Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

direct_rx - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - symptomatic trichomoniasis. metronidazole tablets are indicated for the treatment of t. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). asymptomatic trichomoniasis. metronidazole tablets are indicated in the treatment of asymptomatic t. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. treatment of asymptomatic sexual partners. t. vaginalis infection is a venereal disease. therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. in making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. in any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. amebiasis metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. in amebic liver abscess, metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. anaerobic bacterial infections. metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. in a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. intra-abdominal infections, including peritonitis, intra-abdominal abscess, and liver abscess, caused by bacteroides species including the b. fragilis group (b. fragilis, b. distasonis, b. ovatus, b. thetaiotaomicron, b. vulgatus), clostridium species, eubacterium species, peptococcus species, and peptostreptococcus species. skin and skin structure infections caused by bacteroides species including the b. fragilis group, clostridium species, peptococcus species, peptostreptococcus species, and fusobacterium species. gynecologic infections, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by bacteroides species including the b. fragilis group, clostridium species, peptococcus species, peptostreptococcus species, and fusobacterium species. bacterial septicemia caused by bacteroides species including the b. fragilis group and clostridium species. bone and joint infections, (as adjunctive therapy), caused by bacteroides species including the b. fragilis group. central nervous system (cns) infections, including meningitis and brain abscess, caused by bacteroides species including the b. fragilis group. lower respiratory tract infections, including pneumonia, empyema, and lung abscess, caused by bacteroides species including the b. fragilis group. endocarditis caused by bacteroides species including the b. fragilis group. to reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets 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. hypersensitivity metronidazole tablet are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. in patients with trichomoniasis, metronidazole tablet are contraindicated during the first trimester of pregnancy (see precautions). psychotic reaction with disulfiram use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see precautions, drug interactions). interaction with alcohol use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see precautions, drug interactions).

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

direct_rx - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - symptomatic trichomoniasis. metronidazole tablets are indicated for the treatment of t. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). asymptomatic trichomoniasis. metronidazole tablets are indicated in the treatment of asymptomatic t. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. treatment of asymptomatic sexual partners. t. vaginalis infection is a venereal disease. therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. in making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. in any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. amebiasis metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. in amebic liver abscess, metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. anaerobic bacterial infections. metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. in a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. intra-abdominal infections, including peritonitis, intra-abdominal abscess, and liver abscess, caused by bacteroides species including the b. fragilis group (b. fragilis, b. distasonis, b. ovatus, b. thetaiotaomicron, b. vulgatus), clostridium species, eubacterium species, peptococcus species, and peptostreptococcus species. skin and skin structure infections caused by bacteroides species including the b. fragilis group, clostridium species, peptococcus species, peptostreptococcus species, and fusobacterium species. gynecologic infections, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by bacteroides species including the b. fragilis group, clostridium species, peptococcus species, peptostreptococcus species, and fusobacterium species. bacterial septicemia caused by bacteroides species including the b. fragilis group and clostridium species. bone and joint infections, (as adjunctive therapy), caused by bacteroides species including the b. fragilis group. central nervous system (cns) infections, including meningitis and brain abscess, caused by bacteroides species including the b. fragilis group. lower respiratory tract infections, including pneumonia, empyema, and lung abscess, caused by bacteroides species including the b. fragilis group. endocarditis caused by bacteroides species including the b. fragilis group. to reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets 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. hypersensitivity metronidazole tablet are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. in patients with trichomoniasis, metronidazole tablet are contraindicated during the first trimester of pregnancy (see precautions). psychotic reaction with disulfiram use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see precautions, drug interactions). interaction with alcohol use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see precautions, drug interactions).

