Drugplain

Gentamicin Sulfate in Sodium Chloride 100 mg/100mL

Gentamicin Sulfate · INJECTION, SOLUTION · Baxter Healthcare Corporation

No Recall History
Plain English

Gentamicin Sulfate is an antibiotic injection used to treat serious bacterial infections in the body. It works by killing bacteria and is administered intravenously in a hospital or clinical setting.

Key Facts

Brand Name
Gentamicin Sulfate in Sodium Chloride
Generic Name
Gentamicin Sulfate
NDC Code (Product)
0338-0505
Manufacturer
Baxter Healthcare Corporation
Strength
100 mg/100mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA062373
Marketing Start
09/07/1982

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective188 reports
acute kidney injury173 reports
off label use159 reports
drug hypersensitivity153 reports
pyrexia138 reports
rash113 reports
nausea106 reports
renal failure acute105 reports
renal failure98 reports
pneumonia96 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Gentamicin Sulfate in 0.9% Sodium Chloride Injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa , Proteus species (indole-positive and indole-negative), Escherichia coli , Klebsiella-Enterobacter- Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown gentamicin sulfate to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central…

Dosage & Administration

DOSAGE AND ADMINISTRATION Gentamicin Sulfate in 0.9% Sodium Chloride Injection is for intravenous use only . The patient’s pretreatment body weight should be obtained for calculation of correct dosage. The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. It is desirable to limit the duration of treatment with aminoglycosides to short term. Patients with Normal Renal Function Adults: The recommended dosage of Gentamicin Sulfate in 0.9% Sodium Chloride Injection for patients with serious infections and normal renal function is 3 mg/kg/day administered in three equal doses every eight hours (Table 3). For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses. The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated (Table 3). It is desirable to measure both peak and trough serum concentrations of gentamicin to determine the adequacy and safety of the dosage. When such measurements are feasible, they should be carried out periodically during therapy to assure adequate but not excessive drug levels. For example, the peak concentration (at 30 to 60 minutes f…

Warnings

WARNINGS (See boxed WARNINGS .) Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta, and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Serious side effects to mother, fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides. Animal reproduction studies conducted on rats and rabbits did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate. It is not known whether gentamicin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. If gentamicin is used during pregnancy or if the patient becomes pregnant while taking gentamicin, she should be apprised of the potential hazard to the fetus. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention. Risk of Ototoxicity Due to Mitochondrial DNA Variants Cases of ototoxicity with amin…

Contraindications

CONTRAINDICATIONS Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of known cross-sensitivity of patients to drugs in this class.

Drug Interactions

Drug Interactions The concurrent use of gentamicin with potent diuretics, such as ethacrynic acid or furosemide, should be avoided, since certain diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering the antibiotic concentration in serum and tissue. Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs such as cisplatin, cephaloridine, kanamycin, amikacin, neomycin, polymyxin B, colistin, paromomycin, streptomycin, tobramycin, vancomycin, and viomycin, should be avoided. Increased nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporins. Neuromuscular blockade and respiratory paralysis have been reported in the cat receiving high doses (40 mg/kg) of gentamicin. The possibility of these phenomena occurring in man should be considered if aminoglycosides are administered by any route to patients receiving anesthetics, or to patients receiving neuro-muscular blocking agents, such as succinylcholine, tubocurarine, or decamethonium, or in patients receiving massive transfusion…

Adverse Reactions

ADVERSE REACTIONS Nephrotoxicity - Adverse renal effects, as demonstrated by the presence of casts, cells, or protein in the urine or by rising BUN, NPN, serum creatinine and oliguria, have been reported. They occur more frequently in patients with a history of renal impairment and in patients treated for longer periods or with larger dosages than recommended. Neurotoxicity - Serious adverse effects on both vestibular and auditory branches of the eighth cranial nerve have been reported, primarily in patients with renal impairment (especially if hemodialysis is required) and in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and also hearing loss, which, as with the other aminoglycosides, may be irreversible. Hearing loss is usually manifested initially by diminishing high-tone acuity. Other factors which may increase the risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic drugs. Peripheral neuropathy or encephalopathy, including numbness, skin tingling, muscle twitching, convulsions, and a myasthenia gravis-like syndrome, have been reported. Note : This risk of toxic react…

Frequently Asked Questions

What is Gentamicin Sulfate in Sodium Chloride used for?

Gentamicin Sulfate is an antibiotic injection used to treat serious bacterial infections in the body. It works by killing bacteria and is administered intravenously in a hospital or clinical setting.

Is Gentamicin Sulfate in Sodium Chloride a controlled substance?

Gentamicin Sulfate in Sodium Chloride is not classified as a controlled substance by the DEA.

What is the generic name for Gentamicin Sulfate in Sodium Chloride?

The generic name for Gentamicin Sulfate in Sodium Chloride is Gentamicin Sulfate. There are 10 other brand versions of Gentamicin Sulfate.

What is the NDC code for Gentamicin Sulfate in Sodium Chloride 100 mg/100mL?

The NDC (National Drug Code) for Gentamicin Sulfate in Sodium Chloride 100 mg/100mL is 0338-0505, listed by Baxter Healthcare Corporation.

Product NDC

0338-0505

Package NDC

0338-0505-48

Other Gentamicin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)