Gentamicin 40 mg/mL
GENTAMICIN SULFATE · INJECTION, SOLUTION · Medical Purchasing Solutions, LLC
Gentamicin is a injection, solution containing gentamicin sulfate at 40 mg/mL, taken intramuscular. Manufactured by Medical Purchasing Solutions, LLC.
Key Facts
- Brand Name
- Gentamicin
- Generic Name
- GENTAMICIN SULFATE
- NDC Code (Product)
71872-7311- Manufacturer
- Medical Purchasing Solutions, LLC
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA062366
- Marketing Start
- 08/10/2000
Recall History
H J Harkins Company Inc dba Pharma Pac
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Walgreens Infusion Services
Lack of Assurance of Sterility
Pallimed Solutions
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Lack of Assurance of Sterility
Fresenius Kabi USA, LLC
Defective Container: Vials may be missing stoppers.
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
KRS Global Biotechnology, Inc
Lack of Assurance of Sterility
Hospira Inc.
Presence of Particulate Matter: visible particles were identified floating in the primary container.
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: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP 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 Injection, USP 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 injection to be effective in bacterial neonatal sepsis; bacterial septicemia and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tr…
Dosage & Administration
DOSAGE AND ADMINISTRATION: Gentamicin injection may be given IM or IV. 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 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. This 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 after IM injection) is expected to be in the range of 4 to 6 mcg/mL.…
Warnings
WARNINGS: (See BOXED WARNINGS .) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. 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 whil…
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 the known cross-sensitivity of patients to drugs in this class.
Adverse Reactions
ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Nephrotoxicity Adverse renal effects, as demonstrated by the presence of casts, cells or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients with a history of renal impairment (especially if dialysis is required) and in patients treated for longer periods or with larger doses than recommended. Neurotoxicity Serious adverse effects on both vestibular and auditory branches of the eighth 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 diminution of 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 encephalo…
Frequently Asked Questions
What is Gentamicin used for?
Gentamicin contains GENTAMICIN SULFATE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Gentamicin a controlled substance?
Gentamicin is not classified as a controlled substance by the DEA.
What is the generic name for Gentamicin?
The generic name for Gentamicin is GENTAMICIN SULFATE. There are 12 other brand versions of GENTAMICIN SULFATE.
What is the NDC code for Gentamicin 40 mg/mL?
The NDC (National Drug Code) for Gentamicin 40 mg/mL is 71872-7311, listed by Medical Purchasing Solutions, LLC.
Other Gentamicin Brands
See all →- Gentak3 mg/g63187-873
- Gentamicin Sulfate3 mg/mL66267-971
- Gentamicin Sulfate40 mg/mL0404-9865
- Gentamicin Sulfate1 mg/g45802-046
- Gentamicin Sulfate3 mg/mL61314-633
- Gentamicin Sulfate3 mg/mL68788-8592
- Gentamicin Sulfate40 mg/mL55154-2392
- Gentamicin Sulfate in Sodium Chloride60 mg/50mL0338-0507
- Gentamicin Sulfate in Sodium Chloride100 mg/50mL0338-0511
- Gentamicin Sulfate3 mg/mL76420-254
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)