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

a-s medication solutions - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 250 mg - metronidazole tablets are indicated for the treatment of t. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). metronidazole tablets are indicated in the treatment of asymptomatic t. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion.  since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. t. vaginalis infection is a venereal disease. therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. in making thi

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

watson labs - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - tablet - 250 mg - metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. t. vaginalis infection is a venereal disease. therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. in making this decision, it should be noted that there i

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

watson labs - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - tablet - 250 mg - metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. t. vaginalis infection is a venereal disease. therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. in making this decision, it should be noted that there i

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

a-s medication solutions - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole vaginal gel usp, 0.75% is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis). - note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% koh solution, and (c) contains clue cells on microscopic examination. gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

vivimed labs limited - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 250 mg

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

gland pharma limited - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - to reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole injection and other antibacterial drugs, metronidazole injection 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. treatment of anaerobic infections metronidazole injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. indicated surgical procedures should be performed in conjunction with metronidazole injection therapy. in a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole injection. metronidazole injection is effective in bac

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - to reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole injection and other antibacterial drugs, metronidazole injection 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. treatment of anaerobic infections metronidazole injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. indicated surgical procedures should be performed in conjunction with metronidazole injection therapy. in a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole injection. metronidazole injection is effective in bacteroides fragilis infections resistant to clindamycin, chloramphenicol, and penicillin. intra-abdominal infections , including peritonitis, intra-abdominal abscess, and liver abscess, caused by bacteroides species including the b. fragilis group (b. fragilis, b. distasonis, b. ovatus, b. thetaiotaomicron, b. vulgatus) , clostridium species, eubacterium species, peptococcus species, and peptostreptococcus species. skin and skin structure infections  caused by bacteroides species including the b. fragilis group, clostridium species, peptococcus species, peptostreptococcus species, and fusobacterium species. gynec ologic infections , including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by bacteroides species including the b. fragilis group, clostridium species, peptococcus species, and peptostreptococcus species. bacterial septicemia caused by bacteroides species including the b. fragilis group and clostridium species. bone and joint infections , as adjunctive therapy, caused by bacteroides species including the b. fragilis group. central nervous system (cns) infections , including meningitis and brain abscess, caused by bacteroides species including the b. fragilis group.  lower respiratory tract infections , including pneumonia, empyema, and lung abscess, caused by bacteroides species including the b. fragilis group.  endocarditis caused by bacteroides species including the b. fragilis group. prophylaxis the prophylactic administration of metronidazole injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery which is classified as contaminated or potentially contaminated. prophylactic use of metronidazole injection should be discontinued within 12 hours after surgery. if there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (see dosage and administration ). to reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole 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 antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. metronidazole injection is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. psychotic reaction with disulfiram use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see precautions-drug interactions ). interaction with alcohol use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see precautions-drug interactions ). cockayne syndrome metronidazole injection is contraindicated in patients with cockayne syndrome. severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with cockayne syndrome (see adverse reactions ).

