Vancomycin Viatris
Glycopeptide antibiotic for serious gram-positive bacterial infections
Vancomycin Viatris is a glycopeptide antibiotic used to treat serious infections caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Administered intravenously for systemic infections or orally for Clostridioides difficile colitis, vancomycin is a cornerstone of hospital-based antimicrobial therapy and is included on the WHO Model List of Essential Medicines.
Quick Facts
Key Takeaways
- Vancomycin is one of the most important antibiotics for treating serious MRSA and other resistant gram-positive infections in hospital settings.
- It must be administered as a slow intravenous infusion over at least 60 minutes to prevent Red Man Syndrome, a histamine-mediated flushing reaction.
- Therapeutic drug monitoring (blood level testing) is essential to ensure effective treatment while minimizing kidney and hearing toxicity.
- Oral vancomycin is the treatment of choice for Clostridioides difficile infection (CDI) and acts locally in the gut without systemic absorption.
- Vancomycin should not be used with other nephrotoxic or ototoxic drugs unless carefully monitored, as the risk of kidney and hearing damage increases significantly.
What Is Vancomycin Viatris and What Is It Used For?
Vancomycin belongs to a class of antibiotics known as glycopeptides. It was first isolated from a soil sample in Borneo in 1953 and has been used clinically since the late 1950s. Today, vancomycin remains one of the most critical antibiotics in medicine, particularly for treating infections caused by multidrug-resistant gram-positive organisms. The World Health Organization (WHO) classifies vancomycin as a "Watch" group antibiotic under its AWaRe classification, meaning its use should be carefully monitored to prevent the development of resistance.
Vancomycin works by binding to the D-alanyl-D-alanine terminal of peptidoglycan precursors in the bacterial cell wall. This binding prevents the cross-linking reactions necessary for cell wall integrity, ultimately leading to cell lysis and bacterial death. This mechanism is fundamentally different from that of beta-lactam antibiotics (such as penicillins and cephalosporins), which is why vancomycin remains effective against bacteria that have developed resistance to those drug classes.
Intravenous Uses
When administered intravenously, vancomycin is used to treat serious infections in all age groups, including:
- Skin and soft tissue infections – including surgical wound infections, cellulitis, and abscesses caused by MRSA or other resistant organisms.
- Bone and joint infections – osteomyelitis and septic arthritis, particularly when caused by methicillin-resistant staphylococci.
- Pneumonia – hospital-acquired and ventilator-associated pneumonia caused by susceptible gram-positive pathogens.
- Endocarditis – infection of the inner lining of the heart, both as treatment and as prophylaxis in high-risk patients undergoing major surgical procedures.
- Bloodstream infections (bacteremia) – associated with any of the infections listed above or with central venous catheter-related infections.
- Meningitis – as part of empirical therapy for bacterial meningitis, particularly when resistant pneumococci are suspected.
Oral Uses
When given orally, vancomycin is used specifically to treat Clostridioides difficile infection (CDI), formerly known as Clostridium difficile-associated diarrhea. CDI is an infection of the colon that can cause severe diarrhea, pseudomembranous colitis, and in serious cases, toxic megacolon. Oral vancomycin is not absorbed from the gastrointestinal tract in significant amounts, which means it acts locally within the gut to eliminate the C. difficile bacteria directly.
According to current Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) guidelines, oral vancomycin (or fidaxomicin) is recommended as first-line therapy for initial and recurrent episodes of CDI, replacing the previous standard of metronidazole for non-severe cases.
What Should You Know Before Taking Vancomycin Viatris?
Contraindications
Vancomycin Viatris must not be used if you have a known allergy (hypersensitivity) to vancomycin or any of the other ingredients in this medicine. If you have previously experienced an allergic reaction to vancomycin, including rash, swelling, or breathing difficulties, inform your healthcare provider immediately. Cross-reactivity with teicoplanin (another glycopeptide antibiotic) has been reported, so if you have had an allergic reaction to teicoplanin, you may also be allergic to vancomycin.
Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with vancomycin treatment. Stop using vancomycin and seek immediate medical attention if you develop a widespread rash with blisters and peeling skin, mouth sores, fever, or swollen lymph nodes.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before using vancomycin if any of the following apply to you:
- Previous allergic reaction to teicoplanin – there is a risk of cross-allergy between glycopeptide antibiotics.
- Hearing impairment – vancomycin can cause ototoxicity (damage to hearing), particularly in elderly patients. Hearing tests may be required during treatment.
