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| Product NDC Code | 61919-106 | ||||
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| Drug Name | Gentamicin sulfate |
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| Type | Generic | ||||
| Pharm Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 310467 | ||||
| Application Number | ANDA062452 | ||||
| Labeler Name | DIRECT RX | ||||
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS SECTION 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY SECTION 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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS SECTION Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution for ophthalmic use. Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base) Preservative: Benzalkonium Chloride Inactives: Disodium Phosphate, Monosodium Phosphate, and Sodium Chloride. The pH range is from 6.8 to 7.3. 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 powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE & ADMINISTRATION SECTION Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS & USAGE SECTION 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.
Spl product data elements
Usually a list of ingredients in a drug product.gentamicin sulfate gentamicin sulfate EDETATE DISODIUM POLYVINYL ALCOHOL WATER SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC BENZALKONIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE GENTAMICIN SULFATE GENTAMICIN Gentamicin Sulfate Gentamicin Sulfate SODIUM PHOSPHATE, MONOBASIC GENTAMICIN SULFATE GENTAMICIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS BENZALKONIUM CHLORIDE SODIUM CHLORIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 918-05
106
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED SECTION Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle – NDC 60758-188-05 Storage: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Revised: 08/2013 © 2013 Allergan, Inc. Irvine, CA 92612, U.S.A. ® mark owned by Allergan, Inc. Made in the U.S.A.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS SECTION General Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, 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. 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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS SECTION 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API