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Basic Drug Info
Drug Name:GENTAMICIN SULFATE
Manufacturer:PACIFIC PHARMA
Other Info:

Pregnancy Category C: Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose.

There are no adequate and well-controlled studies in pregnant women.

Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.



Clinical Trials:


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.
Eye Infections -- Infection, moderate to severe, caused by bacteria, fungi, or viruses, which occurs either on the external surface of the eye or intraocularly with probable inflammation, visual impairment, or blindness.

Bacterial Infections -- Infections by bacteria, general or unspecified.

Conjunctivitis -- inflammation of the mucous membrane that lines the inner surface of the eyelids and the anterior part of the sclera; also called pinkeye and redeye.

Keratitis -- Inflammation of the cornea.

Keratoconjunctivitis -- Simultaneous inflammation of the cornea and conjunctiva.

Blepharitis -- Inflammation of the eyelids.

Blepharoconjunctivitis --

Meibomianitis --

Dacryocystitis -- Inflammation of the lacrimal sac. (Dorland, 27th ed)

Contraindications
GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP is contraindicated in patients with known hypersensitivity to any of the components.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

NOT FOR INJECTION INTO THE EYE.GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP is not for injection.

It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
Branded Drugs
The following US Branded drugs contain GENTAMICIN SULFATE


GARAMYCIN -- SCHERING CORP SUB SCHERING PLOUGH CORP

GENTAFAIR -- PHARMAFAIR INC

GENTAMICIN -- PERRIGO NEW YORK INC

APOGEN -- KING PHARMACEUTICALS INC

BRISTAGEN -- BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO

GENTAMICIN -- INTERNATIONAL MEDICATION SYSTEMS LTD

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- HOSPIRA INC

ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

U-GENCIN -- PHARMACIA AND UPJOHN CO

GENTACIDIN -- NOVARTIS PHARMACEUTICALS CORP

GENOPTIC -- ALLERGAN

GENTAK -- AKORN INC

PRED-G -- ALLERGAN PHARMACEUTICAL


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