Rx only

DESCRIPTION

Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7.0 and formulated for ophthalmic use.

Each mL contains

Active: Gentamicin Sulfate (equivalent to 3 mg gentamicin).

Inactives: Dibasic Sodium Phosphate, Sodium Chloride, Monobasic Sodium Phosphate, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.5 - 7.5).

Preservative Added: Benzalkonium Chloride 0.01%.

Gentamicin is an aminoglycoside antibiotic obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of Gentamicin C 1, C 2, C 1a and C 2a. 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:

CLINICAL PHARMACOLOGY

Microbiology

Gentamicin sulfate is active in vitro against many 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.

INDICATIONS AND USAGE

Gentamicin sulfate ophthalmic solution 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.

CONTRAINDICATIONS

Gentamicin sulfate ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS

NOT FOR INJECTION INTO THE EYE

Gentamicin sulfate ophthalmic solution is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

PRECAUTIONS

ADVERSE REACTIONS

Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.

The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.

Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

HOW SUPPLIED

Gentamicin Sulfate Ophthalmic Solution, USP 0.3% is supplied in a plastic bottle with a controlled drop tip and a white polypropylene cap in the following sizes:

NDC 24208-580-60 - 5 mL

NDC 24208-580-64 - 15 mL

NOT FOR INJECTION INTO THE EYE

FOR OPHTHALMIC USE ONLY

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

Storage: Store between 2°-25°C (36°-77°F). Avoid exposure to excessive heat.

KEEP OUT OF REACH OF CHILDREN.

Revised: August 2016

Bausch + Lomb, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

9116003 (Folded)
9116103 (Flat)

DRUG: Gentamicin Sulfate

GENERIC: Gentamicin Sulfate

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: OPHTHALMIC

NDC: 61786-988-57

PACKAGING: 5 in 1 BOTTLE, DROPPER

ACTIVE INGREDIENT(S):

• GENTAMICIN SULFATE 3mg in 1mL

INACTIVE INGREDIENT(S):

• BENZALKONIUM CHLORIDE
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE
• SODIUM PHOSPHATE, DIBASIC
• SODIUM CHLORIDE
• SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
• WATER