Vangacin 500/Vangacin 1 g

Vangacin 500/Vangacin 1 g Dosage/Direction for Use

vancomycin

Manufacturer:

Able Medical

Distributor:

Universal Medical Industry

Marketer:

Able Medical
Full Prescribing Info
Dosage/Direction for Use
Adult: Endocarditis: 500 mg intravenously (IV) every 6 hours or 1 g IV every 12 hours.
C. difficile-associated diarrhea/staphylococcal enterocolitis: 500 mg to 2 g orally daily given in 4 divided doses for 7 to 14 days. (See Preparation for administration as follows.)
Staphylococcal infections: usual 500 mg IV every 6 hours or 1 g IV every 12 hours.
Pediatric: Endocarditis: 1 month and older: 10 mg/kg/dose IV given every 6 hours.
Up to 1 month of age: The total daily IV 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 first week of life and every 8 hours thereafter up to 1 month of age.
In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants.
Pseudomembranous colitis/staphylococcal enterocolitis: Usual dosage: 40 mg/kg/day given orally in 3 or 4 divided doses for 7 to 10 days. (See Preparation for administration as follows.) Maximum dose: 2 g/ day.
Staphylococcal infections: usual dosage: 1 month and older: 10 mg/kg/dose IV given every 6 hours.
Up to 1 month of age: The total IV dosage may be lower. An initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every 8 hours thereafter up to the age of 1 month.
In premature infants, vancomycin clearance decreases as postconceptional age decrease. Therefore, longer dosing interval may be necessary in premature infants.
Prophylaxis against infective endocarditis: Children and adolescents: IV: Dental, oral, or upper respiratory tract surgery: 20 mg/kg/dose administered 1 hour prior to the procedure.
Elderly: Vancomycin dosage schedules should be adjusted in elderly patients. Greater dosage reductions than expected may be necessary because of decreased renal function.
Renal function impairment: Initial dose: The initial dose should be no less than 15 mg/kg even in patients with mild to moderate renal insufficiency.
Dosage adjustment: Dosage adjustment must be made in patients with impaired renal function. In premature infants and elderly patients, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentration can be helpful in optimization therapy, especially in seriously ill patients with changing renal function.
If creatinine clearance (CrCl) can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following data. The dosage of vancomycin per day in milligrams is about 15 times the glomerular filtration rate (GFR) in mL/min. (See Table.)

