Reference ID:3466754 Fonts: Fonts: 8/14/13–hc–R–Indd4 42626G No. 450012196–Job P.O. LLC USA, Kabi Fresenius M01 Form A2 CrossTech–72325–Proof Z m Helvetica Neue (A) Neue Helvetica Typesmiths Pi Font Pi Typesmiths (A) Helvetica Single 2 Must For Gentamicin 1 mL mg/2 20 (PEDI INJECTION, GEN NDC 0 mg/m mL IM 63323 be Dose A or TRIC diluted T L IV - AMICIN 1 Use equivalent Via 73-02 ) BLACK l . for US IV P Rx only use 1 730 . 2 Sterile, Nonpyrogenic Preservative Free Discard unused portion. Each mL contains: Gentamicin sulfate equivalent to 10 mg gentamicin; Water for Injection q.s. Sodium hydroxide 18AB and/or sulfuric acid may have Z been added for pH adjustment. 185C Usual Dosage: See insert. Warning: Patients treated with gentamicin sulfate and other aminoglycosides should be under close clinical observation because of the potential toxicity. See Warnings and Precautions in the insert. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 25 Vials This container closure is not made with natural rubber latex. 283C Fresenius Kabi USA, LLC Lake Zurich, IL 60047 42626G Z 18A NDC 63323-010-02 1002 C GENTAMICIN INJECTION, USP 896F 1 80 mg/2 mL 0 7 40 mg/mL Gentamicin equivalent 4 FPO For IM or IV Use. 6004 Must be diluted for IV use. Z 2 mL Multiple Dose Vial Z Lake Zurich, IL Fresenius Kabi USA, LL Sterile Rx only LOT/EXP Z BLACK 431C m CrossTech–72322–Proof A2 Form M01 Fresenius Kabi USA, LLC P.O. 4500121296–Job No. 401896F 8/14/13–hc–Indd4 Fonts: Helvetica Neue (A) Helvetica (A) Typesmiths Pi Font Reference ID: 3466754 18AB NDC 63323-010-02 1002 . g C m GENTAMICIN .1 sulfate sulfate ture] h ; n INJECTION, USP amino- r Injection or sulfuric r / pera . 80 mg/2 mL . and e under close 7 e because of the gentamicin n 40 mg/mL g See Warnings and . Gentamicin equivalent 6004 been added for pH paraben and 0.2 mg e in the insert . For IM or IV Use. s Must be diluted for IV use. Patients treated wit sodium metabisulfite; 0 Z g Z Controlled Room Tem 2 mL Rx only .8 mg methyl 42625F Lake Zurich, IL Fresenius Kabi USA, LL Multiple Dose Vial Sterile Each mL contains: Gentamici m 40 to equivalent 1 propylparaben as preservatives; 3.2 m disodium edetate; Water fo q.s. Sodium hydroxid acid may hav adjustment Usual Dosage: See insert Warning: gentamicin sulfate and othe glycosides should b clinical observatio potential toxicity Precaution Store at 20° to 25°C (68° 77°F) [see USP This container closure is not made with natural rubber latex. 25 Vials Z BLACK 431C m CrossTech–72324–Proof A2 Form M01 Fresenius Kabi USA, LLC P.O. 4500121296–Job No. 42625F 8/14/13–hc–R–Indd4 Fonts: Helvetica Neue (A) Helvetica (A) Typesmiths Pi Font Reference ID: 3466754 18K . NDC 63323-010-20 1020 m y h C GENTAMICIN n INJECTION, USP gentamicin; . g mgdisodium Temperature] .1 and 0.2 mg m n (68° to 77°F) 800 mg/20 mL C 7 897F 40 mg/mL 1 orsulfuric acid ma the insert 0 / Gentamicin equivalent 6004 4 trolled Roo trolled in For IM or IV Use. Patients treated wit toxicity.See Warnings and Con Z Z l Water forInjection q.s.Sodiu Must be diluted for IV use. ; observation because of the e Rx only ropylparabenpreservatives;as 3.2mg .8mg methylparabe Sterile Each mL contains: Gentamicisulfateequivalent m 40to 1 p sodiummetabisulfite; 0 edetate hydroxideand havebeen added for pH adjustment UsualDosage: See insert Warning: gentamicin sulfate aminoglycosides and othershould be under clos potentia Precautions Store at 20° to 25° USP [see This container closurewith is not natural made rubber latex. Lake Zurich, IL LOT/EXP 20 mL Multiple Dose Vial Fresenius Kabi USA, LL Z BLACK 270C m CrossTech–72323–Proof A3 Form M01 Fresenius Kabi USA, LLC P.O. No. 4500121296–Job No. 401897F 8/14/13–hc–O–Indd4 Fonts: Helvetica Neue (A) Helvetica (A) Typesmiths Pi Font Reference ID: 3466754 18K . NDC 63323-010-20 1020 m y h C GENTAMICIN n INJECTION, USP gentamicin; . g mgdisodium Temperature] .1 and 0.2 mg m n (68° to 77°F) 800 mg/20 mL C 7 897F 40 mg/mL 1 orsulfuric acid ma the insert 0 / Gentamicin equivalent 6004 4 trolled Roo trolled in For IM or IV Use. Patients treated wit toxicity.See Warnings and Con Z Z l Water forInjection q.s.Sodiu Must be diluted for IV use. ; observation because of the e Rx only ropylparabenpreservatives;as 3.2mg .8mg methylparabe Sterile Each mL contains: Gentamicisulfateequivalent m 40to 1 p sodiummetabisulfite; 0 edetate hydroxideand havebeen added for pH adjustment UsualDosage: See insert Warning: gentamicin sulfate aminoglycosides and othershould be under clos potentia Precautions Store at 20° to 25° USP [see This container closurewith is not natural made rubber latex. Lake Zurich, IL LOT/EXP 20 mL Multiple Dose Vial Fresenius Kabi USA, LL Z BLACK 270C m CrossTech–72323–Proof A3 Form M01 Fresenius Kabi USA, LLC P.O. No. 4500121296–Job No. 401897F 8/14/13–hc–O–Indd4 Fonts: Helvetica Neue (A) Helvetica (A) Typesmiths Pi Font Reference ID: 3466754 5AV BOXED WARNINGS CLINICAL PHARMACOLOGY: noglycoside may be resistant to one or more other in body sites where the drug is physiologically con- when penicillins or other less potentially toxic After intramuscular (IM) administration of gentamicin aminoglycosides. The following bacteria are usually centrated. This category also provides a buffer zone drugs are contraindicated and bacterial sus- Patients treated with aminoglycosides should sulfate, peak serum concentrations usually occur resistant to the aminoglycosides, including gentami- that prevents small uncontrolled technical factors ceptibility tests and clinical judgment indicate its be under close clinical observation because between 30 and 60 minutes and serum levels are cin: most streptococcal species (including Strepto- from causing major discrepancies in interpretation. use. It may also be considered in mixed infec- of the potential toxicity associated with their measurable for six to eight hours. When gentamicin coccus pneumoniae and the Group D streptococci), A report of “Resistant” indicates that the antimicrobial tions caused by susceptible strains of staphylo- use. is administered by intravenous (IV) infusion over a most enterococcal species (including Enterococcus is not likely to inhibit growth of the pathogen if the cocci and gram-negative organisms. As with other aminoglycosides, gentamicin two-hour period, the serum concentrations are faecalis, E. faecium, and E. durans), and anaerobic antimicrobial compound reaches the concentrations In the neonate with suspected bacterial sepsis injection is potentially nephrotoxic. The risk similar to those obtained by IM administration. organisms, such as Bacteroides species and Clos- usually achievable at the infection site; other therapy or staphylococcal pneumonia, a penicillin-type of nephrotoxicity is greater in patients with In patients with normal renal function, peak serum tridium species. should be selected. drug is also usually indicated as concomitant impaired renal function and in those who concentrations of gentamicin (mcg/mL) are usu- Aminoglycosides are known to be not effective Quality Control therapy with gentamicin. receive high dosage of prolonged therapy. ally up to four times the single IM dose (mg/kg); against Salmonella and Shigella species in patients. Standardized susceptibility test procedures require Neurotoxicity manifested by ototoxicity, both for example, a 1 mg/kg injection in adults may be Therefore, in vitro susceptibility test results should the use of laboratory controls to monitor and ensure CONTRAINDICATIONS: vestibular and auditory, can occur in patients expected to result in a peak serum concentration not be reported. the accuracy and precision of supplies and Hypersensitivity to gentamicin is a contraindication treated with gentamicin, primarily in those up to 4 mcg/mL; a 1.5 mg/kg dose may produce to its use. A history of hypersensitivity or serious Interactions with Other Antimicrobials reagents used in the assay, and the techniques of with pre-existing renal damage and in patients levels up to 6 mcg/mL. While some variation is to the individuals performing the test.1,2,3 Standard toxic reactions to other aminoglycosides may con- with normal renal function treated with higher be expected due to a number of variables such as In vitro studies show that an aminoglycoside com- traindicate use of gentamicin because of the known bined with an antibiotic that interferes with cell wall gentamicin powder should provide the following doses and/or for longer periods than age, body temperature, surface area and physiologic range of MIC values provided in Table 2. For the dif- cross-sensitivity of patients to drugs in this class. recommended. Aminoglycoside-induced differences, the individual patient given the same synthesis may act synergistically against some enterococcal strains. The combination of gentamicin fusion technique using the 10-mcg gentamicin disk ototoxicity is usually irreversible. Other dose tends to have similar levels in repeated deter- the criteria provided in Table 2 should be achieved. WARNINGS: manifestations of neurotoxicity may include minations. Gentamicin administered at 1 mg/kg and penicillin G has a synergistic bactericidal effect (See BOXED WARNINGS.) numbness, skin tingling, muscle twitching every eight hours for the usual 7 to 10 day treat- against strains of Enterococcus faecalis, E. faecium Table 2: Acceptable Quality Control Ranges Contains sodium metabisulfite, a sulfite that may and convulsions. ment period to patients with normal renal func- and E. durans. An enhanced killing effect against for Susceptibility Testing cause allergic-type reactions including anaphy- Renal and eighth cranial nerve function tion does not accumulate in the serum.