Clotrimazole - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS • Clotrimazole and betamethasone dipropionate cream can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of the treatment.

Risk factor(s) are: use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age.

Modify use should HPA axis suppression develop. ( 5.1 , 8.4 ) • Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 ) • The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended. • Topical corticosteroid products may increase the risk of cataracts and glaucoma.

If visual symptoms occur, consider referral to an ophthalmologist.

5.1 Effects on Endocrine System Clotrimazole and betamethasone dipropionate 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, 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 8 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 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 ] .

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 ] .

5.2 Diaper Dermatitis The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended.

5.3 Ophthalmic Adverse Reactions Use of topical corticosteroids 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, including topical betamethasone products [see Adverse Reactions ].

Avoid contact of clotrimazole and betamethasone dipropionate cream with eyes.

Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.