Mometasone Furoate

5 WARNINGS AND PRECAUTIONS Endocrine System Adverse Reactions: o Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur with the potential for glucocorticosteroid insufficiency. ( 5.1 ) o Consider periodic evaluations for HPA axis suppression if mometasone furoate ointment is applied to a large surface area, to areas under occlusion, for prolonged duration or on altered skin barriers. If HPA axis suppression occurs, withdraw mometasone furoate ointment, reduce the application frequency, or consider switching to a less potent corticosteroid. ( 5.1 , 8.4 ) o Cushing’s syndrome, hyperglycemia, and glucosuria may occur due to systemic absorption. ( 5.1 , 8.4 ) o Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 ) Ophthalmic Adverse Reactions: Topical corticosteroids may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 ) 5.1 Endocrine System Adverse Reactions Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression Systemic absorption of topical corticosteroids, including mometasone furoate ointment, 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. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Because of the potential for systemic absorption, consider periodically evaluating patients who are at risk of HPA axis suppression for evidence of HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of mometasone furoate ointment on the HPA axis, 15 grams were applied twice daily for 7 days to 6 adult subjects with psoriasis or atopic dermatitis. In this trial, mometasone furoate ointment caused a slight lowering of adrenal corticosteroid secretion [see Clinical Pharmacology ( 12.2 )] . If HPA axis suppression occurs, gradually withdraw mometasone furoate ointment, reduce the frequency of application or consider use of a less potent corticosteroid. If signs and symptoms of glucocorticosteroid insufficiency occur, supplemental systemic corticosteroids may be required. Cushing’s Syndrome, Hyperglycemia, and Glucosuria Systemic effects of topical corticosteroids, including mometasone furoate ointment, may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. Additional Considerations Concomitant use of mometasone furoate ointment with other corticosteroid-containing products may increase total systemic corticosteroid exposure, and result in increased risk for adverse reactions. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations ( 8.4 )] . Minimize the risk of adverse reactions by using mometasone furoate ointment as recommended [see Dosage and Administration ( 2 )] . 5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids, including mometasone furoate ointment, 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 mometasone products [see Adverse Reactions ( 6.2 )] Avoid contact of mometasone furoate ointment with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.3 Allergic Contact Dermatitis Use of topical corticosteroids, including mometasone furoate ointment, can cause allergic contact dermatitis. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue mometasone furoate ointment and institute appropriate therapy. 5.4 Concomitant Skin Infections Use of topical corticosteroids, including mometasone furoate ointment, may delay healing or worsen concomitant skin infections. If concomitant skin infections are present or develop, use an appropriate antimicrobial agent. If a favorable response does not occur promptly, gradually withdraw mometasone furoate ointment and discontinue use until the infection has been adequately controlled.

6 ADVERSE REACTIONS Most common adverse reactions are burning, pruritus, skin atrophy, tingling/stinging and furunculosis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc., at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are discussed in more detail in other sections of the labeling: • Endocrine System Adverse Reactions [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Allergic Contact Dermatitis [see Warnings and Precautions ( 5.3 )] • Concomitant Skin infections [see Warnings and Precautions ( 5.4 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trials the incidence of adverse reactions associated with the use of mometasone furoate ointment was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Cases of rosacea associated with the use of mometasone furoate ointment have been reported. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of topical corticosteroids. Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Endocrine Disorders: Cushing’s syndrome, linear growth retardation, and delayed weight gain. Local Adverse Reactions: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, striae, and miliaria. Nervous System Disorders: intracranial hypertension. Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.