United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - cilostazol - oral tablet - 100mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - cilostazol - oral tablet - 100mg

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

remedyrepack inc. - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. cilostazol tablets are contraindicated in patients with: - heart failure of any severity: cilostazol and several of its metabolites are inhibitors of phosphodiesterase iii. several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class iii-iv heart failure. - hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) teratogenic effects cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human mrhd on a body surface area basis. there are no adequate and well-controlled studies in pregnant women. in a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14 th rib, and retarded ossification). at this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the mrhd. increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the mrhd on a systemic exposure basis). in a rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. in nonpregnant rabbits given 150 mg/kg/day, exposure to unbound cilostazol was considerably lower than that seen in humans given the mrhd, and exposure to 3,4-dehydrocilostazol was barely detectable. when cilostazol was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the mrhd on a systemic exposure basis). transfer of cilostazol into milk has been reported in rats. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cilostazol, discontinue nursing or discontinue cilostazol. safety and effectiveness of cilostazol in pediatric patients have not been established. of the total number of subjects (n = 2,274) in clinical studies of cilostazol, 56 percent were 65 years old and over, while 16 percent were 75 years old and over. 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 excluded. pharmacokinetic studies have not disclosed any age-related effects on the absorption, distribution, metabolism, and elimination of cilostazol and its metabolites. no dose adjustment is required in patients with mild hepatic impairment. patients with moderate or severe hepatic impairment have not been studied in clinical trials and dosing recommendations cannot be provided [see clinical pharmacology ( 12.3)]. no dose adjustment is required in patients with renal impairment . patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high protein binding (95 to 98%) [see clinical pharmacology ( 12.3)].

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

bryant ranch prepack - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. cilostazol tablets are contraindicated in patients with: - heart failure of any severity: cilostazol and several of its metabolites are inhibitors of phosphodiesterase iii. several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class iii-iv heart failure. - hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) teratogenic effects cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human mrhd on a body surface area basis. there are no adequate and well-controlled studies in pregnant women. in a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14th rib, and retarded ossification). at this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the mrhd. increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the mrhd on a systemic exposure basis). in a rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. in nonpregnant rabbits given 150 mg/kg/day, exposure to unbound cilostazol was considerably lower than that seen in humans given the mrhd, and exposure to 3,4-dehydrocilostazol was barely detectable. when cilostazol was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the mrhd on a systemic exposure basis). transfer of cilostazol into milk has been reported in rats. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cilostazol, discontinue nursing or discontinue cilostazol. safety and effectiveness of cilostazol in pediatric patients have not been established. of the total number of subjects (n = 2,274) in clinical studies of cilostazol, 56 percent were 65 years old and over, while 16 percent were 75 years old and over. 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 excluded. pharmacokinetic studies have not disclosed any age-related effects on the absorption, distribution, metabolism, and elimination of cilostazol and its metabolites. no dose adjustment is required in patients with mild hepatic impairment. patients with moderate or severe hepatic impairment have not been studied in clinical trials and dosing recommendations cannot be provided [see clinical pharmacology (12.3)]. no dose adjustment is required in patients with renal impairment. patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high protein binding (95 to 98%) [see clinical pharmacology ( 12.3)].

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

lake erie medical dba quality care products llc - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol 100 mg

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

american health packaging - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol 50 mg

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

biokey, inc. - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol 50 mg

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

avera mckennan hospital - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol 50 mg

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

ncs healthcare of ky, inc dba vangard labs - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance. cilostazol and several of its metabolites are inhibitors of phosphodiesterase iii. several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class iii-iv congestive heart failure. cilostazol is contraindicated in patients with congestive heart failure of any severity. cilostazol tablets are contraindicated in patients with hemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding. cilostazol inhibits platelet aggregation in a reversible manner. cilostazol tablets are contraindicated in patients with known or suspected hypersensitivity to any of their components.

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

remedyrepack inc. - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. cilostazol tablets are contraindicated in patients with: - heart failure of any severity: cilostazol and several of its metabolites are inhibitors of phosphodiesterase iii. several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class iii-iv heart failure. - hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) teratogenic effects pregnancy category c . cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human mrhd on a body surface area basis. there are no adequate and well-controlled studies in pregnant women. in a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventri