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Mometasone Furoate (Elocon)

Trade Name : ELOCON

Merck Sharp & Dohme Corp.

CREAM

Strength 1 mg/g

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

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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 (Elocon) which is also known as ELOCON and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 1 mg/g per ml. Read more

Mometasone Furoate (Elocon) 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
  • ELOCON Cream 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.
  • ELOCON Cream 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 ELOCON Cream to the affected skin areas once daily. ELOCON Cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of ELOCON Cream have not been established in pediatric patients below 2 years of age; use in this age group is not recommended .
  • Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary .
  • Do not use ELOCON Cream with occlusive dressings unless directed by a physician. Do not apply ELOCON Cream in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
  • Avoid contact with eyes. Wash hands after each application.
  • Avoid use on the face, groin, or axillae.
  • ELOCON Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
  • Apply a thin film to the affected skin areas once daily. ()
  • Discontinue therapy when control is achieved. ()
  • If no improvement is seen within 2 weeks, reassess diagnosis. ()
  • Do not use with occlusive dressings unless directed by a physician. ()
  • Cream, 0.1%. Each gram of ELOCON Cream contains 1 mg of mometasone furoate in a white to off-white smooth and homogenous cream base.
  • Cream, 0.1%. ()
  • ELOCON Cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
  • ELOCON Cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. ()
  • No data
  • 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. (,)
  • Pediatric patients may be more susceptible to systemic toxicity. (,)
  • May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ()
  • Most common adverse reactions are: burning, pruritus, and skin atrophy. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No drug-drug interaction studies have been conducted with ELOCON Cream.
  • No data
  • Topically applied ELOCON Cream can be absorbed in sufficient amounts to produce systemic effects .
  • ELOCON (mometasone furoate) Cream, 0.1% contains mometasone furoate for topical use. Mometasone furoate 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 empirical 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 ELOCON Cream, 0.1% contains 1 mg mometasone furoate in a white to off-white cream base of aluminum starch octenylsuccinate (Gamma Irradiated), hexylene glycol, hydrogenated soybean lecithin, phosphoric acid, purified water, titanium dioxide, white soft paraffin, and white wax.
  • No data
  • Long-term animal studies have not been performed to evaluate the carcinogenic potential of ELOCON Cream. 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 ELOCON Cream 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 ELOCON Cream 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 ELOCON Cream on a mcg/m basis).
  • The safety and efficacy of the ELOCON Cream for the treatment of corticosteroid-responsive dermatoses were evaluated in two randomized, double-blind, vehicle-controlled clinical trials, one in psoriasis and one in atopic dermatitis. A total 366 subjects (12-81 years of age), of whom 177 received ELOCON Cream and 181 subjects received vehicle cream, were evaluated in these trials. ELOCON Cream or the vehicle cream were applied once daily for 21 days.
  • The two trials showed ELOCON Cream is effective in the treatment of psoriasis and atopic dermatitis.
  • ELOCON Cream is white to off-white in color and supplied in 15-gram (NDC 0085-3149-01) and 50-gram (NDC 0085-3149-03) tubes.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature]. Avoid excessive heat.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Inform patients of the following:
  • Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • Manufactured by:Schering-Plough Labo NVHeist-op-den-Berg, Belgium
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 1987-2019 Merck Sharp & Dohme Corp., a subsidiary of.All rights reserved.
  • uspi-mk0887-cr-1907r009
  • usppi-mk0887-cr-1805r000
  • NDC 0085-3149-0115 g
  • ELOCONn- Cream, 0.1%
  • For topicaluse only.
  • Not forophthalmic use.
  • Rx only

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