Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - sevelamer carbonate, quantity: 800 mg - tablet, film coated - excipient ingredients: hyprolose; crospovidone; silicon dioxide; mannitol; zinc stearate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; purified talc; xanthan gum; polyvinyl alcohol; lecithin - arx-sevelamer is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

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

avkare - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia (fredrickson type iia) as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme a (hmg coa) reductase inhibitor (statin). colesevelam hydrochloride is indicated as monotherapy or in combination with a statin to reduce ldl-c levels in boys and post-menarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: a. ldl-c remains ≥190 mg/dl or b. ldl-c remains ≥160 mg/dl and - there is a positive family history of premature cardiovascular disease or - two or more other cvd risk factors are present in the pediatric patient. lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate [see clinical studies (14.1)] . in patients with coronary heart disease (chd) or chd risk equivalents such as diabetes mellitus, ldl-c treatment goals are <100 mg/dl. an ldl-c goal of <70 mg/dl is a therapeutic option on the basis of recent trial evidence. if ldl-c is at goal but the serum triglyceride (tg) value is >200 mg/dl, then non-hdl cholesterol (non-hdl-c) (total cholesterol [tc] minus high density lipoprotein cholesterol [hdl-c]) becomes a secondary target of therapy. the goal for non-hdl-c in persons with high serum tg is set at 30 mg/dl higher than that for ldl-c. - colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - colesevelam hydrochloride has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor. - colesevelam hydrochloride has not been studied in pediatric patients with type 2 diabetes. - colesevelam hydrochloride has not been studied in fredrickson type i, iii, iv, and v dyslipidemias. - colesevelam hydrochloride has not been studied in children younger than 10 years of age or in pre-menarchal girls. colesevelam hydrochloride is contraindicated in patients with - a history of bowel obstruction [see warnings and precautions (5.4)] - serum tg concentrations >500 mg/dl [see warnings and precautions (5.2)] - a history of hypertriglyceridemia-induced pancreatitis [see warnings and precautions (5.2)] pregnancy category b. there are no adequate and well-controlled studies of colesevelam use in pregnant women. animal reproduction studies in rats and rabbits revealed no evidence of fetal harm. requirements for vitamins and other nutrients are increased in pregnancy. however, the effect of colesevelam on the absorption of fat-soluble vitamins has not been studied in pregnant women. this drug should be used during pregnancy only if clearly needed. in animal reproduction studies, colesevelam revealed no evidence of fetal harm when administered to rats and rabbits at doses 50 and 17 times the maximum human dose, respectively. because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. colesevelam hydrochloride is not expected to be excreted in human milk because colesevelam hydrochloride is not absorbed systemically from the gastrointestinal tract. the safety and effectiveness of colesevelam hydrochloride as monotherapy or in combination with a statin were evaluated in children, 10 to 17 years of age with hefh [see clinical studies (14.1)] . the adverse reaction profile was similar to that of patients treated with placebo. in this limited controlled study, there were no significant effects of growth, sexual maturation, fat-soluble vitamin levels or clotting factors in the adolescent boys or girls relative to placebo [see adverse reactions (6.1)] . due to tablet size, colesevelam hydrochloride for oral suspension is recommended for use in the pediatric population. dose adjustments are not required when colesevelam hydrochloride is administered to children 10 to 17 years of age. colesevelam hydrochloride has not been studied in children younger than 10 years of age or in pre-menarchal girls. primary hyperlipidemia: of the 1350 patients enrolled in the hyperlipidemia clinical studies, 349 (26%) were ≥65 years old, and 58 (4%) were ≥75 years old. 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 ruled out. no special considerations or dosage adjustments are recommended when colesevelam hydrochloride is administered to patients with hepatic impairment. to report suspected adverse reactions contact avkare, inc. at 1-855-361-3993; email drugsafety@avkare.com; or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

