Label: ERYTHROMYCIN ointment

  • NDC Code(s): 17478-070-31, 17478-070-35
  • Packager: Akorn, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Sterile

    Rx only

  • DESCRIPTION:

    Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. 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-(dimethyl-amino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione)) is an antibiotic produced from a strain of Streptomyces erythraeus.

    It has the following structural formula:

    Structural Formula

    Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and 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 nonsusceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.

    Information for Patients: Avoid contaminating the applicator tip 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 that appeared related to erythromycin was reported in animal studies.

    Pregnancy: Teratogenic Effects: 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. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. 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.

    Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

  • ADVERSE REACTIONS:

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

  • DOSAGE AND ADMINISTRATION:

    In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Opthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection.

    For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, 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:

    Sterile Erythromycin Ophthalmic Ointment USP, 0.5% is available as follows:

    3.5 g (1/8 oz) sterile tamper-resistant tube (NDC 17478-070-35)

    Carton of fifty (50) Unit Dose 1 g tube (NDC 17478-070-31)

    STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

    Avoid excessive heat.

    Protect from freezing.

    Akorn

    Manufactured by: Akorn Inc
    Lake Forest, IL 60045
    ERT00N Rev. 06/16

  • Principal Display Panel Text for Container Label

    NDC 17478-070-35

    ERYTHROMYCIN OPHTHALMIC

    OINTMENT USP, 0.5%

    Rx only Sterile Net Wt. 3.5 g (1/8 oz.)

    Principal Display Panel Text for Container Label
  • Principal Display Panel Text for Carton Label

    3.5 g NDC 17478-070-35

    ERYTHROMYCIN OPHTHALMIC

    OINTMENT USP, 0.5%

    Rx only Sterile Net Wt 3.5 g (1/8 oz.) Akorn logo

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    ERYTHROMYCIN 
    erythromycin ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-070
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Erythromycin (UNII: 63937KV33D) (Erythromycin - UNII:63937KV33D) Erythromycin5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    mineral oil (UNII: T5L8T28FGP)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17478-070-351 in 1 CARTON07/18/1996
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:17478-070-3150 in 1 CARTON07/18/1996
    21 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06403007/18/1996
    Labeler - Akorn, Inc. (117696770)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc.117696840MANUFACTURE(17478-070) , ANALYSIS(17478-070) , REPACK(17478-070) , PACK(17478-070) , LABEL(17478-070)