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Drug overview for GENTAMICIN-SODIUM CITRATE (gentamicin sulfate/sodium citrate):
Generic name: gentamicin sulfate/sodium citrate
Drug class:
Therapeutic class: Anti-Infective Agents
Citrates (i.e., potassium citrate and citric acid, sodium citrate, sodium Gentamicin is an aminoglycoside antibiotic. citrate and citric acid, tricitrates) are alkalinizing agents.
No enhanced Uses information available for this drug.
Generic name: gentamicin sulfate/sodium citrate
Drug class:
Therapeutic class: Anti-Infective Agents
Citrates (i.e., potassium citrate and citric acid, sodium citrate, sodium Gentamicin is an aminoglycoside antibiotic. citrate and citric acid, tricitrates) are alkalinizing agents.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for GENTAMICIN-SODIUM CITRATE (gentamicin sulfate/sodium citrate) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for GENTAMICIN-SODIUM CITRATE (gentamicin sulfate/sodium citrate):
Dosage of gentamicin sulfate is expressed in terms of gentamicin. IM and IV dosage is identical.
Like other aminoglycosides, dosage of gentamicin should be individualized taking into consideration the patient's pretreatment body weight, renal status, severity of the infection, and susceptibility of the causative organism. The manufacturers state that dosage in obese patients should be based on the patient's estimated lean body weight. Many clinicians recommend that gentamicin dosage be determined using appropriate pharmacokinetic methods for calculating dosage requirements and patient-specific pharmacokinetic parameters (e.g., elimination rate constant, volume of distribution) derived from serum concentration-time data.
Whenever possible, especially in patients with life-threatening infections, suspected toxicity or nonresponse to treatment, decreased or varying renal function, and/or when increased aminoglycoside clearance (e.g., patients with cystic fibrosis, burns) or prolonged therapy is likely, peak and trough serum concentrations of gentamicin should be determined periodically and dosage should be adjusted to maintain desired serum concentrations. (See Dosage and Administration: Dosage, in the Aminoglycosides General Statement 8:12.02.) A causal relationship between maintenance of certain peak or trough serum concentrations or other pharmacodynamic endpoints and clinical response or toxicity has not been established to date for gentamicin dosing regimens. However, for gentamicin administered in conventional dosage regimens (i.e., multiple daily doses), peak serum concentrations of 4-10 mcg/mL and trough concentrations that do not exceed 1-2 mcg/mL have been suggested.
An increased risk of toxicity may be associated with peak serum gentamicin concentrations greater than 10-12 mcg/mL and/or trough concentrations greater than 2 mcg/mL. The manufacturers state that prolonged peak serum concentrations greater than 12 mcg/mL and trough concentrations greater than 2 mcg/mL should be avoided.
Parenteral aminoglycosides historically have been administered in dosage regimens that include multiple daily doses, and current prescribing information for IM or IV gentamicin only includes dosage regimens that involve multiple daily doses (usually 3 or 4 doses daily). However, there is evidence that once-daily+ (single-daily) aminoglycoside dosage regimens are at least as effective as, may provide superior pharmacokinetics, and may be less toxic than conventional dosage regimens employing multiple daily doses of the drugs. Although once-daily gentamicin regimens are recommended for some indications, once-daily gentamicin regimens should not be used in all patients and should not be used for the treatment of enterococcal or staphylococcal endocarditis+.
Additional controlled studies in children, patients with renal dysfunction, and other appropriate patient groups are needed to fully define the optimal use of once-daily aminoglycoside dosing regimens. In addition, the most appropriate methods for optimizing dosage selection for once-daily regimens and monitoring serum aminoglycoside concentrations in patients receiving such regimens have not been clearly established. (See Dosage and Administration: Dosage, in the Aminoglycosides General Statement 8:12.02.)
The usual duration of gentamicin treatment is 7-10 days. In difficult and complicated infections, a longer course of treatment may be necessary. However, toxicity is more likely to occur if treatment is continued for longer than 10 days and renal, auditory, and vestibular functions should be monitored closely.
