Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)
Bryant Ranch Prepack
TOPICAL
PRESCRIPTION DRUG
Mometasone Furoate Ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone Furoate Ointment, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. There are no adequate and well-controlled studies in pregnant women. Therefore, Mometasone Furoate Ointment, 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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/
Mometasone Furoate Ointment USP, 0.1% is a white to off-white uniform ointment and supplied in 45-gram (NDC 63629-8684-1) tubes; boxes of one. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
MOMETASONE FUROATE- MOMETASONE FUROATE OINTMENT BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MOMETASONE FUROATE OINTMENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MOMETASONE FUROATE OINTMENT. MOMETASONE FUROATE OINTMENT, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1987 RECENT MAJOR CHANGES Warnings and Precautions INDICATIONS AND USAGE Mometasone Furoate Ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥2 years of age (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS Most common adverse reactions are burning, pruritus, skin atrophy, tingling/stinging and furunculosis. (6) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION Ophthalmic Adverse Reactions (5.2) 05/2018 Apply a thin film to the affected skin areas once daily. (2) Discontinue therapy when control is achieved. (2) If no improvement is seen within 2 weeks, reassess diagnosis. (2) Do not use with occlusive dressings unless directed by a physician. (2) Ointment, 0.1%. (3) Mometasone Furoate Ointment, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment, Cushing’s syndrome, and hyperglycemia may occur due to systemic absorption. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Modify use should HPA axis suppression develop. (5.1 Přečtěte si celý dokument