VANCOMYCIN HYDROCHLORIDE 750 mg/150mL Injection, Solution, 150 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Glycopeptide Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Vancomycin injection is used to treat certain serious infections caused by bacteria. Vancomycin injection is in a class of medications called glycopeptide antibiotics. It works by killing bacteria that cause infections. Antibiotics such as vancomycin injection will not work for colds, flu, or other viral infections. Taking or using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗- It depends on what you're being treated for. If you have a serious infection like a bloodstream infection, heart valve infection, or bone infection, the oral form of vancomycin sim...
- Why do I need an IV antibiotic — can't I just take a pill?
- The two biggest things to watch for are changes in your hearing and changes in your urination. If you notice ringing in your ears, muffled hearing, or dizziness, let your doctor kn...
- What should I watch out for while taking vancomycin?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Vancomycin Hydrochloride — tap one for details:
Vancomycin Hydrochloride may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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1.35 g / 150 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.0938 | $14.07 / 150 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J3373 | $0.033 / J3373 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tyzavan 750 mg/150mL 00143-9468-06 | Hikma | 150 ml | — | — | FDA listed | — |
| Vancomycin Hydrochloride 750 mg/150mL 00338-3580-48 | Baxter | 200 ml | — | — | FDA listed | — |
| Vancomycin Hydrochloride 750 mg/150mLthis 00338-3582-01 | Baxter | 150 ml | — | — | FDA listed | — |
| Vancomycin 750 mg/150mL 70594-0056-02 | Xellia | 150 ml | — | — | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00338-3582-01 You're viewing this | 150 mL in 1 BAG (0338-3582-01) | 2015-12-18 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Vancomycin Injection is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: • Septicemia ( 1.1 ) • Infective Endocarditis ( 1.2 ) • Skin and Skin Structure Infections ( 1.3 ) • Bone Infections ( 1.4 ) • Lower Respiratory Tract Infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
( 1.6 )
1.1Septicemia Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of septicemia due to: • Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci. • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.
1.2Infective Endocarditis Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of infective endocarditis due to: • Susceptible isolates of MRSA. • Viridans group streptococci or Streptococcus gallolyticus (previously known as Streptococcus bovis ) and Enterococcus species and Corynebacterium species. For enterococcal endocarditis ( e.g., E. faecalis ), use Vancomycin Injection in combination with an aminoglycoside. • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.
Vancomycin Injection is indicated in adults and pediatric patients for the treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside.
1.3Skin and Skin Structure Infections Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of skin and skin structure infections due to: • Susceptible isolates of MRSA and coagulase negative staphylococci. • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.
1.4Bone Infection Vancomycin Injection is indicated in adults and pediatric patients (and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of bone infections due to: • Susceptible isolates of MRSA and coagulase negative staphylococci. • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.
1.5Lower Respiratory Tract Infections Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of lower respiratory tract infections due to: • Susceptible isolates of MSRA. • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.
1.6 Usage To reduce the development of drug-resistant bacteria a…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • If a dose of Vancomycin Injection is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered. ( 2.1 ) • For Intravenous use only. Do not administer orally.
( 2.1 ). • Administer Vancomycin Injection by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions. ( 2.1 ). • Recommended Dosage in Adult Patients with Normal Renal Function: 2 g divided either as 0.5 grams (g) every 6 hours or 1 g every 12 hours. ( 2.2 ) • Recommended Dosage in Pediatric Patients with Normal Renal Function: 10 mg/kg per dose given every 6 hours.
( 2.3 ) • Recommended Dosage in Patients with Renal Impairment: See full prescribing information for recommended doses in patients with renal impairment. ( 2.4 ) • See full prescribing information for further important preparation and administration instructions. ( 2.1 , 2.5 )
2.1Important Administration Instructions • If a dose of Vancomycin Injection is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered. • Vancomycin Injection is intended for intravenous use only. • Vancomycin Injection is not to be administered orally. • To reduce the risk of infusion related adverse reactions, administer Vancomycin Injection by intravenous infusion over 60 minutes or greater [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .
