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![GENTAMICIN SULFATE OINTMENT [MWI]](https://medic.hrt.org//dailymed/images/83851d99-d526-4a8b-b375-a3034bf3957a/gen08-0002-03.jpg)
| NDC | 13985-603-03 |
| Set ID | 83851d99-d526-4a8b-b375-a3034bf3957a |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | MWI |
| Generic Name | |
| Product Class | Aminoglycoside Antibacterial |
| Product Number | |
| Application Number | ANDA064163 |
- SPL UNCLASSIFIED SECTION
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DESCRIPTION:
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 C1, C2, and C1A. 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:
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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.
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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.
- CONTRAINDICATIONS:
- WARNINGS:
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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.
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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.
- DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
- STORAGE:
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GENTAMICIN SULFATE
gentamicin sulfate ointmentProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13985-603 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Gentamicin Sulfate (UNII: 8X7386QRLV) (Gentamicin - UNII:T6Z9V48IKG) Gentamicin 3 mg in 1 g Inactive Ingredients Ingredient Name Strength Methylparaben (UNII: A2I8C7HI9T) 0.5 mg in 1 g Propylparaben (UNII: Z8IX2SC1OH) 0.1 mg in 1 g Petrolatum (UNII: 4T6H12BN9U) Mineral Oil (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13985-603-03 1 in 1 CARTON 03/23/2015 1 3.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064163 03/23/2015 Labeler - MWI (019926120) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn, Inc 117696840 MANUFACTURE(13985-603) , ANALYSIS(13985-603) , STERILIZE(13985-603) , PACK(13985-603) , LABEL(13985-603)
