Erythromycin-AKOS (Ointment) Instructions for Use

ATC Code

S01AA17 (Erythromycin)

Active Substance

Erythromycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical antiseptic for use in ophthalmology

Pharmacotherapeutic Group

Antibiotic-macrolide

Pharmacological Action

An antibiotic of the macrolide group. It has a bacteriostatic effect. However, in high doses against susceptible microorganisms, it exerts a bactericidal effect. Erythromycin reversibly binds to bacterial ribosomes, thereby suppressing protein synthesis.

It is effective against susceptible microorganisms causing superficial eye infections of the conjunctiva and cornea, including against Neisseria gonorrhoeae and Chlamydia trachomatis.

Pharmacokinetics

It is absorbed into the cornea and the aqueous humor of the eye. With topical application, a therapeutic concentration of erythromycin is achieved in the eye tissues; systemic absorption is low. When the corneal epithelium is damaged, an effective concentration of erythromycin in the anterior chamber humor is reached 30 minutes after application.

Bioavailability is 30-65%. It is distributed in most tissues and body fluids. Plasma protein binding is 70-90%. It is metabolized in the liver, partially forming inactive metabolites. T_1/2 is 1.4-2 hours. It is excreted through the intestines and kidneys.

Indications

Infectious and inflammatory eye diseases caused by susceptible microorganisms: conjunctivitis (including in newborns), bacterial blepharitis, blepharoconjunctivitis, meibomitis; as part of complex therapy for bacterial keratitis, chlamydial conjunctivitis, blepharoconjunctivitis, trachoma; prevention of neonatal ophthalmia.

ICD codes

Dosage Regimen

Apply the ointment topically by placing a 1-1.5 cm strip directly into the conjunctival sac behind the lower eyelid.

For most bacterial infections in adults and children, apply the ointment 2 to 5 times daily. The exact frequency depends on the infection severity.

For trachoma, apply twice daily for 60 days or apply four times daily for 14 days in conjunction with systemic therapy.

For neonatal prophylaxis, apply a single application into each eye immediately after birth.

For neonatal conjunctivitis caused by C. trachomatis or N. gonorrhoeae, apply four times daily for 14 days; concomitant systemic antibiotic therapy is mandatory.

After application, close the eye and roll the eyeball to distribute the ointment. Apply gentle pressure to the lacrimal sac for 1-2 minutes to minimize systemic absorption.

Continue treatment for at least 48 hours after symptoms have resolved. The typical treatment duration is 7 to 14 days.

Do not let the tube tip contact the eye or any other surface to avoid contamination.

If using other topical ophthalmic products, administer eye drops at least 10 minutes before applying the ointment.

Adverse Reactions

Local reactions: hyperemia, irritation of the eye mucosa, blurred vision, allergic reactions.

Contraindications

History of jaundice, severe impairment of liver and kidney function, hypersensitivity to macrolides.

With caution

Elderly patients, mild to moderate impairment of liver and kidney function.

Use in Pregnancy and Lactation

Erythromycin crosses the placental barrier and is excreted in breast milk.

When using erythromycin during pregnancy, the intended benefit for the mother and the potential risk to the fetus should be assessed. If use during lactation is necessary, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Contraindicated in a history of jaundice, severe liver function impairment. Use with caution in cases of liver function impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

Use is possible according to the dosing regimen.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

In children whose mothers have clinically pronounced gonorrhea, Erythromycin as an ophthalmic medicinal product is used simultaneously with an aqueous solution of penicillin G for parenteral administration.

Drug Interactions

It exhibits antagonism with lincomycin, clindamycin, and chloramphenicol.

It reduces the bactericidal effect of beta-lactam antibiotics (penicillins, cephalosporins, carbapenems).

Pharmaceutically incompatible with aminoglycosides.

When used with corticosteroids, it leads to an enhancement of their effect.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.