DailyMed - BETAMETHASONE CLOTRIMAZOLE cream
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Lotrisone® cream (containing betamethasone clotrimazole).Betamethasone And Clotrimazole Topical (Lotrisone)
- Betamethasone And Clotrimazole (Topical Route) Description and Brand Names - Mayo Clinic
Clotrimazole is an antifungal medication that fights infections caused by fungus. Betamethasone and clotrimazole topical for the skin is a combination medicine used to treat fungal skin infections such as athlete's foot, jock itch, and ringworm. Betamethasone and clotrimazole topical may also be used for purposes not listed in this medication guide. You may not be able to use this medicine if you are allergic to betamethasone or clotrimazole, or if you have ever had an allergic reaction to:.
Steroid medicines can increase the glucose sugar levels in your blood or urine. Tell your doctor if you have diabetes. Using highly potent steroid medicine during pregnancy may increase the risk of low birthweight in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. If you apply betamethasone and clotrimazole to your chest, avoid areas that may come into contact with the baby's mouth.
If you are pregnant or breastfeeding, apply this medicine to the smallest skin area and for the shortest amount of time possible to treat your condition. This medicine is not approved for use by anyone younger than 17 years old. Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Do not use betamethasone and clotrimazole topical to treat any skin condition that has not been checked by your doctor.
Avoid using other topical steroid medications on the areas you treat with betamethasone and clotrimazole, unless your doctor tells you to.
Use Betamethasone And Clotrimazole Topical Lotrisone exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cetereath, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.
Clotrimazole and betamethasone dipropionate cream is smooth, uniform, and white to off-white in color. Clotrimazole and betamethasone dipropionate cream has been shown to be at least as effective as clotrimazole alone in a different cream vehicle. Use of corticosteroids in the treatment of fungal infection may lead to suppression of host inflammation leading to worsening or decreased cure rate. Skin penetration and systemic absorption of clotrimazole following topical application of clotrimazole and betamethasone dipropionate cream have not been studied.
No measurable amount of radioactivity less than 0. Only 0. Mechanism of Action: Clotrimazole is an imidazole antifungal agent. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi. Activity In Vitro: In vitro , clotrimazole has been shown to have activity against many dermatophytes, but the clinical significance of this information is unknown.
Drug Resistance: Strains of dermatophytes having a natural resistance to clotrimazole have not been reported. Resistance to azoles including clotrimazole has been reported in some Candida species.
No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes. Betamethasone dipropionate, a corticosteroid, has been shown to have topical dermatologic and systemic pharmacologic and metabolic effects characteristic of this class of drugs. Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Therefore use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion. In clinical studies of tinea corporis, tinea cruris, and tinea pedis, patients treated with clotrimazole and betamethasone dipropionate cream showed a better clinical response at the first return visit than patients treated with clotrimazole cream.
In tinea corporis and tinea cruris, the patient returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in patients treated with clotrimazole and betamethasone dipropionate cream were as good as or better than in those patients treated with clotrimazole cream.
In these same clinical studies, patients treated with clotrimazole and betamethasone dipropionate cream showed better clinical responses and mycological cure rates when compared with patients treated with betamethasone dipropionate cream. Clotrimazole and betamethasone dipropionate cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum.
Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes e.
Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported. Clotrimazole and betamethasone dipropionate cream is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dressings.
Use of more than one corticosteroid- containing product at the same time may increase total systemic glucocorticoid exposure. Patients applying clotrimazole and betamethasone dipropionate cream to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression.
This may be done by using the ACTH stimulation, morning plasma cortisol, and urinary free cortisol tests. If HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
Recovery of HPA-axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. In a small study, clotrimazole and betamethasone dipropionate cream was applied using large dosages, 7 g daily for 14 days BID to the crural area of normal adult subjects.
Three of the eight normal subjects on whom clotrimazole and betamethasone dipropionate cream was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal Cortrosyn test. The effect on morning plasma cortisol was transient and subjects recovered one week after discontinuing dosing.
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.
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Betamethasone is highly potent steroid that reduces itching, swelling, and redness of the skin. Clotrimazole is an antifungal medication that fights infections caused by fungus. Betamethasone and clotrimazole topical for the skin is a combination medicine used to treat fungal skin infections such as athlete's foot, jock itch, and ringworm.
Betamethasone and clotrimazole topical may also be used for purposes not listed in this medication guide. You may not be able to use this medicine if you are allergic to betamethasone or clotrimazole, or if you have ever had an allergic reaction to:. Steroid medicines can increase the glucose sugar levels in your blood or urine.
Tell your doctor if you have diabetes. Using highly potent steroid medicine during pregnancy may increase the risk of low birthweight in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. If you apply betamethasone and clotrimazole to your chest, avoid areas that may come into contact with the baby's mouth. If you are pregnant or breastfeeding, apply this medicine to the smallest skin area and for the shortest amount of time possible to treat your condition. This medicine is not approved for use by anyone younger than 17 years old.
Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Do not use betamethasone and clotrimazole topical to treat any skin condition that has not been checked by your doctor. Avoid using other topical steroid medications on the areas you treat with betamethasone and clotrimazole, unless your doctor tells you to.
Use Betamethasone And Clotrimazole Topical Lotrisone exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Wash your hands before and after using betamethasone and clotrimazole, unless you are using this medicine to treat the skin on your hands. Apply a thin layer of medicine to the affected skin and rub it in gently. Do not apply this medicine over a large area of skin unless your doctor has told you to. Keep your skin clean and dry to avoid further infection.
Do not cover the treated skin area with a bandage or other covering unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects. If you are treating the diaper area, do not use plastic pants or tight-fitting diapers.
Do not use betamethasone and clotrimazole topical to treat diaper rash. Call your doctor if your symptoms do not improve after 1 week of using this medicine or after 2 weeks if using the medicine on your feet. Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.
Do not apply two doses at one time. High doses or long-term use of betamethasone and clotrimazole topical can lead to thinning skin, easy bruising, changes in body fat especially in your face, neck, back, and waistincreased acne or facial hair, menstrual problems, impotence, or loss of interest in sex. Health Conditions A-Z.
Health Tools. See All. DailyOM Courses. Betamethasone And Clotrimazole Topical Lotrisone. Brand Names: Lotrisone. Reviewed: June 23, You may not be able to use this medicine if you are allergic to betamethasone or clotrimazole, or if you have ever had an allergic reaction to: other steroid medicines such as dexamethasone, fludrocortisone, hydrocortisone, prednisone, triamcinolone, and others ; or other antifungal medicines such as itraconazole, ketoconazole, miconazole, posaconazole, or voriconazole.
Tell your doctor if you have ever had: a skin reaction to any steroid medicine; cataract or glaucoma; liver disease; or an adrenal gland disorder. Side Effects. Call your doctor at once if you have: worsening of your skin condition; redness, warmth, swelling, oozing, or severe irritation of any treated skin; blurred vision, tunnel vision, eye pain, or seeing halos around lights; high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor; or possible signs of absorbing this medicine through your skin --weight gain especially in your face or your upper back and torsoslow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.
Common side effects may include: numbness, tingling, or stinging; skin dryness or rash; swelling; or new infections. Based on FDA pregnancy categories. Avoid getting this medicine in your eyes, mouth, or vagina. Do not take by mouth. Topical medicine is for use only on the skin. Shake betamethasone and clotrimazole lotion well just before each use. Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.
Store at room temperature away from moisture and heat. Store the lotion in an upright position. If you think you or someone else may have overdosed on: Betamethasone And Clotrimazole Topical Lotrisonecall your doctor or the Poison Control center. If someone collapses or isn't breathing after taking Betamethasone And Clotrimazole Topical Lotrisonecall Medical Disclaimer Drugs A-Z provides drug information from Everyday Health and our partners, as well as ratings from our members, all in one place.
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This product contains 2 medications. Clotrimazole is an azole antifungal that works by preventing the growth of fungus. Betamethasone is a strong. LOTRISONE (clotrimazole and betamethasone dipropionate) cream, 1%/%, contains combinations of clotrimazole, an azole antifungal, and betamethasone. Clotrimazole-Betamethasone % Cream (45 g Tube) - Generic Lotrisone. If you do get the medication in those areas, flush with plenty of water. Find everything you need to know about Betamethasone And Clotrimazole Topical (Lotrisone), including what it is used for, warnings, reviews. This product contains 2 medications. Clotrimazole is an azole antifungal that works by preventing the growth of fungus. Betamethasone is a strong. Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Adverse events consistent with corticosteroid use have been observed in patients under 12 years of age treated with clotrimazole and betamethasone dipropionate cream. Skin penetration and systemic absorption of clotrimazole following topical application of clotrimazole and betamethasone dipropionate cream have not been studied. If there is a lack of response to clotrimazole and betamethasone dipropionate cream, appropriate confirmation of the diagnosis, including possible mycological studies, is indicated before instituting another course of therapy. Caution should be exercised with the use of these corticosteroid containing topical products on thinning skin. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.If you are a consumer or patient please visit this version. Clotrimazole and Betamethasone Dipropionate Cream USP contains a combination of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use.
Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Clotrimazole and Betamethasone Dipropionate Cream contains 10 mg clotrimazole and 0. Cetereath, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.
Clotrimazole and betamethasone dipropionate cream is smooth, uniform, and white to off-white in color. Clotrimazole and betamethasone dipropionate cream has been shown to be at least as effective as clotrimazole alone in a different cream vehicle. Use of corticosteroids in the treatment of fungal infection may lead to suppression of host inflammation leading to worsening or decreased cure rate. Skin penetration and systemic absorption of clotrimazole following topical application of clotrimazole and betamethasone dipropionate cream have not been studied.
