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oasis trading - ethenzamide (unii: l929zck4bf) (ethenzamide - unii:l929zck4bf), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - relief of: headaches, aches, pain and fever ■ adult and children 15 years of age and older: 1 capsules three times a day ■ children 11 to under 15 years of age: 1/2-2/3 capsules three times a day ■ children 8 to under 11 years of age: 1/2 capsules three times a day ■ children under 8 years of age: ask a doctor

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lupin pharmaceuticals,inc. - trimethobenzamide hydrochloride (unii: wdq5p1sx7q) (trimethobenzamide - unii:w2x096qy97) - trimethobenzamide hydrochloride 300 mg - trimethobenzamide hydrochloride capsules is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. limitation of use: trimethobenzamide hydrochloride capsules is not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (cns) effects, and the risk of exacerbation of the underlying disease in pediatric patients with reye's syndrome or other hepatic impairment. trimethobenzamide hydrochloride capsules are contraindicated in patients with known hypersensitivity to trimethobenzamide [see adverse reactions (6)] . risk summary the limited available data with trimethobenzamide in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.  no adverse developmental effect was observed in animal reproduction studies with administration of trimethobenzamide hydrochloride during organogenesis in pregnant rats at doses 0.16 and 0.8 times the recommended human dose (rhd) and in pregnant rabbits at doses 1.6 times the rhd [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 animal data reproduction studies with trimethobenzamide hydrochloride were conducted in rats and rabbits following administration of trimethobenzamide hydrochloride during organogenesis and no adverse developmental effect was observed in either species. the only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg/kg and 100 mg/kg (0.16 and 0.8 times the rhd of 1200 mg/day, based on body surface area) and increased resorptions in rabbits receiving 100 mg/kg (1.6 times the rhd of 1200 mg/day, based on body surface area). in each study, these adverse effects were attributed to one or two dams. risk summary there is no information on the presence of trimethobenzamide in human milk, the effects of trimethobenzamide hydrochloride capsules on the breastfed infant or the effects of trimethobenzamide hydrochloride capsules on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of trimethobenzamide hydrochloride capsules to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trimethobenzamide hydrochloride capsules and any potential adverse effects on the breastfed infant from trimethobenzamide hydrochloride capsules or from the underlying maternal condition. the safety and effectiveness of trimethobenzamide hydrochloride capsules in pediatric patients has not been established. trimethobenzamide hydrochloride capsules is not recommended for use in pediatric patients due to the risk of eps and other serious cns effects, and the risk of exacerbation of underlying disease in pediatric patients with reye's syndrome, or other hepatic impairment [see warnings and precautions (5.1, 5.2, 5.3, 5.4)]. clinical studies of trimethobenzamide did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. although there are studies reported in the literature that included geriatric patients 65 years and older with younger patients, it is not known if there are differences in efficacy or safety parameters for geriatric and non-geriatric patients treated with trimethobenzamide hydrochloride capsules. trimethobenzamide is excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because geriatric patients are more likely to have decreased renal function, reduce the daily dosage of trimethobenzamide hydrochloride capsules by increasing the dosing interval and adjust as needed based upon therapeutic response and tolerability. monitor renal function [see dosage and administration (2.2), use in specific populations (8.6)] . trimethobenzamide is eliminated by renal excretion [see clinical pharmacology (12.3)] . in patients with renal impairment (creatinine clearance 70 ml/min/1.73m2 or less), reduce the daily dosage by increasing the dosing interval and adjust as needed based upon therapeutic response and tolerability. monitor renal function [see dosage and administration (2.2)]. avoid trimethobenzamide hydrochloride capsules in patients whose signs and symptoms suggest the presence of hepatic impairment due to the risk of hepatotoxicity [see warnings and precautions (5.4)]. discontinue trimethobenzamide hydrochloride capsules in patients who develop impaired liver function while taking trimethobenzamide hydrochloride capsules.

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rebel distributors corp. - trimethobenzamide hydrochloride (unii: wdq5p1sx7q) (trimethobenzamide - unii:w2x096qy97) - trimethobenzamide 300 mg - trimethobenzamide hydrochloride capsules are indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. use of any dosage form in patients with known hypersensitivity to trimethobenzamide is contraindicated.

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aurobindo pharma limited - methenamine hippurate (unii: m329791l57) (methenamine - unii:j50oix95qv) - methenamine hippurate 1 g - methenamine hippurate tablets usp are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. this drug should only be used after eradication of the infection by other appropriate antimicrobial agents. to reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets usp and other antibacterial drugs, methenamine hippurate tablets 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. methenamine hippurate tablets are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.

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corepharma, llc - methenamine hippurate (unii: m329791l57) (methenamine - unii:j50oix95qv) - methenamine hippurate 1 g - methenamine hippurate tablets, usp are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. this drug should only be used after eradication of the infection by other appropriate antimicrobial agents. to reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets, usp and other antibacterial drugs, methenamine hippurate tablets, 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. methenamine hippurate tablets, usp are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. methe

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

physicians total care, inc. - trimethobenzamide hydrochloride (unii: wdq5p1sx7q) (trimethobenzamide - unii:w2x096qy97) - trimethobenzamide hydrochloride 300 mg - trimethobenzamide hydrochloride capsules are indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. use of any dosage form in patients with known hypersensitivity to trimethobenzamide is contraindicated.

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edenbridge pharmaceuticals llc. - methenamine mandelate (unii: 695n30cinr) (methenamine - unii:j50oix95qv) - methenamine mandelate 500 mg - methenamine mandelate, usp is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also for infected residual urine sometimes accompanying neurologic diseases. when used as recommended, methenamine mandelate, usp is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop.  pathogens resistant to other antibacterial agents may respond to methenamine mandelate, usp because of the nonspecific effect of formaldehyde formed in an acid urine. prophylactic use rationale: urine is a good culture medium for many urinary pathogens. inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth-inhibiting medium. there is a growing body of

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sun pharmaceutical industries, inc. - trimethobenzamide hydrochloride (unii: wdq5p1sx7q) (trimethobenzamide - unii:w2x096qy97) - trimethobenzamide hydrochloride 300 mg - trimethobenzamide hydrochloride capsules are indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. limitation of use: trimethobenzamide hydrochloride capsules are not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (cns) effects, and the risk of exacerbation of the underlying disease in pediatric patients with reye’s syndrome or other hepatic impairment. trimethobenzamide hydrochloride capsules are contraindicated in patients with known hypersensitivity to trimethobenzamide [see adverse reactions (6) ]. risk summary the limited available data with trimethobenzamide in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. no adverse developmental effect was observed in animal reproduction studies with administration of trimethobenzamide hydrochloride during organogenesis in pregnant rats at doses 0.16 a

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

county line pharmaceuticals, llc - methenamine hippurate (unii: m329791l57) (methenamine - unii:j50oix95qv) - methenamine hippurate 1 g - to reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets and other antibacterial drugs, methenamine hippurate 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. methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. this drug should only be used after eradication of the infection by other appropriate antimicrobial agents. methenamine hippurate tablets are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. it should not be used

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

alvogen inc. - methenamine hippurate (unii: m329791l57) (methenamine - unii:j50oix95qv) - methenamine hippurate 1 g - to reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets and other antibacterial drugs, methenamine hippurate 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. methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. this drug should only be used after eradication of the infection by other appropriate antimicrobial agents. methenamine hippurate tablets are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. it should not be used