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NDC 00378-8212-93 Erythromycin 20 mg/g Details

Erythromycin 20 mg/g

Erythromycin 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	00378-8212
Product ID	0378-8212_09b16a2d-825a-4d08-b86e-076548926916
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	Generic
Proprietary Name	Erythromycin
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 AUTHORIZED GENERIC
Application Number	NDA050617
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00378-8212-93 (00378821293)

Pricing Information
NDC Package Code	0378-8212-93
Billing NDC	00378821293
Package	1 TUBE in 1 CARTON (0378-8212-93) / 30 g in 1 TUBE
Marketing Start Date	2018-10-19
NDC Exclude Flag	N
Price Per Unit	0.69162
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	ERYTHROMYCIN 2% GEL
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	1, 5, 6
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 09b16a2d-825a-4d08-b86e-076548926916 Details

DESCRIPTION

Erythromycin 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 Saccaropolysporaerythraea (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 erythromycin topical gel USP, 2% contains 20 mg of erythromycin, USP in a vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose.

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 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.

INDICATIONS AND USAGE

Erythromycin topical gel is indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS

Erythromycin topical gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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 Erythromycin 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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Keep this and all medication out of the reach of children.

ADVERSE REACTIONS

In controlled clinical trials, the incidence of burning associated with erythromycin topical gel 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

Erythromycin 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

Erythromycin Topical Gel USP, 2% contains 20 mg of erythromycin, USP per gram. The clear to slightly yellow gel is available as follows:

NDC 0378-8212-93

carton containing one 30 g tube

NDC 0378-8212-60

carton containing one 60 g tube

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.]

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:ERYTOPG:R2

140976-0618

PRINCIPAL DISPLAY PANEL – 2%

NDC 0378-8212-93

Erythromycin

Topical Gel, USP

2%

For Dermatologic

Use Only

Not for Ophthalmic Use

Description: Erythromycin

Topical Gel USP, 2% contains

erythromycin, USP (20 mg/g)

in a vehicle consisting of

dehydrated alcohol and

hydroxypropyl cellulose.

Usual Dosage: Erythromycin

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.