QUESTRAN® (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 QUESTRAN is not absorbed from the digestive tract. Four grams of anhydrous cholestyra-mine resin is contained in 9 grams of QUESTRAN powder. Four grams of anhydrous cholestyramine resin is contained in 5 grams of QUESTRAN LIGHT. It is represented by the following structural formula:

QUESTRAN powder contains the following inactive ingredients:acacia, citric acid, D&C Yellow No. 10, FD&C Yellow No.6, flavor (natural and artificial Orange), polysorbate 80, propylene glycol alginate and sucrose. QUESTRAN LIGHT contains the following inactive ingredients: aspartame, citric acid, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Red No.40, flavor (natural and artificial Orange), maltodextrin, propylene glycol alginate and xanthan gum.

1) QUESTRAN (Cholestyramine for Oral Suspension USP), is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholes-terolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. QUESTRAN may be useful to lower LDL cholesterol in patients who also have hyper-triglyceridemia, 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 in the overweight.

Prior to initiating therapy with QUESTRAN 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 QUESTRAN 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 QUESTRAN therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of QUESTRAN or adding other lipid-lowering agents in combination with QUESTRAN should be considered.

Since the goal of treatment is to lower LDL-C, the NCEP⁴ 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.

LDL-Cholesterol mg/dL (mmol/L)

QUESTRAN monotherapy has been demonstrated to retard the rate of progression^{2, 3} and increase the rate of regression³ of coronary atherosclerosis.

2) QUESTRAN is indicated for the relief of pruritus associated with partial biliary obstruction. QUESTRAN 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.

The recommended starting adult dose for all QUESTRAN powdered products (QUESTRAN Powder and QUESTRAN LIGHT) is one packet or one level scoopful once or twice a day. The recommended maintenance dose for all QUESTRAN powdered products is 2 to 4 packets or scoopfuls daily (8-16 grams anhydrous cholestyramine resin) divided into two doses. Four grams of anhydrous cholestyramine resin is contained in each measured dose of QUESTRAN as follows:

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 packets or scoopfuls of QUESTRAN (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, QUESTRAN may be administered in 1-6 doses per day.

QUESTRAN should not be taken in its dry form. Always mix QUESTRAN with water or other fluids before ingesting. See Preparation Instructions.

Concomitant Therapy

Preliminary evidence suggests that the lipid-lowering effects of QUESTRAN 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 /QUESTRAN therapy. See the DRUG INTERACTIONS subsection of the PRECAUTIONS section for recommendations on administering concomitant therapy.

Preparation

The color of QUESTRAN 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 packet or one level scoopful of QUESTRAN in a glass or cup. Add an amount of water or other non-carbonated beverage of your choice depending on the product being used:

Stir to a uniform consistency and drink.

QUESTRAN may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

QUESTRAN® Powder (Cholestyramine for Oral Suspension USP) is available in cans containing 378 grams and in cartons of sixty 9 gram packets. Four grams of anhydrous cholestyra-mine resin are contained in 9 grams of QUESTRAN Powder. The 378 g can includes a 15 cc scoop. The scoop is not interchangeable with scoops from other products.

QUESTRAN® LIGHT (Cholestyramine for Oral Suspension USP) is available in cans containing 210 grams and in cartons of sixty 5 gram packets.Four grams of anhydrous cholestyramine resin are contained in 5 grams of QUESTRAN LIGHT. The 210 g can includes a 9 cc scoop. The scoop is not interchangeable with scoops from other products.

Storage

Store between 20°-25°C (68°-77°F).[See USP Controlled Room Temperature].Excursions permitted to 15°-30°C (59°-86°F).

REFERENCES

2. Brensike JF, Levy RI, Kelsey SF, et al.Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI type II coronary intervention study. Circulation 1984;69:313-24.

3. Watts, GF, Lewis B, Brunt JNH Lewis ES, et al.Effects on coronary artery disease of lipid-lowering diet, or diet plus cholestyramine. In the St. Thomas Atherosclerosis Regression Study (STARS). Lancet 1992;339:563-69.

4.National Cholesterol Education Program. Second Report of the Expert Panel Detection. Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Circulation 1994 Mar; 89(3):1333-445.

® Registered trademark of Par Pharmaceutical, Inc., Distributed by: PAR PHARMACEUTICAL COMPANIES, INC., Spring Valley, NY 10977. Revised:05/06. FDA revision date: 8/22/1997

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 calcification of the gallbladder, in patients to whom QUESTRAN 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 QUES-TRAN. 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 QUESTRAN 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.

