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

carilion materials management - 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

Združene države Amerike - angleščina - 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.

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - 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

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

bionpharma 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 post-menarchal girls, 10 years 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 > 500 mg/dl [see warnings and precautions (5.1)] - history of hypertriglyceridemia-induced pancreatitis [see warnings and precautions (5.1)]

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

tris pharma 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 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 dyslipidem