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

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

Clotrimazole and betamethasone dipropionate lotion USP, contains combinations of clotrimazole USP, a synthetic antifungal agent, and betamethasone dipropionate USP, a synthetic corticosteroid, for dermatologic use.

Chemically, clotrimazole is 1-(o-chloro-α,α-diphenylbenzyl)imidazole, with the empirical formula C₂₂H₁₇CIN₂, 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 C₂₈H₃₇FO₇, 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 USP contains 10 mg clotrimazole and 0.64 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; benzyl alcohol as a preservative. Clotrimazole and betamethasone dipropionate lotion USP is opaque and white in color.

Clotrimazole and betamethasone dipropionate cream has been shown to be at least as effective as clotrimazole alone in a different cream vehicle. 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 of host inflammation leading to worsening or decreased cure rate.

Skin penetration and systemic absorption of clotrimazole following topical application of clotrimazole and betamethasone dipropionate lotion have not been studied. The following information was obtained using 1% clotrimazole cream and solution formulations. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm³ in the stratum corneum, to 0.5 to 1 mcg/cm³ in the reticular dermis, and 0.1 mcg/cm³ in the subcutis. No measurable amount of radioactivity (<0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream. Only 0.5% or less of the applied radioactivity was excreted in the urine.

Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

In the treatment of tinea pedis twice daily for 4 weeks, clotrimazole and betamethasone dipropionate lotion was shown to be superior to vehicle in relieving symptoms of erythema, scaling, pruritus, and maceration at week 2.

Clotrimazole and betamethasone dipropionate lotion was also shown to have a superior mycological cure rate compared to vehicle 2 weeks after discontinuation of treatment. It is unclear if the relief of symptoms at 2 weeks in this clinical study with clotrimazole and betamethasone dipropionate lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.

In the treatment of tinea cruris twice daily for 2 weeks, clotrimazole and betamethasone dipropionate lotion was shown to be superior to vehicle in the relief of symptoms of erythema, scaling, pruritus after 3 days. It is unclear if the relief of symptoms after 3 days in this clinical study with clotrimazole and betamethasone dipropionate lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.

The comparative efficacy and safety of clotrimazole and betamethasone dipropionate lotion versus clotrimazole alone in a lotion vehicle have not been studied in the treatment of tinea pedis or tinea cruris or tinea corporis. The comparative efficacy and safety of clotrimazole and betamethasone dipropionate lotion and clotrimazole and betamethasone dipropionate cream have also not been studied.

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.

Adverse reactions reported for clotrimazole and betamethasone dipropionate lotion in clinical trials were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients.

The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings. These reactions are uled in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, 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 reported with the use of clotrimazole are as follows: erythema, stinging, bulering, peeling, edema, pruritus, urticaria, and general irritation of the skin.

Amounts greater than 45 mL/week of clotrimazole and betamethasone dipropionate lotion should not be used. Acute overdosage with topical application of clotrimazole and betamethasone dipropionate lotion is unlikely and would not be expected to lead to life-threatening situation. Clotrimazole and betamethasone dipropionate lotion should not be used for longer than the prescribed time period.

Topically applied corticosteroids, such as the one contained in clotrimazole and betamethasone dipropionate lotion can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

Gently massage sufficient clotrimazole and betamethasone dipropionate lotion into the affected skin areas twice a day, in the morning and evening.

Clotrimazole and betamethasone dipropionate lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 mL per week of clotrimazole and betamethasone dipropionate lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with clotrimazole and betamethasone dipropionate lotion, the diagnosis should be reviewed.

Clotrimazole and betamethasone dipropionate lotion should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 mL per week of clotrimazole and betamethasone dipropionate lotion should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate lotion, the diagnosis should be reviewed.

Clotrimazole and betamethasone dipropionate lotion should not be used with occlusive dressings.

Clotrimazole and betamethasone dipropionate lotion USP, 1%/0.05% (base) is supplied as follows

Store at 25°C (77°F) in the upright position only; excursions permitted between 15°C and 30°C
(59°F and 86°F). SHAKE WELL BEFORE EACH USE.

E. FOUGERA & CO.
a division of Altana Inc., MELVILLE, NEW YORK 11747

I2370
R9/04
#104

Remove this portion before dispensing

What is clotrimazole and betamethasone dipropionate lotion?

