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NDC 00378-8075-60 ERYGEL 20 mg/g Details
ERYGEL 20 mg/g
ERYGEL is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is ERYTHROMYCIN.
Product Information
| NDC | 00378-8075 |
|---|---|
| Product ID | 0378-8075_dce86476-c427-48a9-ad60-e4fe26063028 |
| Associated GPIs | 90051020004010 |
| GCN Sequence Number | 007680 |
| GCN Sequence Number Description | erythromycin base in ethanol GEL (GRAM) 2 % TOPICAL |
| HIC3 | Q5W |
| HIC3 Description | TOPICAL ANTIBIOTICS |
| GCN | 31710 |
| HICL Sequence Number | 008712 |
| HICL Sequence Number Description | ERYTHROMYCIN BASE IN ETHANOL |
| Brand/Generic | Brand |
| Proprietary Name | ERYGEL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | erythromycin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/g |
| Substance Name | ERYTHROMYCIN |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050617 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00378-8075-60 (00378807560)
| NDC Package Code | 0378-8075-60 |
|---|---|
| Billing NDC | 00378807560 |
| Package | 1 TUBE in 1 CARTON (0378-8075-60) / 60 g in 1 TUBE |
| Marketing Start Date | 2019-03-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f1c6885e-4136-4542-a8a2-7fa8fcd77a03 Details
DESCRIPTION
ERYGEL® Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6,-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical dermatological use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids.
Chemically, erythromycin is C37H67NO13. It has the following structural formula:
Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically odorless, bitter crystalline powder. Erythromycin is very soluble in very polar organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar solvents such as ether, dichloroethylene and amyl acetate. It is slightly soluble in nonpolar solvents such as hexane. It is very poorly soluble in water.
Each gram of ERYGEL® Topical Gel USP, 2% contains 20 mg of erythromycin, USP in a vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose.
CLINICAL PHARMACOLOGY
MICROBIOLOGY
Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol, and clindamycin.
CONTRAINDICATIONS
WARNINGS
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 this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
PRECAUTIONS
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, desquamating or abrasive agents.
Avoid contact with eyes and all mucous membranes.
The use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. If this occurs, discontinue use and take appropriate measures.
Information for Patients
Patients using ERYGEL® Topical Gel should receive the following information and instructions:
- 1.
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes, nose, mouth, and all mucous membranes.
- 2.
- This medication should not be used for any disorder other than that for which it was prescribed.
- 3.
- Patients should not use any other topical acne medication unless otherwise directed by their physician.
- 4.
- Patients should report to their physician any signs of local adverse reactions.
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 ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.
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 of two successive litters. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.
Nursing Women
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, caution should be exercised when erythromycin is administered to a nursing woman.
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: peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have also been reported with the topical use of erythromycin. A generalized urticarial reaction, possibly related to the use of erythromycin, which required systemic steroid therapy has been reported.
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 weeks, or if the condition becomes worse, treatment should be discontinued, and the physician should be reconsulted. Spread the medication lightly rather than rubbing it in. There are no data directly comparing the safety and efficacy of b.i.d. versus q.d. dosing.
HOW SUPPLIED
STORAGE
NOTE: FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME. Store and dispense in original container.
Keep tube tightly closed. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
© 2018 Delcor Asset Corporation, a Mylan Company
ERYGEL is a registered trademark of Delcor Asset Corporation, a Mylan Company
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured by:
DPT Laboratories, Ltd.
San Antonio, TX 78215 U.S.A.
Revised: 6/2018
DPT:ERYTOP:R2
140973-0618
PRINCIPAL DISPLAY PANEL – 2%
NDC 0378-8075-93
ERYGEL®
(Erythromycin)
Topical Gel
USP, 2%
For Dermatologic Use Only
Not for Ophthalmic Use
Rx only Net Wt 30 g
Description: ERYGEL® Topical Gel
USP, 2% contains erythromycin,
USP (20 mg/g) in a vehicle
consisting of dehydrated alcohol
and hydroxypropyl cellulose.
Usual Dosage: ERYGEL® Topical
Gel USP, 2% 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. Spread the medication
lightly rather than rubbing it in.
The hands should be washed after
application. See accompanying
prescribing information.
Keep this and all medication
out of the reach of children.
NOTE: FLAMMABLE. KEEP AWAY
FROM HEAT AND FLAME.
Keep tube tightly closed.
Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]
To open, reverse cap and push
pointed top into neck seal.
To close, screw cap onto tube.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured by:
DPT Laboratories, Ltd.
San Antonio, TX 78215 U.S.A.
Mylan.com
DPT:8075:93:1C:R2 117506-0618
©2018 Delcor Asset Corporation,
a Mylan Company
ERYGEL is a registered trademark of Delcor
Asset Corporation, a Mylan Company
INGREDIENTS AND APPEARANCE
| ERYGEL
erythromycin gel |
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| Labeler - Mylan Pharmaceuticals Inc. (059295980) |