Click on icon to see table/diagram/image

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.
Indication-specific dosing: Adult & Geriatric: Pneumonia, S. aureus (methicillin-resistant): Community-acquired pneumonia (CAP): 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours for 7 to 21 days depending on severity.
Hospital-acquired pneumonia or ventilation-associated pneumonia: 15 mg/kg/dose every 8 to 12 hours for 7 days; may consider shorter or longer duration depending on rate of clinical improvement. A loading dose of 25 to 30 mg/kg/dose may be used in seriously ill patients.
When used as empiric therapy, use in combination with an antipseudomonal agent (one or two antipseudomonal agents depending on patient and institution specific risk factors).
Sepsis/Septic shock (empiric treatment or treatment for specific sensitive organism): IV: 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours. A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations in seriously ill patients.
Pediatric: Meningitis: infants > 1 month, Children, and Adolescents: IV: 15 mg/kg/dose every 6 hours (for empiric therapy, use in combination with a third-generation cephalosporin); duration of therapy should be individualized based upon clinical response. For methicillin-resistant S. aureus, treat for 2 weeks (with or without rifampin).
Pneumonia: Community-acquired pneumonia (CAP): infants > 3 month, Children, and Adolescents: IV: Note: In children ≥ 5 years, a macrolide antibiotic should be added if atypical pneumonia cannot be ruled out. Also consider if community-acquired MRSA suspected.
Group A Streptococcus (alternative to ampicillin or penicillin in beta-lactam allergic patients): 40 to 60 mg/kg/day divided every 6 to 8 hours.
Presumed bacterial (in addition to recommended antibiotic therapy), S. pneumoniae, moderate to severe infection (MICs to penicillin ≤ 2.0 mcg/mL) (alternative to ampicillin or penicillin): 40 to 60 mg/kg/day divided every 6 to 8 hours.
S. aureus (methicillin-susceptible) (alternative to cefazolin/oxacillin): 40 to 60 mg/kg/day divided every 6 to 8 hours.
S. aureus, moderate to severe infection (methicillin-resistant +/- clindamycin susceptible) (preferred): 40 to 60 mg/kg/day divided every 6 to 8 hours or dosing to achieve AUC/MIC > 400. Alternate regimen: 60 mg/kg/day divided every 6 hours for 7 to 21 days, depending on severity.
S. pneumoniae, moderate to severe infection (MICs to penicillin ≥4.0 mcg/mL) (alternative to ceftriaxone in beta-lactam allergic patients): 40 to 60 mg/kg/day divided every 6 to 8 hours.
Healthcare-associated pneumonia (HAP), S. aureus (methicillin-resistant): IV: Infants, Children, and Adolescent: 60 mg/kg/day divided every 6 hours for 7 to 21 days depending on severity.
Prophylaxis against infective endocarditis: Children and Adolescents: IV: Dental, oral, or upper respiratory tract surgery: 20 mg/kg/dose administered 1 hour prior to the procedure. Note: American Heart Associate (AHA) guidelines recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur.
GI/GU procedure: 20 mg/kg (plus gentamycin 1.5 mg/kg) administered 1 hour prior to surgery.
Note: Routine prophylaxis no longer recommended by the AHA.
Mode of Administration: Intermittent infusion is the recommended method of administration. Vancomycin hydrochloride is administered by slow IV infusion for the treatment of systemic infections. Vancomycin is very irritating to tissue and must not be given IM. Safety and efficacy of intrathecal (intralumbar or intraventricular) or intraperitoneal administration of vancomycin have not been determined. Vancomycin hydrochloride usually is administered by intermittent IV infusion but has been administered by continuous IV infusion when intermittent infusions were not feasible. Vangacin 500 and Vangacin 1 G are administered by intermittent IV infusion or continuous IV infusion.
Preparation for administration: Powder for IV infusion solution: At the time of use, reconstitute by adding 10 mL of sterile water for injection or 5% dextrose injection or 0.9% sodium chloride injection to the 500 mg vial, 20 mL of sterile water for injection or 5% dextrose injection or 0.9% sodium chloride injection to the 1 g vial.
Reconstituted solutions containing vancomycin 500 mg must be diluted with at least 100 mL of diluent. Reconstituted solutions containing vancomycin 1 g must be diluted with at least 200 mL of diluent. Administer vancomycin in concentration of no more than 5 mg/mL.
Admixture compatibilities: Compatibility: The following diluents are physically and chemically compatible with vancomycin: Dextrose 5% injection, dextrose 5% injection and sodium chloride 0.9% injection, Ringer's lactate injection, dextrose 5% and ringer's lactate injection, Normosol-M and dextrose 5%, Sodium chloride 0.9% injection, and Isolyte E.
Incompatibility: 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 IV lines between the administration of these antibiotics. It is recommended to dilute solutions of vancomycin to 5 mg/mL or less.
Vancomycin solution has a low pH and may cause chemical or physical instability when it is mixed with other compounds.
Storage/Stability: After initial reconstitution with sterile water for injection, Dextrose 5% injection, or Sodium chloride 0.9% injection, solution are stable for 14 days if refrigerated. After further dilution with dextrose 5% injection or Sodium chloride 0.9% injection, the solution may be stored in a refrigerator for 14 days without significant loss of potency.
Solution dilute with dextrose 5% and Sodium chloride 0.9% injection, Ringer's lactate injection, Ringer's lactate injection and dextrose 5% injection, or Normosol-M and dextrose 5% may be stored in a refrigerator for 96 hours.
Rate of administration: Administer vancomycin at rate no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer.
Intermittent IV infusion of vancomycin should be given over a period of at least 1 hour.
Rapid infusion (e.g. over several minutes) should be avoided, and patients should be monitored closely during infusion of the drug. However, to minimize adverse effect, vancomycin should be administered IV at a rate not exceeding 10 mg/min.
Parenteral drug product should be inspected visually for particle matter and discoloration prior to administration, whenever solution and container permit.
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