Trade Name: Vancomycin Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: SAMSON MEDICAL TECHNOLOGIES LLC

Presentation: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 100 g/1

Storage and handling

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

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • PHARMACY BULK PACKAGE u2013 NOT FOR DIRECT INFUSION
  • 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 bacteria.
  • Vancomycin Hydrochloride for Injection USP, Pharmacy Bulk Package bag SmartPak should not be used in patients who require less than a 500 mg dose of vancomycin.
  • Vancomycin Hydrochloride for Injection, USP is a white to almost white to brownish lyophilized powder for preparing intravenous (I.V.) infusions, in bags containing the equivalent of 100 grams vancomycin base.u00a0 500 mg of the base are equivalent to 0.34 mmol.u00a0 When reconstituted with Sterile Water for Injection to a concentration of 100 mg/mL, a clear, brownish-yellow solution is formed with the pH of the solution between 2.5 and 4.5.u00a0 This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see ).u00a0 n
  • Each SmartPaku00a0Pharmacy Bulk Package contains Vancomycin Hydrochloride for Injection, USP equivalent to 100 grams of vancomycin activity and is intended for intravenous infusion only following further dilution.u00a0 A Pharmacy Bulk Package is a sterile dosage form containing many single doses.u00a0 The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.u00a0
  • VANCOMYCIN HYDROCHLORIDE FOR INJECTION PHARMACY BULK PACKAGE BAG SMARTPAKSHOULD NOT BE USED IN PATIENTS WHO REQUIRE LESS THAN A 500 MG DOSE OF VANCOMYCIN.
  • BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION USING STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 MG PER ML AND FURTHER DILUTION IN 100 ML OF A COMPATIBLE SOLUTION AND INFUSED INTRAVENOUSLY.
  • THIS PRODUCT IS NOT INTENDED TO BE USED IN PEDIATRIC AND RENALLY IMPAIRED PATIENTS WHO REQUIRE LESS THAN A 500 MG DOSE.
  • Vancomycin is a tricyclic glycopeptide antibiotic derived from (formerly ).u00a0 The chemical name for vancomycin hydrochloride is [3S- [3*,6*(*),7*,22*,23*,26*,36*,38a*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino- 2,3,6-trideoxy-3-C-methyl-u03b1-L-lyxo-hexopyranosyl)-u00df-D-glucopyranosyl]oxy]-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)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1,16-[1,6,9]oxadiazacyclohexadecino[4,5- ][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is CHClNOu2022 HCl and the molecular weight is 1,485.74.
  • Vancomycin Hydrochloride has the following structural formula:
  • Vancomycin is poorly absorbed after oral administration.
  • In subjects with normal kidney function, multiple intravenous dosing of 1 g 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.
  • 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.u00a0 Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h.u00a0 Renal dysfunction slows excretion of vancomycin.u00a0 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.u00a0 Serum concentrations of about 10 mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin.u00a0 However, the safety and efficacy of the intraperitoneal use of vancomycin has not been established in adequate and well-controlled trials (see ).u00a0
  • Total systemic and renal clearance of vancomycin may be reduced in the elderly.
  • 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.u00a0 Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.
  • MICROBIOLOGY
  • The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics. Vancomycin is not active against gram-negative bacilli, mycobacteria, or fungi.
  • Synergy
  • The combination of vancomycin and an aminoglycoside acts synergistically against many strains of ,u00a0, enterococci, and the viridans group streptococci.
  • Vancomycin has been shown to be active against most strains of the following microorganisms, both and in clinical infections as described in the section.
  • Aerobic gram-positive microorganisms
  • DiphtheroidsEnterococci ()Staphylococci, including and (including heterogeneous methicillin-resistant strains)n n Viridans group streptococci
  • The following data are available,u00a0.
  • Vancomycin exhibits MICu2019s of 1 mcg/mL or less against most (u226590%) strains of streptococci listed below and MICu2019s of 4 mcg/mL or less against most (u226590%) strains of other listed microorganisms; however the safety and effectiveness of vancomycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
  • Aerobic gram-positive microorganisms
  • Listeria monocytogenesn- Streptococcus pyogenesn- Streptococcus pneumoniae n- Streptococcus agalactiae
  • Anaerobic gram-positive microorganisms
  • Actinomyces n- Lactobacillus
  • For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: .
  • Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-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 is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
  • Vancomycin 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, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
  • Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by or . For endocarditis caused by enterococci (., ), vancomycin has been reported to be effective only in combination with an aminoglycoside.
  • Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by or diphtheroids.
  • Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.u00a0 When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.u00a0 In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  • The parenteral form of vancomycin hydrochloride 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. Vancomycin is not effective by the oral route for other types of infection.
  • Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.
  • Infusion Reactionsn- e.g.
  • Nephrotoxicity
  • This formulation of Vancomycin Hydrochloride for Injection, USP, Pharmacy Bulk Package bags SmartPakshould not be used for renally impaired patients who require less than a 500 mg dose of vancomycin.
  • Systemic vancomycin exposure may result in acute kidney injury (AKI).u00a0 The risk of AKI increases as systemic exposure/serum levels increase.u00a0 Monitor renal function in all patients receiving vancomycin, 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 in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations.
  • Dosage of vancomycin hydrochloride for injection must be adjusted for patients with renal dysfunction (see and ).
  • Arrayn- 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.u00a0 Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
  • 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.
  • No data
  • No data
  • Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis.u00a0 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.
  • 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 Physiciansu2019 Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.
  • Vancomycin Hydrochloride for Injection USP, Pharmacy Bulk Package bag SmartPak should not be used in patients who require less than a 500 mg dose of vancomycin.
  • The intent of the pharmacy bulk package for this product is for preparation of solutions for intravenous infusion only.
  • THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION WITH STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 mg per mL AND FURTHER DILUTION IN 100 mL OF A COMPATIBLE SOLUTION.
  • Vancomycin Hydrochloride for Injection, USP is a sterile, lyophilized powder available in the following SmartPaku00a0Pharmacy Bulk Package:
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0100 grams*
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0*Each 100 gram pharmacy bulk package contains sterile vancomycin hydrochloride equivalent to 100 grams of vancomycin
  • Prior to reconstitution, Vancomycin Hydrochloride for Injection, USP should be stored at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature].
  • SmartPak system components are not made with natural rubber latex.
  • 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/minute.
  • No data
  • SmartPak is a registered trademark of Samson Medical Technologies, L.L.C.
  • Revised 12/2018n n
  • Manufactured for:Samson Medical Technologies, L.L.C.Cherry Hill, NJ 08003
  • Manufacturedu00a0by:Xellia Pharmaceuticals ApSCopenhagen, Denmark
  • NDC 66288-7100-1 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Smartpakn
  • Vancomycin Hydrochloride for Injection, USP
  • 100 grams [ONE HUNDRED GRAMS]* per Pharmacy Bulk Package Bag
  • PHARMACY BULK PACKAGE -u00a0
  • NOT FOR DIRECT INFUSION
  • FOR INTRAVENOUS USE ONLY
  • NOT TO BE DISPENSED AS A UNIT
  • Rx only

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Vancomycin Hydrochloride (Vancomycin Hydrochloride) which is also known as Vancomycin Hydrochloride and Manufactured by SAMSON MEDICAL TECHNOLOGIES LLC. It is available in strength of 100 g/1.

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