- Kidney disease – vancomycin is eliminated primarily through the kidneys, so dose adjustments are necessary in patients with renal impairment. Blood tests to monitor kidney function and vancomycin levels are essential.
- Long-term treatment – prolonged use increases the risk of superinfection with resistant organisms and may require additional monitoring of liver function, kidney function, and blood counts.
- Concomitant nephrotoxic or ototoxic drugs – using vancomycin with aminoglycosides, NSAIDs, or amphotericin B increases the risk of kidney and hearing damage.
Serious adverse reactions, including vision loss, have been reported following intravitreal (into the eye) injection of vancomycin. This route of administration is not approved.
Use in Children
Vancomycin is used with particular caution in premature neonates and infants because their kidneys are not fully developed, which can lead to accumulation of the drug in the blood. This age group requires frequent blood tests to monitor vancomycin levels. Concurrent use of vancomycin with anesthetic agents has been associated with erythema (skin redness) and allergic-like reactions in children. Similarly, the combination with aminoglycosides, NSAIDs, or amphotericin B increases the risk of nephrotoxicity, and more frequent kidney function monitoring may be necessary.
Pregnancy and Breastfeeding
If you are pregnant or planning to become pregnant, inform your doctor before receiving vancomycin. Vancomycin should only be used during pregnancy if the potential benefit clearly outweighs the potential risk to the fetus. Animal studies have not shown teratogenic effects, but there are limited controlled studies in pregnant women. Some studies have raised concerns about potential ototoxicity to the developing fetus, although the evidence is inconclusive.
Vancomycin passes into breast milk in small amounts and may cause diarrhea in breastfed infants. If you are breastfeeding, your doctor will weigh the benefits of treatment against the potential risks to the infant. Your baby should be carefully monitored for diarrhea and other gastrointestinal disturbances during treatment.
Driving and Using Machines
Vancomycin has no or negligible effect on the ability to drive or operate machinery. However, as vancomycin is typically administered in a hospital setting, this is unlikely to be a practical concern for most patients.
How Does Vancomycin Viatris Interact with Other Drugs?
Drug interactions are an important consideration with vancomycin therapy because many commonly used hospital medications can increase the risk of serious adverse effects. The most clinically significant interactions involve drugs that share vancomycin's potential for nephrotoxicity or ototoxicity. When these medications are used concurrently, the combined toxic effects on the kidneys or hearing can be greater than the sum of each drug's individual toxicity.
Major Interactions
The following combinations require careful monitoring and, in some cases, dose adjustment or alternative therapy:
| Interacting Drug | Type of Interaction | Clinical Significance | Monitoring Required |
|---|---|---|---|
| Aminoglycosides (gentamicin, amikacin, tobramycin) | Additive nephrotoxicity and ototoxicity | High – significantly increased risk of kidney and hearing damage | Serum creatinine, vancomycin levels, audiometry |
| Amphotericin B | Additive nephrotoxicity | High – both drugs are individually nephrotoxic | Serum creatinine, electrolytes, vancomycin levels |
| Piperacillin/tazobactam | Increased acute kidney injury risk | High – meta-analyses show increased AKI compared to other beta-lactams | Serum creatinine daily, urine output |
| Cisplatin | Additive nephrotoxicity and ototoxicity | High – both agents cause renal tubular damage | Serum creatinine, audiometry, vancomycin levels |
| General anesthetics | Potentiation of histamine-mediated reactions | Moderate – increased risk of flushing, hypotension, erythema | Blood pressure, cardiac monitoring during infusion |
| Colistin / Polymyxin B | Additive nephrotoxicity | High – both agents are nephrotoxic | Serum creatinine, urine output |
Minor Interactions
The following interactions are of lower clinical significance but should still be communicated to your healthcare provider:
- NSAIDs (ibuprofen, diclofenac) – may increase the risk of nephrotoxicity, particularly with prolonged concurrent use. Kidney function should be monitored if these are used together.
- Muscle relaxants – used during anesthesia may have their effects enhanced when given concurrently with vancomycin. The anesthesiologist should be informed of vancomycin use.
- Bacitracin – concurrent use may increase the risk of nephrotoxicity and neuromuscular blockade.
Always tell your doctor or pharmacist about all medications you are currently taking, including over-the-counter medicines, herbal supplements, and vitamins. This allows your healthcare team to adjust doses or monitoring schedules to ensure your safety during vancomycin therapy.
What Is the Correct Dosage of Vancomycin Viatris?
