betamethasone and clotrimazole (Topical route)

kloe-TRIM-a-zole, bay-ta-METH-a-sone dye-PROE-pee-oh-nate

Commonly used brand name(s):

In the U.S.

• Lotrisone

In Canada

• Lotriderm
• Pms-Clotrimazole And Betamethasone

Available Dosage Forms:

• Cream
• Lotion

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Betamethasone

Chemical Class: Imidazole

Uses For betamethasone and clotrimazole

Clotrimazole and betamethasone 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 or lotion 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) .

betamethasone and clotrimazole may also be used for other fungus infections of the skin as determined by your doctor.

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

Before Using betamethasone and clotrimazole

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to betamethasone and clotrimazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of clotrimazole and betamethasone combination in teenagers 17 years of age and older. Safety and efficacy have not been established in children and teenagers below 17 years of age .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of clotrimazole and betamethasone combination in the elderly. However, elderly patients are more likely to have a thinning skin, which may require caution in patients receiving clotrimazole and betamethasone .

Interactions with Medicines

Using betamethasone and clotrimazole with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Methylergonovine
• Rotavirus Vaccine, Live

Using betamethasone and clotrimazole with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aldesleukin
• Bupropion
• Quetiapine

Using betamethasone and clotrimazole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alatrofloxacin
• Alcuronium
• Aspirin
• Atracurium
• Balofloxacin
• Cinoxacin
• Ciprofloxacin
• Clinafloxacin
• Enoxacin
• Ethinyl Estradiol
• Etonogestrel
• Fentanyl
• Fleroxacin
• Flumequine
• Fosphenytoin
• Gallamine
• Gemifloxacin
• Grepafloxacin
• Hexafluorenium
• Itraconazole
• Levofloxacin
• Licorice
• Lomefloxacin
• Mestranol
• Metocurine
• Moxifloxacin
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestrel
• Ofloxacin
• Pefloxacin
• Phenobarbital
• Phenytoin
• Primidone
• Prulifloxacin
• Rifampin
• Rifapentine
• Rosoxacin
• Rufloxacin
• Saiboku-To
• Sparfloxacin
• Tacrolimus
• Temafloxacin
• Tosufloxacin
• Trimetrexate
• Trovafloxacin Mesylate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of betamethasone and clotrimazole. 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 children and elderly patients 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 betamethasone and clotrimazole

Before applying betamethasone and clotrimazole, wash the affected area with soap and water, and dry thoroughly.

Do not use betamethasone and clotrimazole in the eyes.

To use:

• Check with your doctor before using betamethasone and clotrimazole 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 betamethasone and clotrimazole 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 betamethasone and clotrimazole 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 betamethasone and clotrimazole unless directed by your doctor. Also, wear loose-fitting clothing when using betamethasone and clotrimazole on the groin area. When using betamethasone and clotrimazole on the diaper area of children, avoid tight-fitting diapers and plastic pants.

To help clear up your skin infection completely, keep using betamethasone and clotrimazole for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses. However, do not use betamethasone and clotrimazole 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

The dose of betamethasone and clotrimazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of betamethasone and clotrimazole. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical cream or lotion dosage form:
  • For jock itch (ringworm of the groin; tinea cruris) or ringworm of the body (tinea corporis):
    • Adults and teenagers 17 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 and teenagers up to 16 years of age—Use and dose must be determined by your doctor .
  • For athlete's foot (ringworm of the foot; tinea pedis):
    • Adults and teenagers 17 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 and teenagers up to 16 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of betamethasone and clotrimazole, 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using betamethasone and clotrimazole

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 betamethasone and clotrimazole 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 betamethasone and clotrimazole 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 betamethasone and clotrimazole 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 betamethasone and clotrimazole 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 betamethasone and clotrimazole. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

betamethasone and clotrimazole Side Effects

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 pain
• backache
• blurred vision
• dry mouth
• facial hair growth in females
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• increased hunger, thirst, or urination
• irritability
• loss of sexual desire or ability
• menstrual irregularities
• muscle wasting
• nausea
• sugar in the urine
• sweating
• troubled breathing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting

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 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.

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