Mometasone topical steroid

This information should not be used to decide whether or not to take mometasone or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to mometasone. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary-cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse- lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay and a rat bone marrow chromosomal aberration assay or a mouse male germ -cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate topical solution USP, % (lotion) during a clinical study, in 14% of 65 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth, 1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder,1. The following signs of skin atrophy were also observed among 65 patients treated with mometasone furoate topical solution USP, % (lotion) in a clinical study: shininess 4, telangiectasia 2, loss of elasticity 2, and loss of normal skin markings 3. Striae, thinness and bruising were not observed in this study.

Ninety-seven pediatric subjects ages 6 to 23 months with atopic dermatitis were enrolled in an open-label HPA axis safety study. ELOCON Cream was applied once daily for approximately 3 weeks over a mean body surface area of 41% (range 15%-94%). In approximately 16% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with ELOCON Cream. The criteria for suppression were: basal cortisol level of ≤ 5 mcg/dL, 30-minute post-stimulation level of ≤ 18 mcg/dL, or an increase of < 7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5 of the subjects, demonstrated suppressed HPA axis function in one subject, using these same criteria [see Use in Specific Populations ].

Mometasone topical steroid

mometasone topical steroid

Ninety-seven pediatric subjects ages 6 to 23 months with atopic dermatitis were enrolled in an open-label HPA axis safety study. ELOCON Cream was applied once daily for approximately 3 weeks over a mean body surface area of 41% (range 15%-94%). In approximately 16% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with ELOCON Cream. The criteria for suppression were: basal cortisol level of ≤ 5 mcg/dL, 30-minute post-stimulation level of ≤ 18 mcg/dL, or an increase of < 7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5 of the subjects, demonstrated suppressed HPA axis function in one subject, using these same criteria [see Use in Specific Populations ].

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