Product Elements:
Cholestyramine cholestyramine cholestyramine cholestyramine d&c yellow no. 10 fd&c yellow no. 6 orange sucrose anhydrous citric acid xanthan gum propylene glycol alginate vanilla orange vanilla
Indications and Usage:
Indications and usage 1) cholestyramine for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [ldl] cholesterol) who do not respond adequately to diet. cholestyramine for oral suspension may be useful to lower ldl cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. 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 specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy i
Read more...n the overweight. prior to initiating therapy with cholestyramine for oral suspension secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess total cholesterol, hdl-c, and triglycerides (tg). for individuals with tg less than 400 mg/dl (< 4.5 mmol/l), ldl-c can be estimated using the following equation:- ldl-c = total cholesterol â [(tg/5) + hdl-c] for tg levels > 400 mg/dl, this equation is less accurate and ldl-c concentrations should be determined by ultracentrifugation. in hypertriglyceridemic patients, ldl-c may be low or normal despite elevated total-c. in such cases cholestyramine for oral suspension may not be indicated. serum cholesterol and triglyceride levels should be determined periodically based on ncep guidelines to confirm initial and adequate long-term response. a favorable trend in cholesterol reduction should occur during the first month of cholestyramine for oral suspension therapy. the therapy should be continued to sustain cholesterol reduction. if adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine for oral suspension or adding other lipid-lowering agents in combination with cholestyramine for oral suspension should be considered. since the goal of treatment is to lower ldl-c, the ncep 4 recommends that ldl-c levels be used to initiate and assess treatment response. if ldl-c levels are not available then total-c alone may be used to monitor long-term therapy. a lipoprotein analysis (including ldl-c determination) should be carried out once a year. the ncep treatment guidelines are summarized below. * 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). 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) cholestyramine for oral suspension monotherapy has been demonstrated to retard the rate of progression 2,3 and increase the rate of regression 3 of coronary atherosclerosis. 2) cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. cholestyramine for oral suspension has been shown to have a variable effect on serum cholesterol in these patients. patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.
Dosage and Administration:
Dosage and administration the recommended starting adult dose for cholestyramine for oral suspension is one pouch or one level scoopful once or twice a day. the recommended maintenance dose for cholestyramine for oral suspension is 2 to 4 pouches or scoopfuls daily (8 to 16 grams anhydrous cholestyramine resin) divided into two doses. four grams of anhydrous cholestyramine resin is contained in each measured dose of cholestyramine for oral suspension as follows: cholestyramine for oral suspension 9 grams it is recommended that increases in dose be gradual with periodic assessment of lipid/lipoprotein levels at intervals of not less than 4 weeks. the maximum recommended daily dose is six pouches or scoopfuls of cholestyramine for oral suspension (24 grams of anhydrous cholestyramine resin). the suggested time of administration is at mealtime but may be modified to avoid interference with absorption of other medications. although the recommended dosing schedule is twice daily, cholestyra
Read more...mine for oral suspension may be administered in 1 to 6 doses per day. cholestyramine for oral suspension should not be taken in its dry form. always mix cholestyramine for oral suspension with water or other fluids before ingesting. see preparation instructions. concomitant therapy preliminary evidence suggests that the lipid-lowering effects of cholestyramine for oral suspension on total and ldl-cholesterol are enhanced when combined with a hmg-coa reductase inhibitor, e.g., pravastatin, lovastatin, simvastatin, and fluvastatin. additive effects on ldl-cholesterol are also seen with combined nicotinic acid /cholestyramine for oral suspension therapy. see the drug interactions subsection of the precautions section for recommendations on administering concomitant therapy. preparation the color of cholestyramine for oral suspension may vary somewhat from batch to batch but this variation does not affect the performance of the product. place the contents of one single-dose pouch or one level scoopful of cholestyramine for oral suspension in a glass or cup. add an amount of water or other noncarbonated beverage of your choice depending on the product being used: product formula amount of water or other non-carbonated liquid cholestyramine for oral suspension 2 to 6 ounces per dose stir to a uniform consistency and drink. cholestyramine for oral suspension may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.