An infusion rate of 10 mg/min or less is associated with fewer infusion-related adverse reactions [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Infusion related adverse reactions may occur, however, at any rate or concentration. • Drug additives should not be made to this solution. • Vancomycin Injection concentrations of no more than 5 mg/mL are recommended in adults [see Dosage and Administration (2.2) ] . See also age-specific recommendations [see Dosage and Administration (2.3) ]. • Administer Vancomycin by a secure intravenous route of administration to reduce the risk of local irritation and phlebitis reactions [see Warnings and Precautions (5.8) ]. • Administer Vancomycin Injection prior to intravenous anesthetic agents to reduce the risk of infusion related adverse reactions [see Warnings and Precautions (5.1) ].
2.2Recommended Dosage in Adult Patients with Normal Renal Function The usual daily intravenous dosage of Vancomycin Injection is 2 grams (g) divided either as 500 mg every 6 hours or 1 g every 12 hours. Administer each dose by intravenous infusion over a period of 60 minutes or greater. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose. The initial daily dose should be no less than 15 mg/kg.
2.3Recommended Dosage in Pediatric Patients with Normal Renal Function If a dose of Vancomycin Injection is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered [see Use in Specific Populations (8.4) ]. Pediatric Patients (Aged 1 Month and Older) The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes.
Close monitoring of serum concentrations of vancomycin may be warranted in these patients. Pediatric Patients (Younger than 1 Month Old) In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1 st week of life and every 8 hours thereafter up to the age of 1 month.
Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: Vancomycin Injection USP, is a frozen, iso-osmotic, sterile, nonpyrogenic premixed solution available in the following strengths: • 500 mg/100 mL (5 mg/mL); Each 100 mL single-dose GALAXY container contains 500 mg Vancomycin (as Vancomycin hydrochloride) in 5% Dextrose or 0.9% Sodium Chloride. • 750 mg/150 mL (5 mg/mL); Each 150 mL single-dose GALAXY container contains 750 mg Vancomycin (as Vancomycin hydrochloride) in 5% Dextrose or 0.9% Sodium Chloride. • 1 g/200 mL (5 mg/mL); Each 200 mL single-dose GALAXY container contains 1 g Vancomycin (as Vancomycin hydrochloride) in 5% Dextrose or 0.9% Sodium Chloride. • 1.25 g/250 mL (5 mg/mL): Each 250 mL single-dose GALAXY container contains 1.25 g of Vancomycin (as Vancomycin hydrochloride) in 5 % Dextrose. • 1.5 g/300 mL (5 mg/mL): Each 250 mL single-dose GALAXY container contains 1.5 g of Vancomycin (as Vancomycin hydrochloride) in 5 % Dextrose. • Injection: Vancomycin Injection (in 5% Dextrose) 500 mg/100 mL; 750 mg/150 mL; 1 g/200 mL; 1.25 g/250 mL; 1.5 g/300 mL (5 mg/mL) in single-dose GALAXY container.
( 3 ) • Injection: Vancomycin Injection (in 0.9% Sodium Chloride) 500 mg/100 mL; 750 mg/150 mL; 1 g/200 mL (5 mg/mL) in single dose GALAXY container. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Vancomycin Injection is contraindicated in patients with known hypersensitivity to vancomycin. • Solutions containing dextrose including Vancomycin Injection, may be contraindicated in patients with a known allergy to corn or corn products. Hypersensitivity to vancomycin ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Infusion Reactions : Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain, and “vancomycin infusion reaction” which manifests as pruritus and erythema that involves the face, neck and upper body may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer Vancomycin Injection over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. ( 2.1 , 5.1 ) • Nephrotoxicity : Monitor renal function in all patients receiving Vancomycin Injection.