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

ascend laboratories, llc - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia. colesevelam hydrochloride tablets are indicated to reduce ldl-c levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification. colesevelam hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - colesevelam hydrochloride has not been studied in fredrickson type i, iii, iv, and v dyslipidemias. colesevelam hydrochloride is contraindicated in patients with: - serum tg concentrations greater than 500 mg/dl [see warnings and precautions (5.1)] - history of hypertriglyceridemia-induced pancreatitis [see warnings and precautions (5.1)] - a history of bowel obstruction [see warnings and precautions (5.2)] risk summary colesevelam hydrochloride is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. limited available data on the use of colesevelam hydrochloride are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. in animal reproduction studies, no evidence of either maternal or fetal toxicity was found in rats or rabbits exposed to colesevelam hydrochloride during the period of fetal organogenesis at 8 and 5 times, respectively, the maximum recommended human dose (mrhd) of 3.75 g/day, based on body surface area (mg/m2 ). no adverse effects on offspring survival and development were observed in rats administered 5 times the mrhd (see data).colesevelam hydrochloride may decrease the absorption of fat-soluble vitamins [see warnings and precautions (5.3)]. there are no data available on the effect of colesevelam hydrochloride on the absorption of fat-soluble vitamins in pregnant women. if the patient becomes pregnant while taking colesevelam hydrochloride, the patient should be advised of the lack of known clinical benefit with continued use during pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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 human data  there are no adequate and well-controlled studies of colesevelam hydrochloride use in pregnant women. in the postmarketing setting there have been infrequent reports of pregnancy with use of colesevelam hydrochloride and a causal association with congenital anomalies has not been established. animal data in pregnant rats given dietary doses of 0.3, 1.0, 3.0 g/kg/day colesevelam hydrochloride from gestation days 7 through 17, no teratogenic effects were observed. exposures at 3.0 g/kg/day were 8 times the human exposure at 3.75 g/day mrhd, based on body surface area (mg/m2 ). in pregnant rabbits given oral gavage doses of 0.1, 0.5, 1.0 g/kg/day colesevelam hydrochloride from gestation days 6 through 18, no teratogenic effects were observed. exposures at 1.0 g/kg/day were 5 times the human exposure at 3.75 g/day mrhd, based on body surface area (mg/m2 ). in pregnant rats given oral gavage doses of 0.1, 0.3, 1.0 g/kg/day colesevelam hydrochloride from gestation day 6 through lactation day 21 (weaning), no adverse effects on survival and development were observed. exposures at 1.0 g/kg/day were 5 times the human exposure at 3.75 g/day mrhd, based on body surface area (mg/m2 ). risk summary colesevelam hydrochloride is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to