Product Monograph - Erythromycin Ophthalmic Ointment USP
ACTION AND CLINICAL PHARMACOLOGY
Erythromycin inhibits protein synthesis by binding to the 50S ribosomal subunit within the microorganism. It is usually bacteriostatic but may be bactericidal depending on the sensitivity and number of organisms and the concentrations of the drug. Its spectrum of activity is similar to that of penicillin G. Resistance to erythromycin of some strains of H. influenza and Staphylococci has been demonstrated.
INDICATIONS
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.
For prophylaxis of ophthalmic neonatorum due to N. gonorrhoeae or C. trachomatis. The Canadian Pediatric Society, the Centers for Diseases Control and the Committee on Drugs (US), the Committee of Fetus and Newborn and the Committee on Infectious Diseases of the American Academy of Pediatrics recommend 1% silver nitrate solution in single dose ampoules or single use tubes of an ophthalmic ointment containing 0.5% erythromycin or 1% tetracycline as effective and acceptable regimens for prophylaxis of gonococcal ophthalmia neonatorum. Erythromycin ophthalmic ointment has also been effective for prevention of neonatal conjunctivitis due to C. trachomatis, a condition that may develop one to several weeks after delivery in infants of mothers whose birth canal harbor the organism.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERYTHROMYCIN ophthalmic ointment and other antibacterial drugs, ERYTHROMYCIN ophthalmic ointment should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
WARNINGS AND PRECAUTIONS
Susceptibility/Resistance
Prescribing ERYTHROMYCIN ophthalmic ointment in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
The rare possibility of superinfection caused by overgrowth of non-susceptible bacteria or fungi should be kept in mind during prolonged or repeated therapy, especially when other antibacterial agents are simultaneously employed. In such instances the drug should be withdrawn and appropriate treatment instituted if necessary.
CONTRAINDICATIONS
Erythromycin and its derivatives should not be used in patients with known hypersensitivity to these drugs or any ingredient in the formulations or with infections that are resistant to the drug (primarily certain Staphylococci organisms).
ADVERSE EFFECTS
Serious allergic reactions to erythromycin have been extremely infrequent. Mild allergic reactions, such as urticaria and morbilliform skin rashes have occurred. Should a patient demonstrate signs of hypersensitivity, administer appropriate countermeasures such as epinephrine, corticosteroid and antihistamines, and withdraw the antibiotic.
DOSAGE AND ADMINISTRATION
In the treatment of external ocular infections, apply the ointment directly to the infected structure one or more times daily, depending on the severity of the infection.
For prophylaxis neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 0.5 to 1 cm in length should be instilled into each conjunctival sac. The ointment should not be flushed from the eye following installation. A new tube should be used for each infant. Infants born by cesarean section as well as those delivered by vaginal route should receive prophylaxis.
AVAILABILITY
Each 1 g of sterile ophthalmic ointment contains: Erythromycin (base) 5 mg in a Mineral Oil and Petrolatum. Tubes of 3.5 g and unit dose tubes of 1 g in boxes of 50.
STORAGE CONDITIONS
Store at room temperature (15-30oC). Protect from freezing. Keep tightly closed.