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Vancomycin Hydrochloride (Vancomycin Hydrochloride)

Trade Name : Vancomycin Hydrochloride

Hospira, Inc.

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 100 mg/mL

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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

Vancomycin Hydrochloride (Vancomycin Hydrochloride) 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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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.

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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  • Rx only
  • 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 is a white to tan lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 10 grams vancomycin base. 500 mg of the base is equivalent to 0.34 mmol. When reconstituted as directed each 5u00a0mL contains 500 mg and each 10 mL contains 1 gram. The reconstituted product is a clear light to dark tan solution with a pH in the range of 2.5 to 4.5. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see ).
  • Vancomycin hydrochloride for injection, USP is a tricyclic glycopeptide antibiotic derived from (formerly ). The chemical name for Vancomycin hydrochloride is ()-(3,672223,26,3638a)-44-[[2--(3-Amino-2,3,6-trideoxy-3--methyl-u03b1-L--hexopyranosyl)-u00df-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-[(2)-4-methyl-2-(methylamino)]valeramido]-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 CHClNO u2022 HCl and the molecular weight is 1485.71. Vancomycin hydrochloride has the following structural formula:
  • A Pharmacy Bulk Package 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.
  • In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (15u00a0mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63u00a0mcg/mL immediately after the completion of infusion, mean plasma concentrations of approximately 23u00a0mcg/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. Mean plasma clearance is about 0.058 L/kg/hr, and mean renal clearance is about 0.048 L/kg/hr. 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 ).
  • 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. Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.
  • 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.
  • 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 reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by or . For endocarditis caused by enterococci (e.g., ), vancomycin has been reported to be effective only in combination with an aminoglycoside.
  • 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.
  • 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 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.
  • 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. n
  • Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.
  • 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.
  • 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 n and ).
  • Clostridium difficilen- C. difficile
  • C. difficile n- 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.
  • No data
  • 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.
  • 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 . In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in your patient.
  • 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/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 ). Infusion-related events may occur, however, at any rate or concentration.
  • Arrayn- Patients with Normal Renal Function
  • Arrayn- 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.
  • Arrayn- 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 monitoring of serum concentrations of vancomycin may be warranted in these patients.
  • Arrayn- Neonates
  • In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.
  • Arrayn- Patients with Impaired Renal Function and Elderly Patients
  • Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.
  • If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).
  • The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.
  • The table is not valid for functionally anephric patients. For such patients, an initial dose of 15u00a0mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.
  • When only serum creatinine is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.
  • The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions:
  • The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.
  • Intermittent infusion is the recommended method of administration.
  • Compatibility with Other Drugs and IV Fluids
  • The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):
  • u00a0u00a0u00a0u00a0u00a05% Dextrose Injection, USPu00a0u00a0u00a0u00a0u00a05% Dextrose Injection and 0.9% Sodium Chloride Injection, USPu00a0u00a0u00a0u00a0u00a0Lactated Ringer's Injection, USPu00a0u00a0u00a0u00a0u00a05% Dextrose and Lactated Ringer's Injectionu00a0u00a0u00a0u00a0u00a0Normosol-M and 5% Dextroseu00a0u00a0u00a0u00a0u00a00.9% Sodium Chloride Injection, USPu00a0u00a0u00a0u00a0u00a0Isolyte E
  • Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.
  • Vancomycin solution has a low pH and may cause physical instability of other compounds.
  • Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.
  • Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.
  • No data
  • NDC No.
  • 0409-6510-01u00a0u00a0u00a0u00a0u00a0u00a0Vancomycin Hydrochloride for Injection, USP equivalent to 10 grams vancomycin in au00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0, (bottle capacity 100 mL), packaged individually.
  • Prior to reconstitution, store dry powder at 20 to 25u00b0C (68 to 77u00b0F). [See USP Controlled Room Temperature.]
  • 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.
  • Distributed by Hospira, Inc., Lake Forest, IL 60045 USA u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
  • LAB-1208-2.0
  • Revised: 9/2018
  • Preservative Free
  • Sterile, nonpyrogenicRx only
  • VancomycinHydrochloride for Injection, USP
  • PHARMACY BULK PACKAGE u2013 NOT FOR DIRECT INFUSION
  • 10 grams*
  • For Intravenous Use.
  • AFTER RECONSTITUTION MUST BEFURTHER DILUTED BEFORE INFUSION.n- Hospira
  • Preservative Free
  • NDC 0409-6510-01Rx only
  • VancomycinHydrochloridefor Injection, USP
  • PHARMACY BULK PACKAGE u2013 NOT FOR DIRECT INFUSION
  • 10 grams*
  • For Intravenous Use.AFTER RECONSTITUTION MUST BE FURTHER DILUTEDBEFORE INFUSION.
  • * Each Pharmacy Bulk Package contains:Vancomycin hydrochloride equivalent to10 g vancomycin.
  • Hospira

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