Vancomycin is administered either intravenously or orally, and the dosing regimen differs significantly between these two routes. Your doctor will determine the appropriate dose based on your age, body weight, kidney function, hearing ability, the type and severity of infection, and other medications you may be taking. It is important to understand that intravenous and oral vancomycin have completely different therapeutic indications and should not be interchanged.
Adults (Intravenous)
Standard IV Dosing – Adults and Adolescents (12 years and older)
The usual dose is 15–20 mg/kg body weight, administered every 8–12 hours as an intravenous infusion. In certain situations, your doctor may decide to give a loading dose of up to 25–30 mg/kg for the first dose. The maximum recommended daily dose is 2 g.
Each dose must be infused over at least 60 minutes (or at a rate not exceeding 10 mg/min, whichever takes longer). Faster infusion rates significantly increase the risk of Red Man Syndrome and other infusion-related reactions.
Children (Intravenous)
Children aged 1 month to under 12 years
The usual dose is 10–15 mg/kg body weight, administered every 6 hours as an intravenous infusion.
Premature and full-term neonates (0–27 days)
Dosing is calculated based on postmenstrual age (the time elapsed between the first day of the last menstrual period and birth, plus the time elapsed after birth). Doses and intervals are individualized based on gestational age and renal maturity. These patients require especially close monitoring of vancomycin blood levels.
Oral Dosing (for C. difficile Infection)
| Patient Group | Dose | Frequency | Maximum Daily Dose |
|---|---|---|---|
| Adults and adolescents (12+ years) | 125 mg | Every 6 hours | 2 g (severe cases: up to 500 mg every 6 hours) |
| Children under 12 years | 10 mg/kg | Every 6 hours | 2 g |
For oral administration, the reconstituted solution from the IV vial can be diluted in 30 mL of water and given to the patient to drink or administered via a nasogastric tube. Oral vancomycin is not significantly absorbed from the gastrointestinal tract; it works locally within the gut lumen.
Elderly and Patients with Kidney Disease
Elderly patients, pregnant women, and those with kidney disease (including patients on dialysis) may require dose adjustments. In patients with impaired kidney function, the dose and/or interval between doses is modified based on creatinine clearance. Therapeutic drug monitoring (measuring vancomycin blood levels) is particularly important in these populations to ensure adequate drug exposure while avoiding toxicity. Current guidelines from the American Society of Health-System Pharmacists (ASHP) and IDSA recommend AUC-guided dosing (targeting an AUC/MIC ratio of 400–600) rather than trough-only monitoring for serious MRSA infections.
How Vancomycin Is Given
Intravenous vancomycin is always given as a slow infusion into a vein, never as a rapid injection and never into a muscle. The powder must first be reconstituted with water for injection and then further diluted before infusion. Each 500 mg vial is dissolved in 10 mL of water, and each 1000 mg vial in 20 mL, giving a concentration of 50 mg/mL. This solution must then be diluted to at least 5 mg/mL (at least 100 mL for 500 mg, or at least 200 mL for 1000 mg) before infusion.
Missed Dose
Since vancomycin is typically administered in a hospital setting by healthcare professionals, missed doses are uncommon. If a dose is delayed or missed, it should be given as soon as possible, and the subsequent dosing schedule should be adjusted accordingly by the prescribing physician. Do not double the dose to make up for a missed one.
Overdose
Overdose with vancomycin is unlikely in a hospital setting where doses are carefully calculated and monitored. However, if an overdose occurs, symptoms may include worsening of known side effects, particularly nephrotoxicity and ototoxicity. There is no specific antidote for vancomycin overdose. Treatment is supportive and may include maintaining adequate hydration, monitoring kidney function, and in severe cases, hemoperfusion or hemodialysis with high-flux membranes may be considered, although vancomycin is poorly removed by conventional hemodialysis.
What Are the Side Effects of Vancomycin Viatris?
Like all medicines, vancomycin can cause side effects, although not everyone will experience them. The side effects listed below are based on post-marketing surveillance data and clinical trial results. Vancomycin that is given orally has minimal systemic absorption, so systemic side effects are less common with oral use. However, patients with inflammatory bowel conditions or concurrent kidney disease may experience systemic effects even with oral administration.
Stop using vancomycin and seek emergency care if you experience: red, target-like patches on the trunk with blistering; peeling skin; sores in the mouth, throat, or eyes (signs of SJS/TEN); widespread rash with fever and swollen lymph nodes (DRESS syndrome); or red, scaly widespread rash with bumps under the skin and blisters accompanied by fever (AGEP).
