	7 (22%)	4 (12%)
Placebo Lotion n=30	20 (67%)	12 (40%)	5 (17%)	3 (10%)

Use in Pregnancy:

Pregnancy category c 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. there are no adequate and well-controlled studies in pregnant women. therefore, betamethasone valerate foam, 0.12% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Pediatric Use:

Pediatric use safety and effectiveness in pediatric patients have not been established. 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 and/or after withdrawal of treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. hypothalamic-pituitary-adrenal (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 an absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Read more...

administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of children.

Overdosage:

Overdosage topically applied betamethasone valerate foam, 0.12% can be absorbed in sufficient amounts to produce systemic effects. (see precautions )

Description:

Description betamethasone valerate foam, 0.12% contains betamethasone valerate, usp, a synthetic corticosteroid, for topical dermatologic use. the corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. betamethasone valerate is 9-fluoro11Î²,17, 21-trihydroxy-16Î²-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula c 27 h 37 fo 6 , a molecular weight of 476.58. the following is the chemical structure: betamethasone valerate betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. betamethasone valerate foam, 0.12%, contains 1.2 mg betamethasone valerate, usp, per gram in a thermolabile hydroethanolic foam vehicle consisting of alcohol (60.4%), cetyl alcohol, citric acid anhydrous, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. chemical structure

Clinical Pharmacology:

Clinical pharmacology like other topical corticosteroids, betamethasone valerate foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. the mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. however, corticosteroids are thought to act by the induction of phospholipase a 2 inhibitory proteins, collectively called lipocortins. it is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. arachidonic acid is released from membrane phospholipids by phospholipase a 2 . pharmacokinetics topical corticosteroids can be absorbed from intact healthy skin. the extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. occlusion, inflammation and/or other disease processes in the skin may also in Read more...

crease percutaneous absorption. the use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection. once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. they are metabolized, primarily in the liver, and are then excreted by the kidneys. in addition, some corticosteroids and their metabolites are also excreted in the bile.

Pharmacokinetics:

Pharmacokinetics topical corticosteroids can be absorbed from intact healthy skin. the extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. the use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection. once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. they are metabolized, primarily in the liver, and are then excreted by the kidneys. in addition, some corticosteroids and their metabolites are also excreted in the bile.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, and impairment of fertility long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of betamethasone valerate. betamethasone was genotoxic in the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation and in the in vivo mouse bone marrow micronucleus assay.

Clinical Studies:

Clinical studies the safety and efficacy of betamethasone valerate foam, 0.12% has been demonstrated in a four-week trial. an adequate and well-controlled clinical trial was conducted in 190 patients with moderate to severe scalp psoriasis. patients were treated twice daily for four weeks with betamethasone valerate foam, 0.12%, placebo foam, a commercially available betamethasone valerate lotion 0.12% (formerly expressed as 0.1% betamethasone), or placebo lotion. at four weeks of treatment, study results of 159 patients demonstrated that the efficacy of betamethasone valerate foam, 0.12% in treating scalp psoriasis is superior to that of placebo foam, and is comparable to that of a currently marketed bmv lotion (see table below). subjects with target lesion parameter clear at endpoint betamethasone valerate foam, 0.12% n (%) bmv lotion n (%) placebo foam n (%) scaling 30 (47%) 22 (35%) 2 (6%) erythema 26 (41%) 16 (25%) 2 (6%) plaque thickness 42 (66%) 25 (40%) 5 (16%) investigator's g Read more...

lobal: subjects completely clear or almost clear at endpoint 43 (67%) 29 (46%) 6 (19%)

How Supplied:

How supplied betamethasone valerate foam, 0.12% is supplied in 50 gram (ndc 51672-4188-3) and 100 gram (ndc 51672-4188-7) aluminum cans. store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature].

Information for Patients:

Information for patients patients using topical corticosteroids should receive the following information and instructions: this medication is to be used as directed by the physician. it is for external use only. avoid contact with the eyes. this medication should not be used for any disorder other than that for which it was prescribed. the treated scalp 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. as with other corticosteroids, therapy should be discontinued when control is achieved. if no improvement is seen within 2 weeks, contact the physician.

