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CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM 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

Rx Only

DESCRIPTION

Clotrimazole and Betamethasone Dipropionate Cream 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 Cream USP, contains 10 mg clotrimazole and 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetearyl alcohol 70/30, ceteareth-30, propylene glycol, sodium phosphate monobasic, and phosphoric acid; benzyl alcohol as a preservative.

Clotrimazole and Betamethasone Dipropionate Cream USP, is smooth, uniform, and white to off-white in color.

CLINICAL PHARMACOLOGY

Clotrimazole and Betamethasone Dipropionate

Clotrimazole and Betamethasone Dipropionate Cream has been shown to be at least as effective as clotrimazole alone in a different cream vehicle.

Use of corticosteroids in the treatment of a fungal infection may lead to suppression of host inflammation leading to worsening or decreased cure rate.

Clotrimazole

Skin penetration and systemic absorption of clotrimazole following topical application of Clotrimazole and Betamethasone Dipropionate Cream 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.

Microbiology

Betamethasone Dipropionate

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

CLINICAL STUDIES

In clinical studies of tinea corporis, tinea cruris, and tinea pedis, patients treated with Clotrimazole and Betamethasone Dipropionate Cream showed a better clinical response at the first return visit than patients treated with clotrimazole cream. In tinea corporis and tinea cruris, the patient returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in patients treated with Clotrimazole and Betamethasone Dipropionate Cream were as good as or better than in those patients treated with clotrimazole cream. In these same clinical studies, patients treated with Clotrimazole and Betamethasone Dipropionate Cream showed better clinical responses and mycological cure rates when compared with patients treated with betamethasone dipropionate cream.

INDICATIONS AND USAGE

Clotrimazole and Betamethasone Dipropionate Cream 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 in patients 17 years and older. 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 Cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis) has not been established.

Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream in the treatment of infections caused by Microsporum canis have been reported.

CONTRAINDICATIONS

Clotrimazole and Betamethasone Dipropionate Cream is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

PRECAUTIONS

ADVERSE REACTIONS

Adverse reactions reported for Clotrimazole and Betamethasone Dipropionate Cream in clinical trials were paresthesia in 1.9% of patients, and rash, edema, and secondary infection, each 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. In the pediatric population, reported adverse events for Clotrimazole and Betamethasone Dipropionate Cream include growth retardation, benign intracranial hypertension, Cushing's syndrome (HPA axis suppression), and local cutaneous reactions, including skin atrophy.

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.

OVERDOSAGE

Amounts greater than 45 g/week of Clotrimazole and Betamethasone Dipropionate Cream should not be used. Acute overdosage with topical application of Clotrimazole and Betamethasone Dipropionate Cream is unlikely and would not be expected to lead to life-threatening situation. Clotrimazole and Betamethasone Dipropionate Cream should not be used for longer than the prescribed time period.

Topically applied corticosteroids, such as the one contained in Clotrimazole and Betamethasone Dipropionate Cream can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

DOSAGE AND ADMINISTRATION

Gently massage sufficient Clotrimazole and Betamethasone Dipropionate Cream into the affected skin areas twice a day, in the morning and evening.

Clotrimazole and Betamethasone Dipropionate Cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream 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 Cream, the diagnosis should be reviewed.

Clotrimazole and Betamethasone Dipropionate Cream should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with Clotrimazole and Betamethasone Dipropionate Cream, the diagnosis should be reviewed.

Clotrimazole and Betamethasone Dipropionate Cream should not be used with occlusive dressings.

HOW SUPPLIED

Clotrimazole and Betamethasone Dipropionate Cream USP 1%/0.05% (base) is supplied as follows:

NDC 0168-0258-1515 gram tube
NDC 0168-0258-4645 gram tube

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°-86°F) [see USP Controlled Room Temperature].

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

I2258D
R10/05
#52

Remove this portion before dispensing

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

Patient Information Leaflet

Rx Only

What is Clotrimazole and Betamethasone Dipropionate Cream?

Clotrimazole and Betamethasone Dipropionate Cream 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 Cream 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 Cream contains a corticosteroid. Notify your doctor if you notice side effects with the use of Clotrimazole and Betamethasone Dipropionate Cream. (see ``What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream?′′ below). Clotrimazole and Betamethasone Dipropionate Cream is not to be used in the eyes, in the mouth, or in the vagina.

How does Clotrimazole and Betamethasone Dipropionate Cream work?

Clotrimazole and Betamethasone Dipropionate Cream 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 Cream?

Clotrimazole and Betamethasone Dipropionate Cream is not recommended for use in patients under the age of 17 years. Clotrimazole and Betamethasone Dipropionate Cream 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 Cream.

How should I use Clotrimazole and Betamethasone Dipropionate Cream?

Gently massage sufficient Clotrimazole and Betamethasone Dipropionate Cream 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 Cream for longer than 4 weeks is not recommended for any condition. Prolonged use of Clotrimazole and Betamethasone Dipropionate Cream may lead to unwanted side effects.

What other important information should I know about Clotrimazole and Betamethasone Dipropionate Cream?

  • 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 Cream without first talking with your physician.
  • Any signs of side effects where Clotrimazole and Betamethasone Dipropionate Cream is applied should be reported to your doctor.
  • When using Clotrimazole and Betamethasone Dipropionate Cream in the groin area, it is especially important to use the medication for two weeks only, and to apply the cream sparingly. You should tell your doctor if your problem persists after 2 weeks. You should also wear loose-fitting clothing so as to avoid tightly covering the area where Clotrimazole and Betamethasone Dipropionate Cream is applied.
  • This medication is not recommended for use in diaper rash.

What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream?

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. In children, reported adverse events for Clotrimazole and Betamethasone Dipropionate Cream include slower growth, Cushing's syndrome (a type of hormone imbalance that can be very serious) and local skin reactions, including thinning skin and stretch marks. Hormone imbalance (adrenal suppression) was demonstrated in clinical studies in children.

Can Clotrimazole and Betamethasone Dipropionate Cream be used if I am pregnant or plan to become pregnant or if I am nursing?

Before using Clotrimazole and Betamethasone Dipropionate Cream, 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 Cream be stored?

Clotrimazole and Betamethasone Dipropionate Cream should be stored at 25°C (77°F); excursions permitted to 15°C-30°C (59°-86°F) [see USP Controlled Room Temperature].

General advice about prescription medicines

This medication was prescribed for your particular condition. Only use Clotrimazole and Betamethasone Dipropionate Cream to treat the condition that your doctor has prescribed it for. Do not give Clotrimazole and Betamethasone Dipropionate Cream 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 Cream. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clotrimazole and Betamethasone Dipropionate Cream that is written for health professionals.

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

R10/05

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