Drug Facts
Composition & Profile
Identifiers & Packaging
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; 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
- 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
- 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
Overview
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
Indications & 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.
Dosage & Administration
Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.
Warnings & Precautions
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.
Contraindications
Gentamicin sulfate ophthalmic ointment is con-traindicated in patients with known hypersensitivity to any of the components.
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.
Storage & 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
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