Kanada - angleščina - Health Canada

pfizer canada ulc - colestipol hydrochloride - granules - 5g - colestipol hydrochloride 5g - bile acid sequestrants

Kanada - angleščina - Health Canada

pfizer canada ulc - colestipol hydrochloride - granules - 5g - colestipol hydrochloride 5g - bile acid sequestrants

Kanada - angleščina - Health Canada

pfizer canada ulc - colestipol hydrochloride - tablet - 1g - colestipol hydrochloride 1g - bile acid sequestrants

Belgija - angleščina - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - colestipol hydrochloride 5000 mg - granules for oral suspension - 5 g - colestipol hydrochloride 5000 mg - colestipol

Združene države Amerike - angleščina - NLM (National Library of Medicine)

avera mckennan hospital - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride 625 mg

Združene države Amerike - angleščina - NLM (National Library of Medicine)

a-s medication solutions - 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 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 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/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. 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=1075) 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.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

a-s medication solutions - 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 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 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/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. 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=1075) 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.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

zydus lifesciences limited - colestipol hydrochloride (unii: x7d10k905g) (colestipol - unii:k50n755924) -

Kanada - angleščina - Health Canada

apotex inc - colesevelam hydrochloride - tablet - 625mg - colesevelam hydrochloride 625mg - bile acid sequestrants

Združene države Amerike - angleščina - NLM (National Library of Medicine)

carilion materials management - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride 625 mg - welchol 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). welchol is indicated as monotherapy or in combination with a statin to reduce ldl-c levels in boys and postmenarchal 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 wit