CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65), BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

CLOTRIMAZOLE

Composition:

CLOTRIMAZOLE 10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clotrimazole and betamethasone dipropionate lotion is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum . Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate lotion for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis ) has not been established. Clotrimazole and betamethasone dipropionate lotion is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

Product summary:

Clotrimazole and betamethasone dipropionate lotion, 1%/0.05% (base) is supplied as follows           NDC 0168-0370-30   30 mL Bottle Store at 25°C (77°F) in the upright position only; excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. SHAKE WELL BEFORE EACH USE. I2370D R12/15 #104 Remove this portion before dispensing

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE LOTION
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION, 1%/0.05% (BASE)
Rx Only
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT
RECOMMENDED FOR DIAPER DERMATITIS.
DESCRIPTION:
Clotrimazole and betamethasone dipropionate lotion contains
combinations of clotrimazole, a synthetic
antifungal agent, and betamethasone dipropionate, a synthetic
corticosteroid, for dermatologic use.
Chemically, clotrimazole is
1-(_o_-chloro-α,α-diphenylbenzyl)imidazole, with the empirical
formula
C
H CIN , a molecular weight of 344.84, and the following structural
formula:
Clotrimazole is an odorless, white crystalline powder, insoluble in
water and soluble in ethanol.
Betamethasone dipropionate has the chemical name
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-
1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C
H FO , a molecular weight
of 504.59, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless
crystalline powder, insoluble in
water.
Each gram of clotrimazole and betamethasone dipropionate lotion
contains 10 mg clotrimazole and 0.64
22
17
2
28
37
7
mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in
a hydrophilic base of purified
water, mineral oil, white petrolatum, cetostearyl alcohol,
ceteareth-30, propylene glycol, sodium
phosphate monobasic monohydrate, and phosphoric acid (used for pH
adjustment, if required); benzyl
alcohol as a preservative. Clotrimazole and betamethasone dipropionate
lotion is opaque and white in
color.
CLINICAL PHARMACOLOGY
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
No comparative studies have been conducted with clotrimazole and
betamethasone dipropionate lotion
and clotrimazole alone. Use of corticosteroids in the treatment of a
fungal infection may lead to
suppression