colesevelam hydrochloride. contraception use of colesevelam hydrochloride may reduce the efficacy of oral contraceptives. advise patients to take oral contraceptives at least 4 hours prior to taking colesevelam hydrochloride [see drug interactions (7)]. primary hyperlipidemia the safety and effectiveness of colesevelam hydrochloride to reduce ldl-c levels in boys and postmenarchal girls 10 to 17 years of age with hefh who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification have been established. use of colesevelam hydrochloride for this indication is supported by a study in 129 colesevelam hydrochloride-treated pediatric patients aged 10 to 17 years with hefh [see clinical studies (14.1)]. adverse reactions commonly observed in pediatric patients compared to placebo, but not in adults, included headache (3.9%), creatine phosphokinase increase (2.3%), and vomiting (2.3%) [see adverse reactions (6.1)]. there were no significant effects on fat-soluble vitamin levels or clotting factors in the adolescent boys or girls relative to placebo. due to colesevelam hydrochloride tablet size, colesevelam hydrochloride for oral suspension is recommended for use in the pediatric population [see dosage and administration (2.2, 2.4)]. the safety and effectiveness of colesevelam hydrochloride in pediatric patients with hefh less than 10 years of age or in premenarchal females have not been established. type 2 diabetes mellitus the safety and effectiveness of colesevelam hydrochloride to improve glycemic control in pediatric patients with type 2 diabetes mellitus have not been established. effectiveness was not demonstrated in a 6-month, adequate and well-controlled study conducted in 141 colesevelam hydrochloride -treated pediatric patients aged 10 to 17 years with type 2 diabetes mellitus. primary hyperlipidemia of the 1350 patients enrolled in the hyperlipidemia clinical studies, 349 (26%) were ≥65 years old, and 58 (4%) were ≥75 years old. 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 ruled out. type 2 diabetes mellitus of the 2048 patients enrolled in the six diabetes studies, 397 (19%) were ≥65 years old, and 36 (2%) were ≥75 years old. in these trials, colesevelam hydrochloride 3.8 g/day or placebo was added onto background anti-diabetic therapy. no overall differences in safety or effectiveness were observed between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. type 2 diabetes mellitus of the 2048 patients enrolled in the six diabetes studies, 807 (39%) had mild renal insufficiency (creatinine clearance [crcl] 50-<80 ml/min), 61 (3%) had moderate renal insufficiency (crcl 30-<50 ml/min), and none had severe renal insufficiency (crcl <30 ml/min), as estimated from baseline serum creatinine using the modification of diet in renal disease (mdrd) equation. no overall differences in safety or effectiveness were observed between patients with crcl <50 ml/min (n=53) and those with a crcl ≥50 ml/min (n=1,075) in the add-on to metformin, sulfonylureas, and insulin diabetes studies. in the monotherapy study and add-on to pioglitazone study, only 3 and 5 patients, respectively, had moderate renal insufficiency.

