Betamethasone Valerate Cream USP, 0.1% | BETAMETHASONE VALERATE

14:15 EDT 25th October 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Rx only

For External Use Only. Not for Ophthalmic Use.

Betamethasone Valerate Cream USP, 0.1% contains a topical corticosteroid, betamethasone valerate. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Betamethasone valerate is chemically designated as Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-17 [(1-oxopentyl) oxy], (11β, 16β)-.

MF: CHFO MW: 476.58

Each gram of Betamethasone Valerate Cream USP, 0.1% contains: 1.2 mg betamethasone valerate (equivalent to 1.0 mg betamethasone), in an aqueous vanishing cream base of mineral oil, white petrolatum, polyethylene glycol 1000, ceteareth-15, cetyl alcohol, stearyl alcohol, propylene glycol, purified water, and 4-chloro-m-cresol as preservative.

IMAGE betamethasone-01.jpg

Betamethasone valerate cream as a topical corticosteroid has anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

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.

Betamethasone valerate cream can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION ).

Once absorbed through the skin, betamethasone valerate cream is handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Betamethasone valerate cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Betamethasone valerate cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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.

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 receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. 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 and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use ).

If irritation develops, use of betamethasone valerate cream should be discontinued and appropriate therapy instituted.

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 cream should be discontinued until the infection has been adequately controlled.

Patients using betamethasone valerate cream should receive the following information and instructions:

The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol testACTH stimulation test

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, betamethasone valerate cream should be used during pregnancy only if the potential benefit justifies 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.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when betamethasone valerate cream is administered to a nursing woman.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children 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.

Administration of betamethasone valerate cream 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.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning Hypertrichosis Maceration of the Skin
Itching Acneiform Eruptions Secondary Infection
Irritation Hypopigmentation Skin Atrophy
Dryness Perioral Dermatitis Striae
Folliculitis Allergic Contact Dermatitis Miliaria

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

Betamethasone Valerate Cream USP, 0.1% is generally applied to the affected skin areas one to three times daily. Dosage once or twice a day is often effective.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.

Betamethasone Valerate Cream USP, 0.1% is supplied in 15 gram (NDC 51672-1269-1) and 45 gram (NDC 51672-1269-6) tubes.

Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Revised: March 2005

PK-0759-4 128

NDC 51672-1269-1

15 g

Betamethasone Valerate Cream USP, 0.1%

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Rx only

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

TARO

IMAGE betamethasone-02.jpg

Manufacturer

Taro Pharmaceuticals U.S.A., Inc.

Active Ingredients

Source

Drugs and Medications [68 Associated Drugs and Medications listed on BioPortfolio]

Betamethasone valerate [Rebel Distributors Corp.]

Betamethasone Valerate Cream USP, 0.1%

Betamethasone valerate [TEVA Pharmaceuticals USA Inc]

BETAMETHASONE VALERATE CREAM USP, 0.1% / LOTION USP, 0.1%(Potency expressed as betamethasone)06730671Rx only

Clotrimazole and betamethasone dipropionate cream usprx only [Actavis Mid Atlantic LLC]

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM USPRx Only

Clotrimazole and betamethasone dipropionate [E. FOUGERA & CO. A division of Nycomed US Inc.]

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION USP, 1%/0.05% (base)

Clotrimazole and betamethasone dipropionate [E. FOUGERA & CO., A division of Nycomed US Inc.]

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM USP 1%/0.05% (base)

Clinical Trials [41 Associated Clinical Trials listed on BioPortfolio]

A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema

The purpose of this study is to investigate whether a moisturizing cream can prevent hand eczema.Patients with previous hand eczema will be studied. In the second part of the study, it wil...

Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser

Topical steroid creams as well as moisturizing creams are important parts of the treatment strategy of atopic eczema. This study aims to investigate the tolerance of a new strong steroid c...

Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in Cortisosensitive Dermatosis

Topical corticosteroids are largely used in dermatology. The major problem related to their use is that the same mechanisms underlying their therapeutic effects (antiinflammatory and antip...

Betamethasone Dosing Interval - 12 or 24 Hours?

The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.

Efficacy and Safety of Calcipotriene/Betamethasone Gel/Ointment in Psoriasis

Patients will receive either a gel containing both calcipotriene plus betamethasone or gel with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this time al...

PubMed Articles [31 Associated PubMed Articles listed on BioPortfolio]

Maternal Glucose Response to Betamethasone Administration.

Objective This study aims to describe the pattern of maternal glucose response to betamethasone administration using a continuous glucose monitoring system. Study Design A prospective observationa...

Retinopathy of prematurity: risk factors and role of antenatal betamethasone in Indian preterm newborn babies.

Increase in the survival of preterm neonates has led to increased incidence of retinopathy of prematurity (ROP). Among various risk factors, only prematurity is well-established and role of others is ...

Effective topical delivery systems for corticosteroids: dermatological and histological evaluations.

Abstract Atopic dermatitis (AD) is a chronic and relapsing skin disease with severe eczematous lesions. Long-term topical corticosteroid treatment can induce skin atrophy, hypopigmentation and transep...

A case of cap polyposis remission by betamethasone enema after antibiotics therapy including Helicobacter pylori eradication.

We report the case of a 58-year-old woman who was referred to our hospital due to frequent bloody mucus diarrhea. She was diagnosed with cap polyposis based on typical endoscopic and histological find...

Effects of 14 frequently used drugs on prostate-specific antigen expression in prostate cancer LNCaP cells.

Prostate cancer occurs more frequently among older males and such elderly individuals often have chronic underlying disorders for which various drugs are administered for treatment. The levels of pros...

Search BioPortfolio:
Loading
Advertisement

Relevant Topic

Dermatology
Latest News Clinical Trials Research Drugs Reports Corporate
Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers a range of diseases including skin allergies, alopecia, Behcet'...

Advertisement

Drugs and Medication Quicklinks


Searches Linking to this Drug Record