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

actavis pharma, inc. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride in men. alosetron hydrochloride should not be initiated in patients with constipation

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

avkare, inc. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. alosetron hydrochloride should not be initiated in patients with constipation [see warnings an

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

amneal pharmaceuticals llc - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated withalosetron tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron tablets in men. alosetron hydrochloride should not be initiated in patients with constipation [see warnings and precautions (5.1)] . alosetron hydrochlori

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

west-ward pharmaceuticals corp. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. alosetron hydrochloride tablets should not be initiated in patients with constipation [see warnings and precautions (5.1) ]. alosetron hydrochloride tablets are contraindicated in patients with a history of the following: concomitant administration of alosetron hydrochloride tablets with fluvoxamine is contraindicated. fluvoxamine, a known strong inhibitor of cyp1a2, has been shown to increase mean alosetron plasma concentrations (auc) approximately 6

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

par pharmaceutical, inc. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. alosetron hydrochloride should not be initiated in patients with constipation [see warnings and

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

rising pharmaceuticals, inc. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. alosetron hydrochloride tablets should not be initiated in patien

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

bryant ranch prepack - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.   clinical studies have not been performed to adequately confirm the benefits of alosetron tablets in men. alosetron tablets should not be initiated in patients with constipation [see warnings and precautions (5.1)] . alosetron tablets are contraindicated in patients with a history of the following: - chronic or severe constipation or sequelae from constipation - intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation and/or adhesions - ischemic colitis, impaired intestinal circulation, thrombophlebitis, or hypercoagulable state - crohn's disease or ulcerative colitis - diverticulitis - severe hepatic impairment concomitant administration of alosetron tablets with fluvoxamine is contraindicated. fluvoxamine, a known strong inhibitor of cyp1a2, has been shown to increase mean alosetron plasma concentrations (auc) approximately 6-fold and prolong the half-life by approximately 3-fold [see drug interactions (7.1)] . risk summary the available data with alosetron tablets use in pregnant women are insufficient to draw conclusions about any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed with oral administration of alosetron in rats and rabbits during organogenesis at doses 160 to 240 times, respectively, the recommended human dosage (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations 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 miscarriage is 15 to 20%, respectively. data animal data no adverse developmental effects were observed with oral administration of alosetron during the period of organogenesis to pregnant rats at doses up to 40 mg/kg/day (about 160 times the recommended human dose based on body surface area) or to pregnant rabbits at doses up to 30 mg/kg/day (about 240 times the recommended daily human dose based on body surface area). risk summary there are no data regarding the presence of alosetron in human milk, the effects on the breastfed infant, or the effects on milk production. alosetron and/or metabolites of alosetron are present in the breast milk of lactating 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 alosetron tablets and any potential adverse effects on the breastfed infant from alosetron or from the underlying maternal condition. clinical considerations monitor infants exposed to alosetron through breast milk for severe constipation and blood in stools. safety and effectiveness in pediatric patients have not been established. use of alosetron tablets are not recommended in the pediatric population, based upon the risk of serious complications of constipation and ischemic colitis in adults. in some studies, in healthy men or women, plasma concentrations were elevated by approximately 40% in individuals 65 years and older   compared to young adults [see warnings and precautions (5.1)] . however, this effect was not consistently observed in men. postmarketing experience suggests that elderly patients may be at greater risk for complications of constipation therefore, appropriate caution   and follow-up should be exercised if alosetron tablets are prescribed for these patients [see warnings and precautions (5.1)] . due to the extensive hepatic metabolism of alosetron, increased exposure to alosetron and/or its metabolites is likely to occur in patients with hepatic impairment. alosetron should not be used in patients with severe hepatic impairment and should be used with caution in patients with mild or moderate hepatic impairment. a single 1 mg oral dose of alosetron was administered to 1 female and 5 male patients with moderate hepatic impairment (child-pugh score of 7 to 9) and to 1 female and 2 male patients with severe hepatic impairment (child-pugh score of >9). in comparison with historical data from healthy subjects, patients with severe hepatic impairment displayed higher systemic exposure to alosetron. the female with severe hepatic impairment displayed approximately 14-fold higher exposure, while the female with moderate hepatic impairment displayed approximately 1.6-fold higher exposure, than healthy females. due to the small number of subjects and high intersubject variability in the pharmacokinetic findings, no definitive quantitative conclusions can be made. however, due to the greater exposure to alosetron in the female with severe hepatic impairment, alosetron should not be used in females with severe hepatic impairment [see dosage and administration (2.2), contraindications (4)] . renal impairment (creatinine clearance 4 to 56 ml/min) has no effect on the renal elimination of alosetron due to the minor contribution of this pathway to elimination. the effect of renal impairment on metabolite pharmacokinetics and the effect of end-stage renal disease have not been assessed.

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

lifestar pharma llc - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.   clinical studies have not been performed to adequately confirm the benefits of alosetron tablets in men. alosetron tablets should not be initiated in patients with constipation [see warnings and precautions (5.1)] . alosetron tablets are co

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

bryant ranch prepack - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.   clinical studies have not been performed to adequately confirm the benefits of alosetron tablets in men. alosetron tablets should not be initiated in patients with constipation [see warnings and precautions (5.1)] . alosetron tablets are co

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

sebela pharmaceuticals inc. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - lotronex is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with lotronex, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of lotronex in men. lotronex should not be initiated in patients with constipation [see warnings and precautions ( 5.1)]