Clotrimazole and betamethasone dipropionate lotion is a medication used on the skin to treat fungal infections of the feet, groin, and body, as diagnosed by your doctor. Clotrimazole and betamethasone dipropionate lotion should be used for fungal infections that are inflamed and have symptoms of redness and/or itching. Talk to your doctor if your fungal infection does not have these symptoms. Clotrimazole and betamethasone dipropionate lotion contains a corticosteroid. Notify your doctor if you notice side effects with the use of clotrimazole and betamethasone dipropionate lotion. (see ``What are the possible side effects of clotrimazole and betamethasone dipropionate lotion?′′ below). Clotrimazole and betamethasone dipropionate lotion is not to be used in the eyes, in the mouth, or in the vagina.

How does clotrimazole and betamethasone dipropionate lotion work?

Clotrimazole and betamethasone dipropionate lotion is a combination of an antifungal agent (clotrimazole) and a corticosteroid (betamethasone dipropionate). Clotrimazole works against fungus. Betamethasone dipropionate, a corticosteroid, is used to help relieve redness, swelling, itching, and other discomforts of fungal infections.

Who should NOT use clotrimazole and betamethasone dipropionate lotion?

Clotrimazole and betamethasone dipropionate lotion is not recommended for use in patients under the age of 17 years. Clotrimazole and betamethasone dipropionate lotion is not recommended for use in diaper rash.

Patients who are sensitive to clotrimazole and betamethasone dipropionate, other corticosteroids or imidazoles or any ingredients in the preparation should not use clotrimazole and betamethasone dipropionate lotion.

How should I use clotrimazole and betamethasone dipropionate lotion?

Gently massage sufficient clotrimazole and betamethasone dipropionate lotion into the affected and surrounding skin areas twice a day, in the morning and evening. Treatment for 2 weeks on the groin or on the body, and for 4 weeks on the feet is recommended. The use of clotrimazole and betamethasone dipropionate lotion for longer than 4 weeks is not recommended for any condition. Prolonged use of clotrimazole and betamethasone dipropionate lotion may lead to unwanted side effects.

What other important information should I know about clotrimazole and betamethasone dipropionate lotion?

• This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify your doctor if there is no improvement after 1 week of treatment on the groin or body or after 2 weeks on the feet.
• This medication should only be used for the disorder for which it was prescribed.
• The treated skin area should not be bandaged or otherwise covered or wrapped.
• Other corticosteroid-containing products should not be used with clotrimazole and betamethasone dipropionate lotion without first talking with your physician.
• Any signs of side effects where clotrimazole and betamethasone dipropionate lotion is applied should be reported to your doctor.
• When using clotrimazole and betamethasone dipropionate lotion in the groin area, it is especially important to use the medication for two weeks only, and to apply the lotion sparingly. You should tell your doctor if your problem persists after 2 weeks.
• This medication is not recommended for use in diaper rash.

What are the possible side effects of clotrimazole and betamethasone dipropionate lotion?

The following side effects have been reported with topical corticosteroid medications: itching, irritation, dryness, infection of the hair follicles, increased hair, acne, change in skin color, allergic skin reaction, skin thinning, and stretch marks.

Can clotrimazole and betamethasone dipropionate lotion be used if I am pregnant or plan to become pregnant or if I am nursing?

Before using clotrimazole and betamethasone dipropionate lotion, tell your doctor if you are pregnant or plan to become pregnant. Also, tell your doctor if you are nursing.

How should clotrimazole and betamethasone dipropionate lotion be stored?

Clotrimazole and betamethasone dipropionate lotion should be stored in an upright position between 15°C - 30°C (59°F - 86°F). Shake well before using clotrimazole and betamethasone dipropionate lotion.

General advice about prescription medicines

This medication was prescribed for your particular condition. Only use clotrimazole and betamethasone dipropionate lotion to treat the condition that your doctor has prescribed. Do not give clotrimazole and betamethasone dipropionate lotion to other people. It may harm them. Keep out of reach of children.

This leaflet summarizes the most important information about clotrimazole and betamethasone dipropionate lotion. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about clotrimazole and betamethasone dipropionate lotion that is written for health professionals.

E. FOUGERA & CO.
a division of Altana Inc.,
MELVILLE NEW YORK 11747