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ERYGEL Gel (2018)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Mylan Pharmaceuticals Inc.

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1. Description

ERYGEL Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)4[(2,6-Dideoxy-3-<em>C</em>-methyl-3-<em>O</em>methylα-L-<em>ribo</em>-hexopyranosyl)oxy]-14-ethyl-7, ...

2. Clinical Pharmacology

The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. Microbiology Erythromycin ...

3. Indications and Usage

ERYGEL Topical Gel is indicated for the topical treatment of acne vulgaris.

4. Contraindications

ERYGEL Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

5. Warnings

<b>Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider ...

6.1. General

For topical use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, ...

6.2. Information for Patients

Patients using ERYGEL Topical Gel should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies have been performed to evaluate carcinogenic and mutagenic potential, or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin ...

6.7. Pregnancy

There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation and through weaning ...

6.9. Nursing Mothers

It is not known whether erythromycin is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. <b>Keep this and all medication out of the reach of children.</b>

7. Adverse Reactions

In controlled clinical trials, the incidence of burning associated with erythromycin topical gel USP, 2% was approximately 25%. The following additional local adverse reactions have been reported occasionally: ...

10. Dosage and Administration

ERYGEL Topical Gel should be applied sparingly as a thin film to affected area(s) once or twice a day after the skin is thoroughly cleansed and patted dry. If there has been no improvement after 6 to 8 ...

11. How Supplied

ERYGEL (Erythromycin) Topical Gel USP, 2% contains 20 mg of erythromycin, USP per gram. The clear to slightly yellow gel is available as follows: NDC 0378-8075-93 carton containing one 30 g tube NDC 0378-8075-60 ...

12. Storage and Handling

<b>NOTE: FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME.</b> Store and dispense in original container. Keep tube tightly closed. <b>Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] ...
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