Vancomycin-0.9% Nacl

Drug overview for VANCOMYCIN-0.9% NACL (vancomycin in 0.9 % sodium chloride/preservative free):

Generic name: VANCOMYCIN IN 0.9 % SODIUM CHLORIDE/PRESERVATIVE FREE
Drug class: Ophthalmic Antibacterials
Therapeutic class: Ophthalmic Agents

Vancomycin is a tricyclic glycopeptide antibiotic.

No enhanced Uses information available for this drug.

DRUG IMAGES

No Image Available

The following indications for VANCOMYCIN-0.9% NACL (vancomycin in 0.9 % sodium chloride/preservative free) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following dosing information is available for VANCOMYCIN-0.9% NACL (vancomycin in 0.9 % sodium chloride/preservative free):

Dosing
Administration
Dosing Information
Generic

Each bottle of commercially available vancomycin hydrochloride powder for oral solution must be reconstituted by a healthcare professional. The manufacturer-supplied premeasured diluent should be used to reconstitute the powder. Prior to reconstitution, tap the bottle on a hard surface to loosen the powder.

Shake the bottle of diluent and then add approximately half of the diluent to the powder. Shake the mixture for approximately 45 seconds. Then, add the remaining diluent and shake the bottle for approximately 30 seconds.

The final concentration of the solution is 25 or 50 mg/mL.

Dosage of vancomycin hydrochloride is expressed in terms of vancomycin.

For the treatment of serious or severe infections in adults with normal renal function, the usual IV dosage of vancomycin is 500 mg every 6 hours or 1 g every 12 hours.

A consensus guideline published by the American Society of Health-System Pharmacists (ASHP), the Infectious Diseases Society of America (IDSA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP) provides recommendations for vancomycin dosing and monitoring in the treatment of serious MRSA infections (e.g., bacteremia, sepsis, infective endocarditis, pneumonia, osteomyelitis, meningitis). In critically ill patients with suspected or documented serious MRSA infections, a vancomycin loading dose of 20-35 mg/kg (based on actual body weight with a maximum dose of 3 g) can be considered for intermittent-infusion administration. A vancomycin loading dose of 20-25 mg/kg using actual body weight, with a maximum dose of 3 g, may be considered in obese adult patients with serious infections.

Consult the guidelines for additional information (https://www.ashp.org/-/media/assets/policy-guidelines/docs/therapeutic-gui delines/therapeutic-guidelines-monitoring-vancomycin-ASHP-IDSA-PIDS.pdf)

For neonates, the manufacturers suggest an initial IV vancomycin dose of 15 mg/kg, followed by 10 mg/kg either every 12 hours (in neonates <1 week of age) or every 8 hours (in infants 1 week to 1 month of age); close monitoring of serum vancomycin concentrations is recommended in these patients. Longer dosing intervals may be necessary in premature infants.

The American Academy of Pediatrics (AAP) provides recommendations for vancomycin dosing in neonates based on serum creatinine concentrations. An initial IV loading dose of 20 mg/kg is recommended followed by a maintenance dosage in Table 1.

Table 1. AAP Recommended General Dosage of Vancomycin in Neonates Following an Initial Loading Dose of 20 mg/kg.

Gestational Age Serum Creatinine (mg/dL) Dosage 28 weeks or less Less than 0.5 15 mg/kg every 12 hours 28 weeks or less 0.5-0.7

20 mg/kg every 24 hours 28 weeks or less 0.8-1 15 mg/kg every 24 hours 28 weeks or less 1.1-1.4

10 mg/kg every 24 hours 28 weeks or less Greater than 1.4 15 mg/kg every 48 hours Greater than 28 weeks Less than 0.7 15 mg/kg every 12 hours Greater than 28 weeks 0.7-0.9

20 mg/kg every 24 hours Greater than 28 weeks 1-1.2 15 mg/kg every 24 hours Greater than 28 weeks 1.3-1.6

10 mg/kg every 24 hours Greater than 28 weeks Greater than 1.6 15 mg/kg every 48 hours

The maintenance dosage should begin at the same number of hours after the loading dose as the interval in the recommended dosage regimen.

For invasive MRSA infections, a 24-hour AUC/MIC ratio >=400 mgxh/L is recommended based on adult studies.

For older infants and children with normal renal function, manufacturers recommend an IV vancomycin dosage of 10 mg/kg every 6 hours. AAP suggests that children >=1 month of age receive IV vancomycin in a dosage of 45-60 mg/kg daily given in 3-4 divided doses.

