United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 125 mg - vancomycin hydrochloride capsules are indicated for the treatment of clostridioides difficil e -associated diarrhea. vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. limitations of use .           parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections.           orally administered vancomycin hydrochloride capsules are not effective for other types of infections. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. vancomycin hydrochloride is contraindicated in patients with known hypersensitivity to vancomycin. risk summary systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules; however, absorption may vary depending on various factors [see  clinical pharmacology (12.3)]. there are no available data on vancomycin use in pregnant women to assess a risk of major birth defects or miscarriage. available published data on intravenous vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse maternal or fetal outcomes (see data) . vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see data) . data human data there are no available data on first trimester use of vancomycin in pregnant women to assess a risk of major birth defects or miscarriage. a published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenous vancomycin for suspected or documented methicillin-resistant staphylococcal aureus in the second or third trimester. the comparison groups were 10 uninfected non-intravenous drug-dependent patients who received no treatment and 10 uninfected untreated intravenous drug-dependent patients. no infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. a published prospective study assessed outcomes in 55 pregnant women with a positive group b streptococcus culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered intravenous vancomycin at the time of delivery. vancomycin dosing ranged from the standard dose of 1 g intravenously every 12 hours to a dose of 20 mg/kg intravenously every 8 hours (maximum individual dose 2 g). no major adverse reactions were recorded either in the mothers or their newborns. none of the newborns had sensorineural hearing loss. neonatal renal function was not examined, but all of the newborns were discharged in good condition. animal data vancomycin did not cause fetal malformation when administered intravenously during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose of 200 mg/kg/day to rats or 120 mg/kg/day to rabbits. no effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area). maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). risk summary there are no data on the presence of vancomycin in human milk, the effects on the breastfed infant, or the effect on milk production following oral administration systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules [see  clinical pharmacology (12.3)] ; therefore, it is unlikely to result in clinically relevant exposure in breastfeeding infants. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vancomycin hydrochloride capsules and any potential adverse effects on the breastfed infant from vancomycin hydrochloride capsules or from the underlying maternal condition. vancomycin hydrochloride capsules is indicated in pediatric patients less than 18 years of age for the treatment of c. difficile -associated diarrhea and enterocolitis caused by s. aureus (including methicillin-resistant strains) [see indications and usage (1) and dosage and administration  (2.2)] . in clinical trials, 54% of vancomycin hydrochloride-treated subjects were >65 years of age. of these, 40% were between the ages of >65 and 75, and 60% were >75 years of age. clinical studies with vancomycin hydrochloride in diarrhea associated with clostridioides difficile have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy. in patients >65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin induced nephrotoxicity [see warnings and precautions (5.3), adverse reactions (6.1), and, clinical studies (14.1)]. patients >65 years of age may take longer to respond to therapy compared to patients ≤65 years of age [see clinical studies (14.1)]. clinicians should be aware of the importance of appropriate duration of vancomycin hydrochloride treatment in patients >65 years of age and not discontinue or switch to alternative treatment prematurely.

United States - English - NLM (National Library of Medicine)

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 500 mg in 4 ml - vancomycin hydrochloride for injection, usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin hydrochloride for injection, usp is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin hydrochloride for injection, usp 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, skin, and skin structure infections. when staphylococcal infect

United States - English - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 125 mg - vancomycin hydrochloride capsules are indicated for the treatment of clostridioides difficile -associated diarrhea. vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. limitations of use to reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. vancomycin hydrochloride capsules are contraindicated in patients with known hypersensitivity

United States - English - NLM (National Library of Medicine)

xellia pharmaceuticals aps - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 5 g in 100 ml - vancomycin hydrochloride for injection, usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin hydrochloride for injection, usp is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin hydrochloride for injection, usp 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, skin and skin structure infections. when staphylococcal infecti

United States - English - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin hydrochloride for oral solution is administered orally for treatment of enterocolitis caused by staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by c. difficile . parenteral administration of vancomycin is not effective for the above indications; therefore, vancomycin hydrochloride for oral solution must be given orally for these infections. orally administered vancomycin hydrochloride for oral solution is not effective for other types of infection. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for oral solution and other antibacterial drugs, vancomycin hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of su

United States - English - NLM (National Library of Medicine)

