Erythromycin Ophthalmic Ointment

— THERAPEUTIC CATEGORIES —
  • Ocular infections
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Erythromycin Ophthalmic Ointment Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Erythromycin 5mg/g.

    Pharmacological Class

    Macrolide.

    How Supplied

    Oint—3.5g

    How Supplied

    Sterile Erythromycin Ophthalmic Ointment USP, 5 mg/g as follows: 3.5g (1/8oz) tamper-evident tubes.

    Storage

    Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing.

    Manufacturer

    Perrigo

    Erythromycin Ophthalmic Ointment Indications

    Indications

    Susceptible infections of conjunctiva and cornea.

    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. gonorrheae 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.

    Erythromycin Ophthalmic Ointment Dosage and Administration

    Adults and Children

    Apply 1cm ribbon of ointment to infected area up to 6 times daily. Prophylaxis of neonatal gonoccocal or chlamydial conjunctivitis: instill 1cm ribbon of ointment into each lower conjunctival sac.

    Erythromycin Ophthalmic Ointment Contraindications

    Not Applicable

    Erythromycin Ophthalmic Ointment Boxed Warnings

    Not Applicable

    Erythromycin Ophthalmic Ointment Warnings/Precautions

    Warnings/Precautions

    Pregnancy (Cat.B). Nursing mothers.

    Warnings/Precautions

    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.

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

    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 Considerations

    Teratogenic Effects: Pregnancy Category B

    • 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 Mother Considerations

    Use caution when erythromycin is administered to a nursing woman.

    Erythromycin Ophthalmic Ointment Pharmacokinetics

    Metabolism

    Hepatic. ~93% serum protein bound.

    Erythromycin Ophthalmic Ointment Interactions

    Not Applicable

    Erythromycin Ophthalmic Ointment Adverse Reactions

    Adverse Reactions

    Ocular irritation, redness; hypersensivity reactions, superinfection.

    Erythromycin Ophthalmic Ointment Clinical Trials

    See Literature

    Erythromycin Ophthalmic Ointment Note

    Not Applicable

    Erythromycin Ophthalmic Ointment Patient Counseling

    Patient Counseling

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

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