DERMOTIC Ear drops (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Royal Pharmaceuticals
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1. Description
DermOtic Oil Ear Drops contain fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a ...
2. Clinical Pharmacology
Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, ...
3. Indications and Usage
DermOtic Oil is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.
4. Contraindications
DermOtic Oil is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (See PRECAUTIONS).
6.1. General
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of ...
6.2. Information for Patients
Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external ear use only. Do not use ...
6.3. Laboratory Tests
The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol test
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of DermOtic Oil. Studies have not been performed to evaluate the mutagenic potential of ...
6.7. Pregnancy
Teratogenic effects Pregnancy category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have ...
6.9. 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 ...
6.10. Pediatric Use
DermOtic Oil may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis. DermOtic Oil is not recommended for use on the face (See ADVERSE ...
7. Adverse Reactions
The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. ...
9. Overdosage
Topically applied DermOtic Oil can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).
10. Dosage and Administration
For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of DermOtic Oil into the affected ear. To apply, tilt head to one side so that the ear is facing up. ...
11. How Supplied
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net content (Dropper Included) (NDC # 68791-103-20). Keep tightly closed. Store at 20°-25° ...
12. Storage and Handling
Keep tightly closed. Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F) [see USP Controlled Room Temperature].
13. Clinical Studies
Efficacy in a placebo-controlled study for the treatment of chronic eczematous external otitis on 154 patients (adults and children 2 years of age and older) treated with five drops per ear of DermOtic ...