Contraindications:
Contraindications cholestyramine for oral suspension is contraindicated in patients with complete biliary obstruction where bile is not secreted into the intestine and in those individuals who have shown hypersensitivity to any of its components.
Adverse Reactions:
Adverse reactions the most common adverse reaction is constipation. when used as a cholesterol-lowering agent predisposing factors for most complaints of constipation are high dose and increased age (more than 60 years old). most instances of constipation are mild, transient, and controlled with conventional therapy. some patients require a temporary decrease in dosage or discontinuation of therapy. less frequent adverse reactions abdominal discomfort and/or pain, flatulence, nausea, vomiting, diarrhea, eructation, anorexia, and steatorrhea, bleeding tendencies due to hypoprothrombinemia (vitamin k deficiency) as well as vitamin a (one case of night blindness reported) and d deficiencies, hyperchloremic acidosis in children, osteoporosis, rash and irritation of the skin, tongue and perianal area. rare reports of intestinal obstruction, including two deaths, have been reported in pediatric patients. occasional calcified material has been observed in the biliary tree, including calcifica
Read more...tion of the gallbladder, in patients to whom cholestyramine for oral suspension has been given. however, this may be a manifestation of the liver disease and not drug related. one patient experienced biliary colic on each of three occasions on which he took cholestyramine for oral suspension. one patient diagnosed as acute abdominal symptom complex was found to have a "pasty mass" in the transverse colon on x-ray. other events (not necessarily drug related) reported in patients taking cholestyramine for oral suspension include gastrointestinal gi-rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccups, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis. laboratory test changes liver function abnormalities. hematologic prolonged prothrombin time, ecchymosis, anemia. hypersensitivity urticaria, asthma, wheezing, shortness of breath. musculoskeletal backache, muscle and joint pains, arthritis. neurologic headache, anxiety, vertigo, dizziness, fatigue, tinnitus, syncope, drowsiness, femoral nerve pain, paresthesia. eye uveitis. renal hematuria, dysuria, burnt odor to urine, diuresis. miscellaneous weight loss, weight gain, increased libido, swollen glands, edema, dental bleeding, dental caries, erosion of tooth enamel, tooth discoloration.
Overdosage:
Overdosage overdosage with cholestyramine for oral suspension has been reported in a patient taking 150% of the maximum recommended daily dosage for a period of several weeks. no ill effects were reported. should an overdosage occur, the chief potential harm would be obstruction of the gastrointestinal tract. the location of such potential obstruction, the degree of obstruction, and the presence or absence of normal gut motility would determine treatment.
Description:
Description cholestyramine for oral suspension usp, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. cholestyramine resin is quite hydrophilic, but insoluble in water. the cholestyramine resin in cholestyramine for oral suspension, usp is not absorbed from the digestive tract. four grams of anhydrous cholestyramine resin is contained in 9 grams of cholestyramine for oral suspension, usp. it is represented by the following structural formula: cholestyramine for oral suspension, usp contains the following inactive ingredients: citric acid, d & c yellow # 10 aluminum lake, flavor (natural and artificial orange, natural and artificial vanilla), fd & c yellow # 6 aluminum lake, propylene glycol alginate, sucrose and xanthan gum. formula
Clinical Pharmacology:
Actions/clinical pharmacology cholesterol is probably the sole precursor of bile acids. during normal digestion, bile acids are secreted into the intestines. a major portion of the bile acids is absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation. only very small amounts of bile acids are found in normal serum. cholestyramine for oral suspension resin adsorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the feces. this results in a partial removal of bile acids from the enterohepatic circulation by preventing their absorption. the increased fecal loss of bile acids due to cholestyramine for oral suspension administration leads to an increased oxidation of cholesterol to bile acids, a decrease in beta lipoprotein or low density lipoprotein plasma levels and a decrease in serum cholesterol levels. although in man, cholestyramine for oral suspension produces an increase in hepatic synthesis o
