ELOCON Cream, 0.1% (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Merck Sharp & Dohme Corp.
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1. Indications and Usage
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.
2. Dosage and Administration
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 ...
3. Dosage Forms and Strengths
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.
4. Contraindications
ELOCON Cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
5. Warnings and Precautions
5.1 Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. ...
6.1. Clinical Trials Experience
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 ...
6.2. Postmarketing Experience
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. ...
7. Drug Interactions
No drug-drug interaction studies have been conducted with ELOCON Cream.
8.1. Pregnancy
Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, ELOCON Cream should be used during pregnancy only if the potential benefit justifies ...
8.3. Nursing Mothers
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 ...
8.4. Pediatric Use
ELOCON Cream may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy ...
8.5. Geriatric Use
Clinical studies of ELOCON Cream included 190 subjects who were 65 years of age and over and 39 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed ...
10. Overdosage
Topically applied ELOCON Cream can be absorbed in sufficient amounts to produce systemic effects <em>[see Warnings and Precautions (5.1)]</em>.
11. Description
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 ...
12.1. Mechanism of Action
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 ...
12.2. Pharmacodynamics
Studies performed with ELOCON Cream 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 cream on the ...
12.3. Pharmacokinetics
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 ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
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 ...
14. Clinical Studies
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 ...
16.1. How Supplied
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. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., ...
16.2. Storage and Handling
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive heat.
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following: Use ELOCON Cream as directed by the physician. It is for external use only. Avoid contact ...