Cholestyramine


Zydus Lifesciences Limited
Human Prescription Drug
NDC 70771-1105
Cholestyramine is a human prescription drug labeled by 'Zydus Lifesciences Limited'. National Drug Code (NDC) number for Cholestyramine is 70771-1105. This drug is available in dosage form of Powder, For Suspension. The names of the active, medicinal ingredients in Cholestyramine drug includes Cholestyramine - 4 g/9g . The currest status of Cholestyramine drug is Active.

Drug Information:

Drug NDC: 70771-1105
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Cholestyramine
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Cholestyramine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Zydus Lifesciences Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Powder, For Suspension
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CHOLESTYRAMINE - 4 g/9g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 Aug, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA202901
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Zydus Lifesciences Limited
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:848943
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0370771110513
UPC stands for Universal Product Code.
NUI:N0000180292
N0000175365
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:4B33BGI082
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:Bile-acid Binding Activity [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Bile Acid Sequestrant [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:Bile Acid Sequestrant [EPC]
Bile-acid Binding Activity [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
70771-1105-1378 g in 1 CAN (70771-1105-1)01 Aug, 2018N/ANo
70771-1105-260 POUCH in 1 CARTON (70771-1105-2) / 9 g in 1 POUCH01 Aug, 2018N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

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
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 – [(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
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
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
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


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