Gentamicin Sulfate 40 mg/mL
GENTAMICIN SULFATE · INJECTION, SOLUTION · Medical Purchasing Solutions, LLC
Gentamicin Sulfate is a injection, solution containing gentamicin sulfate at 40 mg/mL, taken intramuscular. Manufactured by Medical Purchasing Solutions, LLC.
Key Facts
- Brand Name
- Gentamicin Sulfate
- Generic Name
- GENTAMICIN SULFATE
- NDC Code (Product)
71872-7337- Manufacturer
- Medical Purchasing Solutions, LLC
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA062420
- Marketing Start
- 08/29/2005
Recall History
Pallimed Solutions
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Hospira Inc.
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Akorn, Inc.
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Akorn, Inc.
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Oregon Compounding Centers, Inc. dba Creative Compounds
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Gentamicin sulfate ophthalmic solution 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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.
Warnings
WARNINGS NOT FOR INJECTION INTO THE EYE Gentamicin sulfate ophthalmic solution is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
Contraindications
CONTRAINDICATIONS Gentamicin sulfate ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.
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. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Gentamicin Sulfate used for?
Gentamicin Sulfate contains GENTAMICIN SULFATE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Gentamicin Sulfate a controlled substance?
Gentamicin Sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Gentamicin Sulfate?
The generic name for Gentamicin Sulfate is GENTAMICIN SULFATE. There are 4 other brand versions of GENTAMICIN SULFATE.
What is the NDC code for Gentamicin Sulfate 40 mg/mL?
The NDC (National Drug Code) for Gentamicin Sulfate 40 mg/mL is 71872-7337, listed by Medical Purchasing Solutions, LLC.