(5.2) • Ototoxicity : Serial tests of auditory function may be helpful. (5.3) • Severe Dermatologic Reactions : Discontinue Vancomycin Injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. (5.4) • Clostridioides Difficile -Associated Diarrhea (CDAD) : Evaluate patients if diarrhea occurs.
(5.5) • Neutropenia: Periodically monitor leukocyte count. (5.7) • Phlebitis and Other Administration Site Reactions : Vancomycin is irritating to tissue and must be given by a secure intravenous route of administration. (5.8) • Risk of High Sodium Load : Avoid use of Vancomycin Injection in patients with congestive heart failure, elderly patients and patients requiring restricted sodium intake.
(5.10)
5.1Infusion Reactions Hypotension including shock and cardiac arrest, wheezing, dyspnea, urticaria or pruritus, muscular and chest pain may occur with rapid Vancomycin Injection administration. ( e.g. , over several minutes). The reactions may be more severe in pediatric patients [see Use in Specific Populations (8.4) ].
Rapid intravenous administration of Vancomycin Injection may also be associated with “vancomycin infusion reaction”, which manifests as pruritus and erythema that involves the face, neck and upper body or pain and muscle spasm of the chest and back. There have been reports that the frequency of infusion-related reactions (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related adverse reactions are related to both the concentration and the rate of administration of Vancomycin for Injection.
Infusion-related adverse reactions may occur, however, at any rate or concentration. Administer Vancomycin Injection over a period of 60 minutes or greater to reduce the risk of rapid-infusion-related adverse reactions. In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related adverse reactions.
Administer Vancomycin Injection as a 60-minute infusion prior to administration of anesthetic agents when feasible to minimize infusion-related adverse reactions. Stop the infusion if a reaction occurs because this usually results in prompt cessation of these reactions.
5.2Nephrotoxicity Vancomycin Injection can result in acute kidney injury (AKI), including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. AKI is manifested by increasing blood urea nitrogen (BUN) and serum creatinine (Cr). The risk of AKI increases with higher vancomycin serum levels, prolonged exposure, concomitant administration of other nephrotoxic drugs, concomitant administration of piperacillin-tazobactam [see Drug Interactions (7.2) ] , volume depletion, pre-existing renal impairment and in critically ill patients and patients with co-morbid conditions that predispose to renal impairment.
Monitor serum vancomycin concentrations and renal function in all patients receiving Vancomycin Injection. More frequent monitoring is recommended in patients with comorbidities that predispose to impairment in renal function or are concomitantly receiving other nephrotoxic drugs, in critically ill patients, in patients with changing renal function, and in patients requiring higher therapeutic vancomycin levels. If acute…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Infusion Reactions [see Warnings and Precautions (5.1) ] • Nephrotoxicity [see Warnings and Precautions (5.2) ] • Ototoxicity [see Warnings and Precautions (5.3) ] • Severe Dermatologic Reactions [see Warnings and Precautions (5.4) ] • Clostridioides Difficile -Associated Diarrhea [see Warnings and Precautions (5.5) ] • Hemorrhagic Occlusive Retinal Vasculitis [see Warnings and Precautions (5.6) ] • Neutropenia [see Warnings and Precautions (5.7) ] • Phlebitis and Other Administration Site Reactions [see Warnings and Precautions (5.8) ].
The most common adverse reactions are anaphylaxis, “vancomycin infusion reaction”, acute kidney injury, hearing loss, neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions associated with the use of vancomycin were identified in clinical trials: Immune System Disorders: Anaphylaxis and “vancomycin infusion reaction” Renal and urinary Disorders: Acute kidney injury and interstitial nephritis Ear and Labyrinth Disorders: Hearing loss, vertigo, and tinnitus Skin and subcutaneous tissue disorders : Rashes including exfoliative dermatitis, and Stevens-Johnson syndrome (SJS) Gastrointestinal Disorders: Clostridioides difficile colitis, nausea Blood and Lymphatic System Disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia Cardiac Disorders: Cardiac arrest, chest pain General Disorders and Administration Site Conditions : General discomfort, drug fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration (Vancomycin Injection is not approved for intramuscular and intraperitoneal administration) Laboratory Abnormalities: Elevated blood urea nitrogen, elevated serum creatinine Musculoskeletal and connective tissue disorders: Muscle pain Nervous system disorders: Dizziness Respiratory, thoracic and mediastinal disorders: Wheezing, dyspnea Vascular disorders: Hypotension, shock, vasculitis
6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of vancomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.
Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD). Blood and lymphatic system disorders : Hemolytic anemia
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Anesthetic Agents: Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing. ( 2.1 , 7.1 ) • Piperacillin/Tazobactam: Increased incidence of acute kidney injury in patients receiving concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients. ( 7.2 )
7.1Anesthetic Agents Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ].
7.2Piperacillin-Tazobactam Studies have detected an increased incidence of acute kidney injury in patients administered concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients receiving concomitant piperacillin/tazobactam and Vancomycin Injection. No pharmacokinetic interactions have been noted between piperacillin/tazobactam and vancomycin.
7.3Ototoxic and/or Nephrotoxic Drugs Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs with Vancomycin Injection requires more frequent monitoring of renal function.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data over several decades of vancomycin use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenously administered vancomycin for suspected or documented methicillin-resistant Staphylococcus-aureus (MRSA) in the second or third trimester.
The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated intravenous drug-dependent patients who served as substance abuse controls. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus (GBS) culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin at the time of delivery.
Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss.
Neonatal renal function was not examined, but all of the newborns were discharged in good condition. Animal Data Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits. No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively).
Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). 1
8.2Lactation Risk Summary Vancomycin is present in human milk following intravenous administration, however, there are insufficient data to inform the levels. There are no data on the effects of vancomycin on the breastfed infant or milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for vancomycin and any potential adverse effects on the breastfed infant from vancomycin or from the underlying maternal condition.
8.4Pediatric Use Vancomycin Injection is indicated in pediatric patients for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections for whom appropriate dosing with this formulation can be achieved [see Indications and Usage (1.1 to 1.5 ) and Dosage and Administration (2.1 , 2.3 )]. Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of Vancomycin Injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of Vancomycin Injection that does not equal 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g is required, and an alternative formula…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data over several decades of vancomycin use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenously administered vancomycin for suspected or documented methicillin-resistant Staphylococcus-aureus (MRSA) in the second or third trimester.
The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated intravenous drug-dependent patients who served as substance abuse controls. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus (GBS) culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin at the time of delivery.
Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss.
Neonatal renal function was not examined, but all of the newborns were discharged in good condition. Animal Data Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits. No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively).
Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). 1
🧒 Pediatric Use ▾
8.4Pediatric Use Vancomycin Injection is indicated in pediatric patients for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections for whom appropriate dosing with this formulation can be achieved [see Indications and Usage (1.1 to 1.5 ) and Dosage and Administration (2.1 , 2.3 )]. Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of Vancomycin Injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of Vancomycin Injection that does not equal 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g is required, and an alternative formulation of vancomycin should be considered [see Dosage and Administration (2.1 , 2.3 )].
More severe infusion related reactions related to vancomycin administration may occur in pediatric patients. In pediatric patients, monitor vancomycin serum concentration and renal function when administering Vancomycin injection [see Dosage and Administration (2.3) and Warnings and Precautions (5.2) ]. Concomitant administration of vancomycin and intravenous anesthetic agents has been associated with erythema and histamine-like flushing in all patients including pediatric patients [see Warnings and Precautions (5.1) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Vancomycin injection is known to be substantially excreted by the kidney, and the risk of adverse 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 [see Dosage and Administration (2.4) ] , and it may be useful to monitor renal function [see Warnings and Precautions (5.2) ].