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

dr.reddys laboratories inc - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia). colesevelam hydrochloride tablets are indicated to reduce ldl-c levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification. colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - colesevelam hydrochloride tablets should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - colesevelam hydrochloride tablets have not been studied in fredrickson type i, iii, iv, and v dyslipidemias. colesevelam hydrochloride tablets are contraindicated in patients with: - serum tg concentrations >500 mg/dl [see warnings and precaution

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

ohm laboratories, inc. - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia. colesevelam hydrochloride is indicated to reduce ldl-c levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification. colesevelam hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - colesevelam hydrochloride has not been studied in fredrickson type i, iii, iv, and v dyslipidemias. colesevelam hydrochloride is contraindicated in patients with: - serum tg concentrations >500 mg/dl [see warnings and precautions (5.1)] - history of hypertriglyceridemia-induced pan

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

amneal pharmaceuticals of new york llc - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia. colesevelam hydrochloride tablets are indicated to reduce ldl-c levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification. - colesevelam hydrochloride tablets should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - colesevelam hydrochloride tablets have not been studied in fredrickson type i, iii, iv, and v dyslipidemias. colesevelam hydrochloride is contraindicated in patients with: - serum tg concentrations >500 mg/dl [see warnings and precautions (5.1)] - history of hypertriglyceridemia-induced pancreatitis [see warnings and precautions (5.1)] - a history of bowel obstruction [see warnings and precautions (5.2)] risk summary colesevelam hydrochloride is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. limited available data on the use of colesevelam hydrochloride are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. in animal reproduction studies, no evidence of either maternal or fetal toxicity was found in rats or rabbits exposed to colesevelam hydrochloride during the period of fetal organogenesis at 8 and 5 times, respectively, the maximum recommended human dose (mrhd) of 3.75 g/day, based on body surface area (mg/m2 ). no adverse effects on offspring survival and development were observed in rats administered 5 times the mrhd (see data). colesevelam hydrochloride may decrease the absorption of fat-soluble vitamins [see warnings and precautions (5.3)]. there are no data available on the effect of colesevelam hydrochloride on the absorption of fat-soluble vitamins in pregnant women. if the patient becomes pregnant while taking colesevelam hydrochloride, the patient should be advised of the lack of known clinical benefit with continued use during pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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 human data there are no adequate and well-controlled studies of colesevelam hydrochloride use in pregnant women. in the post-marketing setting there have been infrequent reports of pregnancy with use of colesevelam hydrochloride and a causal association with congenital anomalies has not been established. animal data in pregnant rats given dietary doses of 0.3, 1.0, 3.0 g/kg/day colesevelam hydrochloride from gestation days 7 through 17, no teratogenic effects were observed. exposures at 3.0 g/kg/day were 8 times the human exposure at 3.75 g/day mrhd, based on body surface area (mg/m2 ). in pregnant rabbits given oral gavage doses of 0.1, 0.5, 1.0 g/kg/day colesevelam hydrochloride from gestation days 6 through 18, no teratogenic effects were observed. exposures at 1.0 g/kg/day were 5 times the human exposure at 3.75 g/day mrhd, based on body surface area (mg/m2 ). in pregnant rats given oral gavage doses of 0.1, 0.3, 1.0 g/kg/day colesevelam hydrochloride from gestation day 6 through lactation day 21 (weaning), no adverse effects on survival and development were observed. exposures at 1.0 g/kg/day were 5 times the human exposure at 3.75 g/day mrhd, based on body surface area (mg/m2 ). risk summary colesevelam hydrochloride is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to colesevelam hydrochloride. contraception use of colesevelam hydrochloride may reduce the efficacy of oral contraceptives. advise patients to take oral contraceptives at least 4 hours prior to taking colesevelam hydrochloride [see drug interactions (7)]. primary hyperlipidemia the safety and effectiveness of colesevelam hydrochloride to reduce ldl-c levels in boys and postmenarchal girls 10 to 17 years of age with hefh  who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification have been established. use of colesevelam hydrochloride for this indication is supported by a study in 129 colesevelam hydrochloride -treated pediatric patients aged 10 to 17 years with hefh [see clinical studies (14.1)] . adverse reactions commonly observed in pediatric patients compared to placebo, but not in adults, included headache (3.9%), creatine phosphokinase increase (2.3%), and vomiting (2.3%) [see adverse reactions (6.1)] . there were no significant effects on fat-soluble vitamin levels or clotting factors in the adolescent boys or girls relative to placebo. due to colesevelam hydrochloride tablet size, colesevelam hydrochloride for oral suspension is recommended for use in the pediatric population [see dosage and administration (2.2, 2.4)].  the safety and effectiveness of colesevelam hydrochloride in pediatric patients with hefh less than 10 years of age or in premenarchal females have not been established. primary hyperlipidemia of the 1,350 patients enrolled in the hyperlipidemia clinical studies, 349 (26%) were ≥65 years old, and 58 (4%) were ≥75 years old. 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 ruled out.

