Vanconex

Vanconex

vancomycin

Manufacturer:

Amarox
Full Prescribing Info
Contents
Vancomycin.
Description
VANCONEX Lyophilized Powder Injection 500 mg, each vial contains: Vancomycin HCl equivalent to Vancomycin 500 mg.
Action
Vancomycin is an active glycopeptide antibiotic against Staphylococci including Staphylococcus aureus and Staphylococcus epidermidis, Streptococci including Streptococcus pyogenic, Streptococcus pneumoniae, Streptococcus agalactiae, viridans group, Streptococcus bovis dan Enterococci, Clostridium difficile dan Diphtheroids. Other organisms that are sensitive in vitro to Vancomycin are Listeria monocytogenes, Lactobacillus sp., Actinomyces sp., Clostridium sp., and Bacillus sp. This mechanism of action by inhibiting bacterial cell wall synthesis in different places with Penicillin and Cephalosporin by binding strongly to the D-alanyl-D-alanine cell wall precursor.
Vancomycin can change the permeability of the bacterial cytoplasmic membrane and selectively inhibit RNA synthesis.
Indications/Uses
VANCONEX is indicated for the treatment of serious or severe infections caused by Staphylococcus susceptible strains of Methicillin-resistant (β-lactam resistant).
Penicillin-allergic patients.
Patients who cannot receive or who have failed to respond to other drugs, including treatment with the Penicillin or Cephalosporin class.
Infection caused by Vancomycin-susceptible microorganisms that are resistant to other antimicrobial drugs.
Treatment of Staphylococcal endocarditis.
Treatment of endocarditis caused by Enterococci (such as E. faecalis), which can be combined with Aminoglycosides.
Treatment of diphtheroid endocarditis.
VANCONEX is used in combination with Rifampin, Aminoglycosides or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
Dosage/Direction for Use
Patients with normal renal function: Adult: Usual intravenous dosage : 2 g divided doses is given 500 mg every 6 hours or 1 g every 12 hours. The dose should be administered at no more than 10 mg/minute with duration no less than 60 minutes. The usual dosage per day is adjusted according to the condition of the patient's age or body weight.
Children: Usual intravenous dosage: 10 mg/kg body weight, given every 6 hours. Dosage should be given with duration no less than 60 minutes.
Infants and neonates: In infants and neonates, the dose of I.V. administration can be reduced. Both in infants and neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for infants in the 1st week of life or every 8 hours for 1 month old infants. Each dose should be administered over 60 minutes. Close monitoring of serum concentration of Vancomycin is needed in this group of patients.
Patients with impaired renal function and elderly: Dosage adjustment must be made in patients with impaired renal function. In the elderly, the dose can be reduced because of decreased renal function.
Measurement of Vancomycin serum concentration can helpful in optimizing therapy, especially in seriously ill patients with changing renal function. If renal clearance (creatinine clearance) can be measured, the dosage for patients with impaired renal function is adjusted as follows: See table.


Click on icon to see table/diagram/image


The initial dose should be no less than 15 mg/kg body weight in patients with mild to moderate renal failure. Renal clearance measurements are as follows: (See Formula 1 and Formula 2).


Click on icon to see table/diagram/image




Click on icon to see table/diagram/image


Reconstitution instructions: Add 10 mL of water for injection into the 500 mg vial.
Then add 100 mL of 5% Dextrose injection or 9% NaCl injection or Ringer's lactate.
Stability: After reconstitution, the potential of Vancomycin can last for 96 hours in refrigerator storage.
Contraindications
Patients who are hypersensitive to Vancomycin.
Warnings
VANCONEX should be given in solution with duration no less than 60 minutes.
VANCONEX administration can cause ototoxicity, which is temporary or permanent.
Concomitant administration with excessive doses of ototoxic agent can cause hearing loss.
VANCONEX should be used with caution in patients with renal failure.
Dosage of VANCONEX must be adjusted for patients with renal dysfunction.
The hearing function needs to be tested regularly to minimize the risk of ototoxicity.
Special Precautions
Prolonged use of Vancomycin may result in the overgrowth of non-susceptible microorganisms. Therefore, careful observation of the patient is essential.
Sometimes pseudomembranous colitis can occur due to C. difficile.
Reversible neutropenia has been reported in patients receiving I.V. Vancomycin. Therefore, it is necessary to monitor the leukocyte count.
Vancomycin is irritating to tissue, therefore must be given by I.V.
Use in pregnant and lactating women only if very necessary.
Concomitant administration of anesthetic agent can cause erythema and histamine-like flushing in children.
If superinfection occurs, the treatment is replaced with the right treatment.
To minimize the risk of nephrotoxicity in patients with renal dysfunction or patients receiving treatment with other Aminoglycosides, serial monitoring of renal function should be performed and the dose must be adjusted to the dosage for patients with impaired renal function.
The safety and efficacy of Vancomycin administered by intrathecal (intralumbar or intraventricular) has not been established.
Adverse Reactions
Cold, nausea, chills, urticaria, anaphylaxis, eosinophilia, neutropenia, Stevens-Johnson syndrome, vertigo, dizziness, tinnitus ototoxicity, toxic epidermal necrolysis, vasculitis, fever, hypotension, nephrotoxicity, redness of skin, thrombophlebitis, pain at the injection site.
Drug Interactions
Aminoglycosides injection of Amphotericin B, Aspirin or class of salicylates, Bacitracin injection, Bumetanida injection, Capreomycin, Carmustine, Cisplatin, Cyclosporin, Ethacrynic acid, Furosemide injection, Paromomycin, Polymyxin, Cyclizine, Meclizine, Phenothiazine, Trimethobenzamide.
Storage
Store below 30°C.
Shelf Life After Reconstitution: To reconstitute: VANCONEX is stable within 96 hours at 2°C - 8°C if it is diluted in water for injection and if it is further diluted in a 5% Dextrose infusion solution, it will be stable in 60 minutes at room temperature with 0.9% NACl or Ringer's lactate.
MIMS Class
ATC Classification
J01XA01 - vancomycin ; Belongs to the class of glycopeptide antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Lyo powd for inj (vial) 500 mg x 10's.
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