Drug Catalog - Product Detail
GENTAMICIN SULFATE OPTH SOL 0.30% 5ML X 1
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 60758-0188-05 | GREENSTONE | 5 | 0.3% | SOLUTION |
PACKAGE FILES
Generic Name
GENTAMICIN SULFATE
Substance Name
GENTAMICIN SULFATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA062452
Description
DESCRIPTION Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use. Gentamicin is obtained from cultures of Micromonospora purpurea . It is a mixture of the sulfate salts of gentamicin C 1 , C 2 , and C 1A . All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows: Each mL contains: Active: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. Preservative: benzalkonium chloride. Inactives : edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The solution is an aqueous, buffered solution with a shelf life pH range of 6.5 to 7.5. The structural formula for Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol.
How Supplied
HOW SUPPLIED Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle – NDC 60758-188-05 PACIFIC PHARMA Storage : Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Revised : 1 0 /201 7 Distributed for: Allergan USA, Inc. Madison, NJ 07940 ©2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Made in the U.S.A. v1.0USPI188
Indications & Usage
INDICATIONS AND USAGE Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens .
Dosage and Administration
DOSAGE AND ADMINISTRATION Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.