Read more...f cholesterol, plasma cholesterol levels fall. in patients with partial biliary obstruction, the reduction of serum bile acid levels by cholestyramine for oral suspension reduces excess bile acids deposited in the dermal tissue with resultant decrease in pruritus. clinical studies in a large, placebo-controlled, multi-clinic study, lrc-cppt 1 , hypercholesterolemic subjects treated with cholestyramine for oral suspension had mean reductions in total and low-density lipoprotein cholesterol (ldl-c) which exceeded those for diet and placebo treatment by 7.2% and 10.4%, respectively. over the seven-year study period the cholestyramine for oral suspension group experienced a 19% reduction (relative to the incidence in the placebo group) in the combined rate of coronary heart disease death plus non-fatal myocardial infarction (cumulative incidences of 7% cholestyramine for oral suspension and 8.6% placebo). the subjects included in the study were men aged 35 to 59 with serum cholesterol levels above 265 mg/dl and no previous history of heart disease. it is not clear to what extent these findings can be extrapolated to females and other segments of the hypercholesterolemic population. (see also precautions: carcinogenesis, mutagenesis, impairment of fertility .) two controlled clinical trials have examined the effects of cholestyramine for oral suspension monotherapy upon coronary atherosclerotic lesions using coronary arteriography. in the nhlbi type ii coronary intervention trial 2 , 116 patients (80% male) with coronary artery disease (cad) documented by arteriography were randomized to cholestyramine for oral suspension or placebo for five years of treatment. final study arteriography revealed progression of coronary artery disease in 49% of placebo patients compared to 32% of the cholestyramine for oral suspension group (p < 0.05). in the st. thomas atherosclerosis regression study (stars) 3 , 90 hypercholesterolemic men with cad were randomized to three blinded treatments: usual care, lipid-lowering diet, and lipid-lowering diet plus cholestyramine for oral suspension. after 36 months, follow-up coronary arteriography revealed progression of disease in 46% of usual care patients, 15% of patients on lipid-lowering diet and 12% of those receiving diet plus cholestyramine for oral suspension (p < 0.02). the mean absolute width of coronary segments decreased in the usual care group, increased slightly (0.003mm) in the diet group and increased by 0.103mm in the diet plus cholestyramine for oral suspension group (p < 0.05). thus in these randomized controlled clinical trials using coronary arteriography, cholestyramine for oral suspension monotherapy has been demonstrated to slow progression 2,3 and promote regression 3 of atherosclerotic lesions in the coronary arteries of patients with coronary artery disease. the effect of intensive lipid-lowering therapy on coronary atherosclerosis has been assessed by arteriography in hyperlipidemic patients. in these randomized, controlled clinical trials, patients were treated for two to four years by either conventional measures (diet, placebo, or in some cases low dose resin), or intensive combination therapy using diet plus colestipol (an anion exchange resin with a mechanism of action and an effect on serum lipids similar to that of cholestyramine for oral suspension) plus either nicotinic acid or lovastatin. when compared to conventional measures, intensive lipid-lowering combination therapy significantly reduced the frequency of progression and increased the frequency of regression of coronary atherosclerotic lesions in patients with or at risk for coronary artery disease.
How Supplied:
How supplied cholestyramine for oral suspension, usp is available in cans containing 378 grams and in cartons of sixty 9 gram pouches. four grams of anhydrous cholestyramine resin are contained in 9 grams of cholestyramine for oral suspension, usp. the 378 grams can includes a 15 cc scoop. the scoop is not interchangeable with scoops from other products. ndc 70771-1105-1 can, 378 grams ndc 70771-1105-2 carton of 60, 9 grams pouches storage store between 20 to 25 c (68 to 77 f). [see usp controlled room temperature]. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088.
Package Label Principal Display Panel:
Package label.principal display panel ndc 70771-1105-1 cholestyramine for oral suspension usp powder, 4 gm r x only 378 gm zydus ndc 70771-1105-2 cholestyramine for oral suspension usp powder, 4 gm r x only 60 pouch zydus label carton