Professional Information
Erythromycin (Ophthalmic)
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VA CLASSIFICATION
Primary: OP201
Commonly used brand name(s): Ilotycin.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antibacterial (ophthalmic)—
Indications
Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.
Accepted
Conjunctivitis, neonatal (prophylaxis)—Erythromycin is indicated in the topical prophylaxis of neonatal conjunctivitis caused by Chlamydia trachomatis . {06}
Ocular infections (treatment)—Erythromycin is indicated in the topical treatment of superficial ocular infections of the conjunctiva and/or cornea caused by susceptible organisms. {05} {06} {09}
Ophthalmia neonatorum (prophylaxis)— Erythromycin is indicated alone in the prophylaxis of ophthalmia neonatorum caused by Neisseria gonorrhoeae or C. trachomatis . However, in infants born to mothers who have clinically apparent gonorrhea, ophthalmic erythromycin is indicated concurrently with parenteral aqueous penicillin G. {04} {05} {06} {09}
[Blepharitis, bacterial (treatment) ]1 {03}
[Blepharoconjunctivitis (treatment) ]1 {03}
[Chlamydial infections (treatment) ]1 {03}
[Conjunctivitis, bacterial (treatment) ]1 {03}
[Keratitis, bacterial (treatment) ]1 {03}
[Keratoconjunctivitis, bacterial (treatment) ]1 {03}
[Meibomianitis (treatment)]1 or {03}
[Trachoma (treatment)]1—Erythromycin is used in the topical treatment of bacterial blepharitis, blepharoconjunctivitis, chlamydial infections, bacterial conjunctivitis, bacterial keratitis, bacterial keratoconjunctivitis, meibomianitis, and trachoma. {03}
—Not all species or strains of a particular organism may be susceptible to erythromycin. {06}
1 Not included in Canadian product labeling.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
733.94
Family
Macrolide group of antibiotics. {02}
Mechanism of action/Effect:
Erythromycin is a bacteriostatic macrolide antibiotic. However, it may be bactericidal in high concentrations or when used against highly susceptible organisms. It is thought to penetrate the bacterial cell membrane and to reversibly bind to the 50 S subunit of bacterial ribosomes or near the “P” or donor site so that binding of tRNA (transfer RNA) to the donor site is blocked. Translocation of peptides from the “A” or acceptor site to the “P” or donor site is prevented, and subsequent protein synthesis is inhibited.
Erythromycin is effective only against actively dividing organisms.
Absorption:
Topical application of the ophthalmic ointment to the eye may result in absorption into the cornea and aqueous humor.
Precautions to Consider
Cross-sensitivity and/or related problems
Patients intolerant of one erythromycin may be intolerant of other erythromycins also.
Tumorigenicity
Two-year studies of rats administered erythromycin orally showed no evidence of tumorigenicity. {05}
Mutagenicity
Studies have not been done. {05}
Pregnancy/Reproduction
Fertility—
Studies of rats, mice, and rabbits given high doses of systemic erythromycin showed no evidence of impaired fertility {05}
Pregnancy—
Problems in humans have not been documented.
Studies of rats, mice, and rabbits given high doses of systemic erythromycin showed no evidence of harm to the fetus. {05}
FDA Pregnancy Category B. {05} {06}
Breast-feeding
Problems in humans have not been documented.
Pediatrics
Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date.
Geriatrics
Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Risk-benefit should be considered when the following medical problem exists
Intolerance to erythromycin or parabens{05}
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence rare
Eye irritation not present before therapy{05}{06}
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Erythromycin (Ophthalmic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Allergy to this or any of the other erythromycins
Proper use of this medication
Proper administration technique for ophthalmic ointment
» Compliance with full course of therapy
» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose
» Proper storage
Precautions while using this medication
Checking with physician if no improvement within a few days
Blurred vision after application of ophthalmic ointments
Side/adverse effects
Signs of potential side effects, especially eye irritation not present before therapy
General Dosing Information
Use of topical antibacterials may lead to skin sensitization, resulting in hypersensitivity reactions with subsequent topical or systemic use of the medication. {09}
In the prophylaxis of ophthalmia neonatorum, erythromycin ophthalmic ointment should not be flushed from the eye following administration. In addition, ophthalmic erythromycin is given concurrently with parenteral aqueous penicillin G in infants born to mothers who have clinically apparent gonorrhea. {04} {05} {09}
Ophthalmic Dosage Forms
ERYTHROMYCIN OPHTHALMIC OINTMENT USP
Usual adult and adolescent dose
Ocular infections
Topical, to the conjunctiva, a thin strip (approximately 1 cm) of ointment up to six times a day, depending on the severity of the infection. {05} {06} {09}
Usual pediatric dose
Conjunctivitis, neonatal or
Ophthalmia neonatorum
Topical, to each conjunctiva, a thin strip (approximately 0.5 to 1 cm) of ointment as a single dose following cesarean or vaginal delivery. {05} {06} {09}
Ocular infections
See Usual adult and adolescent dose. {05} {06}
Strength(s) usually available
U.S.—
0.5% (Rx) [Ilotycin{05}{10}{11} (methylparaben, propylparaben)][Generic]
Canada—
0.5% (Rx) [Ilotycin{08}{09}][Generic]
Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing. {05}
Auxiliary labeling:
• For the eye.
• Continue medicine for full time of treatment.
Revised: 11/28/1994
References
- Open.
- Ilotycin Tablets (Dista). In: PDR Physicians' desk reference. 40th ed. 1986. Oradell, NJ: Medical Economics Company, 1986: 840.
- Indications Index review, 1986.
- Ilotycin (Dista). In: PDR Physicians' desk reference. 42nd ed. 1988. Oradell, NJ: Medical Economics Company, 1988: 908.
- Ilotycin (Dista). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 870.
- Ilotycin package insert (Dista—US), Rev 3/15/90, Rec 6/90.
- Open.
- Generic (Metapharma). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 460.
- Ilotycin (Lilly). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 591.
- Generic (B&L). In: PDR Physicians' desk reference for ophthalmology. 22nd ed. 1994. Montvale, NJ: Medical Economics Data, 1994: 262.
- Generic package insert (Fougera—US), Rev 1/93, Rec 7/93.
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