If IM or IV gentamicin is used for the treatment of serious infections caused by susceptible bacteria in adults with normal renal function, the usual adult dosage recommended by the manufacturers is 3 mg/kg daily given in 3 equally divided doses every 8 hours. For life-threatening infections in adults with normal renal function, the manufacturers state that an IM or IV gentamicin dosage up to 5 mg/kg daily given in 3 or 4 equally divided doses may be used, but dosage should be reduced to 3 mg/kg daily as soon as clinically indicated.
If a once-daily+ gentamicin regimen is used in adults with normal renal function, some clinicians recommend a dosage of 4-5 mg/kg once daily. A once-daily regimen of 5-7 mg/kg once daily also has been recommended. It has been suggested that, if gentamicin is used alone for the treatment of serious infections (e.g., without concomitant use of a beta-lactam), a dosage of 7 mg/kg once daily usually is required.
When IM or IV gentamicin is used in premature or full-term neonates 1 week of age or younger, the manufacturers recommend 2.5 mg/kg every 12 hours. For neonates older than 1 week of age, the manufacturers recommend a dosage of 2.5
mg/kg every 8 hours.
The American Academy of Pediatrics (AAP) recommends that neonates younger than 1 week of age receive IM or IV gentamicin in a dosage of 2.5 mg/kg every 18-24 hours if they weigh less than 1.2 kg or 2.5
mg/kg every 12 hours if they weigh 1.2 kg or more. For neonates 1-4 weeks of age, the AAP recommends a dosage of 2.5
mg/kg every 18-24 hours for those weighing less than 1.2 kg, 2.5 mg/kg every 8 or 12 hours for those weighing 1.2-2
kg, and 2.5 mg/kg every 8 hours for those weighing more than 2 kg. The AAP states that the drug is inappropriate for the treatment of mild to moderate infections.
Once-daily+ gentamicin regimens have been used in neonates. Neonates have received 4-5 mg/kg of gentamicin once daily by IV infusion over 30-60 minutes.
The usual dosage of IM or IV gentamicin recommended by the manufacturers for older infants with normal renal function is 2.5 mg/kg every 8 hours. The manufacturers recommend that children receive gentamicin in a dosage of 2-2.5
mg/kg every 8 hours.
The AAP recommends that pediatric patients beyond the neonatal period receive gentamicin in a dosage of 3-7.5 mg/kg daily given in 3 equally divided doses for the treatment of severe infections. The AAP states that the drug is inappropriate for the treatment of mild to moderate infections.
Once-daily+ gentamicin regimens have been used in infants and children. The AAP states that a gentamicin regimen of 5-6 mg/kg once every 24 hours is investigational in children. In clinical studies, children have received gentamicin in a dosage of 4.5-7.5
mg/kg once daily.
In patients with impaired renal function, doses and/or frequency of administration must be modified in response to serum concentrations of the drug and the degree of renal impairment. There are various methods to determine dosage and a wide variation in dosage recommendations for these patients. However, even when one of these methods is used, peak and trough serum concentrations of the drug should be monitored, especially in patients with changing renal function.
The manufacturers recommend that adults with renal impairment receive an initial dose of 1-1.7 mg/kg. For subsequent therapy, the manufacturers state that 1 mg/kg doses can be given at intervals (in hours) calculated by multiplying the patient's steady-state serum creatinine (in mg/dL) by 8.
Alternatively, many clinicians recommend the dosing method of Sarubbi and Hull, which is based on corrected creatinine clearance. (See Dosage and Administration: Dosage in Renal Impairment, in the Aminoglycosides General Statement 8:12.02.) These dosage calculation methods should not be used in patients undergoing hemodialysis or peritoneal dialysis.
In adults with renal failure undergoing hemodialysis, the manufacturers recommend supplemental doses of 1-1.7 mg/kg at the end of each dialysis period in adults and supplemental doses of 2-2.5 mg/kg at the end of each dialysis period in children.
Some clinicians suggest supplemental doses of 50-75% of the initial loading dose at the end of each dialysis period. Serum gentamicin concentrations should be monitored in dialysis patients and dosage adjusted as needed to maintain desired serum concentrations.
