Betamethasone dipropionate (augmented) topical

Generic

Generic for Diprolene af

ID: 51672130903

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BETAMETHASONE DIPROPIONATE AUGMENTED TOPICAL 005 PERCENT 50 GM GEL 5167213093

📜 Prescription Required

FORM

Gel

STRENGTH

0.05%/50 gm

QUANTITY

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TL;DR — Quick Summary

Key facts from the full medication guide below

SPL UNCLASSIFIED SECTION DESCRIPTION CLINICAL PHARMACOLOGY Pharmacokinetics INDICATIONS AND USAGE

🩺What it's for

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.

💊How to take it

Topically applied betamethasone dipropionate gel (augmented) can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

ℹ️Common side effects

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.

📦Storage & missed dose

Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature].

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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.

Other Manufacturers

Prescription Required

Betamethasone dipropionate (augmented) topical

Diprolene af

0.05%/15 gm

$64.00

Betamethasone dipropionate (augmented) topical

FORM

STRENGTH

QUANTITY

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