Odan-Erythromycin Product Monograph

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 ODAN- ERYTHROMYCIN and other antibacterial drugs, ODAN-ERYTHROMYCIN 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

Susceptibility/Resistance

Prescribing ODAN-ERYTHROMYCIN 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.

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).

PRECAUTIONS

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.

OVERDOSE

In case of drug overdose, including ingestion, contact a healthcare professional, hospital emergency department or regional poison control centre, even if there are no symptom.

ADVERSE REACTIONS

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 of 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 the vaginal route should receive prophylaxis.

AVAILABILITY

Each 1 g of sterile ophthalmic ointment contains: Erythromycin (base) 5 mg and the following non-medicinal ingredients: Mineral Oil and White Petrolatum. Single tubes of 3.5 g and unit dose tubes of 1 g in boxes of 50.

STORAGE CONDITIONS

Store at room temperature (15°C to 30°C). Protect from freezing.

SCIENTIFIC INFORMATION

Drug Substance

Proper Name: Erythromycin

Chemical Name: (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-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione

Molecular Formula: C₃₇H₆₇NO₁₃

Molecular Weight: 733.94

Structural Formula:

Erythromycin contains primarily erythromycin A but also contains erythromycin B and C, with each having antibacterial activity.

Melting Point: 133-140°C

Physicochemical properties:

Physical description: White or slightly yellow, odorless or almost odorless, slightly hygroscopic crystals or powder with a bitter taste.

Solubility: It is freely soluble in methanol, ethanol, acetone and chloroform. It is soluble in water at 2 mg/mL.

SUPPORTING PRODUCT MONOGRAPHS

pdp-ERYTHROMYCIN (Erythromycin Ophthalmic Ointment, USP; 5 mg / g), submission control. No. 200704, Prescribing Information, Pendopharm, Division of Pharmascience Inc., January 16, 2017.