Vancosan

Vancosan

vancomycin

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Vancomycin.
Description
Each vial contains: Vancomycin Hydrochloride Sterile Lyophillized Powder equivalent to Vancomycin 0.5 g.
Action
Pharmacology: Vancomycin is a glycopeptide antibiotic that is active against staphylococci including Staphylococcus aureus and Staphylococcus epidermidis, streptococci including Streptococcus pyogenis, Streptococcus pneumoniae, Streptococcus agalactiae, viridans group, Streptococcus bovis and enterococci, Clostridium difficile and diphtheroids. Other organisms that are sensitive in vitro to Vancomycin are Listeria monocytogenes, Lactobacillus sp., Actinomyces sp., Clostridium sp., and Bacillus sp. Mechanism of action by inhibiting bacterial cell wall synthesis in different places with penicillin and cephalosporins by binding strongly to the precursor of the D-alanyl-D-alanine cell wall.
Vancomycin can alter the permeability of the bacterial cytoplasmic membrane and selectively inhibit RNA synthesis.
Indications/Uses
VANCOSAN is indicated for the treatment of serious or severe infections caused by sensitive staphylococcus susceptible strains Methicillin resistant (resistant to β-lactam).
Patients who are allergic to penicillin.
Patients who cannot receive or fail with the treatment of other drugs, including treatment with penicillin or cephalosporins.
Infections caused by microorganisms that are sensitive to Vancomycin but 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.
VANCOSAN is used in combination with Rifampin, aminoglycosides or a combination of both, resulting in rapid onset of prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
Dosage/Direction for Use
Patients with normal kidney function: Adult: Usual intravenous dosage: 2 g in divided doses given 500 mg every 6 hours or 1 g every 12 hours. Dosage should be given no more than 10 mg/minute with duration no less than 60 minutes. The usual dose per day is adjusted according to the age or body weight of the patient.
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 intravenous administration can be reduced. Both in infants and neonates, it is recommended to give an initial dose of 15mg/kg, followed by 10 mg/kg every 12 hours for infants in first week of birth or every 8 hours for 1 month old infants. Each dose must be given over than 60 minutes duration. It is necessary to closely monitor Vancomycin HCl concentration in serum in this group of patients.
Patients with impaired kidney function and elderly: Dosage must be adjusted for patients with impaired kidney function. In the elderly, the dose can be lowered due to decreased kidney function.
Measurement of Vancomycin HCl serum concentration can help optimum treatment, especially in patients with serious diseases with changing kidney clearance function. If kidney clearance (creatinine clearance) can be measured, the dose for patients with impaired kidney function is adjusted as follows: see table.


Click on icon to see table/diagram/image


The initial dose should be not less than 15 mg/kg body weight in patients with mild to moderate kidney failure.
Measurement of creatinine clearance as follows: see equation.


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 0.9% NaCl injection, or Ringer's lactate.
Contraindications
Patients who are hypersensitive to Vancomycin HCl.
Warnings
Vancomycin HCl powder for injection should be given in solution with duration no less than 60 minutes.
Administration of this product can cause ototoxicity, which is temporary or permanent.
Concomitant use with an ototoxic preparation with excessive doses can cause hearing loss.
Given carefully in patients with kidney failure.
The doses must be adjusted for patients with damaged kidney function.
The hearing function needs to be tested periodically to minimize the risk of ototoxicity.
Special Precautions
Prolonged use of Vancomycin HCl can cause the growth of insensitive microorganisms, therefore careful observation is needed in patients.
Sometimes pseudomembranous colitis can occur due to C. difficile.
Reversible neutropenia has been reported in patients receiving intravenous Vancomycin HCl, therefore it is necessary to monitor the leukocytes count.
Vancomycin HCl can irritate tissues, therefore the administration should be intravenous.
Use in pregnant and lactating women only if very necessary.
Concomitant use with anesthetic preparations can cause erythema and histamine-like flushing in children.
If superinfection occur, treatment is replaced with right treatment.
To reduce the risk of nephrotoxicity in patients with renal dysfunction or patients who are treated with other aminoglycosides it is necessary to periodically examine the kidneys and the dosage must be adjusted to the dose for patients with impaired kidney function.
Safety and effectiveness of intrathecal (intralumbar or intraventricular) Vancomycin HCl administration has not been established.
Adverse Reactions
Coldness, nausea, chills, urticaria, anaphylaxis, eosinophilia, neutropenia, Stevens-Johnson syndrome, vertigo, dizziness, tinnitus ototoxicity, toxic epidermal necrolysis, vasculitis, fever, hypotension, nephrotoxicity, redness of the skin, thrombophlebitis, pain at the injection site.
Drug Interactions
Aminoglycosides, injection of Amphotericin B, Aspirin or class of Salicylates, Bacitracin injection, Bumetanide injection, Capreomycin, Carmustine, Cisplatin, Cyclosporin, Ethacrynic acid, Furosemide injection, Paromomycin, Polymyxin, Cyclizine, Meclizine, Phenothiazine, Trimethobenzamide.
Caution For Usage
Stability: After reconstitution, Vancomycin potency can last for 96 hours in storage between 2°C and 8°C.
Storage
Store between 2°C and 8°C.
MIMS Class
Other Antibiotics
ATC Classification
J01XA01 - vancomycin ; Belongs to the class of glycopeptide antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Form
Vancosan powd for inj 0.5 g
Packing/Price
2 × 1's (Rp367,800/boks)
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