Like other aminoglycosides, dosage of gentamicin should be individualized taking into consideration the patient's pretreatment body weight, renal status, severity of the infection, and susceptibility of the causative organism. The manufacturers state that dosage in obese patients should be based on the patient's estimated lean body weight. Many clinicians recommend that gentamicin dosage be determined using appropriate pharmacokinetic methods for calculating dosage requirements and patient-specific pharmacokinetic parameters (e.g., elimination rate constant, volume of distribution) derived from serum concentration-time data.
Whenever possible, especially in patients with life-threatening infections, suspected toxicity or nonresponse to treatment, decreased or varying renal function, and/or when increased aminoglycoside clearance (e.g., patients with cystic fibrosis, burns) or prolonged therapy is likely, peak and trough serum concentrations of gentamicin should be determined periodically and dosage should be adjusted to maintain desired serum concentrations. (See Dosage and Administration: Dosage, in the Aminoglycosides General Statement 8:12.02.) A causal relationship between maintenance of certain peak or trough serum concentrations or other pharmacodynamic endpoints and clinical response or toxicity has not been established to date for gentamicin dosing regimens. However, for gentamicin administered in conventional dosage regimens (i.e., multiple daily doses), peak serum concentrations of 4-10 mcg/mL and trough concentrations that do not exceed 1-2 mcg/mL have been suggested.
An increased risk of toxicity may be associated with peak serum gentamicin concentrations greater than 10-12 mcg/mL and/or trough concentrations greater than 2 mcg/mL. The manufacturers state that prolonged peak serum concentrations greater than 12 mcg/mL and trough concentrations greater than 2 mcg/mL should be avoided.
Parenteral aminoglycosides historically have been administered in dosage regimens that include multiple daily doses, and current prescribing information for IM or IV gentamicin only includes dosage regimens that involve multiple daily doses (usually 3 or 4 doses daily). However, there is evidence that once-daily+ (single-daily) aminoglycoside dosage regimens are at least as effective as, may provide superior pharmacokinetics, and may be less toxic than conventional dosage regimens employing multiple daily doses of the drugs. Although once-daily gentamicin regimens are recommended for some indications, once-daily gentamicin regimens should not be used in all patients and should not be used for the treatment of enterococcal or staphylococcal endocarditis+.
Additional controlled studies in children, patients with renal dysfunction, and other appropriate patient groups are needed to fully define the optimal use of once-daily aminoglycoside dosing regimens. In addition, the most appropriate methods for optimizing dosage selection for once-daily regimens and monitoring serum aminoglycoside concentrations in patients receiving such regimens have not been clearly established. (See Dosage and Administration: Dosage, in the Aminoglycosides General Statement 8:12.02.)
The usual duration of gentamicin treatment is 7-10 days. In difficult and complicated infections, a longer course of treatment may be necessary. However, toxicity is more likely to occur if treatment is continued for longer than 10 days and renal, auditory, and vestibular functions should be monitored closely.
If IM or IV gentamicin is used for the treatment of serious infections caused by susceptible bacteria in adults with normal renal function, the usual adult dosage recommended by the manufacturers is 3 mg/kg daily given in 3 equally divided doses every 8 hours. For life-threatening infections in adults with normal renal function, the manufacturers state that an IM or IV gentamicin dosage up to 5 mg/kg daily given in 3 or 4 equally divided doses may be used, but dosage should be reduced to 3 mg/kg daily as soon as clinically indicated.
If a once-daily+ gentamicin regimen is used in adults with normal renal function, some clinicians recommend a dosage of 4-5 mg/kg once daily. A once-daily regimen of 5-7 mg/kg once daily also has been recommended. It has been suggested that, if gentamicin is used alone for the treatment of serious infections (e.g., without concomitant use of a beta-lactam), a dosage of 7 mg/kg once daily usually is required.
When IM or IV gentamicin is used in premature or full-term neonates 1 week of age or younger, the manufacturers recommend 2.5 mg/kg every 12 hours. For neonates older than 1 week of age, the manufacturers recommend a dosage of 2.5
mg/kg every 8 hours.
The American Academy of Pediatrics (AAP) recommends that neonates younger than 1 week of age receive IM or IV gentamicin in a dosage of 2.5 mg/kg every 18-24 hours if they weigh less than 1.2 kg or 2.5
mg/kg every 12 hours if they weigh 1.2 kg or more. For neonates 1-4 weeks of age, the AAP recommends a dosage of 2.5
mg/kg every 18-24 hours for those weighing less than 1.2 kg, 2.5 mg/kg every 8 or 12 hours for those weighing 1.2-2
kg, and 2.5 mg/kg every 8 hours for those weighing more than 2 kg. The AAP states that the drug is inappropriate for the treatment of mild to moderate infections.
