Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)
Cosette Pharmaceuticals, Inc.
Mometasone Furoate
Mometasone Furoate 1 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Mometasone furoate, USP 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, USP ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate, USP 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 produce
Mometasone furoate, USP ointment 0.1% is supplied in 15 gram (NDC 0713-0635-15) and 45 gram (NDC 0713-0635-37) tubes; boxes of one. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
MOMETASONE FUROATE- MOMETASONE FUROATE OINTMENT COSETTE PHARMACEUTICALS, INC. ---------- 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 0.1%, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1987 RECENT MAJOR CHANGES Warnings and Precautions Ophthalmic Adverse Reactions ( 5.2) 05/2018 INDICATIONS AND USAGE Mometasone furoate, USP 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 • 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) DOSAGE FORMS AND STRENGTHS • Ointment, 0.1%. ( 3) CONTRAINDICATIONS • Mometasone furoate, USP ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. ( 4) WARNINGS AND PRECAUTIONS • 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, 8.4) • Pediatric patients may be more susceptible to systemic toxicity. ( 5.1, 8.4) • May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.( 5.2) ADVERSE REACTIONS Most common adverse reactions are: burning, pruritus, skin atrophy, tingling/stinging and furunculosis. ( 6) TO REPORT SUSPECTED ADVERSE REACT Olvassa el a teljes dokumentumot