Lotrisone

— THERAPEUTIC CATEGORIES —
  • Skin infections (topicals)
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Lotrisone Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Betamethasone (as dipropionate) 0.05%, clotrimazole 1%; crm.

    Pharmacological Class

    Steroid + azole antifungal.

    How Supplied

    Crm—15g, 45g

    How Supplied

    Lotrisone is white to off-white cream base and supplied in: 

    • 15-gram tubes
      • boxes of 1
    • 45-gram tubes
      • boxes of 1

    Storage

    Store at 20–25° C (68–77° F); excursions permitted to 15–30° C (59–86° F). 

    Manufacturer

    Merck & Co., Inc.

    Generic Availability

    YES

    Mechanism of Action

    Clotrimazole, an azole antifungal agent, inhibits 14-α-demethylation of lanosterol in fungi by binding to one of the cytochrome P450 enzymes. This leads to the accumulation of 14-α-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi. Betamethasone dipropionate is a corticosteroid. Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action for the treatment of tinea pedis, tinea cruris and tinea corporis is unknown.

    Lotrisone Indications

    Indications

    Tinea pedis, t. cruris, t. corporis.

    Lotrisone Dosage and Administration

    Adult

    T. cruris, t. corporis: apply thin film twice daily for 1 week; max 2 weeks. T. pedis: apply sufficient amount twice daily for 2 weeks; max 4 weeks. Max 45g per week. Do not occlude.

    Children

    <17yrs: not recommended.

    Lotrisone Contraindications

    Not Applicable

    Lotrisone Boxed Warnings

    Not Applicable

    Lotrisone Warnings/Precautions

    Warnings/Precautions

    Avoid eyes. Do not use for diaper dermatitis. Risk of HPA axis suppression with high-potency steroids, prolonged use, application to large surface area, use of occlusive dressings, altered skin barrier, liver failure, young age; discontinue gradually, or reduce dose or potency if occurs. Increased risk of posterior subcapsular cataracts and glaucoma; monitor for visual symptoms. Thinning skin. Reevaluate periodically. Pregnancy. Nursing mothers: avoid direct infant exposure.

    Warnings/Precautions

    Effects on Endocrine System 

    • Lotrisone cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency; may occur during 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.
    • 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.

    Diaper Dermatitis 

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

    Ophthalmic Adverse Reactions 

    • Topical corticosteroid use may increase the risk of posterior subcapsular cataracts and glaucoma.
    • Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products.
    • Avoid contact of Lotrisone cream with eyes.
    • Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 

    Pregnancy Considerations

    There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify a Lotrisone cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy.

    Advise pregnant women that Lotrisone cream may increase the risk of having a low birthweight infant; use Lotrisone cream on the smallest area of skin and for the shortest duration possible. 

    Nursing Mother Considerations

    There are no data regarding the excretion of betamethasone dipropionate or clotrimazole into breast milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. It is possible that topical use of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lotrisone cream and any potential adverse effects on the breastfed infant from Lotrisone cream or from the underlying maternal condition.

    Use Lotrisone cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Lotrisone cream directly to the nipple and areola to avoid direct infant exposure.

    Pediatric Considerations

    The use of Lotrisone cream in patients <17 years of age is not recommended. 

    Due to a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids; also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. 
    Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. 
    HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. 

    Avoid use of Lotrisone cream in the treatment of diaper dermatitis. 

    Geriatric Considerations

    Clinical studies of Lotrisone cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, greater sensitivity of some older individuals cannot be ruled out. 

    The use of Lotrisone cream under occlusion, such as in diaper dermatitis, is not recommended. 

    Postmarket adverse event reporting in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. 

    Use caution when applying these corticosteroid-containing topical products on thinning skin. 

    Lotrisone Pharmacokinetics

    Metabolism

    Hepatic. 

    Elimination

    Renal.

    Lotrisone Interactions

    Not Applicable

    Lotrisone Adverse Reactions

    Adverse Reactions

    Rash, edema, secondary infections; HPA axis suppression (esp. in children), skin atrophy.

    Lotrisone Clinical Trials

    Clinical Trials

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

    Lotrisone Note

    Not Applicable

    Lotrisone Patient Counseling

    Patient Counseling

    Pregnancy

    • Advise pregnant women that Lotrisone cream may increase the risk of having a low birthweight infant and to use Lotrisone cream on the smallest area of skin and for the shortest duration possible.

    Lactation 

    • Advise a woman to use Lotrisone cream on the smallest area of skin and for the shortest duration possible while breastfeeding.
    • Advise breastfeeding women not to apply Lotrisone cream directly to the nipple and areola to avoid direct infant exposure

    Administration 

    Inform patients 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.     
    • Advise patients to report any visual symptoms to their healthcare providers.     
    • 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. 

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