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Lotrisone

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Overview

What is Lotrisone?

LOTRISONE (clotrimazole and betamethasone dipropionate) cream, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use.

Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula CHCLN, a molecular weight of 344.84, and the following structural formula:

Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.

Betamethasone dipropionate has 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula CHFO, a molecular weight of 504.59, and the following structural formula:

Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water.

Each gram of LOTRISONE cream contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a white to off-white, hydrophilic cream consisting of 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.



What does Lotrisone look like?



What are the available doses of Lotrisone?

Cream, 1%/0.05% ()

Each gram of LOTRISONE cream contains 10 mg of clotrimazole and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) ()

What should I talk to my health care provider before I take Lotrisone?

How should I use Lotrisone?

LOTRISONE cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to , , and in patients 17 years and older.

Treatment of tinea corporis or tinea cruris:

Treatment of tinea pedis:

LOTRISONE cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.


What interacts with Lotrisone?

Sorry No Records found


What are the warnings of Lotrisone?

Sorry No Records found


What are the precautions of Lotrisone?

Sorry No Records found


What are the side effects of Lotrisone?

Sorry No records found


What should I look out for while using Lotrisone?

None.


What might happen if I take too much Lotrisone?

Sorry No Records found


How should I store and handle Lotrisone?

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Clotrimazole is an azole antifungal

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.

Non-Clinical Toxicology
None.

In controlled trials, terazosin has been added to diuretics, and several beta-adrenergic blockers; no unexpected interactions were observed. Terazosin has also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies, no interactions were observed. Terazosin has been used concomitantly in at least 50 patients on the following drugs or drug classes: 1) analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine, ibuprofen, indomethacin); 2) antibiotics (e.g., erythromycin, trimethoprim and sulfamethoxazole); 3) anticholinergic/sympathomimetics (e.g., phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride); 4) antigout (e.g., allopurinol); 5) antihistamines (e.g., chlorpheniramine); 6) cardiovascular agents (e.g., atenolol, hydrochlorothiazide, methyclothiazide, propranolol); 7) corticosteroids; 8) gastrointestinal agents (e.g., antacids); 9) hypoglycemics; 10) sedatives and tranquilizers (e.g., diazepam).

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 .

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 .

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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