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Brand Name
Gentak
Generic Name
Opth
View Brand Information FDA approval date: September 07, 1982
Classification: Aminoglycoside Antibacterial
Form: Injection, Ointment, Cream, Solution
What is Gentak (Opth)?
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.
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Brand Information
Gentak (Gentamicin Sulfate)
1DESCRIPTION
GENTAK
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
2INDICATIONS 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.
3CONTRAINDICATIONS
Gentamicin sulfate ophthalmic ointment is con-traindicated in patients with known hypersensitivity to any of the components.
4WARNINGS
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.
5ADVERSE 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.
6DOSAGE AND ADMINISTRATION
Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.
7HOW SUPPLIED
GENTAK
(NDC 63187-873-35)