Stati Uniti - Ingliż - 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.

Stati Uniti - Ingliż - 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

Stati Uniti - Ingliż - 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

Stati Uniti - Ingliż - 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.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

glenmark pharmaceuticals inc.,usa - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride for oral suspension 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 for oral suspension 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 for oral suspension is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. colesevelam hydrochloride for oral suspension is contraindicated in patients with: 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

Stati Uniti - Ingliż - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - 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 are contraindicated in patients with: 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 malform

Stati Uniti - Ingliż - 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.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

ascend laboratories, llc - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride for oral suspension 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 for oral suspension 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 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 warnin

Stati Uniti - Ingliż - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - sevelamer hydrochloride (unii: gls2pgi8qg) (sevelamer - unii:941n5duu5c) - sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (ckd) on dialysis. the safety and efficacy of sevelamer hydrochloride tablets in ckd patients who are not on dialysis have not been studied. sevelamer hydrochloride is contraindicated in patients with bowel obstruction. sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. risk summary sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [ see clinical pharmacology (12.2)] . consider supplementing with these vitamins. data animal data in pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin d, occurred at 7-21 times the maximum human equivalent dose of 13 g based on 60 kg body weight. in pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurredin the high-dose group (human equivalent dose approximately 5 times the maximum clinical trial dose based on 60 kg body weight). risk summary sevelamer hydrochloride is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the child to sevelamer hydrochloride. clinical considerations sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in lactating women [see clinical pharmacology (12.2)] . consider supplementing with these vitamins. the safety and efficacy of sevelamer hydrochloride has not been established in pediatric patients. clinical studies of sevelamer hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

zydus pharmaceuticals usa 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 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 hyp