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

sandoz inc - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron 4 mg - ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: ondansetron orally disintegrating tablets are also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron is contraindicated in patients: risk summary available data do not reliably inform the association of ondansetron and adverse fetal outcomes. published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation [see data ]. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively [see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimat

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

mylan institutional inc. - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 4 mg - ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: - highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . - initial and repeat courses of moderately emetogenic cancer chemotherapy. - radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron tablets are contraindicated in patients: - known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see adverse reactions (6.2)] . - receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness. available data do not reliably inform the association of ondansetron and adverse fetal outcomes. published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsist

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

auromedics pharma llc - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron injection is approved for patients aged 1 month and older. ondansetron injection is contraindicated for pat

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

physicians total care, inc. - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron 4 mg - 1. prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2 . 2. prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and/or vomiting must be avoided postoperatively, ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets, and ondansetron hydrochloride oral solution are recommended even where the incidence of postoperative nausea and/or vomiting is low. ondansetron orally disintegrating tablets are contraindi

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

lake erie medical dba quality care products llc - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron 4 mg - 1. prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2 . 2. prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and/or vomiting must be avoided postoperatively, ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets, and ondansetron hydrochloride oral solution are recommended even where the incidence of postoperative nausea and/or vomiting is low. the concomitant use of apomorphine with ondansetron is contraindic

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

rebel distributors corp. - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron 8 mg - 1. prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2 . 2. prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and/or vomiting must be avoided postoperatively, ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets, and ondansetron hydrochloride oral solution are recommended even where the incidence of postoperative nausea and/or vomiting is low. ondansetron orally disintegrating tablets are contraindicated for

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

direct rx - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron 8 mg - prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2. prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and/or vomiting must be avoided postoperatively, ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets, and ondansetron hydrochloride oral solution are recommended even where the incidence of postoperative nausea and/or vomiting is low. close the concomitant use of apomorphine with ondansetron is contraindicated b

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

accord healthcare, inc. - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection usp is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection usp is approved for patients aged 6 months and older. ondansetron injection usp is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection usp is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection usp and experience nausea and/or vomiting postoperatively, ondansetron injection usp may be given to prevent further episodes. ondansetron injection usp is approved for patients aged 1 month and older. ondansetron injection is cont

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

preferred pharmaceuticals, inc. - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron 4 mg - ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron orally disintegrating tablets are contraindicated in patients: risk summary available data do not reliably inform the association of ondansetron and adverse fetal outcomes. published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation (see data ). reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown.  in

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

mylan pharmaceuticals inc. - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron 4 mg - ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: ondansetron orally disintegrating tablets are also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron orally disintegrating tablets are contraindicated in patients: published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy (see data). available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area (bsa), respectively (see data) . the background risk of major birth defec