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

encube ethicals private limited - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis in females 12 years of age and older. metronidazole vaginal gel is contraindicated in persons who have shown hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives. psychotic reactions have been reported with co-administration of disulfiram and oral metronidazole. do not administer concurrently with or within 2 weeks of disulfiram. disulfiram-like reactions to alcohol have been reported with co-administration of oral metronidazole; do not consume ethanol or propylene glycol, during and for at least 24 hours following treatment. risk summary there are no data available on the use of metronidazole vaginal gel in pregnant women. metronidazole usage in pregnancy has been associated with certain congenital anomalies (see data) . in animal reproduction studies, no fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant rats and rabbits, during organogenesis at up to 30 times and 60 times the recommended human dose based on body surface area comparison, respectively(see  data ) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.   data   human data blood levels following metronidazole vaginal administration are lower than those achieved with oral metronidazole. following a single intravaginal 5 g dose of metronidazole vaginal gel, mean maximum concentration (cmax) and total exposure (auc0-∞) are approximately 2% and 4%, respectively, of those following a single oral 500 mg dose of metronidazole tablets [see clinical pharmacology (12.3)] . metronidazole crosses the placental barrier and enters the fetal circulation rapidly. there are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than 5000 pregnant women who used metronidazole during pregnancy. many studies included first trimester exposures. one study showed an increased risk of cleft lip, with or without cleft palate, in infants exposed to metronidazole in utero;  however, these findings were not confirmed. in addition, more than ten randomized placebo-controlled clinical trials enrolled more than 5000 pregnant women to assess the use of antibiotic treatment (including metronidazole) for bacterial vaginosis on the incidence of preterm delivery. most studies did not show an increased risk for congenital anomalies or other adverse fetal outcomes following metronidazole exposure during pregnancy. three studies conducted to assess the risk of infant cancer following metronidazole exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited. animal data no fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant rabbits at up to 200 mg/kg (about 60 times the maximum human dose based on body surface area comparison). similarly, no fetotoxic or teratogenic effects were observed in five studies in rats where dosing was administered orally in the diet or by gastric intubation at doses up to 200 mg/kg (about 30 times the maximum human dose based on body surface area comparison). as well, no fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant mice at doses up to 100 mg/kg (about 7 times the maximum human dose based on body surface area comparison). however, some intrauterine deaths were observed in swiss webster mice administered metronidazole intraperitoneally at doses up to 15 mg/kg (about 1 times the maximum human dose based on body surface area comparison). the relationship of these intraperitoneal findings in mice to the vaginal use of metronidazole vaginal gel is unknown. risk summary there are no data on the presence of metronidazole in human milk following intravaginal administration. metronidazole is present in human milk following oral metronidazole administration, at concentrations similar to those found in plasma (see data ). the metronidazole vaginal gel achieves 2% of the mean maximum serum concentration of a 500 mg oral metronidazole dose [see clinical pharmacology (12.3)]. the published literature reports no adverse effects in infants exposed through breastmilk to maternal orally administered metronidazole. there are no data on the effects on milk production. animal studies have shown the potential for tumorigenicity after oral metronidazole was administered chronically to rats and mice [see nonclinical toxicology (13.1)]. the clinical relevance of these findings is unclear. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metronidazole vaginal gel, and any potential adverse effects on the breastfed child from metronidazole gel or from the underlying maternal condition. alternatively, a lactating patient may interrupt breastfeeding and choose to pump and discard breastmilk during treatment with metronidazole vaginal gel and for 48 hours after the last dose and feed her infant previously stored human milk or formula.  data   in a study of lactating women receiving oral metronidazole 600 mg (n=11) or 1200 mg (n=4) daily, mean maternal plasma concentrations were 5.0 and 12.5 mcg/ml respectively, within 2 hours following administration; the milk: maternal plasma ratio was approximately 1. the safety and effectiveness of metronidazole vaginal gel have been established in pediatric subjects between the ages of 12 and less than 18 years old. use of metronidazole vaginal gel in this age group is supported by evidence from a multicenter, open-label safety and tolerability study in 60 pediatric patients with bacterial vaginosis [see adverse reactions   ( 6.1 )] and, evidence from adequate and well-controlled studies in adult women. the safety and effectiveness of metronidazole vaginal gel in pediatric subjects below the age of 12 years have not been established. clinical studies with metronidazole vaginal gel did not include sufficient numbers of subjects 65 years of age or older to determine whether they respond differently than younger subjects. metronidazole vaginal gel 1.3%   for vaginal use only. you will need the following supplies (see figure a) figure a   step 1: remove the pre-filled applicator and plunger from the foil package (see figure b) - tear open the foil packet just before using. - remove the pre-filled applicator and plunger from the foil packaging. figure b step 2: insert the plunger into the open end of the pre-filled applicator (see figure c) -   with the pink cap still on, push the tip of the plunger into the open end of the pre-filled applicator figure c step 3: remove the pink cap (see figure d) - pull the pink cap straight off the top of the pre-filled applicator. figure d step 4: prepare to insert the pre-filled applicator (see figure e) -   the pre-filled applicator may be inserted while lying on your back with your knees bent or in any comfortable position. figure e step 5: insert the pre-filled applicator (see figure f) -   hold the pre-filled applicator by the barrel and gently insert the rounded tip into your vagina as far as it will comfortably go, then pull back slightly figure f step 6: push the plunger (see figure g) -   while holding the barrel in place, slowly press the plunger until it stops to release the gel into your vagina. figure g step 7: remove the pre-filled applicator from your vagina and throw it away in your household trash.   how should i store metronidazole vaginal gel? - store metronidazole vaginal gel at room temperature between 68°f to 77°f (20°-25°c). - do not freeze. - do not refrigerate. keep metronidazole vaginal gel and all medicines out of the reach of children.   rx only manufactured by: encube ethicals private limited plot no. c-1, madkaim industrial estate, madkaim, post: mardol, ponda, goa - 403 404, india.   distributed by: encube ethicals, inc. 200 meredith drive, suite 202 durham, nc 27713 usa this patient information and instructions for use have been approved by the us food and drug administration. revised: 08/23