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aurobindo pharma limited - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 4 mg in 5 ml - ondansetron oral solution is indicated for the prevention of nausea and vomiting associated with: - highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 - 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 oral solution is also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron oral solution is 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 risk summary 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 defects and miscarriage for the indicated population is unknown.  all pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. one large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. relative risks (rr) ranged from 0.97 (95% ci 0.86 to 1.10) to 1.62 (95% ci 1.04, 2.54). a subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (rr 2.05, 95% ci 1.19, 3.28); however, this association was not confirmed in other studies. several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. a retrospective cohort study of 1.8 million pregnancies in the u.s. medicaid database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (rr 1.24, 95% ci 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (rr 0.95, 95% ci 0.63, 1.43). in the subgroup of women who received both forms of administration, the rr was 1.07 (95% ci 0.59, 1.93). two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (or 1.6 [95% ci 1.1, 2.3] and 0.5 [95% ci 0.3, 1.0]). it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of ondansetron up to 15 mg/kg/day and 30 mg/kg/day, respectively, during the period of organogenesis. with the exception of a slight decrease in maternal body weight gain in the rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring.  at doses of 15 mg/kg/day in rats and 30 mg/kg/day in rabbits, the maternal exposure margin was approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, respectively, based on bsa. in a pre- and postnatal developmental toxicity study, pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21. with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation.  at a dose of 15 mg/kg/day in rats, the maternal exposure margin was approximately 6 times the maximum recommended human oral dose of 24 mg/day, based on bsa. risk summary it is not known whether ondansetron is present in human milk. there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production. however, it has been demonstrated that ondansetron is present in the milk of rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron and any potential adverse effects on the breastfed infant from ondansetron or from the underlying maternal condition. the safety and effectiveness of orally administered ondansetron have been established in pediatric patients 4 years and older for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. use of ondansetron in these age-groups is supported by evidence from adequate and well-controlled studies of ondansetron in adults with additional data from 3 open-label, uncontrolled, non-u.s. trials in 182 pediatric patients aged 4 to 18 years with cancer who were given a variety of cisplatin or noncisplatin regimens [see dosage and administration (2.2), clinical studies (14.1)] . additional information on the use of ondansetron in pediatric patients may be found in ondansetron injection prescribing information. the safety and effectiveness of orally administered ondansetron have not been established in pediatric patients for: - prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy - prevention of nausea and vomiting associated with radiotherapy - prevention of postoperative nausea and/or vomiting of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in u.s.- and foreign-controlled clinical trials, for which there were subgroup analyses, 938 (19%) were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology (12.3)] . there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age group. 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. no dosage adjustment is needed in elderly patients. no dosage adjustment is needed in patients with mild or moderate hepatic impairment. in patients with severe hepatic impairment, clearance is reduced and the apparent volume of distribution is increased, resulting in a significant increase in the half-life of ondansetron. therefore, do not exceed a total daily dose of 8 mg in patients with severe hepatic impairment (child-pugh score of 10 or greater) [see dosage and administration (2.2), clinical pharmacology (12.3)] . no dosage adjustment is recommended for patients with any degree of renal impairment (mild, moderate, or severe). there is no experience beyond first-day administration of ondansetron [see clinical pharmacology (12.3)] . animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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apotex corp. - 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 patients know

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h. j. harkins company 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: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. 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 orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron orally disintegrating 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. 8.1 pregnancy risk summary available data do not reliably inform the association of ondansetron and adverse fetal outcomes. published epidemio

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hikma pharmaceuticals usa inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection, usp is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction  studies  have  been  performed  in  pregnant  rats  at  intravenous  doses  up  to  9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. benzyl alcohol may cross the placenta. granisetron hydrochloride injection 1 mg/ml is preserved with benzyl alcohol and should be used in pregnancy only if the benefit outweighs the potential risk. it is not known whether granisetron is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when granisetron hydrochloride injection is administered to a nursing woman. benzyl alcohol, a component of granisetron hydrochloride injection 1 mg/ml, has been associated with serious adverse reactions and death, particularly in neonates [see warnings and precautions (5.4)] . chemotherapy-induced nausea and vomiting [see dosage and administration (2)] for use in chemotherapy-induced nausea and vomiting in pediatric patients 2 to 16 years of age. safety and effectiveness in pediatric patients under 2 years of age have not been established. postoperative nausea and vomiting safety and efficacy have not been established in pediatric patients for the prevention of postoperative nausea and vomiting (ponv). granisetron has been evaluated in a pediatric patient clinical trial for use in the prevention of ponv. due to the lack of efficacy and the qt prolongation observed in this trial, use of granisetron for the prevention of ponv in children is not recommended. the trial was a prospective, multicenter, randomized, double-blind, parallel-group trial that evaluated 157 children aged 2 to 16 years who were undergoing elective surgery for tonsillectomy or adenotonsillectomy. the purpose of the trial was to assess two dose levels (20 mcg/kg and 40 mcg/kg) of intravenous granisetron in the prevention of ponv. there was no active comparator or placebo. the primary endpoint was total control of nausea and vomiting (defined as no nausea, vomiting/retching, or use of rescue medication) in the 24 hours following surgery. efficacy was not established due to lack of a dose response. the trial also included standard 12 lead ecgs performed pre-dose and after the induction of anesthesia. ecgs were repeated at the end of surgery after the administration of granisetron and just prior to reversal of anesthesia. qt prolongation was seen at both dose levels. five patients in this trial experienced an increase of ≥ 60 msec in qtcf. in addition, there were two patients whose qtcf was ≥ 500 msec. interpretation of the qtcf prolongation was confounded by multiple factors, including the use of concomitant medication and the lack of either a placebo or active control. a thorough qt trial in adults has not been performed. other adverse events that occurred in the study included: vomiting (5 to 8%), post-procedural hemorrhage (3 to 5%), and dehydration (0 to 5%). pediatric patients under 2 years of age have not been studied. during chemotherapy clinical trials, 713 patients 65 years of age or older received granisetron hydrochloride injection. the safety and effectiveness were similar in patients of various ages.

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cipla usa inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 0.1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: •  the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not alw

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

cipla usa inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not alwa

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

wockhardt usa llc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 0.1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. pregnancy  category  b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predi

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

sagent pharmaceuticals - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection, usp is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not

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

taro pharmaceuticals u.s.a., inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg - granisetron hydrochloride usp is indicated for the prevention of: - nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. - nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. granisetron hydrochloride usp is contraindicated in patients with known hypersensitivity to the drug or any of its components.

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teva pharmaceuticals usa, inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg - granisetron hydrochloride tablets are indicated for the prevention of: - nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. - nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. granisetron hydrochloride tablets are contraindicated in patients with known hypersensitivity to the drug or any of its components. manufactured in israel by: teva pharmaceutical ind. ltd. jerusalem, 9777402, israel manufactured for: teva pharmaceuticals usa, inc. north wales, pa 19454 rev. f 2/2016