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What is Lotrisone?

Clotrimazole is an antifungal antibiotic that treats or prevents infection caused by fungus.

Betamethasone is a topical steroid that reduces itching, swelling, and redness of the skin.

The combination of betamethasone and clotrimazole is used to treat fungal skin infections such as athletes foot, jock itch, and ringworm.

Lotrisone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lotrisone?

Do not cover treated skin areas with a bandage or tight clothing, unless your doctor has told you to. Do not use this medication on a child younger than 17 years old. Children are more likely to absorb the steroid through the skin. Never use Lotrisone to treat diaper rash. It may take up to 1 or 2 weeks of using Lotrisone before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your groin symptoms do not improve after 1 week, or if your foot symptoms do not improve after 2 weeks of treatment.

What should I discuss with my healthcare provider before using Lotrisone?

Do not use this Lotrisone if you have ever had an allergic reaction to:
  • betamethasone (such as Betaderm, Diprolene, Luxiq, Taclonex, Uticort, Valisone);

  • clotrimazole (such as Desenex, Lotrimin, Mycelex);

  • other topical steroid medications such as alclometasone (Aclovate), clobetasol (Olux, Temovate), desonide (Desowen), desoximetasone (Topicort), diflorasone (Florone, Psorcon), fluocinolone (Capex, Dermotic, Fluonid, Fluorosyn, Synalar), fluocinonide (Dermacin, Lidex), fluticasone (Cutivate), halcinonide (Halog), halobetasol (Ultravate), mometasone (Elocon), triamcinolone (Aristocort, Kenalog); or

  • other topical antibiotics such as econazole (Spectazole), ketoconazole (Kuric, Nizoral), miconazole (Cruex, Desenex, Fungoid, Lotrimin, Micatin, Monistat), sertaconazole (Ertaczo), or sulconazole (Exelderm).

Before using Lotrisone, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection. You may not be able to use this medication, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. Lotrisone may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Lotrisone passes into breast milk or if it could harm a nursing baby. Do not use Lotrisone without telling your doctor if you are breast-feeding a baby. Do not use Lotrisone on a child younger than 17 years old. Children are more likely to absorb the steroid through the skin. Never use Lotrisone to treat diaper rash.

How should I use Lotrisone?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after applying Lotrisone. Shake the lotion form of Lotrisone well just before you use it.

Apply a thin layer of Lotrisone and rub it in completely.

Do not cover treated skin areas with a bandage or tight clothing, unless your doctor has told you to.

After applying Lotrisone, allow your skin to dry completely before dressing. Wear loose-fitting clothing while you are treating jock itch. If you are treating athletes foot, wear clean cotton socks and keep your feet as dry as possible.

Do not use Lotrisone for longer than 2 weeks for jock itch or 4 weeks for athletes foot, unless your doctor has told you to. It may take up to 1 or 2 weeks of using Lotrisone before your symptoms improve. For best results, keep using Lotrisone as directed. Talk with your doctor if your groin symptoms do not improve after 1 week, or if your foot symptoms do not improve after 2 weeks of treatment. Store Lotrisone at room temperature away from moisture and heat. Keep the tube or bottle capped and tightly closed when not in use.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of Lotrisone applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Lotrisone?

Avoid getting Lotrisone 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 Lotrisone on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid wearing tight-fitting clothing that doesnt allow air circulation. Until the infection is healed, wear clothing that is made of natural fibers such as cotton.

What are the possible side effects of Lotrisone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Lotrisone and call your doctor at once if you have any of these serious side effects:
  • swelling, redness, or any signs of new infection;

  • severe burning or stinging of treated skin;

  • weight gain, rounding of the face;

  • increased thirst or hunger, urinating more than usual; or

  • anxiety, depressed mood.

Less serious Lotrisone side effects may include:

  • mild skin itching or irritation;

  • dry skin;

  • changes in skin color;

  • increased acne; or

  • scarring or thinning of the skin.

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.

What other drugs will affect Lotrisone?

It is not likely that other drugs you take orally or inject will have an effect on topically applied Lotrisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

For the Consumer

Applies to betamethasone / clotrimazole topical: topical cream, topical lotion

Along with its needed effects, betamethasone / clotrimazole topical 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 while taking betamethasone / clotrimazole topical:

Less common
  • Blistering, burning, itching, peeling, dryness, redness, or other signs of skin irritation not present before use of this medicine
  • burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
  • hives
Rare
  • Cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • rash
  • stinging
  • swelling
Incidence not known
  • 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 while taking betamethasone / clotrimazole topical:

Incidence not known
  • 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

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Applies to betamethasone / clotrimazole topical: topical cream, topical lotion

Local

Skin atrophy may become evident within one to two months of use and is due to the inhibitory effect of corticosteroids on collagen formation. Skin on the face, axilla, and groin appears to be most susceptible to the adverse long-term effects of topical betamethasone. Use of high potency topical corticosteroids on these areas should be minimized or avoided.

Topical corticosteroid use may impair local immune response rendering the skin more susceptible to infections. Folliculitis is occasionally reported.

Perioral dermatitis or rosacea-like dermatitis has occurred patients treated with potent topical corticosteroids who are of seborrheic skin type. This condition may flare temporarily upon discontinuation of topical steroids, prompting patients to continue their use. If topical corticosteroids are discontinued, this flare and the initial dermatitis generally resolves over a few weeks.

Worsening of psoriasis has occurred in a few patients.

Local side effects have commonly included burning, itching, dryness, or irritation, especially if applied to denuded skin. Allergic contact dermatitis has occasionally been reported. Long-term use of topical corticosteroids has resulted in skin atrophy and thinning, and the development of striae, telangiectasia, subcutaneous hemorrhage, and easy bruising and bleeding.

Endocrine

Endocrinologic side effects have included suppression of the hypothalamic-pituitary-adrenal axis and has resulted in Cushing's Syndrome and symptoms of adrenal suppression following withdrawal of the drug. This has been more common when higher potency topical corticosteroids were used over extensive areas and when occlusive dressing were used.

Adrenal suppression has been reported in patients with psoriasis using betamethasone dipropionate. Plasma cortisol concentrations generally return to normal within one to two weeks following discontinuation of the drug, and in some cases returned to normal during continued therapy.

If betamethasone dipropionate is to be used for an extended period to time, adrenal function should be evaluated periodically. Supplemental systemic steroids may be necessary during times of stress.

Ocular

Ocular side effects have included rare reports of glaucoma in patients who used betamethasone on the face for long periods of time. Intraocular pressure did not always return to normal following discontinuation of the drug.

Steroid-induced cataracts and glaucoma have been reported, most often in patients receiving betamethasone eyedrops (not available in the US). In one patient, permanent eye damage resulted from long-term application of betamethasone cream to the eyelids.

Musculoskeletal

Musculoskeletal side effect have included rare reports of osteoporosis in long-term betamethasone use. Vertebral fractures and avascular necrosis of the hips has been documented.

Dermatologic

Betamethasone-clotrimazole topical is not recommended for the treatment of diaper dermatitis. Adverse events consistent with corticosteroid use have been observed in patients treated for diaper dermatitis.

Dermatologic side effects have included rash, edema, dry skin, burning and stinging.