🆘 Overdosage ▾
10 OVERDOSAGE Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance. For current information on the management of overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Vancomycin is an antibacterial drug [see Microbiology (12.4) ].
12.2Pharmacodynamics Based on animal models of infection, the antimicrobial activity of vancomycin appears to correlate with the AUC/MIC (area under the concentration-time curve/minimum inhibitory concentration) ratio for certain pathogens, including methicillin resistant Staphylococcus aureus. The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials 2,3.
12.3Pharmacokinetics General Pharmacokinetics In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately after the completion of infusion, mean plasma concentrations of approximately 23 mcg/mL 2 hours after infusion, and mean plasma concentrations of approximately 8 mcg/mL 11 hours after the end of the infusion. Multiple dosing of 500 mg infused over 30 minutes produces mean plasma concentrations of about 49 mcg/mL at the completion of infusion, mean plasma concentrations of about 19 mcg/mL 2 hours after infusion, and mean plasma concentrations of about 10 mcg/mL 6 hours after infusion.
The plasma concentrations during multiple dosing are similar to those after a single dose. Distribution The distribution coefficient is from 0.3 to
0.43L/kg. Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL. After IV administration of vancomycin, inhibitory concentrations are present in pleural, pericardial, ascitic, and synovial fluids; in urine; in peritoneal dialysis fluid; and in atrial appendage tissue.
Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs. Elimination Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h. The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function.
In anephric patients, the average half-life of elimination is 7.5 days. Total systemic and renal clearance of vancomycin may be reduced in the elderly. Metabolism There is no apparent metabolism of vancomycin.
Excretion In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Renal dysfunction slows excretion of vancomycin.
12.4Microbiology Mechanism of Action The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. Resistance There is no cross-resistance between vancomycin and other antibacterial(s).
Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi. Interaction With Other Antimicrobials The combination of vancomycin and an aminoglycoside acts synergistically in vitro against many isolates of Staphylococcus aureus, Streptococcus gallolyticus (previously known as Streptococcus bovis ), Enterococcus spp, and the viridans group streptococci. Antimicrobial Activity Vancomycin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections [see Indications and Usage section (1) ].
Aerobic bacteria Gram-positive bacteria Corynebacterium spp. Enterococcus spp. (including Enterococcus faecalis ) Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates) Coagulase negative staphylococci (including S. epidermidis and methicillin-resistant isolates) Streptococcus gallolyticus ( previously known as Streptococcus bovis) Viridans group streptococci The following in vitro data are available, but their clinical significance is unknown.
At least 90 percent of the following bacteria exhib…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Vancomycin is an antibacterial drug [see Microbiology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Vancomycin Injection, USP is supplied as a frozen, iso-osmotic, premixed solution packaged in a single-dose GALAXY plastic container and is available as follows: Supply Information for Vancomycin Injection, in 5% Dextrose Strength Number of Containers/ Carton NDC 500 mg of vancomycin / 100 mL (5 mg/mL) 12 count 0338-3551-48 750 mg of vancomycin / 150 mL (5 mg/mL) 6 count 0338-3580-48 1 g of vancomycin / 200 mL (5mg/mL) 6 count 0338-3552-48 1.25 g of vancomycin / 250 mL (5 mg/mL) 4 count 0338-0122-04 1.5 g of vancomycin / 300 mL (5 mg/mL) 4 count 0338-0124-04 Supply Information for Vancomycin Injection, in 0.9% Sodium Chloride Strength Number of Containers/ Carton NDC 500 mg of vancomycin / 100 mL (5 mg/mL) 12 count 0338-3581-01 750 mg vancomycin / 150 mL (5 mg/mL) 6 count 0338-3582-01 1 g of vancomycin / 200 mL (5mg/mL) 6 count 0338-3583-01 Storage Store Vancomycin Injection at or below -20°C (-4°F) or Store in a freezer capable of maintaining a temperature at or below -20°C (-4°F).
