Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Sterile Erythromycin Ophthalmic Ointment USP, 0.5% is available as follows: 3.5 g (1/8 oz) sterile tamper-resistant tube (NDC 72485-670-35) Carton of fifty (50) Unit Dose 1 g tube (NDC 72485-670-31) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Distributed by: Armas Pahrmaceuticals, Inc. Freehold, NJ 07728 (USA) Manufactured by: Ophtapharm AG, Riethofstrasse 1, Hellingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland 83008101 Rev. 07/23; Principal Display Panel Text for Container Label NDC 72485-670-35 ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5% Rx only Sterile Net Wt. 3.5 g (1/8 oz.) NDC 72485-670-31 ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5% Rx only Sterile Net Wt. 1 g 35 label Container label 31; Principal Display Panel Text for Carton Label 3.5 g NDC 72485-670-35 ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5% Rx only Sterile Net Wt 3.5 g (1/8 oz.) 1 g NDC 72485-670-31 ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5% Rx only Sterile Net Wt 1 g 35 container container label 31
- HOW SUPPLIED: Sterile Erythromycin Ophthalmic Ointment USP, 0.5% is available as follows: 3.5 g (1/8 oz) sterile tamper-resistant tube (NDC 72485-670-35) Carton of fifty (50) Unit Dose 1 g tube (NDC 72485-670-31) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Distributed by: Armas Pahrmaceuticals, Inc. Freehold, NJ 07728 (USA) Manufactured by: Ophtapharm AG, Riethofstrasse 1, Hellingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland 83008101 Rev. 07/23
- Principal Display Panel Text for Container Label NDC 72485-670-35 ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5% Rx only Sterile Net Wt. 3.5 g (1/8 oz.) NDC 72485-670-31 ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5% Rx only Sterile Net Wt. 1 g 35 label Container label 31
- Principal Display Panel Text for Carton Label 3.5 g NDC 72485-670-35 ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5% Rx only Sterile Net Wt 3.5 g (1/8 oz.) 1 g NDC 72485-670-31 ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5% Rx only Sterile Net Wt 1 g 35 container container label 31
Overview
Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin ((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-(dimethyl-amino)-β-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione)) is an antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula: Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum. Structural Formula
Indications & 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
: 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.
Warnings & Precautions
No warnings available yet.
Contraindications
: This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.
Adverse Reactions
The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.
Storage & Handling
STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Distributed by: Armas Pahrmaceuticals, Inc. Freehold, NJ 07728 (USA) Manufactured by: Ophtapharm AG, Riethofstrasse 1, Hellingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland 83008101 Rev. 07/23
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