Drugplain

TYZAVAN 1.25 g/250mL

Vancomycin · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.

No Recall HistoryCurrently in Shortage
Plain English

TYZAVAN is a injection, solution containing vancomycin at 1.25 g/250mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..

Key Facts

Brand Name
TYZAVAN
Generic Name
Vancomycin
NDC Code (Product)
0143-9466
Manufacturer
Hikma Pharmaceuticals USA Inc.
Strength
1.25 g/250mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA211962
Drug Class
Glycopeptide Antibacterial [EPC]
Marketing Start
10/17/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective6,285 reports
acute kidney injury4,254 reports
off label use4,085 reports
pyrexia3,550 reports
drug reaction with eosinophilia and systemic symptoms2,350 reports
renal failure2,209 reports
sepsis2,080 reports
diarrhoea2,065 reports
pneumonia1,921 reports
hypotension1,898 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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, includi…

Dosage & 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…

Contraindications

4 CONTRAINDICATIONS TYZAVAN is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin ( 4 )

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 freq…

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 rate…

Frequently Asked Questions

What is TYZAVAN used for?

TYZAVAN contains Vancomycin. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is TYZAVAN a controlled substance?

TYZAVAN is not classified as a controlled substance by the DEA.

What is the generic name for TYZAVAN?

The generic name for TYZAVAN is Vancomycin. There are 11 other brand versions of Vancomycin.

What is the NDC code for TYZAVAN 1.25 g/250mL?

The NDC (National Drug Code) for TYZAVAN 1.25 g/250mL is 0143-9466, listed by Hikma Pharmaceuticals USA Inc..

Product NDC

0143-9466

Package NDC

0143-9466-06

Other TYZAVAN Dosages

Other Vancomycin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)