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

taro pharmaceuticals u.s.a., inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. metronidazole gel, 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 gel 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 gel 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 topi

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)

ncs healthcare of ky, inc dba vangard labs - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 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

Israel - English - Ministry of Health

lapidot medical import and marketing ltd - metronidazole - solution for infusion - metronidazole 500 mg / 100 ml - metronidazole - metronidazole - treatment and prophylaxis of infection which are or may be due to anerobic bacteria,especially bacteriodes species,including bacteriodes fragilis, fusobacterium,eurobacterium and clostridium species.

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

h.j. harkins company, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 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

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

state of florida doh central pharmacy - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 mg - metronidazole tablets are 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 tablets are 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

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

physicians total care, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole vaginal gel 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. 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 is contraindicated in patient

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

preferred pharmaceuticals, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - 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 male partne

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

preferred pharmaceuticals inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - 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 male partner wh

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

preferred pharmaceuticals, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - 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 male partner wh