MOMETASONE FUROATE_- mometasone furoate_lotion

Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 2 Studies performed with mometasone furoate lotion indicate that it is in the medium range of potency as compared with other topical corticosteroids. In a study evaluating the effects of mometasone furoate lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline [ see Warnings and Precautions ( 5. 1 see Use in Specific Populations ( 8. 4 The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0. 7% of the applied dose of mometasone furoate ointment enters the circulation after 8 hours of contact on normal skin without occlusion. A similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Mometasone furoate topical solution USP, 0. 1% (lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. 1% (lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients >= 12 years of age.

Apply a few drops of mometasone furoate lotion to the affected skin areas once daily and massage lightly until it disappears. see Warnings and Precautions ( 5. 4 Apply a few drops to the affected skin areas once daily and massage lightly until it disappears.

Most common adverse reactions included are acneiform reaction, burning, itching and folliculitis. (6) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited, at-833-285-4151 or FDA at 1-800-FDA-1088 or www. gov/medwatch. 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. 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. Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings.

Mometasone furoate lotion is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Mometasone furoate topical solution USP, 0. 1% (lotion) is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Teratogenic Effects Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0. 05 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m 2 In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0. 4 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m 2 In rabbits, mometasone furoate caused multiple malformations (e. , flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0. 2 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m 2 2 When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7. (Doses of 7. 5 and 15 mcg/kg in the rat are approximately 0. 01 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m 2 Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate lotion is administered to a nursing woman. Since safety and efficacy of mometasone furoate lotion have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended. [see Clinical Pharmacology ( 12. 2 HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Mometasone furoate lotion should not be used in the treatment of diaper dermatitis. Clinical trials of mometasone furoate lotion did no include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range.

No drug-drug interaction studies have been conducted with mometasone furoate lotion.

OVERDOSAGE
Topically applied mometasone furoate lotion can be absorbed in sufficient amounts to produce systemic effects [ see Warnings and Precautions ( 5.1
NONCLINICAL TOXICOLOGY
Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate lotion. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m 2 2 2
CLINICAL STUDIES
The safety and efficacy of mometasone furoate lotion for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 405 subjects (age range: 12 to 95 years) received mometasone furoate lotion (205 subjects) or the vehicle lotion applied once daily for 21 days.
PATIENT INFORMATION
Mometasone Furoat Topical Solution USP, 0.1% (lotion) Mometasone furoate lotion is for use on skin only. Do not use mometasone furoate lotion if you Tell your healthcare provider about all the medicines you take, How should I use mometasone furoate lotion? What are the possible side effects of mometasone furoate lotion? Mometasone furoate lotion can pass through your skin. Vision problems. Skin problems. The most common side effects of mometasone furoate lotion How should I store mometasone furoate lotion? General information about the safe and effective use of mometasone furoate lotion. What are the ingredients in mometasone furoate lotion? Inactive ingredients: Manufactured by: Encube Ethicals Pvt. Ltd. Distributed by: Encube Ethicals, Inc. Revised:12/2024

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