United States - English - NLM (National Library of Medicine)

macleods pharmaceuticals limited - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. 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-solub

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - sevelamer carbonate - film-coated tablet - 800 milligram(s) - drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

Ireland - English - HPRA (Health Products Regulatory Authority)

genthon b.v. - sevelamer carbonate anhydrous - film-coated tablet - 800 milligram(s) - drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - sevelamer carbonate - film-coated tablet - 800 milligram(s) - drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

Ireland - English - HPRA (Health Products Regulatory Authority)

waymade b.v. - sevelamer hydrochloride - film-coated tablet - 800 milligram(s) - drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

consilient health ltd - sevelamer carbonate - powder - 2.4gram

Ireland - English - HPRA (Health Products Regulatory Authority)

waymade b.v. - sevelamer hydrochloride - film-coated tablet - 400 milligram(s) - drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - 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

United States - English - NLM (National Library of Medicine)

genzyme corporation - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - renvela ® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. renvela is contraindicated in patients with bowel obstruction. renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. 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 in mid and

United States - English - 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.