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin hydrochloride capsules are indicated for the treatment of clostridioides difficile -associated diarrhea. vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. limitations of use - parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. - orally administered vancomycin hydrochloride capsules are not effective for other types of infections. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. vancomycin hydrochloride capsules are contraindicated in patients with known hypersensitivity to vancomycin. risk summary systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride; however, absorption may vary depending on various factors [see clinical pharmacology (12.3)] . there are no available data on vancomycin use in pregnant women to assess a risk of major birth defects or miscarriage. available published data on intravenous vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse maternal or fetal outcomes (see data) . vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see data) . data human data there are no available data on first trimester use of vancomycin in pregnant women to assess a risk of major birth defects or miscarriage. a published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenous vancomycin for suspected or documented methicillin-resistant staphylococcal aureus in the second or third trimester. the comparison groups were 10 uninfected non-intravenous drug-dependent patients who received no treatment and 10 uninfected untreated intravenous drug-dependent patients. no infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. a published prospective study assessed outcomes in 55 pregnant women with a positive group b streptococcus culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered intravenous vancomycin at the time of delivery. vancomycin dosing ranged from the standard dose of 1 g intravenously every 12 hours to a dose of 20 mg/kg intravenously every 8 hours (maximum individual dose 2 g). no major adverse reactions were recorded either in the mothers or their newborns. none of the newborns had sensorineural hearing loss. neonatal renal function was not examined, but all of the newborns were discharged in good condition. animal data vancomycin did not cause fetal malformation when administered intravenously during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose of 200 mg/kg/day to rats or 120 mg/kg/day to rabbits. no effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area). maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). risk summary there are no data on the presence of vancomycin in human milk, the effects on the breastfed infant, or the effect on milk production following oral administration. systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride [see clinical pharmacology (12.3)] ; therefore, it is unlikely to result in clinically relevant exposure in breastfeeding infants. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vancomycin hydrochloride and any potential adverse effects on the breastfed infant from vancomycin hydrochloride or from the underlying maternal condition. vancomycin hydrochloride is indicated in pediatric patients less than 18 years of age for the treatment of c. difficile -associated diarrhea and enterocolitis caused by s. aureus (including methicillin-resistant strains) [see indications and usage (1) and dosage and administration (2.2)] . in clinical trials, 54% of vancomycin hydrochloride-treated subjects were >65 years of age. of these, 40% were between the ages of >65 and 75, and 60% were >75 years of age. clinical studies with vancomycin hydrochloride in diarrhea associated with clostridioides difficile have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy. in patients >65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin induced nephrotoxicity [see warnings and precautions (5.3), adverse reactions (6.1), and clinical studies (14.1)] . patients >65 years of age may take longer to respond to therapy compared to patients ≤65 years of age [see clinical studies (14.1)]. clinicians should be aware of the importance of appropriate duration of vancomycin hydrochloride treatment in patients >65 years of age and not discontinue or switch to alternative treatment prematurely.

United States - English - NLM (National Library of Medicine)

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 10 g in 80 ml - vancomycin hydrochloride for injection, usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin hydrochloride for injection, usp is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin hydrochloride for injection, usp 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, skin and skin-structure infections. when staphylococcal infecti

United States - English - NLM (National Library of Medicine)

xellia pharmaceuticals, aps - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 500 mg - vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin 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,  skin and skin structure infections. when staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measur

United States - English - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 125 mg - vancocin is indicated for the treatment of clostridioides difficil e-associated diarrhea. vancocin is also used for the treatment of enterocolitis caused by staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. limitations of use to reduce the development of drug-resistant bacteria and maintain the effectiveness of vancocin and other antibacterial drugs, vancocin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. vancocin is contraindicated in patients with known hypersensitivity to vancomycin. risk summary systemic absorption of vancomycin is low following oral administration of vancocin; however, absorpt

United States - English - NLM (National Library of Medicine)

xellia pharmaceuticals usa llc - vancomycin (unii: 6q205eh1vu) (vancomycin - unii:6q205eh1vu) - vancomycin injection is indicated in adults and pediatric patients (1 month and older) for the treatment of septicemia due to: - susceptible isolates of methicillin-resistant staphylococcus aureus (mrsa) and coagulase negative staphylococci. - methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. vancomycin injection is indicated in adults and pediatric patients (1 month and older) for the treatment of infective endocarditis due to: - susceptible isolates of mrsa. - viridans group streptococci streptococcus gallolyticus (previously known as streptococcus bovis ), enterococcus species and corynebacterium species. for enterococcal endocarditis, use vancomycin injection in combination with an aminoglycoside. - methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, includin