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| Product NDC Code | 51672-1309 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Betamethasone dipropionate |
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| Type | Generic | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 848208 | ||||||
| Application Number | ANDA076508 | ||||||
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. | ||||||
| Packages |
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Overdosage of Betamethasone Dipropionate
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE Topically applied betamethasone dipropionate gel (augmented) can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse events associated with the use of betamethasone dipropionate gel (augmented) was 10%. These included stinging or burning in 6% of patients, dry skin in 4% of patients, and pruritus in 2% of patients. Less frequently reported adverse reactions were irritation, skin atrophy, telangiectasia, erythema, cracking/tightening of the skin, follicular rash, and allergic contact dermatitis. The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids, such as betamethasone dipropionate gel (augmented). These reactions are listed in approximate decreasing order of occurrence: acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae, and miliaria.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, anti-pruritic, 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 pre-cursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. In addition, inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with betamethasone dipropionate gel (augmented) indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. In addition, inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with betamethasone dipropionate gel (augmented) indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Betamethasone dipropionate gel (augmented) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Betamethasone dipropionate gel (augmented), 0.05%, contains betamethasone dipropionate, USP, a synthetic fluorinated corticosteroid for topical dermatologic use. Betamethasone dipropionate is included in a class of compounds consisting primarily of synthetic corticosteroids for use topically as anti-inflammatory and anti-pruritic agents. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C 28 H 37 FO 7 , a molecular weight of 504.6, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate gel (augmented) contains: 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in an augmented gel base of carbomer homopolymer type C, propylene glycol, purified water and sodium hydroxide. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION Apply a thin layer of betamethasone dipropionate gel (augmented) to the affected skin once or twice daily and rub it in gently and completely. Betamethasone dipropionate gel (augmented) is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g per week should not be used. Betamethasone dipropionate gel (augmented) should not be used with occlusive dressings.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Betamethasone dipropionate gel (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dose should not exceed 50 g per week because of potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. This product is not recommended for use in pediatric patients under 12 years of age.
Spl product data elements
Usually a list of ingredients in a drug product.Betamethasone Dipropionate Betamethasone Dipropionate Betamethasone Dipropionate Betamethasone carbomer homopolymer type c (allyl pentaerythritol crosslinked) propylene glycol water sodium hydroxide
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. 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 the rabbits and mice.
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test, Morning plasma-cortisol test, Urinary free-cortisol test
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 15 g Tube Carton NDC 51672-1309-1 15 g Betamethasone Dipropionate Gel (Augmented*), 0.05% (Potency expressed as betamethasone) *Vehicle augments the penetration of the steroid. FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.(Potency expressed as betamethasone) *Vehicle augments the penetration of the steroid. FOR DERMATOLOGICAL USE ONLY NOT FOR OPHTHALMIC USE Rx only
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 PK-4240-1 0116-1 28
Betamethasone Dipropionate: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Information for Patients Patients using topical corticosteroids should receive the following information and instructions: The medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. The medication 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. Patients should report to their physician any signs of local adverse reactions.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use Clinical studies of betamethasone dipropionate gel (augmented) included 65 subjects who were 65 years of age and over and 15 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.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 human milk. Because many drugs are excreted in human milk, caution should be exercised when betamethasone dipropionate gel (augmented) is administered to a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Data regarding use of betamethasone dipropionate gel (augmented) in pediatric patients are not available, so use of this product in patients under the age of 12 is not recommended. 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 when they are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and pediatric patients. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects 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 to laboratory animals. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 26 times the human topical dose of betamethasone dipropionate gel (augmented) assuming human percutaneous absorption of approximately 3% and the use in a 70 kg person of 7 g per day. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. There are no adequate and well-controlled studies of the teratogenic potential of betamethasone dipropionate in pregnant women. Therefore, betamethasone dipropionate gel (augmented) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects 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 to laboratory animals. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 26 times the human topical dose of betamethasone dipropionate gel (augmented) assuming human percutaneous absorption of approximately 3% and the use in a 70 kg person of 7 g per day. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. There are no adequate and well-controlled studies of the teratogenic potential of betamethasone dipropionate in pregnant women. Therefore, betamethasone dipropionate gel (augmented) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Betamethasone Dipropionate Gel (Augmented), 0.05% is supplied as follows: 15 g NDC 51672-1309-1 50 g NDC 51672-1309-3 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
| 15 g | NDC 51672-1309-1 | |
| 50 g | NDC 51672-1309-3 |
Storage and handling
Information about safe storage and handling of the drug product.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General Betamethasone dipropionate gel (augmented) should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or in the axillae. Systemic absorption of topical corticosteroids can produce 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. At 7 g per day (applied once daily or as 3.5 g twice daily), betamethasone dipropionate gel (augmented) was shown to cause inhibition of the HPA axis following application for one, two or three weeks to diseased skin in some patients with psoriasis or atopic dermatitis. These effects were reversible upon discontinuation of treatment. Patients receiving betamethasone dipropionate gel (augmented) applied to large areas should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH-stimulation, morning plasma cortisol and urinary free-cortisol tests. Patients should not be treated with betamethasone dipropionate gel (augmented) for more than 2 weeks at a time, and amounts greater than 50 g per week should not be used because of the potential for the drug to suppress the HPA axis. 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 corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for systemic corticosteroids. 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 dipropionate gel (augmented) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant fungal and/or bacterial 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 betamethasone dipropionate gel (augmented) should be discontinued until the infection has been adequately controlled.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Betamethasone dipropionate gel (augmented) should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or in the axillae. Systemic absorption of topical corticosteroids can produce 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. At 7 g per day (applied once daily or as 3.5 g twice daily), betamethasone dipropionate gel (augmented) was shown to cause inhibition of the HPA axis following application for one, two or three weeks to diseased skin in some patients with psoriasis or atopic dermatitis. These effects were reversible upon discontinuation of treatment. Patients receiving betamethasone dipropionate gel (augmented) applied to large areas should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH-stimulation, morning plasma cortisol and urinary free-cortisol tests. Patients should not be treated with betamethasone dipropionate gel (augmented) for more than 2 weeks at a time, and amounts greater than 50 g per week should not be used because of the potential for the drug to suppress the HPA axis. 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 corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for systemic corticosteroids. 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 dipropionate gel (augmented) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant fungal and/or bacterial 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 betamethasone dipropionate gel (augmented) should be discontinued until the infection has been adequately controlled. Information for Patients Patients using topical corticosteroids should receive the following information and instructions: The medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. The medication 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. Patients should report to their physician any signs of local adverse reactions. Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test, Morning plasma-cortisol test, Urinary free-cortisol test Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. 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 the rabbits and mice. Pregnancy Teratogenic Effects 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 to laboratory animals. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 26 times the human topical dose of betamethasone dipropionate gel (augmented) assuming human percutaneous absorption of approximately 3% and the use in a 70 kg person of 7 g per day. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. There are no adequate and well-controlled studies of the teratogenic potential of betamethasone dipropionate in pregnant women. Therefore, betamethasone dipropionate gel (augmented) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 human milk. Because many drugs are excreted in human milk, caution should be exercised when betamethasone dipropionate gel (augmented) is administered to a nursing woman. Pediatric Use Data regarding use of betamethasone dipropionate gel (augmented) in pediatric patients are not available, so use of this product in patients under the age of 12 is not recommended. 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 when they are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and pediatric patients. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Geriatric Use Clinical studies of betamethasone dipropionate gel (augmented) included 65 subjects who were 65 years of age and over and 15 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API