Once-daily+ gentamicin regimens have been used in neonates. Neonates have received 4-5 mg/kg of gentamicin once daily by IV infusion over 30-60 minutes.
The usual dosage of IM or IV gentamicin recommended by the manufacturers for older infants with normal renal function is 2.5 mg/kg every 8 hours. The manufacturers recommend that children receive gentamicin in a dosage of 2-2.5
mg/kg every 8 hours.
The AAP recommends that pediatric patients beyond the neonatal period receive gentamicin in a dosage of 3-7.5 mg/kg daily given in 3 equally divided doses for the treatment of severe infections. The AAP states that the drug is inappropriate for the treatment of mild to moderate infections.
Once-daily+ gentamicin regimens have been used in infants and children. The AAP states that a gentamicin regimen of 5-6 mg/kg once every 24 hours is investigational in children. In clinical studies, children have received gentamicin in a dosage of 4.5-7.5
mg/kg once daily.
In patients with impaired renal function, doses and/or frequency of administration must be modified in response to serum concentrations of the drug and the degree of renal impairment. There are various methods to determine dosage and a wide variation in dosage recommendations for these patients. However, even when one of these methods is used, peak and trough serum concentrations of the drug should be monitored, especially in patients with changing renal function.
The manufacturers recommend that adults with renal impairment receive an initial dose of 1-1.7 mg/kg. For subsequent therapy, the manufacturers state that 1 mg/kg doses can be given at intervals (in hours) calculated by multiplying the patient's steady-state serum creatinine (in mg/dL) by 8.
Alternatively, many clinicians recommend the dosing method of Sarubbi and Hull, which is based on corrected creatinine clearance. (See Dosage and Administration: Dosage in Renal Impairment, in the Aminoglycosides General Statement 8:12.02.) These dosage calculation methods should not be used in patients undergoing hemodialysis or peritoneal dialysis.
In adults with renal failure undergoing hemodialysis, the manufacturers recommend supplemental doses of 1-1.7 mg/kg at the end of each dialysis period in adults and supplemental doses of 2-2.5 mg/kg at the end of each dialysis period in children.
Some clinicians suggest supplemental doses of 50-75% of the initial loading dose at the end of each dialysis period. Serum gentamicin concentrations should be monitored in dialysis patients and dosage adjusted as needed to maintain desired serum concentrations.
Citrate preparations (i.e., potassium citrate and citric acid, sodium citrate, sodium citrate and citric acid, tricitrates) are administered orally. Oral citrate solutions should be diluted with adequate amounts of water prior to administration to minimize the risk of GI complications, and followed by additional water after administration; palatability may be enhanced by chilling the solution before administration. For reconstitution of potassium citrate and citric acid for oral solution in single-dose packets, the contents of one packet should be mixed thoroughly with at least 180 mL of cool water or juice prior to administration and followed by additional water or juice after administration.
Oral citrate solutions should preferably be taken after meals to avoid the saline laxative effect of the drug. Gentamicin sulfate is administered by IM injection or IV infusion. IV administration may be preferred in patients with septicemia, shock, congestive heart failure, hematologic disorders, severe burns, or reduced muscle mass.
Gentamicin sulfate has been administered intrathecally+ or intraventricularly+ as an adjunct to IM or IV administration of the drug for the treatment of meningitis and other CNS infections. Patients should be well hydrated prior to and during gentamicin therapy since dehydration increases the risk of toxicity. Renal function should be assessed prior to and monitored during gentamicin therapy.
Patients should be under close clinical observation because of the risk of ototoxicity and nephrotoxicity. (See Cautions in the Aminoglycosides General Statement 8:12.02.) Prior to administration, gentamicin solutions should be inspected visually for particulate matter or discoloration.
