POWDER FOR PREPARATION OF INJECTION SOLUTION 500 mg/1000 mg
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Composition

Powder for preparation of injection solution 500 mg
Vancomycin HC1 for injection B.P.
Each vial contains:
Sterile Vancomycin Hydrochloride B.P.
Equivalent to Vancomycin 500 mg

Powder for preparation of injection solution 1000 mg
Vancomycin HC1 for injection B.P.
Each vial contains:
Sterile Vancomycin Hydrochloride B.P.
Equivalent to Vancomycin 1000 mg

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Indications
Vancomycin for Intravenous Infusion is indicated for potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. Vancomycin is useful in therapy of severe staphylococcal (including methicillin resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. Once sensitivity data are available, therapy should be adjusted accordingly.

Vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by Strep. viridans or Strep. bovis. For endocarditis caused by enterococci (eg Strep. faecalis),vancomycin is effective only in combination with an aminoglycoside. Vancomycin is effective for the treatment of diphtheroid endocarditis. Vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by Staph. epidermidis or diphtheroids.

Dosage and Administration

Dosage depends upon the severity, sensitivity, site and type of infection and upon the age and renal function of the patient.

Adults

The usual intravenous dose is 500 milligrams every 6 hours or 1 g every 12 hours. A 500 milligram dose of vancomycin should be infused over a period of at least 60 minutes, whereas a 1g dose should be administered over a period of at least two hours. Vancomycin must not be given by intramuscular injections. Adults with impaired renal function and the elderly Dosage adjustment must be made in patients with impaired renal function to avoid toxic serum levels. In the elderly, dosage reduction may be necessary to a greater extent than expected because of decreasing renal function. Measurement of vancomycin serum concentrations is required to optimise therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations may be determined by use of a microbiological assay, a radioimmunoassay, a fluorescence polarisation immunoassay, a fluorescence immunoassay, or high pressure liquid chromatography.

Contraindications

Vancomycin hydrochloride is contraindicated in patients with known hypersensitivity to this drug.

WARNINGS & PRECAUTIONS:

Rapid bolus administration (e.g. over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest. Vancomycin hydrochloride should be administered in a dilute solution at a rate not exceeding 500 mg/hour to avoid rapid-infusion-related reactions, e.g. hypotension, flushing, erythema, urticaria and pruritus. Stopping the infusion usually results in a prompt cessation of these reactions (see Dosage and Administration and Adverse Effects). When given intravenously, toxic serum levels can occur. Vancomycin is excreted fairly rapidly by the kidney and blood levels increase markedly with decreased renal clearance. During parenteral therapy, the risk of toxicity and nephrotoxicity appears appreciably increased by high blood concentrations or prolonged treatment.

DRUG-INTERACTIONS:

Concurrent administration with other neurotoxic or nephrotoxic drugs, eg streptomycin, neomycin, gentamicin, kanamycin, amikacin, amphotericin B, bacitracin, tobramycin, polymyxin B, colistin and cisplatin requires careful monitoring.

PREGNANCY AND LACTATION:

Animal reproduction studies have not been conducted with vancomycin hydrochloride. It is not known whether vancomycin hydrochloride can affect reproduction capacity. In a controlled clinical study, vancomycin was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse to evaluate potential ototoxic and nephrotoxic effects on the infant. Vancomycin was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant whose mother received vancomycin in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin. As only 10 patients were treated with vancomycin in this study, and it was administered only in the second and third trimesters, it is not known whether vancomycin causes foetal harm. Vancomycin hydrochloride should be given to a pregnant woman only if clearly needed.

Vancomycin hydrochloride is excreted in breast milk but it is not known whether it is harmful to the newborn. Therefore, it is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.

UNDESIRABLE EFFECTS:

The use of vancomycin may result in overgrowth of non-susceptible organisms resulting in new bacterial or fungal infections. If the new infections due to bacteria or fungi appear during therapy with this product, appropriate measures should be taken.

Chemical peritonitis has been reported following intraperitoneal administration of vancomycin .

OVERDOSE AND TREATMENT:

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is not effectively removed by either haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit.

PHARMACOKINETICS:

Vancomycin is poorly absorbed by mouth. It is given intravenously for the treatment of systemic infections. In subjects with normal renal function participating in a multi dose study 1g (1,000,000 IU) given over 60 minutes produced mean plasma levels of approximately 63 micrograms/mL immediately after the completion of infusion and mean plasma levels of approximately 23 micrograms/mL and approximately 8 micrograms/mL at 2 hour and 11 hour respectively, after completion of the infusion. Serum levels will be higher in patients with renal impairment, and toxicity may result.

The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function. In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in the urine by glomerular filtration. Mean plasma clearance is about 0.06 L/kg/hour, and mean renal clearance is about 0.05 L/kg/hour. Renal dysfunction slows excretion of vancomycin. In anephric patients, the average half-life of elimination is 7.5 days. The distribution coefficient is from 0.3 to 0.69 L/kg. There is no apparent metabolism of the drug.

STORAGE INSTRUCTIONS:

Store below 25°C , in a dry place. protect from light.

NATURE AND CONTENTS OF CONTAINER:

A vial of 500 mg is packed in a printed Primary Carton along with the Pack Insert.

A vial of 1000 mg is packed in a printed Primary Carton along with the Pack Insert.

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