Common (up to 1 in 10 people)
May affect up to 1 in 10 people
- Drop in blood pressure (hypotension)
- Shortness of breath, wheezing, stridor (high-pitched breathing sound)
- Rash, itching, hives (urticaria)
- Inflammation of the mucous membranes of the mouth
- Red Man Syndrome – flushing and redness of the upper body and face during or shortly after infusion
- Kidney problems (primarily detected through blood tests showing elevated creatinine)
- Inflammation of a vein at the infusion site (phlebitis)
Uncommon (up to 1 in 100 people)
May affect up to 1 in 100 people
- Temporary or permanent hearing loss (ototoxicity)
Rare (up to 1 in 1,000 people)
May affect up to 1 in 1,000 people
- Decrease in white blood cells, red blood cells, and platelets (pancytopenia)
- Increase in certain white blood cells (eosinophilia)
- Loss of balance, tinnitus (ringing in the ears), dizziness
- Inflammation of blood vessels (vasculitis)
- Nausea
- Kidney inflammation (interstitial nephritis) and kidney failure
- Pain in the chest and back muscles
- Fever, chills
Very Rare (up to 1 in 10,000 people)
May affect up to 1 in 10,000 people
- Severe allergic skin reactions with peeling, blistering, or scaling skin (SJS/TEN) – may be associated with high fever and joint pain
- Cardiac arrest
- Enterocolitis – inflammation of the intestines causing abdominal pain and bloody diarrhea
Frequency Not Known
Cannot be estimated from available data
- Vomiting, diarrhea
- Confusion, drowsiness, lack of energy
- Swelling, fluid retention, decreased urine output
- Rash with swelling or pain behind the ears, on the neck, groin, under the chin, or in the armpits (swollen lymph nodes)
- Abnormal blood and liver function test results
- Rash with blisters and fever (linear IgA bullous dermatosis)
Red Man Syndrome (Infusion-Related Reaction)
Red Man Syndrome (RMS) is the most characteristic adverse effect of vancomycin and deserves special attention. It is a histamine-mediated pseudoallergic reaction that typically occurs during or shortly after rapid intravenous infusion. Symptoms include flushing, erythema (redness) of the face, neck, and upper torso, itching, and in more severe cases, hypotension, chest pain, and muscle spasm. RMS is not a true allergy and does not preclude future vancomycin use. It is prevented by ensuring the infusion rate does not exceed 10 mg/min and that each dose is administered over at least 60 minutes. Pre-treatment with antihistamines (such as diphenhydramine) may be given if a patient has experienced RMS previously.
Reporting Side Effects
If you experience any side effects, including those not listed above, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to your national medicines regulatory authority. By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Vancomycin Viatris?
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the vial label and carton after "EXP." The expiry date refers to the last day of that month.
The unopened powder requires no special storage conditions and can be kept at room temperature. Once the powder has been reconstituted and diluted, the chemical and physical stability of the solution has been demonstrated for 48 hours at 25°C and up to 96 hours when refrigerated at 2–8°C. From a microbiological safety perspective, however, the prepared infusion solution should be used immediately. If not used immediately, the user is responsible for storage times and conditions, which normally should not exceed 24 hours at 2–8°C unless reconstitution took place under controlled, validated aseptic conditions.
Before administration, the reconstituted and diluted solutions should be visually inspected for particles and discoloration. Only clear, colorless solutions free from particles should be used. Do not dispose of medicines in household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
What Does Vancomycin Viatris Contain?
Vancomycin Viatris contains vancomycin as the hydrochloride salt. The powder is white to almost white or slightly pink to yellowish in appearance. It is a freeze-dried (lyophilized) powder that must be reconstituted before use. The reconstituted solution has a pH between 2.8 and 4.5.
| Strength | Vancomycin Content | Equivalent IU | Pack Sizes |
|---|---|---|---|
| 500 mg vial | 500 mg vancomycin (as hydrochloride) | 500,000 IU | 1, 5, 10, or 20 vials |
| 1000 mg vial | 1000 mg vancomycin (as hydrochloride) | 1,000,000 IU | 1, 5, 10, or 20 vials |
Not all pack sizes may be marketed in all countries. The only other ingredient (excipient) is hydrochloric acid, which is used for pH adjustment during manufacturing. Vancomycin Viatris does not contain any preservatives, colorants, or other additives.
Antibiotics are used to treat bacterial infections. They are not effective against viral infections. If your doctor has prescribed vancomycin, you need it for your current condition. Misuse of antibiotics increases bacterial resistance. Always follow the prescribed dosage, schedule, and duration of treatment. Never reuse an antibiotic without a prescription, even if you wish to treat a similar condition.
