Malven Vancomycin Hydrochloride Injection

Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: 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 susceptible bacteria. …

• Use this formulation of Vancomycin Injection only in patients who require the entire (500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g) dose and not any fraction thereof
• For intravenous use only
• Do Not administer orally
• Administer Vancomycin Injection by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions Adult Patients: 2 g divided either as 0.5 grams (g) every 6 hours or 1 g every 12 hours
• Pediatric Patients (1 Month and Older): 10 mg/kg per dose given every 6 hours Patients with Renal Impairment: See full prescribing information for recommended doses in patients with renal impairment See full prescribing information for further important administration and preparation instructions Important Administration Instructions Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with Vancomycin Injection [see Warnings and Precautions , and Use in Specific Populations ]
• Use this formulation of Vancomycin Injection only in patients who require the entire (500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g) dose and not any fraction thereof
• Vancomycin Injection in transparent single-dose flexible bags are intended for intravenous use only
• Do NOT administer 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 and Adverse Reactions ] . …

Vancomycin Injection, USP is a ready to use clear, colorless to light brown solution in single-dose flexible bags containing 500 mg vancomycin in 100 mL, 750 mg vancomycin in 150 mL, 1 g vancomycin in 200 mL, 1.25 g vancomycin in 250 mL, 1.5 g vancomycin in 300 mL, 1.75 g vancomycin in 350 mL and 2 g vancomycin in 400 mL of liquid [see Description (11) ] . …

• Vancomycin Injection is indicated
• In pediatric patients (1 month and older) [see Indications and Usage (1.1 to 1.5) and Dosage and Administration ]
• In pediatric patients, monitor vancomycin serum concentration and renal function when administering Vancomycin Injection [see Dosage and Administration and Warnings and Precautions ]
• More severe infusion related reactions related to vancomycin administration may occur
• In pediatric patients. …

Vancomycin 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 (2.2) ] , and it may be useful to monitor renal function [see Warnings and Precautions (5.2) ] .

• Potential Risk of Exposure to Excipients During the First or Second Trimester of Pregnancy Advise patients to notify their healthcare provider if they are pregnant prior to treatment with this formulation of vancomycin [see Boxed Warning , Warnings and Precautions and Use in Specific Populations ]
• 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 Vancomycin Injection infusion
• These reactions can be lessened or prevented by infusing the drug over at least 60 minutes [see Warnings and Precautions ] . …

• Vancomycin Injection is contraindicated in patients with known hypersensitivity to vancomycin
• Hypersensitivity to vancomycin

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 (5.2) and Use in Specific Populations (8.4) ] . …

Infusion Reactions : Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain and "red man syndrome" which manifests as pruritus and erythema that involves the face, neck and upper torso 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 , 5.2 ) Nephrotoxicity : Systemic vancomycin exposure may result in acute kidney injury (AKI) including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. …

The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.2) ] Nephrotoxicity [see Warnings and Precautions (5.3) ] Ototoxicity [see Warnings and Precautions (5.4) ] Severe Dermatologic Reactions [see Warnings and Precautions (5.5) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.6) ] Hemorrhagic Occlusive Retinal Vasculitis [see Warnings and Precautions (5.7) ] Neutropenia [see Warnings and Precautions (5.8) ] The common adverse reactions are anaphylaxis, "red man syndrome", acute kidney injury, hearing loss, neutropenia. …

8.1 Pregnancy Risk Summary This formulation of Vancomycin Injection is not recommended for use during the first or second trimester of pregnancy because it contains the excipients, PEG 400 and NADA, which caused fetal malformations in animal reproduction studies (see Data ) . Advise pregnant women of the potential risk to the fetus. …

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.

16.2 Storage NDC number Packaging configuration 70594-041-02 Carton of six 500 mg/100 mL bags 70594-041-03 Carton of twelve 500 mg/100 mL bags 70594-056-02 Carton of six 750 mg/150 mL bags 70594-056-03 Carton of twelve 750 mg/150 mL bags 70594-042-02 …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.