Betamethasone and clotrimazole Topical

Clotrimazole and betamethasone topical 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 topical cream or lotion is applied to the skin to treat:

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

betamethasone and clotrimazole is available only with your doctor's prescription.

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:

• Blistering, burning, itching, peeling, dryness, redness, or other signs of skin irritation not present before use of betamethasone and clotrimazole
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• hives

• Cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination
• rash
• stinging
• swelling

• Abdominal or stomach pain
• dry mouth
• full or round face, neck, or trunk
• irritability
• nausea
• reddish purple lines on the arms, face, legs, trunk, or groin
• redness and scaling around the mouth
• softening of the skin
• unusual tiredness or weakness
• vomiting

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to betamethasone or clotrimazole.

To make sure this medicine is safe for you, tell your doctor if you have:

• any type of skin infection.

It is not known whether betamethasone and clotrimazole topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether betamethasone and clotrimazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use this medication on a child younger than 17 years old. Children are more likely to absorb the steroid through the skin. Do not use betamethasone and clotrimazole topical to treat diaper rash.

Avoid getting this medicine in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use betamethasone and clotrimazole topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid wearing tight-fitting clothing that doesn't allow air circulation. Until the infection is healed, wear clothing that is made of natural fibers such as cotton.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Topical steroid medicine can be absorbed through the skin, which may affect your adrenal gland. Call your doctor if you have:

• nausea, vomiting, severe dizziness;

• muscle weakness;

• depressed mood, feeling irritable;

• weight loss; or

• tired feeling.

Common side effects may include:

• burning or tingling of treated skin;

• rash; or

• swelling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Apply to affected area twice a day for 2 weeks.

Betamethasone-clotrimazole has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity when corticosteroids are administered orally or potent steroids are applied topically. Betamethasone has been shown to be teratogenic when administered intramuscularly in rabbits. There are no controlled data in human pregnancy. Betamethasone has been shown to cross the placenta. Betamethasone-clotrimazole is only recommended for use during pregnancy when benefit outweighs risk.

Following oral administration of betamethasone prior to delivery, the umbilical serum concentration to maternal serum ratio averaged 0.28. Intravaginal clotrimazole use has been studied during pregnancy. Clotrimazole has been used in several clinical trials for the treatment of vaginal candidiasis during the second and third trimester without evidence of fetal harm. One trial included 57 patients in their first trimester. Again no adverse fetal effects were attributed to clotrimazole. In a review of 229,101 deliveries to Michigan Medicaid patients, 2624 first-trimester exposures to clotrimazole and 8590 exposures any time during pregnancy were recorded. A total of 118 birth defects were reported with first trimester exposure (112 expected) and included (observed/expected) 27/26 cardiovascular defects, 3/1 spina bifida, 4/4 oral clefts, 9/6 polydactyly, 1 limb reductions, and 6/6 hypospadias. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association between clotrimazole use during pregnancy and birth defects. Animals given high doses of clotrimazole intravaginally and orally have not revealed evidence of teratogenicity. In clinical trials of women in their second and third trimester, clotrimazole treatment of vaginal candidiasis has not been associated with fetal harm.