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redpharm drug, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 mg - symptomatic trichomoniasis. metronidazole tablets usp 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 usp 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 m

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physicians total care, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metrogel is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. teratogenic effects: pregnancy category b. there are no adequate and well-controlled studies with the use of metrogel in pregnant women. metronidazole crosses the placental barrier and enters the fetal circulation rapidly. no fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. however, oral metronidazole has shown carcinogenic activity in rodents. because animal reproduction studies are not always predictive of human response, metrogel should be used during pregnancy only if clearly needed. after oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. even though blood levels taken after topical metronidazole application are significantly lower than those achieved after oral metronidazole a decision should be

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taro pharmaceuticals u.s.a., 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. teratogenic effects: pregnancy category b. there are no adequate and well-controlled studies with the use of metronidazole in pregnant women. metronidazole crosses the placental barrier and enters the fetal circulation rapidly. no fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. however, oral metronidazole has shown carcinogenic activity in rodents. because animal reproduction studies are not always predictive of human response, metronidazole should be used during pregnancy only if clearly needed. after oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. even though blood levels taken after top

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rebel distributors corp - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole topical gel usp, 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. metronidazole topical gel usp, 0.75%, is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation. safety and effectiveness in pediatric patients have not been established.

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b. braun medical inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 mg in 100 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole injection usp and other antibacterial drugs, metronidazole injection usp 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 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 fragil

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hospira, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 mg in 100 ml - treatment of anaerobic infections 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 therapy. in a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. metronidazole 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 b. fragilis group, clostridium species, peptococcus species, peptostreptococcus s

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - 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 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. fragili s 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 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 ). cockayne syndrome 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.

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

remedyrepack inc. - 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 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. other pathogens commonly associated with vulvovaginitis, e.g., trichomonas vaginalis , chlamydia trachomatis , n . gonorrhoeae , candida albicans , and herpes simplex virus should be ruled out. metronidazole vaginal gel usp, 0.75% is contraindicated in patients with a prior history of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.

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liberty pharmaceuticals, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 250 mg - metronidazole, usp 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, usp 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 t