G-Vanc

Vancomycin hydrochloride.

Each vial contains Vancomycin Hydrochloride USP equivalent to Vancomycin 500 mg.

Pharmacology: MECHANISM OF ACTION: Vancomycin is bactericidal and appears to bind to the bacterial cell wall causing blockage of glycopeptide polymerization. This effect, which occurs at a site different from that affected by the penicillins, produces immediate inhibition of cell wall synthesis and secondary damage to the cytoplasmic membrane. Magnesium, manganese, calcium, and ferrous ions reduce the degree of adsorption of Vancomycin to the cell wall, but the in vivo importance of this interaction is unknown.
PHARMACOKINETICS: Distribution: Widely in body tissues and fluids. Except for CSF.
Relative diffusion from blood into CSF: Good only with inflammation (exceeds usual MICs).
CSF: Blood level ratio: Normal meninges: Nil; Inflamed meninges: 20% to 30%.
Protein binding: 10% to 50%.
Half-life elimination: Newborns: 6-10 hours.
Infants and Children 3 months to 4 years: 4 hours.
Children > 3 years: 2.2-3 hours.
Adults: 5-11 hours: Significantly prolonged with renal impairment.
End-stage renal disease: 200-250 hours.
Time to peak, serum: I.V: 45-65 minutes (Immediately after completion of infusion).
Excretion: I.V: Urine (80% to 90% as unchanged drug).

Vancomycin is indicated in the treatment of severe, potentially life-threatening Staphylococcal infections in patients who can not receive penicillins or cephalosporins or who have failed to respond to them.
Vancomycin is indicated for prophylaxis of bacterial endocarditis in penicillin-allergic patients with prosthetic heart valves or congenital, rheumatic, or other acquired valvular heart disease who are undergoing dental procedures or surgical procedures of the upper respiratory tract.
Vancomycin is indicated in the treatment of bone and joint infections (including osteomyelitis), pneumonia, septicemia, skin and soft tissue infections caused by susceptible strains of Staphylococcus species (including methicillin-resistant strains), endocarditis caused by Staphylococcus species (including methicillin-resistant strains).
Vancomycin is also indicated as a primary agent, alone or concurrently with an aminoglycoside or rifampin, in endocarditis caused by Corynebacterium species (diphtheroids) (including penicillin-resistant and cephalosporin-resistant strains) in penicillin-allergic patients, and as a secondary agent in endocarditis caused by Streptococcus viridians or Streptococcus bovis.

Administration: Vancomycin is administered by slow IV infusion for the treatment of systemic infections. (See preparation of dosage form for intravenous use as follows.)
Dosage: Neonates: Postnatal age ≤ 7 days: < 1200 g: 15 mg/kg/dose every 24 hours.
1200-2000 g: 10 mg/kg/dose every 12 hours.
> 2000 g: 15 mg/kg/dose every 12 hours.
Postnatal age > 7 days: < 1200 g: 15 mg/kg/dose every 24 hours.
≥ 1200 g: 10 mg/kg/dose divided every 8 hours.
Infants > 1 month and Children: 40 mg/kg/day in divided doses every 6 hours.
Prophylaxis for bacterial endocarditis: Dental, oral, or upper respiratory tract surgery: 20 mg/kg 1 hour prior to the procedure.
GI/GU procedure: 20 mg/kg plus gentamicin 2 mg/kg 1 hour prior to surgery.
Infants > 1 month and Children with staphylococcal central nervous system infection: 60 mg/kg/day in divided doses every 6 hours.
Adults: With normal renal function: 1 g or 10-15 mg/kg/dose every 12 hours.
Prophylaxis for bacterial endocarditis: Dental, oral, or upper respiratory tract surgery: 1 g 1 hour before surgery.
GI/GU procedure: 1 g plus 1.5 mg/kg gentamicin 1 hour prior to surgery.
Dosage interval in renal impairment (vancomycin levels should be monitored in patients with any renal impairment): Cl_cr > 60 mL/minute: Start with 1 g or 10-15 mg/kg/dose every 12 hours.
Cl_cr 40-60 mL/minute: Start with 1 g or 10-15 mg/kg/dose every 24 hours.
Cl_cr < 40 mL/minute: Will need longer intervals; determine by serum concentration monitoring.
Hemodialysis: Not dialyzable (0% to 5%); generally not removed; exception minimal moderate removal by some of the newer high-flux filters; dose may need to be administered more frequently; monitor serum concentrations.
Preparation of dosage form for intravenous use: To prepare initial dilution for intravenous use, 10 or 20 mL of sterile water for injection should be added to each 500-mg or 1-gram vial, respectively. For intermittent intravenous infusion (preferred), the 10-mL or 20-mL solution should be further diluted in 100 or 200 mL, respectively, of 5% dextrose injection or 0.9% sodium chloride injection. The resulting solution should be administrated over a 60-minute period or longer.
For continuous intravenous infusion (used only when intermittent infusion is not feasible), 1 to 2 grams (20 to 40 mL) may be added to a sufficiently large volume of 5% dextrose injection or 0.9% sodium chloride injection to permit the total daily dose to be administrated slowly by intravenous drip over a 24-hour period. Avoid extravasation.

Symptoms include ototoxicity and nephrotoxicity. There is no specific therapy for vancomycin overdose. Care is symptomatic and supportive. Peritoneal filtration and hemofiltration (not dialysis) have been shown to reduce the serum concentration of vancomycin. High flux dialysis may remove up to 25%.
TREATMENT OF OVERDOSE: To enhance elimination: Poorly removed by dialysis: hemofiltration and hemoperfusion with polysulfone resin have been used to reduce elevated serum concentrations of vancomycin.
Monitoring: Patients should be monitored for electrolytes, fluid, hearing function, hematologic status (especially platelet and white blood cell counts), renal function, and vestibular function.
Supportive care: Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.

Hypersensitivity to vancomycin or any component of the formulation; avoid in patients with previous severe hearing loss.

Use with caution in patients with renal impairment or those receiving other nephrotoxic or ototoxic drugs; dosage modification required in patients with impaired renal function (especially elderly).

Pregnancy Risk Factor: C.
Intravenous vancomycin crosses the placenta. Should be given to a pregnant woman only if clearly needed.
Vancomycin is excreted in human milk. Caution should be exercised when vancomycin is administered to a nursing woman.

>10%: Cardiovascular: Hypotension accompanied by flushing.
Dermatologic: Erythematous rash on face and upper body (red neck or red man syndrome).
1% to 10%: Central nervous system: Chills, drug fever.
Hematologic: Eosinophilia.
<1% (limited to important or life-threatening): Ototoxicity, renal failure, thrombocytopenia.

Ototoxic and Nephrotoxic Drugs: Because of the possibility of additive toxicities, the concurrent or sequential systemic or topical use of other ototoxic and/or nephrotoxic drugs (e.g., aminoglycosides, amphotericin B. bacitracin, cisplatin, colistin, polymyxin B) and vancomycin requires careful monitoring of renal and auditory functions; these drugs should be used with caution in patients receiving vancomycin therapy.

STABILITY: After reconstitution with 5% dextrose injection or 0.9% sodium chloride injection, solutions retain their potency for 14 days if refrigerated.

Store below 25°C.

Other Antibiotics

J01XA01 - vancomycin ; Belongs to the class of glycopeptide antibacterials. Used in the systemic treatment of infections.

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