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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (P's) » Pediatric Gentamicin



DESCRIPTION

PEDIATRIC GENTAMICIN SULFATE INJECTION, USP
10 mg/ml (gentamicin sulfate, USP equivalent to 10 mg gentamicin base)

WARNINGS

Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated wi th their use.

As with other aminoglycosides, Pediatric Gentamicin Sulfate 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 Pediatric Gentamicin Sulfate Injection, 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 or casts. Blood urea nitrogen, 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 aminoglycosides, on rare occasions changes in renal and eighth cranial name 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 peak concentrations, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided. When monitoring gentamicin 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 overdosage or toxic reactions, hemodialysis may aid in the removal of gentamicin from the blood, especially if renal function is, or becomes, compromised. The rate of removal of gentamicin is considerably lower by peritoneal dialysis than it is by hemodialysis. In the newborn 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. Another factor which may increase patient risk of toxicity is dehydration. 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.


Gentamicin sulfate, USP, a water-soluble antibiotic of the aminoglycoside group, is derived from Micromonospora purpurea, an actinomycete. Pediatric Gentamicin Sulfate Injection is a sterile, aqueous solution intended for intramuscular or intravenous administration. Each mL contains gentamicin sulfate, USP equivalent to 10 mg gentamicin base, methylparaben 1.3 mg, propylparaben 0.2 mg, sodium metabisulfite 3.2 mg and edetate disodium 0.1 mg in Water for Injection. pH 3.0-5.5; sodium hydroxide and/or sulfuric acid added, if needed, for PH adjustment. Sealed under nitrogen.





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