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

prasco laboratories - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole topical gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. metronidazole topical gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

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

owen laboratories - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole topical gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. metronidazole topical gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

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cambridge therapeutics technologies, llc - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 mg - 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

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cambridge therapeutics technologies, llc - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 250 mg - 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

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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

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

teva pharmaceuticals usa, inc. - 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 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. metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. in amebic liver abscess, metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. 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 tablets 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. metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. in patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see precautions ). 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 ). 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 ). metronidazole tablets are 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) .

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

remedyrepack inc. - 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 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. metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. in amebic liver abscess, metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. 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 tablets 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. metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. in patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see precautions ). 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 ). 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 ). metronidazole tablets are 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) .

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

sandoz inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metronidazole gel usp, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. metronidazole gel usp, 1% is contraindicated in patients with a history of  hypersensitivity to metronidazole or to any other ingredient in the formulation. risk summary available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. no fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. the available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole gel usp, 1%. the 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. risk summary it is not known whether metronidazole is present in human milk after topical administration. published literature reports the presence of metronidazole in human milk after oral administration. there are reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole. there are no data on the effects of metronidazole on milk production. because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with  metronidazole gel usp, 1%. safety and effectiveness in pediatric patients have not been established. sixty-six subjects aged 65 years and older were treated with metronidazole gel usp, 1% in the clinical study.   no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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west-ward pharmaceutical corp - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 mg in 100 ml - metronidazole injection, usp is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. indicated surgical procedures should be performed in conjunction with metronidazole injection, usp 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, usp. metronidazole injection, usp 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, peptost

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

baxter healthcare corporation - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 mg in 100 ml - metronidazole injection, usp is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. indicated surgical procedures should be performed in conjunction with metronidazole injection, usp 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, usp. metronidazole injection, usp 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, pept