ELOCON Lotion, 0.1% (2020)
Βιβλιογραφική αναφορά
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Merck Sharp & Dohme Corp.
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1. Indications and Usage
ELOCON Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.
2. Dosage and Administration
Apply a few drops of ELOCON Lotion to the affected skin areas once daily and massage lightly until it disappears. Therapy should be discontinued when control is achieved. If no improvement is seen within ...
3. Dosage Forms and Strengths
Lotion, 0.1%. Each gram of ELOCON Lotion contains 1 mg of mometasone furoate in a colorless, clear to translucent lotion base.
4. Contraindications
ELOCON Lotion 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 Lotion.
8.1. Pregnancy
Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, ELOCON Lotion 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
Since safety and efficacy of ELOCON Lotion have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended. ELOCON Lotion caused HPA axis suppression ...
8.5. Geriatric Use
Clinical trials of ELOCON Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience ...
10. Overdosage
Topically applied ELOCON Lotion can be absorbed in sufficient amounts to produce systemic effects <em>[see Warnings and Precautions (5.1)]</em>.
11. Description
ELOCON (mometasone furoate) Lotion, 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 Lotion 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 lotion on ...
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 Lotion. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route ...
14. Clinical Studies
The safety and efficacy of ELOCON Lotion, 0.1% for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in scalp psoriasis and one in seborrheic ...
16.1. How Supplied
ELOCON Lotion is colorless, clear to translucent and supplied in 30-mL (27.5 gram) (NDC 0085-0854-01) and 60-mL (55 gram) (NDC 0085-0854-02) bottles; boxes of one. Distributed by: Merck Sharp & Dohme Corp., ...
16.2. Storage and Handling
Store ELOCON Lotion, 0.1% at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following: Use ELOCON Lotion as directed by the physician. It is for external use only. Avoid ...