Vancomycin
FDA Drug Information • Also known as: Tyzavan, Vancomycin
- Brand Names
- Tyzavan, Vancomycin
- Drug Class
- Glycopeptide Antibacterial [EPC]
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis ). The chemical name is ( S a )-(3 S ,6 R ,7 R ,22 R ,23 S ,26 S ,36 R ,38a R )-44-{[2- O -(3-amino-2,3,6-trideoxy-3- C -methyl-α-L- lyxo -hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2 R )-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22 H -8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1 H ,16 H -[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66 H 75 Cl 2 N 9 O 24
What Is Vancomycin Used For?
1 INDICATIONS AND USAGE TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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 TYZAVAN and other antibacterial drugs, TYZAVAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Septicemia TYZAVAN is indicated in adults and pediatric patients (1 month 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 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. 1.2 Infective Endocarditis TYZAVAN is indicated in adults and pediatric patients (1 month 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 infective endocarditis due to: Susceptible isolates of MRSA. Viridans group streptococci Streptococcus gallolyticus (previously known as Streptococcus bovis ), Enterococcus species and Corynebacterium species. For enterococcal endocarditis, use TYZAVAN 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. TYZAVAN is indicated in adults and pediatric patients (1 month 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 early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside. 1.3 Skin and Skin Structure Infections TYZAVAN is indicated in adults and pediatric patients (1 month 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 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. 1.4 Bone Infections TYZAVAN is indicated in adults and pediatric...
Dosage and Administration
2 DOSAGE AND ADMINISTRATION If a dose of TYZAVAN is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 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 TYZAVAN 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 (1 Month and Older) 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 ) 2.1 Important Administration Instructions If a dose of TYZAVAN is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered. TYZAVAN is intended for intravenous use only. TYZAVAN is not to be administered orally. To reduce the risk of infusion related adverse reactions, administer TYZAVAN 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) ] . Infusion related adverse reactions may occur, however, at any rate or concentration. Drug additives should not be made to this solution. TYZAVAN concentrations of no more than 5 mg/mL are recommended in adults and pediatric patients (1 month and older) [see Dosage and Administration (2.2) ] . See also age-specific recommendations [see Dosage and Administration (2.3) ] . Administer TYZAVAN by a secure intravenous route of administration to reduce the risk of local irritation and phlebitis reactions [see Warnings and Precautions (5.8) ] . Administer TYZAVAN prior to intravenous anesthetic agents to reduce the risk of infusion related adverse reactions [see Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage in Adult Patients with Normal Renal Function The usual daily intravenous dosage of TYZAVAN 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. 2.3 Recommended Dosage in Pediatric Patients (1 Month and Older) with Normal Renal Function If a dose of TYZAVAN is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g, this product is...
Side Effects (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 reactions”, acute kidney injury, hearing loss, neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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, fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration (TYZAVAN 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 6.2 Postmarketing 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).
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 ) 7.1 Anesthetic 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) ] . 7.2 Piperacillin-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 TYZAVAN. No pharmacokinetic interactions have been noted between piperacillin/tazobactam and vancomycin. 7.3 Ototoxic and/or Nephrotoxic Drugs Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs with TYZAVAN requires more frequent monitoring of renal function.
Contraindications
4 CONTRAINDICATIONS TYZAVAN is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary The available data on the use of this formulation of TYZAVAN (which includes the excipient NADA) in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data ) . Available data over several decades of vancomycin (without the excipient NADA) 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 Available data from postmarketing cases on use of this formulation of vancomycin injection (with the excipient NADA) in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or infant outcomes. There are no available data on first trimester use of vancomycin (without the excipient NADA); however, available published data on use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes. A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenously administered vancomycin (formulation did not include the excipient NADA) for suspected or documented methicillin-resistant Staphylococcus aureus (MRSA) in the second or third trimester. The comparison...
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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied TYZAVAN (Vancomycin Injection, USP) is supplied as a ready to use clear, colorless to light brown solution in single-dose flexible bags containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g and 2 g vancomycin in 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL and 400 mL of liquid (consists of water for injection together with the excipients NADA and lysine) [see Description (11) ] . The flexible bags are supplied in sealed aluminum overpouches. The bags are supplied in the following packages described in table 1 below: Table 1: TYZAVAN PACKAGE INFORMATION Strength of TYZAVAN NDC number Packaging configuration 500 mg/100 mL (5 mg/mL) 0143-9471-06 Carton of 6 bags 500 mg/100 mL (5 mg/mL) 0143-9471-12 Carton of 12 bags 750 mg/150 mL (5 mg/mL) 0143-9468-06 Carton of 6 bags 750 mg/150 mL (5 mg/mL) 0143-9468-12 Carton of 12 bags 1 g/200 mL (5 mg/mL) 0143-9472-06 Carton of 6 bags 1 g/200 mL (5 mg/mL) 0143-9472-12 Carton of 12 bags 1.25 g/250 mL (5 mg/mL) 0143-9466-06 Carton of 6 bags 1.5 g/300 mL (5 mg/mL) 0143-9469-06 Carton of 6 bags 1.75 g/350 mL (5 mg/mL) 0143-9467-06 Carton of 6 bags 2 g/400 mL (5 mg/mL) 0143-9470-06 Carton of 6 bags 16.2 Storage Store at 15°C to 25°C (59°F to 77ºF), in original package. Use within 28 days of removal from aluminum overpouch. 16.1 How Supplied TYZAVAN (Vancomycin Injection, USP) is supplied as a ready to use clear, colorless to light brown solution in single-dose flexible bags containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g and 2 g vancomycin in 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL and 400 mL of liquid (consists of water for injection together with the excipients NADA and lysine) [see Description (11) ] . The flexible bags are supplied in sealed aluminum overpouches. The bags are supplied in the following packages described in table 1 below: Table 1: TYZAVAN PACKAGE INFORMATION Strength of TYZAVAN NDC number Packaging configuration 500 mg/100 mL (5 mg/mL)...
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.