Gentamicin Sulfate in Sodium Chloride Dailymed

Precautions

General

Prescribing Gentamicin Sulfate in 0.9% Sodium Chloride Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Do not use additives or premix with other drugs. See DOSAGE AND ADMINISTRATION.

Neurotoxic and nephrotoxic antibiotics may be almost completely absorbed from body surfaces (except the urinary bladder) after local irrigation and after topical application during surgical procedures. The potential toxic effects of antibiotics administered in this fashion (neuromuscular blockade, respiratory paralysis, oto- and nephrotoxicity) should be considered (see boxed WARNINGS).

Aminoglycosides should be used with caution in patients with neuromuscular disorders such as myasthenia gravis or parkinsonism, since these drugs may aggravate muscle weakness because of their potential curare-like effects on the neuromuscular junction. During or following gentamicin therapy, paresthesias, tetany, positive Chvostek and Trousseau signs and mental confusion have been described in patients with hypomagnesemia, hypocalcemia and hypokalemia. When this has occurred in infants, tetany and muscle weakness has been described. Both adults and infants required appropriate corrective electrolyte therapy (see PRECAUTIONS, Pediatric Use section).

A Fanconi-like syndrome, with aminoaciduria and metabolic acidosis has been reported in some adults and infants being given gentamicin injections.

Cross allergenicity among aminoglycosides has been demonstrated.

Patients should be well hydrated during treatment.

Treatment with gentamicin may result in overgrowth of nonsusceptible organisms. If this occurs, appropriate therapy is indicated.

See boxed WARNINGS regarding concurrent use of potent diuretics and regarding concurrent and/or sequential use of other neurotoxic and/or nephrotoxic antibiotics, and for other essential information (see also PRECAUTIONS, Drug Interactions section).

Information for Patients

Patients should be counseled that antibacterial drugs including Gentamicin Sulfate in 0.9% Sodium Chloride Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Gentamicin Sulfate in 0.9% Sodium Chloride Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Gentamicin Sulfate in 0.9% Sodium Chloride Injection or other antibacterial drugs in the future.

Laboratory Tests

Laboratory abnormalities possibly related to gentamicin include: increased levels of serum transaminase (SGOT, SGPT), serum LDH and billirubin; decreased serum calcium, magnesium, sodium and potassium; anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts and thrombocytopenia. While clinical laboratory test abnormalities may be isolated findings, they may also be associated with clinically related signs and symptoms. For example, tetany and muscle weakness may be associated with hypomagnesemia, hypocalcemia, and hypokalemia.

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, coulin, 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 transfusions of citrate-anticoagulated blood. If neuromuscular blockade occurs, calcium salts may reverse it.

Although the in vitro mixing of gentamicin and carbenicillin results in a rapid and significant inactivation of gentamicin, this interaction has not been demonstrated in patients with normal renal function who received both drugs by different routes of administration. A reduction in gentamicin serum half-life has been reported in patients with severe renal impairment receiving carbenicillin concomitantly with gentamicin.

Probenecid does not affect renal tubular transport of gentamicin.

Pregnancy

See WARNINGS section.

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.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from gentamicin, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.

During or following gentamicin therapy, paresthesias, tetany, positive Chvostek and Trousseau signs and mental confusion have been described in patients with hypomagnesemia, hypocalcemia and hypokalemia. When this has occurred in infants, tetany and muscle weakness have been described. Both adults and infants required appropriate corrective electrolyte therapy.

A Fanconi-like syndrome, with aminoaciduria and metabolic acidosis has been reported in some adults and infants being given gentamicin injections.

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine. A creatinine clearance determination may be more useful. Monitoring of renal function during treatment with gentamicin, as with other aminoglycosides, is particularly important in such patients.

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 reactions is low in patients with normal renal function who do not receive gentamicin sulfate at higher doses or for longer periods of time than recommended.

Other reported adverse reactions possibly related to gentamicin include: respiratory depression, lethargy, confusion, depression, visual disturbances, decreased appetite, weight loss, hypotension and hypertension; rash, itching, urticaria, generalized burning, laryngeal edema, anaphylactoid reactions, fever, and headache; nausea, vomiting, increased salivation, and stomatitis; purpura, pseudotumor cerebri, acute organic brain syndrome, pulmonary fibrosis, alopecia, joint pain, transient hepatomegaly, and splenomegaly.

Laboratory abnormalities possibly related to gentamicin include: increased levels of serum transaminase (SGOT, SGPT), serum LDH and bilirubin; decreased serum calcium, magnesium, sodium and potassium; anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts and thrombocytopenia. While clinical laboratory test abnormalities may be isolated findings, they may also be associated with clinically related signs and symptoms. For example, tetany and muscle weakness may be associated with hypomagnesemia, hypocalcemia, and hypokalemia.

While local tolerance of gentamicin sulfate is generally excellent, there has been an occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis suggesting local irritation has been reported rarely.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Overdosage

In the event of overdosage or toxic reactions, hemodialysis may aid in the removal of gentamicin from the blood, and is especially important if renal function is, or becomes compromised. The rate of removal of gentamicin is considerably lower by peritoneal dialysis than it is by hemodialysis.

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 following cessation of infusion) is expected to be in the range of 4 to 6 mcg/mL. When monitoring peak concentrations, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided. When monitoring trough concentrations (just prior to the next dose), dosage should be adjusted so that levels above 2 mcg/mL are avoided. Determination of the adequacy of a serum level for a particular patient must take into consideration the susceptibility of the causative organism, the severity of the infection, and the status of the patient’s host-defense mechanisms.

In patients with extensive burns, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. In such patients treated with gentamicin, measurement of serum concentrations is recommended as a basis for dosage adjustment.

Table 3: Dosage Schedule Guide for Adults With Normal Renal Function (Dosage at Eight-Hour Intervals)

Patient’sWeightThe dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass.		Usual Dose for Serious Infections 1 mg/kg q8h (3 mg/kg/day)	Dose for Life-Threatening Infections (Reduce as Soon as Clinically Indicated) 1.7 mg/kg q8hFor q6h schedules, dosage should be recalculated. (5 mg/kg/day)
kg	(lb)
		mg/dose q8h	mg/dose q8h
40	( 88)	40	66
45	( 99)	45	75
50	(110)	50	83
55	(121)	55	91
60	(132)	60	100
65	(143)	65	108
70	(154)	70	116
75	(165)	75	125
80	(176)	80	133
85	(187)	85	141
90	(198)	90	150
95	(209)	95	158
100	(220)	100	166

Children: 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every eight hours).

Infants and Neonates: 7.5 mg/kg/day (2.5 mg/kg administered every eight hours).

Premature or Full-Term Neonates One Week of Age or Less: 5 mg/kg/day (2.5 mg/kg administered every 12 hours).

NOTE: For further information concerning the use of gentamicin in infants and children, see Pediatric Gentamicin Sulfate Injection product information.

The usual duration of treatment for all patients is seven to ten days. In difficult and complicated infections, a longer course of therapy may be necessary. In such cases monitoring of renal, auditory, and vestibular functions is recommended, since toxicity is more apt to occur with treatment extended for more than ten days. Dosage should be reduced if clinically indicated.

For Intravenous Administration

The intravenous administration of gentamicin may be particularly useful for treating patients with bacterial septicemia or those in shock. It may also be the preferred route of administration for some patients with congestive heart failure, hematologic disorders, severe burns, or those with reduced muscle mass. For intermittent intravenous administration in adults, a single dose of Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be administered according to individual patient requirements from the appropriate premixed container. The solution may be infused over a period of one-half to two hours.

Gentamicin Sulfate Injection should not be physically premixed with other drugs, but should be administered separately in accordance with the recommended route of administration and dosage schedule.

Patients with Impaired Renal Function

Dosage must be adjusted in patients with impaired renal function to assure therapeutically adequate, but not excessive blood levels. Whenever possible, serum concentrations of gentamicin should be monitored. One method of dosage adjustment is to increase the interval between administration of the usual doses. Since the serum creatinine concentration has a high correlation with the serum half-life of gentamicin, this laboratory test may provide guidance for adjustment of the interval between doses. The interval between doses (in hours) may be approximated by multiplying the serum creatinine level (mg/100 mL) by 8. For example, a patient weighing 60 kg with a serum creatinine level of 2 mg/100 mL could be given 60 mg (1 mg/kg) every 16 hours (2 x 8).

In patients with serious systemic infections and renal impairment, it may be desirable to administer the antibiotic more frequently but in reduced dosage. In such patients, serum concentrations of gentamicin should be measured so that adequate, but not excessive levels result. A peak and trough concentration measured intermittently during therapy will provide optimal guidance for adjusting dosage. After the usual initial dose, a rough guide for determining reduced dosage at eight-hour intervals is to divide the normally recommended dose by the serum creatinine level (Table 4). For example, after an initial dose of 60 mg (1 mg/kg), a patient weighing 60 kg with a serum creatinine level of 2 mg/100 mL could be given 30 mg every eight hours (60 ÷ 2). It should be noted that the status of renal function may be changing over the course of the infectious process.

It is important to recognize that deteriorating renal function may require a greater reduction of dosage than that specified in the above guidelines for patients with stable renal impairment.

This container system may be inappropriate for the dosage requirements of children, infants, and neonates. Other dosage forms may be more appropriate.

Table 4: Dosage Adjustment Guide For Patients With Renal Impairment (Dosage at Eight-Hour Intervals After the Usual Initial Dose)

SerumCreatinine(mg %)	Approximate CreatinineClearance (mL/min/1.73 m2	Percent of Usual DosesShown in Table 3
≤1	>100	100
1.1 - 1.3	70 - 100	80
1.4 - 1.6	55 - 70	65
1.7 - 1.9	45 - 55	55
2 - 2.2	40 - 45	50
2.3 - 2.5	35 - 40	40
2.6 - 3	30 - 35	35
3.1 - 3.5	25 - 30	30
3.6 - 4	20 - 25	25
4.1 - 5.1	15 - 20	20
5.2 - 6.6	10 - 15	15
6.7 - 8	<10	10

In adults with renal failure undergoing hemodialysis, the amount of gentamicin removed from the blood may vary depending upon several factors including the dialysis method used. An eight hour hemodialysis may reduce serum concentrations of gentamicin by approximately 50%. The recommended dosage at the end of each dialysis period is 1 to 1.7 mg/kg depending upon the severity of infection.

In children, a dose of 2 mg/kg may be administered.

The above dosage schedules are not intended as rigid recommendations but are provided as guides to dosage when the measurement of gentamicin serum levels is not feasible.

A variety of methods are available to measure gentamicin concentrations in body fluids; these include microbiologic, enzymatic and radioimmunoassay techniques.

Gentamicin Sulfate in 0.9% Sodium Chloride Injection is a ready-to-use isotonic solution. No dilution or buffering is required.

If the prescribed dose is exactly 60, 80, or 100 mg use the appropriate container. If the prescribed dose is higher or lower than that of the supplied container adjustments can be made. If the dose is higher than the contents of a 100 mg container the additional amount should be removed from a container of gentamicin sulfate (60 mg/mL) and added to the 100 mg container. If the prescribed dose is less than that contained in a supplied container, use the container with the dose closest to (but above) the prescribed dose, removing and discarding an appropriate amount from it.

Do not use plastic containers in series connection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if solution is clear and container and seals are intact.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Instructions for the Administration of Gentamicin Sulfate in 0.9% Sodium Chloride Injection.

This product is intended for use only as an IV secondary medication unit.

Use aseptic technique when removing contents from these units.

Do not add other drugs to Gentamicin Sulfate in 0.9% Sodium Chloride Injection.

All injections in VIAFLEX PLUS plastic containers are intended for intravenous administration using sterile equipment.

Container Label - 60 mg / 50 mL
LOTEXPNDC 0338-0507-41

Gentamicin Sulfate in 0.9% Sodium Chloride Injection

60 mg / 50 mL (1.2 mg / mL)

Cautions For Intravenous Use OnlyMaintain unit in overwrap until ready for use Do not add supplementary medication Each 50 mL contains Gentamicin SulfateUSP (equivalent to 60 mg gentamicin)450 mg Sodium Chloride USPpH may have been adjusted with sodium hydroxide or sulfuric acidSee prescribing information for dosingStore at room temperature (25°C)Avoid excessive heat Sterile Single dose container Rx Only

Baxter Logo Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in USA

2B0851
Container Label - 80 mg / 50 mL
LOTEXPNDC 0338-0509-41

Gentamicin Sulfatein 0.9% Sodium ChlorideInjection

80 mg / 50 mL (1.6 mg / mL)

Cautions For Intravenous Use OnlyMaintain unit in overwrap until ready for use Do not add supplementary medication Each 50 mL contains Gentamicin SulfateUSP (equivalent to 80 mg gentamicin)450 mg Sodium Chloride USPpH may havebeen adjusted with sodium hydroxide or sulfuric acidSee prescribing information for dosingStore at room temperature(25°C)Avoid excessive heatSterile Single dose container Rx Only

Baxter Logo Baxter Healthcare CorporationDeerfield IL 60015 USA Made in USA

2B0852
Container Label Code - 100 mg / 100 mL
LOT EXPNDC 0338-0505-48

Gentamicin Sulfatein 0.9% Sodium Chloride Injection

100 mg / 100 mL (1 mg / mL)

Cautions For Intravenous Use OnlyMaintain unit in overwrap until readyfor use Do not add supplementarymedication Each 100 mL contains GentamicinSulfate USP (equivalent to 100 mgGentamicin) 900 mg Sodium ChlorideUSP pH may have been adjusted withsodium hydroxide or sulfuric acidSee prescribing information for dosingStore at room temperature (25°C)Avoid excessive heat Sterile Single Dose ContainerRx Only

Baxter Logo Baxter Healthcare CorporationDeerfield IL 60015 USA Made in USA

2B0863
Container Label Code - 100 mg / 50 mL
LOT EXPNDC 0338-0511-41

Gentamicin Sulfate in 0.9% Sodium Chloride Injection

100 mg / 50 mL (2 mg / mL)

Cautions For Intravenous Use OnlyMaintain unit in overwrap until ready foruse Do not add supplementary medication Each 50 mL contains Gentamicin SulfateUSP (equivalent to 100 mg gentamicin)450 mg Sodium Chloride USPpH may have been adjusted with sodiumhydroxide or sulfuric acidSee prescribing information for dosingStore at room temperature (25°C)Avoid excessive heat Sterile Single dose container Rx Only

Baxter Logo Baxter Healthcare CorporationDeerfield IL 60015 USA

2B0853
Container Label Code - 80 mg / 100 mL
LOT EXPNDC 0338-0503-48

Gentamicin Sulfatein 0.9% Sodium ChlorideInjection

80 mg / 100 mL (0.8 mg / mL)

Cautions For Intravenous Use OnlyMaintain unit in overwrap until readyfor use Do not add supplementarymedication Each 100 mL contains GentamicinSulfate USP (equivalent to 80 mggentamicin) 900 mg Sodium ChlorideUSP pH may have been adjusted withsodium hydroxide or sulfuric acidSee prescribing information for dosingStore at room temperature (25°C)Avoid excessive heat Sterile Single Dose ContainerRx Only

Baxter Logo Baxter Healthcare CorporationDeerfield IL 60015 USA MADE IN USA

2B0862
Container Label
LOT EXP

NDC 0338-0507-48

Gentamicin Sulfate in 0.9% Sodium Chloride Injection

120 mg / 100 mL (1.2 mg / mL)

CAUTIONS FOR INTRAVENOUS USE ONLYMAINTAIN UNIT IN OVERWRAP UNTIL READY FOR USE DO NOT ADD SUPPLEMENTARY MEDICATION

EACH 100 mL CONTAINS GEN TAMICIN SULFATE USP (EQUIVALEN T TO 120 mg GENTAMICIN) 900 mg SODIUM CHLORIDE USP pH MAY HAVE BEEN ADJUSTED WITH SODIUM HYDROXIDE OR SULFURIC ACIDSEE PRESCRIBING INFORMATION FOR DOSINGSTORE AT ROOM TEMPE RATURE (25°C)AVOID EXCE SSIVE HEAT STERILE SINGLE DOSE CONTAINERRx ONLY

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