Oral citrate solutions should preferably be taken after meals to avoid the saline laxative effect of the drug. Gentamicin sulfate is administered by IM injection or IV infusion. IV administration may be preferred in patients with septicemia, shock, congestive heart failure, hematologic disorders, severe burns, or reduced muscle mass.
Gentamicin sulfate has been administered intrathecally+ or intraventricularly+ as an adjunct to IM or IV administration of the drug for the treatment of meningitis and other CNS infections. Patients should be well hydrated prior to and during gentamicin therapy since dehydration increases the risk of toxicity. Renal function should be assessed prior to and monitored during gentamicin therapy.
Patients should be under close clinical observation because of the risk of ototoxicity and nephrotoxicity. (See Cautions in the Aminoglycosides General Statement 8:12.02.) Prior to administration, gentamicin solutions should be inspected visually for particulate matter or discoloration.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for GENTAMICIN-SODIUM CITRATE (gentamicin sulfate/sodium citrate):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Selected Nephrotoxic Agents/Polymyxin B SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Polymyxin B can cause nephrotoxicity with a slight degree of tubular damage. Concurrent administration of other nephrotoxic agents may result in an increased risk of nephrotoxicity.(1) CLINICAL EFFECTS: Concurrent use of polymyxin B with other nephrotoxic agents may result in additive nephrotoxic effects. Polymyxin B nephrotoxicity is characterized by albuminuria, cellular casts, azotemia, diminished urine output, elevated BUN and rising blood levels usually after about 4 days of therapy.(1,2) PREDISPOSING FACTORS: Factors predisposing to nephrotoxicity include higher cumulative doses and longer duration of therapy of polymyxin B and exposure to multiple nephrotoxins.(2) PATIENT MANAGEMENT: Concurrent or sequential use of potentially nephrotoxic agents with polymyxin B should be avoided. If concurrent use is necessary, it should be undertaken with great caution. Check renal function at baseline and monitor renal function and polymyxin B blood levels frequently during therapy.(1) DISCUSSION: Polymyxin B is associated with high rates of nephrotoxicity. Concurrent use with other nephrotoxins may increase the risk of nephrotoxicity. |
POLYMYXIN B SULFATE |
There are 0 moderate interactions.
The following contraindication information is available for GENTAMICIN-SODIUM CITRATE (gentamicin sulfate/sodium citrate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Mt-RNr1 increased risk of aminoglycoside-induced hearing loss |
There are 8 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Dehydration |
| Disorder of the vestibulocochlear nerve |
| Hypocalcemia |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Myasthenia gravis |
| Pregnancy |
| Tinnitus |
| Vertigo |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Parkinsonism |
The following adverse reaction information is available for GENTAMICIN-SODIUM CITRATE (gentamicin sulfate/sodium citrate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 25 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Auditory neurotoxicity Kidney disease with reduction in glomerular filtration rate (GFr) Nephrotoxicity Ototoxicity |
Allergic dermatitis Angioedema Erythema Pruritus of skin Skin rash |
| Rare/Very Rare |
|---|
|
Anaphylaxis Anemia Clostridioides difficile infection Eosinophilia Exfoliative dermatitis Hearing loss Hypersensitivity drug reaction Increased alanine transaminase Increased aspartate transaminase Leukocytosis Leukopenia Neuromuscular blockade Seizure disorder Stevens-johnson syndrome Thrombocytopenic disorder Toxic epidermal necrolysis |
There are 12 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Diarrhea Fever Headache disorder Hypoesthesia Lethargy Muscle fasciculation Nausea Paresthesia Urticaria Vertigo Vomiting |
The following precautions are available for GENTAMICIN-SODIUM CITRATE (gentamicin sulfate/sodium citrate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Controlled studies to date in pregnant women receiving potassium citrate have not shown a risk to the fetus in the first trimester of pregnancy and there is no evidence of risk in subsequent trimesters.
It is not known whether potassium citrate is distributed into milk. Because potassium freely distributes into and out of milk, use of potassium citrate by a nursing woman with normal plasma potassium concentrations should have no adverse effect on the nursing infant; milk potassium concentrations may be increased in hyperkalemic women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for GENTAMICIN-SODIUM CITRATE (gentamicin sulfate/sodium citrate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for GENTAMICIN-SODIUM CITRATE (gentamicin sulfate/sodium citrate)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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