Vancomax

Vancomax

vancomycin

Manufacturer:

Reyoung Pharma

Distributor:

Global Pharmatrade

Marketer:

Global Pharmatrade
Full Prescribing Info
Contents
Vancomycin hydrochloride.
Description
500 mg: Each vial contains: Vancomycin (as HCl) 500 mg.
1 g: Each vial contains: Vancomycin (as HCl) 1 g.
Action
Antibacterial.
Pharmacology: Pharmacokinetics: Vancomycin is only poorly absorbed from the gastrointestinal tract, although absorption may be somewhat greater when gastrointestinal tract is inflamed. Intramuscular administration is associated with pain and tissue necrosis; systemic doses are therefore given intravenously. Infusion of a 1-g dose intravenously over 60 minutes has reportedly been associated with plasma concentrations of up to about 60 μg per mL immediately after completion of the fusion, and about 25 μg per mL 2 hours later, falling to under 10 μg per mL after 11 hours. However, there may be considerable interindividual variation in the pharmacokinetics of vancomycin: a range of half-lives between 3 and 13 hours has been reported, with an average of about 6 hours, in patients with normal renal function. Half-life may be prolonged in patients with renal impairment, to 7 days or more anephric patients. About 55% is bound to plasma protein, although large variations have been reported.
Indications/Uses
Vancomycin is a glycopeptide antibiotic that is used in the treatment of serious staphylococcal or other Gram-positive infections where other drugs such as the penicillins cannot be used because of resistance or patient intolerance. It is used particularly in the treatment of methicillin-resistant staphylococcal infections, in conditions such as brain abscess, staphylococcal meningitis, peritonitis associated with continuous ambulatory peritoneal dialysis, and septicaemia. It is used alone, or in combination with another drug such as an aminoglycoside, in the treatment and prophylaxis of endocarditis, for prophylaxis of surgical infection, and in intensive care and the management of immunocompromised patients. It is also used (by mouth) in the treatment of antibiotic-associated colitis.
Dosage/Direction for Use
Vancomycin is given as the hydrochloride but doses are expressed in terms of the base. It is administered intravenously, preferably by intermittent infusion, although continuous infusion has been used. For intermittent infusion, a concentrated solution containing the equivalent of 500 mg of vancomycin in 10 mL of water is prepared and then added to glucose 5% or sodium chloride 0.9% to produce a diluted solution containing not more than 5 mg per mL; this diluted solution is then infused over at least 60 minutes for 500-mg dose or 100 minutes for 1-g dose. Final concentration of up to 10 mg per mL may be used for patients requiring fluid restriction, although there is an increased risk of adverse events. For continuous intravenous infusion the equivalent of 1 to 2 g is added to a sufficiently large volume of glucose or sodium chloride to permit the daily dose to be given over a period of 24 hours.
The usual adult dose is the equivalent of 500 mg of vancomycin every 6 hours or 1 g every 12 hours. Response is generally seen within 48 to 72 hours in sensitive infections. In patients with staphylococcal endocarditis, treatment for at least 3 weeks has been recommended.
For the prophylaxis of endocarditis in high-risk penicillin-allergic patients undergoing dental or other procedures, vancomycin may be given before the procedure in a single dose of 1 g by intravenous infusion over at least 100 minutes followed by intravenous gentamicin. Or as prescribed by the physician.
Doses in infants and children: Children and infants over 4 weeks of age may be given 10 mg per kg bodyweight every 6 hours. Neonates and infants up to 4 weeks old may be given an initial dose of 15 mg per kg; this is followed by 10 mg per kg every 12 hours in the first week of life or by 10 mg per kg every 7 hours in those aged 1 to 4 weeks. For the prophylaxis of endocarditis in children a single dose mg per kg may be used. Or as prescribed by the physician.
Direction for Reconstitution: For intermittent infusion, a concentrated solution containing the equivalent of 500 mg of vancomycin in 10 mL of water is prepared and then added to glucose 5% or sodium chloride 0.9% to produce a diluted solution containing not more than 5 mg per mL; this diluted solution is then infused over at least 60 minutes for 500-mg dose or 100 minutes for 1-g dose. Final concentration of up to 10 mg per mL may be used for patients requiring fluid restriction, although there is an increased risk of adverse events. For continuous intravenous infusion the equivalent of 1 to 2 g is added to a sufficiently large volume of glucose or sodium chloride to permit the daily dose to be given over a period of 24 hours.
Special Precautions
Vancomycin should not be given to patients who have experienced hypersensitivity reactions to it. It should not be given intramuscularly, and care should be taken when it is given intravenously to avoid extravasation, because of the risk of tissue necrosis. The adverse effects of infusion may be minimized by dilution of each 500 mg of vancomycin in at least 100 mL of fluid, and by infusion of doses over not less than 60 minutes.
Adverse Reactions
The intravenous administration of vancomycin may be associated with the so-called 'red-neck' or 'red-man' syndrome, characterized by erythema, flushing, or rash over the face and upper torso, and sometimes by hypotension and shock-like symptoms. The effect appears to be due in part to the release of histamine and usually related to rapid infusion.
Hypersensitivity reactions may occur in about 5% of patients and include rashes, fever, chills, and rarely, anaphylactoid reactions, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and vasculitis. Many reactions have become less frequent with the availability of more highly purified preparations. Reversible neutropenia, eosinophilia, and rarely thrombocytopenia and agranulocytosis have been reported; neutropenia is stated to be more common in patients who have received a total dose of 25 g or more. Nephrotoxicity may occur, particularly at high doses or in patients with predisposing factors, but has declined in frequency with greater awareness of the problem and appropriate monitoring of plasma concentrations and renal function.
Drug Interactions
Other ototoxic or nephrotoxic drugs, such as the aminoglycosides, polymyxins, and loop diuretics, markedly increase the risk of toxicity and should be given concomitantly with vancomycin only with great caution. Some of adverse effects of vancomycin may be enhanced by the concurrent use of general anaesthesia. Vancomycin may increase neuromuscular blockade produced by drugs such as suxamethonium or vecuronium.
Storage
Store at temperatures not exceeding 25°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
Vancomax powd for IV infusion 1 g
Packing/Price
10 mL x 1's
Form
Vancomax powd for IV infusion 500 mg
Packing/Price
10 mL x 1's
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