No measurable amount of radioactivity less than 0. Only 0. Mechanism of Action: Clotrimazole is an imidazole antifungal agent.
The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi. Activity In Vitro: In vitro , clotrimazole has been shown to have activity against many dermatophytes, but the clinical significance of this information is unknown. Drug Resistance: Strains of dermatophytes having a natural resistance to clotrimazole have not been reported.
Resistance to azoles including clotrimazole has been reported in some Candida species. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes. Betamethasone dipropionate, a corticosteroid, has been shown to have topical dermatologic and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.
Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Therefore use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion. In clinical studies of tinea corporis, tinea cruris, and tinea pedis, patients treated with clotrimazole and betamethasone dipropionate cream showed a better clinical response at the first return visit than patients treated with clotrimazole cream. In tinea corporis and tinea cruris, the patient returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week.
Mycological cure rates observed in patients treated with clotrimazole and betamethasone dipropionate cream were as good as or better than in those patients treated with clotrimazole cream. In these same clinical studies, patients treated with clotrimazole and betamethasone dipropionate cream showed better clinical responses and mycological cure rates when compared with patients treated with betamethasone dipropionate cream.
Clotrimazole and betamethasone dipropionate cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections.
The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes e. Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported.
Clotrimazole and betamethasone dipropionate cream is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.
Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dressings. Use of more than one corticosteroid- containing product at the same time may increase total systemic glucocorticoid exposure.
Patients applying clotrimazole and betamethasone dipropionate cream to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression. This may be done by using the ACTH stimulation, morning plasma cortisol, and urinary free cortisol tests.
If HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA-axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.
In a small study, clotrimazole and betamethasone dipropionate cream was applied using large dosages, 7 g daily for 14 days BID to the crural area of normal adult subjects. Three of the eight normal subjects on whom clotrimazole and betamethasone dipropionate cream was applied exhibited low morning plasma cortisol levels during treatment.
One of these subjects had an abnormal Cortrosyn test. The effect on morning plasma cortisol was transient and subjects recovered one week after discontinuing dosing. In addition, two separate studies in pediatric patients demonstrated adrenal suppression as determined by cosyntropin testing.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. If irritation develops, clotrimazole and betamethasone dipropionate cream should be discontinued and appropriate therapy instituted. Adverse reactions reported for clotrimazole and betamethasone dipropionate cream in clinical trials were paresthesia in 1.
The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings.
These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria and general irritation of the skin.
Acute overdosage with topical application of clotrimazole and betamethasone dipropionate cream is unlikely and would not be expected to lead to life-threatening situation. Clotrimazole and betamethasone dipropionate cream should not be used for longer than the prescribed time period. Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening.
Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used.
If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Patients using clotrimazole and betamethasone dipropionate cream should receive the following information and instructions:.
The medication is to be used as directed by the physician and is not recommended for use longer than the prescribed time period. It is for external use only. Avoid contact with the eyes, mouth, or intravaginally. 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. Other corticosteroid-containing products should not be used with clotrimazole and betamethasone dipropionate without first talking with your physician. The treated skin area should not be bandaged, covered, or wrapped so as to be occluded.
When using clotrimazole and betamethasone dipropionate cream in the groin area, patients should use the medication for two weeks only, and apply the cream sparingly.
Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks. The safety of clotrimazole and betamethasone dipropionate cream has not been demonstrated in the treatment of diaper dermatitis. Adverse events consistent with corticosteroid use have been observed in patients treated with clotrimazole and betamethasone dipropionate cream for diaper dermatitis. The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended.
If there is a lack of response to clotrimazole and betamethasone dipropionate cream, appropriate confirmation of the diagnosis, including possible mycological studies, is indicated before instituting another course of therapy. The following tests may be helpful in evaluating HPA-axis suppression due to the corticosteroid components:. There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis.
It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1. These doses are approximately 5- and fold the maximum human dose based on body surface areas, respectively. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted.
Pregnancy Category C: There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.
This dose is approximately one-fifth the maximum human dose. The abnormalities observed included umbilical hernias, cephalocele and cleft palates. Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. There are no adequate and well-controlled studies in pregnant women of the teratogenic effects of topically applied corticosteroids.
Therefore, clotrimazole and betamethasone dipropionate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroids production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
Because many drugs are excreted in human milk, caution should be exercised when clotrimazole and betamethasone dipropionate cream is administered to a nursing woman.
Adverse events consistent with corticosteroid use have been observed in patients under 12 years of age treated with clotrimazole and betamethasone dipropionate cream.
In open-label studies, 17 of 43 In another open-label study, 8 of 17
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