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

american health packaging - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia. colesevelam hydrochloride tablets are indicated to reduce ldl-c levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification. - colesevelam hydrochloride tablets should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - colesevelam hydrochloride tablets have not been studied in fredrickson type i, iii, iv, and v dyslipidemias. colesevelam hydrochloride is contraindicated in patients with: - serum tg concentrations > 500 mg/dl [see warnings and precautions (5.1)] - history of hypertriglyceridemia-induced pancreatitis [see warnings and precautions (5.1)] - a history of bowel obstruction [see warnings and precautions (5.2)] risk summary colesevelam hydrochloride is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. limited available data on the use of colesevelam hydrochloride are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. in animal reproduction studies, no evidence of either maternal or fetal toxicity was found in rats or rabbits exposed to colesevelam hydrochloride during the period of fetal organogenesis at 8 and 5 times, respectively, the maximum recommended human dose (mrhd) of 3.75 g/day, based on body surface area (mg/m 2 ). no adverse effects on offspring survival and development were observed in rats administered 5 times the mrhd (see data). colesevelam hydrochloride may decrease the absorption of fat-soluble vitamins [see warnings and precautions (5.3)]. there are no data available on the effect of colesevelam hydrochloride on the absorption of fat-soluble vitamins in pregnant women. if the patient becomes pregnant while taking colesevelam hydrochloride, the patient should be advised of the lack of known clinical benefit with continued use during pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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 human data there are no adequate and well-controlled studies of colesevelam hydrochloride use in pregnant women. in the post-marketing setting there have been infrequent reports of pregnancy with use of colesevelam hydrochloride and a causal association with congenital anomalies has not been established. animal data in pregnant rats given dietary doses of 0.3, 1.0, 3.0 g/kg/day colesevelam hydrochloride from gestation days 7 through 17, no teratogenic effects were observed. exposures at 3.0 g/kg/day were 8 times the human exposure at 3.75 g/day mrhd, based on body surface area (mg/m 2 ). in pregnant rabbits given oral gavage doses of 0.1, 0.5, 1.0 g/kg/day colesevelam hydrochloride from gestation days 6 through 18, no teratogenic effects were observed. exposures at 1.0 g/kg/day were 5 times the human exposure at 3.75 g/day mrhd, based on body surface area (mg/m 2 ). in pregnant rats given oral gavage doses of 0.1, 0.3, 1.0 g/kg/day colesevelam hydrochloride from gestation day 6 through lactation day 21 (weaning), no adverse effects on survival and development were observed. exposures at 1.0 g/kg/day were 5 times the human exposure at 3.75 g/day mrhd, based on body surface area (mg/m 2 ). risk summary colesevelam hydrochloride is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to colesevelam hydrochloride. contraception use of colesevelam hydrochloride may reduce the efficacy of oral contraceptives. advise patients to take oral contraceptives at least 4 hours prior to taking colesevelam hydrochloride [see drug interactions (7)]. primary hyperlipidemia the safety and effectiveness of colesevelam hydrochloride to reduce ldl-c levels in boys and postmenarchal girls 10 to 17 years of age with hefh who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification have been established. use of colesevelam hydrochloride for this indication is supported by a study in 129 colesevelam hydrochloride -treated pediatric patients aged 10 to 17 years with hefh [see clinical studies (14.1)]. adverse reactions commonly observed in pediatric patients compared to placebo, but not in adults, included headache (3.9%), creatine phosphokinase increase (2.3%), and vomiting (2.3%) [see adverse reactions (6.1)]. there were no significant effects on fat-soluble vitamin levels or clotting factors in the adolescent boys or girls relative to placebo. due to colesevelam hydrochloride tablet size, colesevelam hydrochloride for oral suspension is recommended for use in the pediatric population [see dosage and administration (2.2, 2.4)]. the safety and effectiveness of colesevelam hydrochloride in pediatric patients with hefh less than 10 years of age or in premenarchal females have not been established. primary hyperlipidemia of the 1,350 patients enrolled in the hyperlipidemia clinical studies, 349 (26%) were ≥65 years old, and 58 (4%) were ≥75 years old. 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 ruled out.

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

zydus lifesciences limited - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia. colesevelam hydrochloride tablets are indicated to reduce ldl-c levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification. - colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - the effect of colesevelam hydrochloride on cardiovascular morbidity and mortality has not been determined. - colesevelam hydrochloride has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor. - colesevelam hydrochloride has not been studied in fredrickson type i, iii, iv, and v dyslipidemias. - colesevelam hydrochloride has not bee

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

nivagen pharmaceuticals, inc. - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia. colesevelam hydrochloride tablets are indicated to reduce ldl-c levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification. colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. • colesevelam hydrochloride has not been studied in fredrickson type i, iii, iv, and v dyslipidemias. colesevelam hydrochloride is contraindicated in patients with: • serum tg concentrations >500 mg/dl [see

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

bryant ranch prepack - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia. colesevelam hydrochloride tablets are indicated to reduce ldl-c levels in boys and post-menarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification. - colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - the effect of colesevelam hydrochloride on cardiovascular morbidity and mortality has not been determined. - colesevelam hydrochloride has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor. - colesevelam hydrochloride has not been studied in fredrickson type i, iii, iv, and v dyslipidemias. - colesevelam hydrochloride has not been studied in children younger than