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|Lotriderm Topical

CLOTRIMAZOLE AND BETAMETHASONE (Topical)

Some commonly used brand names are:

In the U.S.—

• Lotrisone

In Canada—

• Lotriderm

Category

• Antifungal-corticosteroid, topical

Description

Clotrimazole and betamethasone (kloe-TRIM-a-zole and bay-ta-METH-a-sone) combination is used to treat fungus infections. Clotrimazole works by killing the fungus or preventing its growth. Betamethasone, a corticosteroid (cortisone-like medicine or steroid), is used to help relieve redness, swelling, itching, and other discomfort of fungus infections.

Clotrimazole and betamethasone cream is applied to the skin to treat:

• athlete"s foot (ringworm of the foot; tinea pedis);
• jock itch (ringworm of the groin; tinea cruris); and
• ringworm of the body (tinea corporis).

This medicine may also be used for other fungus infections of the skin as determined by your doctor.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Topical
• Cream (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For clotrimazole and betamethasone combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or to clotrimazole (e.g., Gyne-Lotrimin, Lotrimin), betamethasone (e.g., Valisone), butoconazole (e.g., Femstat), econazole (e.g., Ecostatin, Spectazole), ketoconazole (e.g., Nizoral), miconazole (e.g., Monistat, Monistat-Derm), terconazole (e.g., Terazol 7), or to any of the other corticosteroids. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Clotrimazole and betamethasone combination has not been studied in pregnant women. However, for the individual medicines:

• Clotrimazole —Clotrimazole (e.g., Gyne-Lotrimin), used in the vagina, has not been shown to cause birth defects or other problems in studies in rats or humans. However, clotrimazole (e.g., Mycelex), given by mouth, has been shown to cause a decrease in successful pregnancies, but no birth defects, in rats and mice.
• Betamethasone —Studies in animals have shown that corticosteroids, given by mouth or by injection, may cause birth defects, even at low doses. Also, some of the stronger corticosteroids have been shown to cause birth defects when applied to the skin of animals.

Therefore, this medicine should not be used on large areas of the skin, in large amounts, or for a long time in pregnant patients. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether topical clotrimazole and betamethasone combination passes into the breast milk. However, clotrimazole and betamethasone may be absorbed into the mother"s body and risk-benefit should be considered.

• Betamethasone —Corticosteroids, given by mouth or by injection, do pass into the breast milk. They may cause unwanted effects, such as slower growth rate of nursing babies.

Children—Clotrimazole and betamethasone combination may rarely cause serious side effects. Some of these side effects may be more likely to occur in children, who may absorb greater amounts of this medicine than adults do. Long-term use in children may affect growth and development as well. Therefore, it is especially important that you discuss with the child"s doctor the good that this medicine may do, as well as the risks of using it.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of clotrimazole and betamethasone combination in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of clotrimazole and betamethasone combination. Make sure you tell your doctor if you have any other medical problems, especially:

• Bacteria infections of the skin or
• Diaper dermatitis (diaper rash) on your child or
• Skin diseases causing impaired circulation, such as stasis dermatitis—Betamethasone may make the condition worse

• Herpes or
• Vaccinia (cowpox) or
• Varicella (chickenpox) or
• Other virus infections of the skin—Betamethasone may speed up the spread of virus infections

• Tuberculosis (TB) of the skin—Betamethasone may make a TB infection worse

Proper Use of This Medicine

Before applying this medicine, wash the affected area with soap and water, and dry thoroughly.

Do not use this medicine in the eyes .

To use:

• Check with your doctor before using this medicine on any other skin problems . It should not be used on bacterial or virus infections or on diaper rash. Also, it should only be used on certain kinds of fungus infections of the skin.
• Apply a thin layer of this medicine to the affected area(s) and surrounding skin. Rub in gently and thoroughly.

The use of any kind of occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine may increase absorption of the medicine and the chance of irritation and other side effects. Therefore, do not bandage, wrap, or apply any occlusive dressing over this medicine unless directed by your doctor. Also, wear loose-fitting clothing when using this medicine on the groin area. When using this medicine on the diaper area of children, avoid tight-fitting diapers and plastic pants .

To help clear up your skin infection completely, keep using this medicine for the full time of treatment , even if your symptoms have disappeared. Do not miss any doses . However, do not use this medicine more often or for a longer time than your doctor ordered . To do so may increase absorption through your skin and the chance of side effects. In addition, too much use, especially on thin skin areas (for example, face, armpits, genitals [sex organs], between the toes, groin), may result in thinning of the skin and in stretch marks.

Dosing—Follow your doctor"s orders or the directions on the label . The following information includes only the average dose of clotrimazole and betamethasone combination. If your dose is different, do not change it unless your doctor tells you to do so.

• For topical cream dosage form:
  • For jock itch (ringworm of the groin; tinea cruris) or ringworm of the body (tinea corporis):
    • Adults and children 12 years of age and over—Apply to the affected skin and surrounding area(s) two times a day, morning and evening, for 2 weeks.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For athlete"s foot (ringworm of the foot; tinea pedis):
    
    • Adults and children 12 years of age and over—Apply to the affected skin and surrounding area(s) two times a day, morning and evening, for 4 weeks.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your skin infection does not improve within 1 week for jock itch or ringworm of the body and 2 weeks for athlete"s foot, or if it becomes worse, check with your doctor. Redness and itching should get better within 3 to 5 days of therapy.

To help clear up your skin infection completely and to help make sure it does not return, the following good health habits are important:

• For patients using this medicine for athlete"s foot :
  • Carefully dry the feet, especially between the toes, after bathing.
  • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat freely.
  • Wear well-ventilated shoes (for example, shoes with holes) or sandals.
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder freely between the toes, on the feet, and in socks and shoes once or twice a day. Be sure to use the powder after clotrimazole and betamethasone cream has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
  
  These measures will help keep the feet cool and dry.
• For patients using this medicine for jock itch :
  • Carefully dry the groin area after bathing.
  • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder freely once or twice a day. Be sure to use the powder after clotrimazole and betamethasone cream has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
  
  These measures will help reduce chafing and irritation and will also help keep the groin area cool and dry.
• For patients using this medicine for ringworm of the body :
  • Carefully dry yourself after bathing.
  • Avoid too much heat and humidity if possible. Try to keep moisture from building up on affected areas of the body.
  • Wear well-ventilated clothing.
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder freely once or twice a day. Be sure to use the powder after clotrimazole and betamethasone cream has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
  
  These measures will help keep the affected areas cool and dry.

If you have any questions about this, check with your health care professional.

For diabetic patients:

• Rarely, the corticosteroid in this medicine may cause higher blood and urine sugar levels. This is more likely to occur if you have severe diabetes and are using large amounts of this medicine . Check with your doctor before changing your diet or the dosage of your diabetes medicine.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Additional side effects may occur if you use this medicine for a long time. Check with your doctor as soon as possible if any of the following side effects occur:

Acne or oily skin; increased hair growth, especially on the face and body; increased loss of hair, especially on the scalp; pus in the hair follicles; reddish purple lines on arms, face, legs, trunk, or groin; redness and scaling around the mouth; softening of the skin; thinning of skin with easy bruising; white spots

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 06/14/1999

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