Spl Patient Package Insert:

Patient information betamethasone valerate (bay'' ta meth' a sone val' er ate) foam, 0.12% about betamethasone valerate foam, 0.12% your doctor has prescribed betamethasone valerate foam, 0.12%, for the relief of corticosteroid-responsive skin conditions of the scalp. betamethasone valerate foam, 0.12% works because its active ingredient is betamethasone valerate, 0.12%. betamethasone belongs to a group of medicines known as topical corticosteroids. these agents are used to reduce the inflammation, redness, swelling, itching, and tenderness associated with dermatologic conditions. other ingredients in betamethasone valerate foam, 0.12% include alcohol (60.4%), cetyl alcohol, citric acid anhydrous, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol. the foam is dispensed from an aluminum can that is pressurized by a hydrocarbon propellant (propane and butane). if you answer yes to one or more of the following questions, tell your doctor (or pharmaci Read more...

st) before using this medicine, so you can get advice about what to do. are you allergic to any of the ingredients contained in betamethasone valerate foam, 0.12%? are you pregnant? planning on becoming pregnant while using betamethasone valerate foam, 0.12%? or are you breastfeeding? do you think you have an infection on your scalp? how to apply betamethasone valerate foam, 0.12% turn the can upside down and dispense a small amount of betamethasone valerate foam onto a clean saucer or other cool, clean surface. do not dispense directly onto hands, as foam will begin to melt immediately upon contact with warm skin. pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. repeat until entire affected scalp area is treated. apply twice daily, once in the morning and once at night. use sparingly-only enough to cover the affected areas. gently massage the foam in until it is absorbed and allow the areas to dry naturally. when applying to the scalp, move the hair away so that the foam can be applied directly to each affected area. wash your hands immediately after applying betamethasone valerate foam, and discard any unused dispensed medication. do not wash or rinse the treated areas immediately after applying betamethasone valerate foam. do not use this medication for any condition other than the one for which it was prescribed. betamethasone valerate foam, 0.12% is for external use only. keep the foam away from your eyes, as it will sting. if the foam gets into your eyes, rinse well with cold water. if the stinging continues, contact your doctor immediately. what you should know about betamethasone valerate foam, 0.12%: what to do if you miss an application if you forget to apply betamethasone valerate foam, 0.12% at the scheduled time, use it as soon as you remember, and then go back to your regular schedule. if you remember at or about the time of your next daily application, apply that dose and continue with your normal application schedule. if you miss several doses, tell your doctor at your next appointment. about side effects as with all medications, there may be some side effects. the most frequent side effects associated with the use of betamethasone valerate foam, 0.12% include mild burning, stinging, or itching at the site of application. these side effects typically disappear shortly after application. let your doctor know if you notice any of the following: any unusual effects that you do not understand. affected areas that do not seem to be healing after several weeks of using the foam. important safety notes the treated areas should not be bandaged or covered unless directed by your doctor. keep this and all medicines out of the reach of children. store the can at controlled room temperature 68Â° to 77Â°f (20Â° to 25Â°c) and protect it from direct sunlight, as this is a pressurized container. keep away from and do not spray near fire, open flame, or direct heat--this product is flammable. do not smoke while using or holding the can. keep the can away from all sources of ignition. do not pierce or burn the can, and never throw the can in a fire, even if empty. when you have finished your treatment, dispose of the can safely. do not use the foam after the expiration date shown on the can. do not give betamethasone valerate foam, 0.12% to anyone else. your doctor has prescribed this medicine for your use only. mfd. by: taro pharmaceutical industries ltd., haifa bay, israel, 2624761 dist. by: taro pharmaceuticals u.s.a., inc., hawthorne, ny 10532 revised: september 2016 20740-0916-1 88 figure figure figure figure

Package Label Principal Display Panel:

Principal display panel - 50 g can carton 50 g 51672-4188-3 betamethasone valerate foam 0.12% for dermatologic use only. not for ophthalmic use. keep this and all medications out of the reach of children. rx only taro principal display panel - 50 g can carton

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