Vancomycin Hydrochloride (Vancomycin)

Trade Name : Vancomycin

Sagent Pharmaceuticals

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 5 g/100mL

Storage and handling for Vancomycin

VANCOMYCIN HYDROCHLORIDE Glycopeptide Antibacterial [EPC],Glycopeptides [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Vancomycin Hydrochloride (Vancomycin) which is also known as Vancomycin and Manufactured by Sagent Pharmaceuticals. It is available in strength of 5 g/100mL per ml. Read more

Vancomycin Hydrochloride (Vancomycin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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SAGENTn Rx onlyn
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride and other antibacterial drugs, vancomycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.n

Vancomycin Hydrochloride for Injection, USP is an off white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 grams or 10 grams vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg per mL for the 5 gram Pharmacy Bulk Package bottle and 100 mg per mL for the 10 gram Pharmacy Bulk Package bottle, the pH of the solution is between 2.5 and 4.5. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see ).n
Vancomycin Hydrochloride for Injection, USP is a tricyclic glycopeptide antibiotic derived from (formerly ).n
The chemical name for vancomycin hydrochloride is (n )-(,,,)-44-[[2--(3-Amino- 2,3,6-trideoxy-3--methyl-u03b1-L--hexopyranosyl)-u03b2-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-[()-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo--8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-,-[1,6,9]oxadiazacyclohexadecino[4,5-][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is CHClNOu2022HCl and the molecular weight is 1,485.73.n
Vancomycin hydrochloride has the following structural formula:n
A is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see ). n

Vancomycin is poorly absorbed after oral administration.n
In subjects with normal kidney function, multiple intravenous dosing of 1 gram of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately after the completion of infusion, mean plasma concentrations of approximately 23 mcg/mL 2 hours after infusion, and mean plasma concentrations of approximately 8 mcg/mL 11 hours after the end of the infusion. Multiple dosing of 500 mg infused over 30 minutes produces mean plasma concentrations of about 49 mcg/mL at the completion of infusion, mean plasma concentrations of about 19 mcg/mL 2 hours after infusion, and mean plasma concentrations of about 10 mcg/mL 6 hours after infusion. The plasma concentrations during multiple dosing are similar to those after a single dose.n
The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function. In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h. Renal dysfunction slows excretion of vancomycin. In anephric patients, the average half-life of elimination is 7.5 days. The distribution coefficient is from 0.3 to 0.43 L/kg. There is no apparent metabolism of the drug. About 60% of an intraperitoneal dose of vancomycin administered during peritoneal dialysis is absorbed systemically in 6 hours. Serum concentrations of about 10u00a0mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin. However, the safety and efficacy of the intraperitoneal use of vancomycin has not been established in adequate and well-controlled trials (see .n
Total systemic and renal clearance of vancomycin may be reduced in the elderly.n
Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL. After IV administration of vancomycin, inhibitory concentrations are present in pleural, pericardial, ascitic, and synovial fluids; in urine; in peritoneal dialysis fluid; and in atrial appendage tissue. Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.n

Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (u03b2-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.n
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.n
Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by or . For endocarditis caused by enterococci (e.g., ), Vancomycin Hydrochloride for Injection, USP has been reported to be effective only in combination with an aminoglycoside.n
Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by or diphtheroids.n
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin hydrochloride.n
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.n
The parenteral form of Vancomycin Hydrochloride for Injection, USP may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. n

Vancomycin hydrochloride is contraindicated in patients with known hypersensitivity to this antibiotic.n

Infusion Reactions
Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock and rarely cardiac arrest.n
Vancomycin hydrochloride 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.n
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.n
Ototoxicity
Ototoxicity has occurred in patients receiving vancomycin hydrochloride. 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 in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations.n
Dosage of vancomycin hydrochloride must be adjusted for patients with renal dysfunction (see and ).n
Clostridium Difficilen- Associated Diarrhea (CDAD)
Clostridium difficilen- C. difficile
C. difficilen- C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.n
Hemorrhagic Occlusive Retinal Vasculitis (HORV)
Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials. Vancomycin is not indicated for the prophylaxis of endophthalmitis.n

