Lotrisone

Lotrisone is a cream or lotion consisting of a combination of the drugs clotrimazole and betamethasone. Clotrimazole is an anti-fungal drug related to:

• fluconazole (Diflucan)
• ketoconazole (Nizoral)
• itraconazole (Sporanox)
• miconazole (Micatin, Monistat)

• Lotrisone cream is gently massaged into the affected skin and surrounding area in the morning and evening. The treated skin should not be bandaged, covered, or wrapped in order to avoid excessive absorption of Lotrisone into the body.
• Lotrisone cream or lotion should not be used for more than 2 weeks for treatment of tinea corporis or tinea cruris. If there is no clinical improvement after one week of treatment, the diagnosis should be reviewed.
• Lotrisone should not be used longer than 4 weeks for treatment of tinea pedis. If there is no clinical improvement after 2 weeks of treatment, the diagnosis should be reviewed. These limits on duration of use are based on the clinical studies that were used by the FDA to approve Lotrisone and concerns that with longer use absorption of betamethasone might be enough to have effects on the body.
• Amounts greater than 45 g per week of Lotrisone cream or amounts greater than 45 mL per week of Lotrisone lotion should not be used.

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Reviewed on 2/27/2017 References Reference: FDA Prescribing Information

Burning, tingling, dry skin, or stinging may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: extreme hair growth, skin thinning/discoloration, acne, stretch marks, "hair bumps" (folliculitis).Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Do not share this medication with others. Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details. This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

Lotrisone is a brand name medication included in the following groups of medications: Corticosteroids acting locally, Antiinflammatory Corticosteroids, Corticosteroids, potent group III, Corticosteroids, potent, other combinations, Corticosteroids/antiinfectives/mydriatics in combination, Antiinfectives and antiseptics for local oral treatment, Imidazole and triazole derivatives, Imidazole derivatives. For more information about Lotrisone see its generics Betamethasone, Clotrimazole

Effects on Endocrine System

Lotrisone cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Cushing's syndrome and hyperglycemia may also occur due to the systemic effect of corticosteroids while on treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure, and young age.

Because of the potential for systemic corticosteroid effects, patients may need to be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a small trial, Lotrisone cream was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal adult subjects. Three of the 8 normal subjects on whom Lotrisone cream was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal cosyntropin test. The effect on morning plasma cortisol was transient and subjects recovered 1 week after discontinuing dosing. In addition, 2 separate trials in pediatric subjects demonstrated adrenal suppression as determined by cosyntropin testing [see Use in Specific Populations (8.4)].

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body mass ratios [see Use in Specific Populations (8.4)].

Diaper Dermatitis

The use of Lotrisone cream in the treatment of diaper dermatitis is not recommended.

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

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform the patient of the following:

• Use Lotrisone cream as directed by the physician. It is for external use only.
• Avoid contact with the eyes, the mouth, or intravaginally.
• Do not use Lotrisone cream on the face or underarms.
• Do not use more than 45 grams of Lotrisone cream per week.
• When using Lotrisone cream in the groin area, patients should use the medication for 2 weeks only, and apply the cream sparingly. Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks.
• Do not use Lotrisone cream for any disorder other than that for which it was prescribed.
• Do not bandage, cover or wrap the treatment area unless directed by the physician. Avoid use of Lotrisone cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
• Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use.
• This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1983-2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk5335A-cr-1707r003

Lotrisone® (LOW-tre-zone)
(clotrimazole and betamethasone dipropionate) cream, 1%/0.05%

Important information: Lotrisone cream is for use on skin only. Do not use Lotrisone cream in your eyes, mouth, or vagina.

What is Lotrisone cream?

• Lotrisone cream is a prescription medication used on the skin (topical) to treat fungal infections of the feet, groin, and body in people 17 years of age and older. Lotrisone cream is used for fungal infections that are inflamed and have symptoms of redness or itching.
• Lotrisone cream should not be used in children under 17 years of age.

Before using Lotrisone cream, tell your healthcare provider about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Lotrisone cream will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Lotrisone cream passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.

What should I avoid while using Lotrisone cream?

Lotrisone cream should not be used to treat diaper rash or redness. You should avoid applying Lotrisone cream in the diaper area.

How should I use Lotrisone cream?

• Use Lotrisone cream exactly as your healthcare provider tells you to use it.
• Use Lotrisone cream for the prescribed treatment time, even if your symptoms get better.
• Do not use more than 45 grams of Lotrisone cream in 1 week.
• Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. Wear loose-fitting clothing if you use Lotrisone cream in the groin area.
• Do not use Lotrisone cream on your face or underarms (armpits).
• For treatment of fungal infections of the groin and body:
  • Apply a thin layer of Lotrisone cream to the affected skin area 2 times a day for 1 week.
  • Tell your healthcare provider if the treated skin area does not improve after 1 week of treatment.
  • Do not use Lotrisone cream for longer than 2 weeks.
• For treatment of fungal infections of the feet:
  • Apply a thin layer of Lotrisone cream to the affected skin area 2 times a day for 2 weeks.
  • Tell your healthcare provider if the treated skin area does not improve after 2 weeks of treatment. Do not use Lotrisone cream longer than 4 weeks.
  • Wash your hands after applying Lotrisone cream.

What are the possible side effects of Lotrisone cream?

Lotrisone cream may cause serious side effects, including:

• Lotrisone cream can pass through your skin. Too much Lotrisone cream passing through your skin can cause your adrenal glands to stop working. Your healthcare provider may do blood tests to check for adrenal gland problems.

The most common side effects of Lotrisone cream include burning, tingling, rash, swelling, and infections.

These are not all the possible side effects of Lotrisone cream.

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

How should I store Lotrisone cream?

• Store Lotrisone cream at room temperature between 68 to 77°F (20 to 25°C)
• Keep Lotrisone cream and all medicines out of the reach of children.

General information about the safe and effective use of Lotrisone cream.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Lotrisone cream that is written for health professionals. Do not use Lotrisone cream for a condition for which it was not prescribed. Do not give Lotrisone cream to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in Lotrisone cream?

Active ingredients: clotrimazole and betamethasone dipropionate

Inactive ingredients: benzyl alcohol as a preservative, ceteareth-30, cetyl alcohol plus stearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, and white petrolatum

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1983-2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: July 2017

usppi-mk5335A-cr-1707r003