Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

pharmacia limited company trading as pharmacia - colestipol hydrochloride 1040mg (as a 96:4 mix of colestipol hcl & povidone) - tablet - 1 g - active: colestipol hydrochloride 1040mg (as a 96:4 mix of colestipol hcl & povidone) excipient: carnauba wax cellacefate colloidal silicon dioxide hypromellose magnesium stearate triacetin

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

daiichi sankyo inc. - 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. welchol 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. welchol is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - welchol has not been studied in fredrickson type i, iii, iv, and v dyslipidemias. welchol 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 precaution

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - colestipol hydrochloride 5 g - granules for oral suspension - 5 g - active: colestipol hydrochloride 5 g - colestid is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol and low-density lipoprotein (ldl) cholesterol in patients with primary hypercholesterolaemia (elevated low density lipoproteins (ldl) cholesterol) who do not respond adequately to diet and to reduce the risks of atherosclerotic coronary artery disease and myocardial infarction. it may be used as the sole agent or in combination with additional lipid lowering agents. when compared to conventional measures, intensive lipid-lowering combination therapy, which included colestid plus either niacin or lovastatin, significantly reduced the frequency of progression and increased the frequency of regression of coronary atherosclerotic lesions in patients with, or at risk for, symptomatic coronary artery disease

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

a-s medication solutions - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride tablets 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 tablets 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. - 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 10

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

bryant ranch prepack - 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 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. pediatric information describing a clinical study in which efficacy was not demonstrated is approved for daiichi sankyo inc.’s welchol® (colesevelam hydrochloride) powder for oral suspension. however, due to daiichi sankyo inc.’s marketing exclusivity rights, this product is not labeled with that information. 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

colestipol hydrochloride -

Australija - anglų - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - colestipol hydrochloride -

Didžioji Britanija - anglų - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - colestipol hydrochloride - granules for oral suspension - 5gram

Didžioji Britanija - anglų - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - colestipol hydrochloride - granules for oral suspension - 5gram

Malta - anglų - Medicines Authority

laboratorios rubio s.a industria, 29, pol.ind. comte de sert, 08755 castellbisbal, barcelona, spain - colestyramine - powder for oral suspension - colestyramine 4 g - lipid modifying agents