Frequently Asked Questions About Vancomycin Viatris
Vancomycin is a glycopeptide antibiotic used to treat serious bacterial infections caused by gram-positive organisms, particularly methicillin-resistant Staphylococcus aureus (MRSA). When given intravenously, it treats skin and soft tissue infections, bone and joint infections, pneumonia, endocarditis, and bloodstream infections. When given orally, it treats Clostridioides difficile infection (CDI) of the colon, which causes severe diarrhea and pseudomembranous colitis.
Intravenous vancomycin is given as a slow infusion directly into a vein, never as a rapid injection or intramuscular injection. Each dose must be infused over at least 60 minutes, or at a rate not exceeding 10 mg per minute, whichever takes longer. This slow infusion rate is critical to prevent Red Man Syndrome. For oral use (C. difficile infection), the reconstituted solution is diluted in water and drunk by the patient or given through a nasogastric tube.
Red Man Syndrome (RMS) is a histamine-mediated reaction that occurs when vancomycin is infused too rapidly. It causes flushing, redness, and itching of the face and upper body, and sometimes hypotension. It is not a true allergy. It can be prevented by infusing vancomycin slowly over at least 60 minutes. If a patient has experienced RMS before, pre-treatment with antihistamines such as diphenhydramine can help prevent recurrence. The reaction typically resolves once the infusion is slowed or stopped.
Yes, therapeutic drug monitoring (TDM) is recommended for intravenous vancomycin. Current guidelines recommend targeting an AUC/MIC ratio of 400–600 for serious MRSA infections, which is achieved through measuring vancomycin blood levels and calculating the area under the concentration-time curve. Previously, trough levels of 15–20 mcg/mL were targeted, but AUC-guided dosing is now preferred as it provides better outcomes with less nephrotoxicity. Blood tests for kidney function (serum creatinine) should also be monitored regularly.
Vancomycin should only be used during pregnancy if the potential benefit clearly outweighs the risk to the fetus. There are limited controlled studies in pregnant women, although animal studies have not shown teratogenic effects. Vancomycin passes into breast milk in small amounts and may cause diarrhea in breastfed infants. If breastfeeding, your doctor will weigh the benefits against the risks, and your infant should be monitored for gastrointestinal disturbances. Always discuss with your healthcare provider before using this medication during pregnancy or breastfeeding.
Yes, vancomycin has been one of the primary treatment options for MRSA infections for over 60 years and is often considered the gold standard. However, vancomycin-intermediate S. aureus (VISA) and, very rarely, vancomycin-resistant S. aureus (VRSA) strains have emerged globally, making susceptibility testing essential. Alternative agents for MRSA include linezolid, daptomycin, ceftaroline, and trimethoprim-sulfamethoxazole, depending on the site and severity of infection.
References
- Rybak MJ, Le J, Lodise TP, et al. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. American Journal of Health-System Pharmacy. 2020;77(11):835-864.
- World Health Organization. WHO Model List of Essential Medicines – 23rd List (2023). Geneva: WHO; 2023.
- European Medicines Agency. Vancomycin – Summary of Product Characteristics. EMA/CHMP/2015.
- Johnson S, Lavergne V, Skinner AM, et al. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. Clinical Infectious Diseases. 2021;73(5):e1029-e1044.
- Liu C, Bayer A, Cosgrove SE, et al. Clinical Practice Guidelines by the Infectious Diseases Society of America for the Treatment of Methicillin-Resistant Staphylococcus aureus Infections in Adults and Children. Clinical Infectious Diseases. 2011;52(3):e18-e55.
- Bruniera FR, Ferreira FM, Saviolli LR, et al. The use of vancomycin with its therapeutic and adverse effects: a review. European Review for Medical and Pharmacological Sciences. 2015;19(4):694-700.
- World Health Organization. AWaRe Classification of Antibiotics for Evaluation and Monitoring of Use, 2021. Geneva: WHO; 2021.
- Filippone EJ, Kraft WK, Farber JL. The Nephrotoxicity of Vancomycin. Clinical Pharmacology & Therapeutics. 2017;102(3):459-469.
Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, which includes board-certified specialists in infectious disease, clinical pharmacology, and internal medicine. All content follows the GRADE evidence framework and is based on current international guidelines from IDSA, SHEA, WHO, EMA, and FDA.
All medical claims are supported by peer-reviewed research and international clinical guidelines. Evidence Level 1A.
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