Vancomycin CJ Dosage

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Dosage of Vancomycin CJ in details

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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 CJ. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min, are recommended in adults. 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. Infusion-related events may occur, however, at any rate or concentration.

Patients with Normal Renal Function

Adults

The usual daily intravenous dose is 2 g divided either as 500 mg every six 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.

Pediatric Patients

The usual intravenous dosage of Vancomycin CJ 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 CJ may be warranted in these patients.

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 CJ clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of Vancomycin CJ is recommended in these patients.

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 CJ serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin CJ 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 CJ Hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min.

DOSAGE TABLE FOR Vancomycin CJ PATIENTS WITH IMPAIRED RENAL FUNCTION

(Adapted from Moellering et al. 4)

Creatinine Clearance mL/min

Vancomycin CJ Dose mg/24 hr

100

90

80

70

60

50

40

30

20

10

1,545

1,390

1,235

1,080

925

770

620

465

310

155

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 15 mg/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 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 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.

Men: [Weight (kg) x (140 - age in years)]

72 x serum creatinine concentration (mg/dL)

Women: 0.85 x above value

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: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity. The safety and efficacy of Vancomycin CJ administration by the intrathecal (intralumbar or intraventricular) route 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 4g/L Vancomycin CJ Hydrochloride):

5% Dextrose Injection, USP

5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

Lactated Ringer's Injection, USP

5% Dextrose and Lactated Ringer's Injection

Normosol®-M and 5% Dextrose

0.9% Sodium Chloride Injection, USP

Isolyte® E

Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

Vancomycin CJ solution has a low pH and may cause physical instability of other compounds.

Mixtures of solutions of Vancomycin CJ and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of Vancomycin CJ. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of Vancomycin CJ to 5 mg/mL or less.

Although intravitreal injection is not an approved route of administration for Vancomycin CJ, precipitation has been reported after intravitreal injection of Vancomycin CJ 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.

What other drugs will affect Vancomycin CJ?

Other drugs may interact with Vancomycin CJ, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Vancomycin CJ interactions

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Aminoglycosides: Vancomycin CJ may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Bile Acid Sequestrants: May diminish the therapeutic effect of Vancomycin CJ. Management: Avoid concurrent administration of oral Vancomycin CJ and bile acid sequestrants when possible. If use of both agents is necessary, consider separating doses by at least 2 hours to minimize the significance of the interaction. Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

Colistimethate: Vancomycin CJ may enhance the nephrotoxic effect of Colistimethate. Management: Avoid coadministration of colistimethate and Vancomycin CJ whenever possible due to the potential for additive or synergistic nephrotoxicity. If coadministration cannot be avoided, closely monitor renal function. Consider therapy modification

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Neuromuscular-Blocking Agents: Vancomycin CJ may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May increase the serum concentration of Vancomycin CJ. Monitor therapy

Piperacillin: May enhance the nephrotoxic effect of Vancomycin CJ. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification


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References

  1. FDA/SPL Indexing Data. "6Q205EH1VU: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  2. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "vancomycin: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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