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ERYTHROMYCIN OPTHALMIC OINTMENT .5% 3.5GM - 5 mg/g OINTMENT
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ERYTHROMYCIN OPTHALMIC OINTMENT .5% 3.5GM

Generic: Erythromycin

ERYTHROMYCIN OPTHALMIC OINTMENT .5% 3.5GM

NDC:72485-0670-35
Manufacturer:ARMAS PHARMACEUTICALS INC.
Strength:5 mg/g
Dosage Form:OINTMENT
Route:OPHTHALMIC

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Drug Information

Identification

Generic Name

Erythromycin

Brand Name

Erythromycin

Labeler / Distributor

ARMAS PHARMACEUTICALS INC.

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

OINTMENT

Route of Administration

OPHTHALMIC

FDA Application Number

ANDA064030

Active Ingredients

IngredientStrength
ERYTHROMYCIN5 mg/g

Pharmacological Class

Decreased Sebaceous Gland Activity [PE]Macrolide AntimicrobialMacrolideMacrolides [CS]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

Indications & Usage

INDICATIONS AND USAGE: 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.

Dosage & Administration

DOSAGE AND ADMINISTRATION: In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Opthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.

Adverse Reactions

ADVERSE REACTIONS: The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.

Information for Patients

Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers, or other source.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.