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Mometasone Furoate (Mometasone Furoate)

Trade Name : Mometasone Furoate

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

OINTMENT

Strength 1 mg/g

MOMETASONE FUROATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]

Delivery Process

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Mometasone Furoate (Mometasone Furoate) which is also known as Mometasone Furoate and Manufactured by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. It is available in strength of 1 mg/g per ml. Read more

Mometasone Furoate (Mometasone Furoate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions
  • u00a0
  • 5.2
  • Mometasone furoate ointment USP, 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 USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients u22652 years of age. ()
  • Apply a thin film of mometasone furoate ointment 0.1% to the affected skin areas once daily.
  • Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary n
  • Do not use mometasone furoate ointment 0.1% with occlusive dressings unless directed by a physician. Do not apply mometasone furoate ointment 0.1% in the diaper area, as diapers or plastic pants constitute occlusive dressing.
  • Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application.
  • Mometasone furoate ointment 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
  • Ointment, 0.1%. Each gram of mometasone furoate ointment USP, 0.1% contains 1 mg of mometasone furoate, USP in a white to off-white uniform ointment base.
  • u2022
  • 3
  • Mometasone furoate ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. ()
  • No data
  • 5.1n- 8.4
  • 5.1n- 8.4
  • Arrayn- 5.2
  • Most common adverse reactions are burning, pruritus, skin atrophy, tingling/stinging and furunculosis. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or .
  • No drug-drug interaction studies have been conducted with mometasone furoate ointment 0.1%.
  • No data
  • Topically applied mometasone furoate ointment 0.1% can be absorbed in sufficient amounts to produce systemic effects n
  • Mometasone furoate Ointment USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate,USP is a synthetic corticosteroid with anti-inflammatory activity.
  • Chemically, mometasone furoate is 9u03b1, 21-dichloro-11u03b2,17-dihydroxy-16u03b1-methylpregna-1,4-diene-3,20-dione 17-
  • (2-furoate), with the molecular formula CHClO, a molecular weight of 521.4 and the following structural formula:
  • Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.
  • Each gram of Mometasone furoate Ointment USP, 0.1% contains 1 mg mometasone furoate, USP in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol monostearate, white wax, white petrolatum, and purified water.
  • No data
  • Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate ointment 0.1%. 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 ointment 0.1% on a mcg/m basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate ointment 0.1% on a mcg/m basis).
  • Mometasone furoate increased chromosomal aberrations in an Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an mouse micronucleus assay, 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 rat hepatocytes.
  • In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate ointment 0.1% on a mcg/m basis).
  • The safety and efficacy of mometasone furoate ointment 0.1% for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in psoriasis and one in atopic dermatitis. A total of 218 subjects received mometasone furoate ointment 0.1% (109 subjects) or the vehicle ointment applied once daily for 21 days.
  • Mometasoneu00a0Furoate Ointment USP, 0.1%
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling ().
  • Inform patients of the following:
  • E. FOUGERA & CO.
  • A division of
  • Fougera
  • PHARMACEUTICALS INC.
  • Melville, New York 11747
  • 46234681A
  • R07/18
  • #121
  • This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 07/18
  • No data
  • NDC
  • Fougeran
  • MOMETASONE FUROATE OINTMENTUSP, 0.1%
  • FOR DERMATOLOGIC USE ONLY.n- NOT FOR OPHTHALMIC USE.
  • KEEP OUT OF THE REACHOF CHILDREN.
  • Rx Only
  • NET WT 15 grams
  • NDC
  • Rx Only
  • Fougeran
  • MOMETASONE FUROATE OINTMENT USP, 0.1%
  • FOR DERMATOLOGIC USE ONLY.n- NOT FOR OPHTHALMIC USE.
  • KEEP OUT OF THE REACHOF CHILDREN.
  • NET WT 15 grams

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