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Description: Sterile Vancomycin Hydrochloride, USP is a glycopeptide antibiotic derived from Nocardia orientalis and is active against many gram-positive bacteria including Staphylococcus aureus, Staph. Epidermidis, alpha and beta hemolytic streptococci, group D. streptococci, cornybacteria and clostridia. Mode of action: The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics. Indications and Usage Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. Sterile Vancomycin Hydrochloride, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, and skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Contraindications Sterile Vancomycin Hydrochloride, USP is contraindicated in patients with known hypersensitivity to this antibiotic. Dosage And Administration Patients with Normal Renal Function Adults The usual daily dose intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Pediatric Patients The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Neonates In pediatric patients an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month. Each dose should be administered over 60 minutes. Patients with Impaired Renal Function and Elderly Patients Dosage adjustment must be made in patients with impaired renal function Vancomycin Hydrochloride, USP per day in mg is about 15 times the glomerular filtration rate in mL/min: Dosage table for vancomycin in patients with impaired renal function : Creatinine Clearance mL/min 100 90 80 70 60 50 40 30 20 10 Vancomycin Dose mg/24 hr 1,545 1,390 1,235 1,080 925 770 620 465 310 155 Size: 108 x 224mm mqmyJrKmKi (Administration procedure) Î 1 Diluent for Covan KxKr† KhP~ TokPã 10 Ko.Ku. cJAuMP~≤ nJ~JPur oJgJ ßgPT dJTjJKa fáPu 10 Ko.Ku. cJAuMP~≤ nJ~Ju Fr oPiq k´Pmv TrJj FmÄ xKuCvj ‰frL Tr∆j 2 (NaCl Solution 0.9%) ßaPj Kjj 4 QfrLTíf kMPrJ xKuCvj nJ~Ju ßgPT KxKr†F ßaPj Kjj Diluted for Covan KxKr† ßgPT kMPrJ xKuCvj cJAuMP~≤ (NaCl Solution 0.9%) Fr nJ~JuF k´Pmv TrJj 3 Covan® Presentation: Covan® 500mg Injection: Each vial contains sterile Vancomycin Hydrochloride USP powder equivalent to Vancomycin 500mg. Covan® 1gm Injection: Each vial contains sterile Vancomycin Hydrochloride USP powder equivalent to Vancomycin 1gm. Covan® Vancomycin 500mg & 1g IV Infusion Precaution: Prolonged use of vancomycin may result in the overgrowth of nonsusceptible microorganisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile developing in patients who received intravenous vancomycin. Covan® Covan® 5 Diluent for Covan 500 Ko.V´J. TokPã 1 W≤J FmÄ 1 V´Jo TokPã 2 W≤J xo~ iPr AjKlCvj KyxJPm Khj Side-effects: During or soon after rapid infusion of vancomycin, few patients may develop anaphylactic reactions, including hypotension, wheezing, dyspnea, urticaria, or pruritus. Use in pregnancy and lactation: Pregnancy Category C. Vancomcyin 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. Overdosage Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance. Commercial pack: Covan® 500mg Injection: Each box contains 1 vial of sterile Vancomycin Hydrochloride USP equivalent to Vancomycin 500mg. Covan® 1gm Injection: Each box contains 1 vial of sterile Vancomycin Hydrochloride USP equivalent to Vancomycin 1gm. Manufactured by : RENATA LIMITED Section VII Milk Vita Road Mirpur, Dhaka, Bangladesh May, 2012 C-Code No. : 6147/V 01 Size: 108 x 224mm