ERYTHROMYCIN

Main information

  • Trade name:
  • ERYTHROMYCIN- erythromycin ointment
  • Composition:
  • ERYTHROMYCIN 5 mg in 1 g
  • Administration route:
  • OPHTHALMIC
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ERYTHROMYCIN- erythromycin ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis . The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants. This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.
  • Product summary:
  • Erythromycin Ophthalmic Ointment, USP 0.5% is available in the following sizes: 1/8 oz. (3.5 g) tamper-resistant tube - NDC 24208-910-55 DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. 1 g tin container (in cartons of 50) - NDC 24208-910-19 DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED. Store between 15°-25°C (59°-77°F). KEEP OUT OF REACH OF CHILDREN. Revised: July 2016 Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA ©Bausch & Lomb Incorporated 9043404 (Folded) 9043504 (Flat)

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 24208-910-19, 24208-910-55
  • Last update:
  • 17-06-2019

Summary of Product characteristics: dosage, interactions, side effects

ERYTHROMYCIN- erythromycin ointment

Bausch & Lomb Incorporated

----------

Erythromycin Ophthalmic Ointment, USP 0.5% (Sterile)

Rx only

DESCRIPTION

Erythromycin Ophthalmic Ointment, USP belongs to the macrolide group of antibiotics. The sterile

ophthalmic ointment flows freely over the conjunctiva. Erythromycin base, as crystals or powder, is

slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform.

Erythromycin is an antibiotic produced from a strain of Streptomyces erythraeus. It is basic and readily

forms a salt when combined with an acid. It has the following structural formula:

H NO

Mol. Wt. 733.94

Chemical Name: (3R , 4S , 5S , 6R , 7R , 9R , 11R , 12R , 13S , 14R )-4-[(2,6-Dideoxy-3-C-methyl-

3-0-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

Each Gram Contains: ACTIVE: Erythromycin, USP 5 mg (0.5%); INACTIVES: Mineral Oil, White

Petrolatum.

CLINICAL PHARMACOLOGY

Microbiology

Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is

usually active against the following organisms in vitro and in clinical infections: Streptococcus pyogenes

(group A β-hemolytic), Alpha-hemolytic streptococci (viridans group); Staphylococcus aureus,

including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to

erythromycin); Streptococcus pneumoniae; Mycoplasma pneumoniae (Eaton Agent, PPLO); Haemophilus

influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily

achieved); Treponema pallidum; Corynebacterium diphtheriae; Neisseria gonorrhoeae; Chlamydia

trachomatis.

INDICATIONS AND USAGE

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by

organisms susceptible to erythromycin.

For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis.

The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing

N. gonorrhoeae is not established.

For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections

of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or

20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.

CONTRAINDICATIONS

This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

PRECAUTIONS

General

The use of antimicrobial agents may be associated with the overgrowth of non-susceptible organisms

including fungi; in such a case, antibiotic administration should be stopped and appropriate measures

taken.

Information for Patients:

Avoid contaminating the tip of container with material from the eye, fingers or other source.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity.

Mutagenicity studies have not been conducted. No evidence of impaired fertility or harm to the fetus

that appeared related to erythromycin was reported in these studies.

Pregnancy:

Pregnancy Category B.

Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various

salts and esters, at doses that were several multiples of the usual human dose. There are, however, no

adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not

always predictive of human response, the erythromycins should be used during pregnancy only if

clearly needed.

Nursing Mothers:

Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use:

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS

The most frequently reported adverse reactions are minor ocular irritations, redness and

hypersensitivity reactions.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant

Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

In the treatment of superficial ocular infections, erythromycin ophthalmic ointment approximately 1 cm

in length should be applied directly to the infected eye(s) up to six times daily, depending on the

severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, a ribbon of ointment approximately 1

cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed

from the eye following instillation. A new tube should be used for each infant.

HOW SUPPLIED

Erythromycin Ophthalmic Ointment, USP 0.5% is available in the following sizes:

1/8 oz. (3.5 g) tamper-resistant tube - NDC 24208-910-55

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

1 g tin container (in cartons of 50) - NDC 24208-910-19

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

Storage:

Store between 15°-25°C (59°-77°F).

KEEP OUT OF REACH OF CHILDREN.

Revised: July 2016

Bausch + Lomb, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

9043404 (Folded)

9043504 (Flat)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 24208-910-55

Erythromycin

Ophthalmic

Ointment, USP

0.5% (Sterile)

FOR TOPICAL ADMINISTRATION

IN THE EYE

Bausch & Lomb Incorporated

Rx only

Net wt. 1/8 oz (3.5 g)

BAUSCH + LOMB

ERYTHROMYCIN

erythromycin ointment

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:2420 8 -9 10

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ERYTHRO MYCIN (UNII: 6 39 37KV33D) (ERYTHROMYCIN - UNII:6 39 37KV33D)

ERYTHROMYCIN

5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

MINERAL O IL (UNII: T5L8 T28 FGP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:2420 8 -9 10 -19

50 in 1 BOX

0 7/29 /19 9 4

1

1 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:2420 8 -9 10 -55

1 in 1 CARTON

0 7/29 /19 9 4

2

3.5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 6 40 6 7

0 7/29 /19 9 4

Labeler -

Bausch & Lomb Incorporated (196603781)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bausch & Lo mb Inco rpo rated

0 79 58 76 25

MANUFACTURE(2420 8 -9 10 )

Revised: 7/2016