For children with normal renal function and suspected serious MRSA infections (e.g., pneumonia, pyomyositis, multifocal osteomyelitis, complicated bacteremia, necrotizing fasciitis), the consensus guideline published by ASHP, IDSA, PIDS, and SIDP recommends an initial IV vancomycin dosage of 60-80 mg/kg per day, in divided doses given every 6 hours for children 3 months to <12 years of age, or an initial vancomycin dosage of 60-70 mg/kg per day, in divided doses given every 6 to 8 hours, for pediatric patients >=12 years of age. The consensus guideline states that the maximum empiric daily dose of IV vancomycin is usually 3.6 g in children with adequate renal function.

Consult the guidelines for additional information (https://www.ashp.org/-/media/assets/policy-guidelines/docs/therapeutic-gui delines/therapeutic-guidelines-monitoring-vancomycin-ASHP-IDSA-PIDS.pdf)

Vancomycin hydrochloride is administered by IV infusion for the treatment of systemic infections. Vancomycin hydrochloride is administered orally as capsules or solution for the treatment of Clostridioides difficile (formerly known as Clostridium difficile-associated diarrhea or enterocolitis caused by Staphylococcus aureus (including MRSA). If necessary, the parenteral form of vancomycin hydrochloride may be diluted and administered orally by mouth or nasogastric tube for these indications.

Orally administered vancomycin is not effective for and should not be used for the treatment of systemic infections. Vancomycin has been administered rectally+ in the treatment of fulminant CDI in adults. Safety and efficacy of intrathecal (intralumbar or intraventricular), intracameral, intravitreal, or intraperitoneal administration of vancomycin have not been established.

No dosing information available.

No generic dosing information available.

Moderate List
No disease contraindications

The following precautions are available for VANCOMYCIN-0.9% NACL (vancomycin in 0.9 % sodium chloride/preservative free):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of oral vancomycin have not been established in pediatric patients. IV vancomycin should be used with caution in premature neonates and young infants because of the renal immaturity of these patients and the potential for increased serum concentrations of the drug. Close monitoring of serum vancomycin concentrations may be warranted in pediatric patients, especially neonates and young infants. Safety of the chemical components that may leach out of the plastic containers of commercially available frozen vancomycin injections has not been established in children.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

There was no evidence of teratogenicity when vancomycin was administered IV to rats in dosages up to 200 mg/kg daily (1180 mg/m2 or equivalent to the recommended maximum human dosage based on mg/m2) or to rabbits in dosages up to 120 mg/kg daily (1320 mg/m2 or 1.1 times the recommended maximum human dosage based on mg/m2). There were no effects on fetal weight or development in rats at the highest dosage tested or in rabbits given 80 mg/kg daily (880 mg/m2 or 0.74 times the maximum recommended human dosage based on mg/m2). In one study, no sensorineural hearing loss or nephrotoxicity was reported in neonates born to women who received IV vancomycin for severe staphylococcal infections associated with injection drug abuse- during pregnancy.

In one infant whose mother received IV vancomycin in the third trimester of pregnancy, conductive hearing loss was reported; however, a causal relationship to vancomycin has not been established. Because the number of pregnant women in this study was limited and vancomycin was only administered during the second and third trimester of pregnancy, it is not known whether the drug can cause fetal harm when administered to pregnant women. In a prospective study, no major adverse effects were observed in mothers or their newborns when IV vancomycin was administered at the time of delivery.

This study included 55 pregnant women with positive group B Streptococcus culture with resistance to clindamycin or unknown sensitivity and a high-risk penicillin allergy. Vancomycin dosage ranged from 1 g every 12 hours to 20 mg/kg (maximum individual dose 2 g) every 8 hours. None of the newborns had sensorineural hearing loss; although renal function of the neonates was not assessed, all neonates were discharged in good condition. Vancomycin should be used during pregnancy only when clearly needed.

Vancomycin is distributed into milk following IV administration. Systemic absorption of oral vancomycin is very low and it is not known whether the drug distributes into human milk following oral administration. However, IV and oral vancomycin should be used with caution in nursing women. Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of vancomycin to the woman.

In clinical studies of oral vancomycin, 54% of patients were >65 years of age; of these, 40% were >65-75 years of age and 60% were >75 years of age. In these studies, geriatric patients treated with oral vancomycin capsules for diarrhea associated with CDI were more likely to develop nephrotoxicity during or after completion of therapy. Renal function should be monitored during and after treatment with oral vancomycin in all geriatric patients, including those with normal renal function.

Geriatric patients >65 years of age may take longer to respond to oral vancomycin therapy compared with younger patients. Clinicians should be aware of the appropriate duration of oral vancomycin treatment in geriatric patients and therapy should not be prematurely discontinued or prematurely switched to an alternate therapy. IV vancomycin dosage in geriatric patients should be adjusted based on the degree of renal impairment. Because geriatric patients may have decreasing glomerular filtration with increasing age, increased serum vancomycin concentrations may occur if dosage is not adjusted in these patients.