Summary of product characteristics
Adverse Reactions
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.
Contraindications
CONTRAINDICATIONS Gentamicin sulfate ophthalmic ointment is con-traindicated in patients with known hypersensitivity to any of the components.
Description
DESCRIPTION GENTAK ® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives. 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 activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows: Figure
Dosage And Administration
DOSAGE AND ADMINISTRATION Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.
Indications And Usage
INDICATIONS AND USAGE Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: 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.
Warnings
WARNINGS NOT FOR INJECTION INTO THE EYE. Gentamicin sulfate ophthalmic ointment is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
Clinical Pharmacology
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.
Effective Time
20191101
Version
3
Spl Product Data Elements
Gentak Gentamicin Sulfate Gentamicin Sulfate Gentamicin Methylparaben Propylparaben Petrolatum Mineral Oil
Carcinogenesis And Mutagenesis And Impairment Of Fertility
Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.
Application Number
ANDA064093
Brand Name
Gentak
Generic Name
Gentamicin Sulfate
Product Ndc
63187-873
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Microbiology
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.
Package Label Principal Display Panel
Principal Display Panel Text for Container Label: NDC 63187-873-35 Akorn Logo Gentak ® brand of Gentamicin Sulfate Ophthalmic Ointment USP, 0.3% (equivalent to 3 mg gentamicin per gram) Net Wt 3.5 g (1/8 oz) Sterile Rx only 63187-873-35
Spl Unclassified Section
Sterile Rx only
Information For Patients
Information for patients: To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.
Pediatric Use
Pediatric Use: Safety and effectiveness in neonates have not been established.
Pregnancy
Pregnancy: 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.
How Supplied
HOW SUPPLIED GENTAK ® Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 g tube, box of one. (NDC 63187-873-35) STORAGE: Store at 2° to 30°C (36° to 86°F). Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 Relabeled by: Proficient Rx LP. Thousand Oaks, CA 91320 GKO00N Rev. 09/08
Storage And Handling
STORAGE: Store at 2° to 30°C (36° to 86°F). Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 Relabeled by: Proficient Rx LP. Thousand Oaks, CA 91320 GKO00N Rev. 09/08
General Precautions
General: Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician. If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted. Ophthalmic ointments may retard corneal healing.
Precautions
PRECAUTIONS General: Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician. If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted. Ophthalmic ointments may retard corneal healing. Information for patients: To avoid contamination, do not touch tip of container to the eye, eyelid or any surface. Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic. Pregnancy: 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. Pediatric Use: Safety and effectiveness in neonates have not been established.
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