Clinically significant serum concentrations have been reported in some patients being treated for active -induced pseudomembranous colitis after multiple oral doses of vancomycin.n
Prolonged use of vancomycin hydrochloride may result in the overgrowth of nonsusceptible microorganisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to developing in patients who received intravenous vancomycin hydrochloride.n
Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.n
Reversible neutropenia has been reported in patients receiving vancomycin hydrochloride (see ). Patients who will undergo prolonged therapy with vancomycin hydrochloride or those who are receiving concomitant drugs which may cause neutropenia should have periodic monitoring of the leukocyte count.n
Vancomycin hydrochloride for injection is irritating to tissue and must be given by a secure IV route of administration. Pain, tenderness, and necrosis occur with intramuscular (IM) injection of vancomycin hydrochloride for injection or with inadvertent extravasation. Thrombophlebitis may occur, the frequency and severity of which can be minimized by administering the drug slowly as a dilute solution (2.5 to 5 g/L) and by rotation of venous access sites.n
There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related events may be minimized by the administration of vancomycin as a 60-minute infusion prior to anesthetic induction. The safety and efficacy of vancomycin administered by the intrathecal (intralumbar or intraventricular) route or by the intraperitoneal route have not been established by adequate and well controlled trials.n
Reports have revealed that administration of sterile vancomycin by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has resulted in a syndrome of chemical peritonitis. To date, this syndrome has ranged from cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be short-lived after discontinuation of intraperitoneal vancomycin.n
Prescribing Vancomycin Hydrochloride for Injection, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.n

No data

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. The median lethal intravenous dose is 319 mg/kg in rats and 400 mg/kg in mice.n
To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.n

The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only.
Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg per mL and rates of no more than 10u00a0mg/min, are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10u00a0mg per 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 ). Infusion-related events may occur, however, at any rate or concentration.n

For Administration by Intravenous Drip
Refer to Directions for Proper Use of a Pharmacy Bulk Package Bottle.n
CAUTION: NOT TO BE DISPENSED AS A UNIT.

In animal studies, hypotension and bradycardia occurred in dogs receiving an intravenous infusion of vancomycin hydrochloride 25 mg/kg, at a concentration of 25 mg/mL and an infusion rate of 13.3 mL/min.n

Brands listed are the trademarks of their respective owners.n
SAGENTn
Mfd. for SAGENT PharmaceuticalsSchaumburg, IL 60195 (USA)Made in Indiau00a92018 Sagent Pharmaceuticals, Inc.n
Revised: January 2018n
SAGENT Pharmaceuticalsn

PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Bottle Labeln
NDC 25021-157-99n
Rx onlyn
Vancomycin Hydrochloride for Injection, USPn
(Formerly: Sterile Vancomycin Hydrochloride)n
PHARMACY BULK PACKAGEn
NOT FOR DIRECT INFUSIONn
5 gramsn
per Pharmacy Bulk Packagen
For Intravenous Use After Dilutionn
AFTER RECONSTITUTION MUST BE FURTHER DILUTED BEFORE INFUSION. NOT TO BE DISPENSED AS A UNIT.n

PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Bottle Labeln
NDC 25021-158-99n
Rx onlyn
Vancomycin Hydrochloride for Injection, USPn
(Formerly: Sterile Vancomycin Hydrochloride)n
PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSIONn
10 gramsn
per Pharmacy Bulk Packagen
For Intravenous Use After Dilutionn
AFTER RECONSTITUTION MUST BE FURTHER DILUTED BEFORE INFUSION. NOT TO BE DISPENSED AS A UNIT.n

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Vancomycin Hydrochloride (Vancomycin)

Trade Name : Vancomycin

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Storage and handling for Vancomycin

Disclaimer

Delivery Process

Product information is meant for

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About GNH

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Vancomycin Hydrochloride (Vancomycin)

Trade Name : Vancomycin

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Storage and handling for Vancomycin

Disclaimer

Delivery Process

Product information is meant for

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

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Losartan Potassium (Losartan Potassium)

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