Pharmaceutical Name

Trade (marketing or proprietary) name: Ilotycin^® Opthalmic, Romycin^® Ophthalmic

Generic (nonproprietary or active ingredient) name: Erythromycin (e rith” roe mye’ sin) Ophthalmic

Indication and Usage

Reason the product has been approved for sale on the market.

This antibiotic eye ointment is indicated for:

• 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. gonorrhoeae 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.

Manufacturer Insert

Ingredients

Erythromycin, Petrolatum, and Mineral Oil

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

The use of antimicrobial agents may be associated with the overgrowth of non-susceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Minor ocular irritations, redness and hypersensitivity reactions, redness, itching, stinging, or burning of the eye. Erythromycin eye ointment may cause other side effects.

Limitations of Effectiveness

The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established.

Specific Populations

Pregnancy

Pregnancy Category B.

Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. 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.

Breastfeeding

Caution should be exercised when erythromycin is administered to a nursing woman.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

Erythromycin Ophthalmic Ointment USP belongs to the macrolide group of antibiotics. The sterile ophthalmic ointment flows freely over the conjunctiva. 

What is informed consent?