Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

pharmacia & upjohn company llc - colestipol hydrochloride (unii: x7d10k905g) (colestipol - unii:k50n755924) - colestipol hydrochloride 5 g in 5 g - since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. colestid granules and flavored colestid granules are indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (ldl) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [ldl] cholesterol) who do not respond adequately to diet. generally, colestid and flavored colestid have no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy (see ncep guidelines). a minimum of six months of intensive dietary therapy and counseling should

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

pharmacia & upjohn company llc - colestipol hydrochloride (unii: x7d10k905g) (colestipol - unii:k50n755924) - colestipol hydrochloride 1 g - since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. colestid tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and ldl-c in patients with primary hypercholesterolemia (elevated ldl-c) who do not respond adequately to diet. generally, colestid tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy (see ncep guidelines). a minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. shorter periods may be considered in patients with severe elevat

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

greenstone llc - colestipol hydrochloride (unii: x7d10k905g) (colestipol - unii:k50n755924) - colestipol hydrochloride 1 g - since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and ldl-c in patients with primary hypercholesterolemia (elevated ldl-c) who do not respond adequately to diet. generally, colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy (see ncep guidelines). a minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. shorter periods may be considere

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - colestipol hydrochloride (unii: x7d10k905g) (colestipol - unii:k50n755924) - colestipol hydrochloride 5 g - since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. colestipol hydrochloride for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (ldl) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [ldl] cholesterol) who do not respond adequately to diet. generally, colestipol hydrochloride for oral suspension has no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy (see ncep guidelines). a minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. shorter periods may be considered in patients with severe elevations of ldl-c or with definite chd. according to the ncep guidelines, the goal of treatment is to lower ldl-c, and ldl-c is to be used to initiate and assess treatment response. only if ldl-c levels are not available, should the total-c be used to monitor therapy. the ncep treatment guidelines are shown below. ldl-cholesterol mg/dl (mmol/l) definite atherosclerotic disease* two or more other risk factors** initiation level goal no no ≥ 190 (≥ 4.9) < 160 (< 4.1) no yes ≥ 160 (≥ 4.1) < 130 (< 3.4) yes yes or no ≥ 130 (≥ 3.4) ≤ 100 (≤ 2.6) * coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). ** other risk factors for coronary heart disease (chd) include: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature chd; current cigarette smoking; hypertension; confirmed hdl-c < 35 mg/dl (0.91 mmol/l); and diabetes mellitus. subtract one risk factor if hdl-c is ≥ 60 mg/dl (1.6 mmol/l). colestipol hydrochloride for oral suspension is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - colestipol hydrochloride (unii: x7d10k905g) (colestipol - unii:k50n755924) - colestipol hydrochloride 1 g - since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and ldl-c in patients with primary hypercholesterolemia (elevated ldl-c) who do not respond adequately to diet. generally, colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy (see ncep guidelines). a minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. shorter periods may be considere

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

greenstone llc - colestipol hydrochloride (unii: x7d10k905g) (colestipol - unii:k50n755924) - colestipol hydrochloride 5 g in 5 g - since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. colestipol hydrochloride granules are indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (ldl) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [ldl] cholesterol) who do not respond adequately to diet. generally, colestipol hydrochloride granules have no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy (see ncep guidelines). a minimum of six months of intensive dietary therapy and counseling should be carried o

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

physicians total care, inc. - colestipol hydrochloride (unii: x7d10k905g) (colestipol - unii:k50n755924) - colestipol hydrochloride 1 g - since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. micronized colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and ldl-c in patients with primary hypercholesterolemia (elevated ldl-c) who do not respond adequately to diet. generally, micronized colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy (see ncep guidelines). a minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. shorter pe

Jungtinės Valstijos - anglų - 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.

Jungtinės Valstijos - anglų - 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.

Jungtinės Valstijos - anglų - 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.