Storage of the thawed solution is described elsewhere in the labeling [see Dosage and Administration (2.5) ] Handling Handle frozen product containers with care. Product containers may be fragile in the frozen state.
📋 Description ▾
11 DESCRIPTION Vancomycin Injection USP, in the GALAXY plastic container contains vancomycin, added as Vancomycin Hydrochloride USP. It is a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis ). The chemical name of vancomycin hydrochloride is (Sa)-(3S, 6R, 7R, 22R, 23S, 26S, 36R, 38aR)-44-[[2-O-(3-Amino-2, 3, 6-trideoxy-3-Cmethyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)- 10,19dichloro 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6[(2R)-4-methyl-2-(methylamino) valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno23, 36-(iminomethano)-13, 16:31, 35-dimetheno-1H, 16H-[l, 6, 9] oxadiazacyclohexadecino [4, 5-m] [10, 2, 16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride.
The molecular formula is C 66 H 75 Cl 2 N 9 O 24 ·HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula: Vancomycin Injection, USP in the GALAXY container is a frozen, iso-osmotic, sterile, nonpyrogenic, premixed single-dose formulation. The composition of Vancomycin Injection, USP, available in the following strengths are: • 500 mg/100 mL (5 mg/mL): containing 500 mg of vancomycin (equivalent to 513 mg of vancomycin hydrochloride); approximately 5 g of dextrose hydrous or 0.9 g of sodium chloride (equivalent to 354 mg total sodium content) • 750 mg/150 mL (5 mg/mL): containing 750 mg of vancomycin (equivalent to 769 mg of vancomycin hydrochloride); approximately 7.5 g of dextrose hydrous or 1.35 g of sodium chloride (equivalent to 531 mg total sodium content) • 1 g/200 mL (5 mg/mL): containing 1 g of vancomycin (equivalent to 1.025 g of vancomycin hydrochloride); approximately 10 g of dextrose hydrous or 1.8 g of sodium chloride (equivalent to 708 mg total sodium content) • 1.25 g/250 mL (5 mg/mL): containing 1.25 g of vancomycin (equivalent to 1.281 g of vancomycin hydrochloride); approximately 12.5 g of dextrose hydrous. • 1.5 g/300 mL (5 mg/mL): containing 1.5 g of vancomycin (equivalent to 1.538 g of vancomycin hydrochloride); approximately 15 g of dextrose hydrous.
The pH of the solution may have been adjusted with hydrochloric acid and/or sodium hydroxide. Thawed solutions have a pH in the range of 3.0 to 5.0. After thawing to room temperature, this solution is intended for intravenous use only.
This GALAXY container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Vancomycin Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Infusion Reactions During or After Intravenous Use Advise patients that generalized skin redness, skin rash, itching, flushing, muscle pain, chest pain, shortness of breath, wheezing, or dizziness may occur during intravenous infusion of Vancomycin Injection. [see Warnings and Precautions (5.1) ]. Acute Kidney Injury Advise patients that Vancomycin Injection can result in kidney damage and that blood tests are required to monitor vancomycin blood levels and kidney function during therapy [see Warnings and Precautions (5.2) ].
Hearing Loss or Balance Problems Advise patients that Vancomycin injection may result in decreased hearing and to report hearing loss or balance problems to their healthcare provider [see Warnings and Precautions (5.3) ]. Severe Dermatologic Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop Vancomycin Injection immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions and blisters [see Warnings and Precautions (5.4) ].
Diarrhea Diarrhea is a common problem caused by antibacterial drugs, including Vancomycin Injection, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.5) ].
Antibacterial Resistance Patients should be counseled that antibacterial drugs including Vancomycin Injection, should only be used to treat bacterial infections. They do not treat viral infections ( e.g. , the common cold). When Vancomycin 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 Vancomycin Injection or other antibacterial drugs in the future. Manufactured by, Packed by, Distributed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in the USA 07-19-08-904 Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries.