"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Injection, USP (Pediatric)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP (gentamicin injection pediatric) and other antibacterial drugs, Gentamicin Injection, USP (gentamicin injection pediatric) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use.
As with other aminoglycosides, Gentamicin (gentamicin injection pediatric) Injection is potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage or prolonged therapy.
Neurotoxicity manifested by ototoxicity, both vestibular and auditory, can occur in patients treated with gentamicin (gentamicin injection pediatric) , primarily in those with pre-existing renal damage and in patients with normal renal function treated with higher doses and/or for longer periods than recommended. Aminoglycoside-induced ototoxicity is usually irreversible. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
Renal and eighth cranial nerve function should be closely monitored, especially in patients with known or suspected reduced renal function at onset of therapy, and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Urine should be examined for decreased specific gravity, increased excretion of protein, and the presence of cells Blood urea nitrogen (BUN), serum creatinine, or creatinine clearance should be determined periodically. When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears or hearing loss) or nephrotoxicity requires dosage adjustment or discontinuance of the drug. As with the other amino glycosides, on rare occasions changes in renal and eighth cranial nerve function may not become manifest until soon after completion of therapy.
Serum concentrations of aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. When monitoring gentamicin (gentamicin injection pediatric) peak concentrations, dosage should be adjusted so that prolonged levels above 12mcg/mL are avoided.
When monitoring gentamicin (gentamicin injection pediatric) trough concentrations,dosage should be adjusted so that levels above 2 mcg/mL are avoided. Excessive peak and/or trough serum concentrations of aminoglycosides may increase the risk of renal and eighth cranial nerve toxicity. In the event of overdose or toxic reactions, hemodialysis may aid in the removal of gentamicin (gentamicin injection pediatric) from the blood, especially if renal function is, or becomes, compromised. The rate of removal of gentamicin (gentamicin injection pediatric) is considerably less by peritoneal dialysis than by hemodialysis.
In the new born infant, exchange transfusions may also be considered.
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. Other factors which may increase patient risk of toxicity are advanced age and dehydration.
The concurrent use of gentamicin (gentamicin injection pediatric) 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.
Aminoglycosides can cause fetal harm when administered to a pregnant woman (see WARNINGS section).
Gentamicin (gentamicin injection pediatric) sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from Micromonospora purpurea, an actinomycete.
It has the following structural formula:
Gentamicin (gentamicin injection pediatric) Injection is a sterile, nonpyrogenic, aqueous solution for parenteral administration and is available both with and without preservatives.
Each mL of the preservative free product contains: Gentamicin (gentamicin injection pediatric) sulfate, equivalent to gentamicin (gentamicin injection pediatric) 10 mg; Water for Injection q.s.Sulfuric acid and/or sodium hydroxide may have been added for pH adjustment (3-5.5).
Each mL of the preserved product contains: Gentamicin (gentamicin injection pediatric) sulfate equivalent to gentamicin (gentamicin injection pediatric) 10mg; methylparaben 1.3 mg and propylparaben 0.2 mg as preservatives; sodium metabisulfite 3.2 mg; edetate disodium 0.1mg; Water for Injection q.s. Sulfuric acid and/or sodium hydroxide may have been added for pH adjustment (3.0 to 5.5).
Last reviewed on RxList: 6/24/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Gentamicin Pediatric Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.