Vancomycin 750 mg/150mL
Vancomycin · INJECTION, SOLUTION · Xellia Pharmaceuticals USA LLC
Vancomycin is a injection, solution containing vancomycin at 750 mg/150mL, taken intravenous. Manufactured by Xellia Pharmaceuticals USA LLC.
Key Facts
- Brand Name
- Vancomycin
- Generic Name
- Vancomycin
- NDC Code (Product)
70594-056- Manufacturer
- Xellia Pharmaceuticals USA LLC
- Strength
- 750 mg/150mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA211962
- Drug Class
- Glycopeptide Antibacterial [EPC]
- Marketing Start
- 05/13/2020
Recall History
SCA Pharmaceuticals
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Sentara Infusion Services
Lack of sterility assurance
SCA Pharmaceuticals
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Denver Solutions, LLC DBA Leiters Health
Labeling: Not Elsewhere Classified
Liberty Drug & Surgical
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Central Admixture Pharmacy Services, Inc.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Walter's Pharmacy
Lack of Assurance of Sterility
Apollo Care, LLC
Lack of Assurance of Sterility
New England Life Care, Inc. dba Advanced Compounding Solutions
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Clinical Specialties Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been re…
Dosage & Administration
DOSAGE AND ADMINISTRATION Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min, are recommended in adults (see also age-specific recommendations). 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 events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS ). Infusion-related events may occur, however, at any rate or concentration. Patients with Normal Renal Function Adults The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose. Pediatric patients 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 …
Warnings
WARNINGS Infusion Reactions Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock and rarely cardiac arrest. Vancomycin hydrochloride for injection should be administered in a diluted solution over a period of not less than 60 minutes to avoid rapid-infusion-related reactions. Stopping the infusion usually results in prompt cessation of these reactions. Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Monitor renal function in all patients, especially patients with underlying renal impairment, patients with co-morbidities that predispose to renal impairment, and patients receiving concomitant therapy with a drug known to be nephrotoxic. Ototoxicity Ototoxicity has occurred in patients receiving vancomycin hydrochloride for injection. It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution …
Contraindications
CONTRAINDICATIONS Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.
Drug Interactions
Drug Interactions Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see Pediatric Use, PRECAUTIONS ) and anaphylactoid reactions (see ADVERSE REACTIONS ). Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially, neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin.
Adverse Reactions
ADVERSE REACTIONS Infusion-Related Events During or soon after rapid infusion of vancomycin hydrochloride for injection, patients may develop anaphylactoid reactions, including hypotension (see ANIMAL PHARMACOLOGY ), wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“red neck”) or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if vancomycin hydrochloride for injection is given by a slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin hydrochloride for injection was administered at a rate of 10 mg/min or less. Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Additional risk factors for AKI in patients receiving vancomycin include receipt of concomitant drugs known to be nephrotoxic, in patients with pre-existing renal impairment, or with co-morbidities that predispose to renal impairment. Interstitial nephritis has also been reported in patients receiving v…
Frequently Asked Questions
What is Vancomycin used for?
Vancomycin contains Vancomycin. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Vancomycin a controlled substance?
Vancomycin is not classified as a controlled substance by the DEA.
What is the generic name for Vancomycin?
The generic name for Vancomycin is Vancomycin. There are 12 other brand versions of Vancomycin.
What is the NDC code for Vancomycin 750 mg/150mL?
The NDC (National Drug Code) for Vancomycin 750 mg/150mL is 70594-056, listed by Xellia Pharmaceuticals USA LLC.
Other Vancomycin Brands
See all →- Vancomycin Hydrochloride1 g/172572-029
- Vancomycin Hydrochloride1.5 g/30mL82449-007
- Vancomycin Hydrochloride1.5 g/139822-0470
- Vancomycin Hydrochloride5 g/10143-9358
- TYZAVAN500 mg/100mL0143-9471
- VANCOMYCIN HYDROCHLORIDE1.25 g/250mL0338-0122
- VANCOMYCIN HYDROCHLORIDE750 mg/150mL0338-3580
- Vancomycin Hydrochloride100 g/166288-7100
- Vancomycin Hydrochloride10 g/100mL67457-342
- Vancomycin Hydrochloride10 g/168001-407
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)