QUESTRAN (Cholestyramine for Oral Suspension USP) may delay or reduce the absorption of concomitant oral medication such as phenylbutazone, warfarin, thiazide diuretics (acidic), or propranolol (basic), as well as tetracycline, penicillin G, phenobarbital, thyroid and thyroxine preparations, estrogens and progestins, and digitalis. Interference with the absorption of oral phosphate supplements has been observed with another positively-charged bile acid sequestrant. QUESTRAN may interfere with the pharmacokinetics of drugs that undergo enterohepatic circulation. The discontinuance of QUESTRAN could pose a hazard to health if a potentially toxic drug such as digitalis has been titrated to a maintenance level while the patient was taking QUESTRAN.

Because cholestyramine binds bile acids, QUESTRAN may interfere with normal fat digestion and absorption and thus may prevent absorption of fat-soluble vitamins such as A, D, E and K. When QUESTRAN is given for long periods of time, concomitant supplementation with water-miscible (or parenteral) forms of fat-soluble vitamins should be considered.

SINCE QUESTRAN MAY BIND OTHER DRUGS GIVEN CONCURRENTLY, IT IS RECOMMENDED THAT PATIENTS TAKE OTHER DRUGS AT LEAST ONE HOUR BEFORE OR 4 TO 6 HOURS AFTER QUESTRAN (OR AT AS GREAT AN INTERVAL AS POSSIBLE) TO AVOID IMPEDING THEIR ABSORPTION.

PHENYLKETONURICS: QUESTRAN LIGHT CONTAINS 14.0 MG PHENYLALANINE PER 5 GRAM DOSE.

General

Chronic use of QUESTRAN may be associated with increased bleeding tendency due to hypoprothrombinemia associated with Vitamin K deficiency. This will usually respond promptly to parenteral Vitamin K₁ and recurrences can be prevented by oral administration of Vitamin K₁. Reduction of serum or red cell folate has been reported over long term admin-istration of QUESTRAN. Supplementation with folic acid should be considered in these cases.

There is a possibility that prolonged use of QUESTRAN, since it is a chloride form of anion exchange resin, may produce hyperchloremic acidosis. This would especially be true in younger and smaller patients where the relative dosage may be higher. Caution should also be exercised in patients with renal insufficiency or volume depletion, and in patients receiving concomitant spironolactone.

QUESTRAN may produce or worsen pre-existing constipation. The dosage should be increased gradually in patients to minimize the risk of developing fecal impaction. In patients with pre-existing constipation, the starting dose should be 1 packet or 1 scoop once daily for 5-7 days, increasing to twice daily with monitoring of constipation and of serum lipoproteins, at least twice, 4-6 weeks apart. Increased fluid intake and fiber intake should be encouraged to alleviate constipation and a stool softener may occasionally be indicated. If the initial dose is well tolerated, the dose may be increased as needed by one dose/day (at monthly intervals) with periodic monitoring of serum lipoproteins.

If constipation worsens or the desired therapeutic response is not achieved at one to six doses/day, combination therapy or alternate therapy should be considered. Particular effort should be made to avoid constipation in patients with symptomatic coronary artery disease. Constipation associated with QUESTRAN may aggravate hemorrhoids.

Laboratory Tests

Serum cholesterol levels should be determined frequently during the first few months of therapy and periodically thereafter. Serum triglyceride levels should be measured periodically to detect whether significant changes have occurred.

The LRC-CPPT showed a dose-related increase in serum triglycerides of 10.7%-17.1% in the cholestyramine-treated group, compared with an increase of 7.9%-11.7% in the placebo group. Based on the mean values and adjusting for the placebo group, the cholestyramine-treated group showed an increase of 5% over pre-entry levels the first year of the study and an increase of 4.3% the seventh year.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In studies conducted in rats in which cholestyramine resin was used as a tool to investigate the role of various intestinal factors, such as fat, bile salts and microbial flora, in the development of intestinal tumors induced by potent carcinogens, the incidence of such tumors was observed to be greater in cholestyramine resin-treated rats than in control rats.

The relevance of this laboratory observation from studies in rats to the clinical use of QUES-TRAN is not known. In the LRC-CPPT study referred to above, the total incidence of fatal and nonfatal neoplasms was similar in both treatment groups. When the many different categories of tumors are examined, various alimentary system cancers were somewhat more prevalent in the cholestyramine group. The small numbers and the multiple categories prevent conclusions from being drawn. However, in view of the fact that cholestyramine resin is confined to the GI tract and not absorbed, and in light of the animal experiments referred to above, a six-year post-trial follow-up of the LRC-CPPT⁵ patient population has been completed (a total of 13.4 years of in-trial plus post-trial follow-up) and revealed no significant difference in the incidence of cause-specific mortality or cancer morbidity between cholestyramine and placebo treated patients.

Pregnancy

Pregnancy Category C

There are no adequate and well controlled studies in pregnant women. The use of QUES-TRAN in pregnancy or lactation or by women of childbearing age requires that the potential benefits of drug therapy be weighed against the possible hazards to the mother and child. QUESTRAN is not absorbed systemically, however, it is known to interfere with absorption of fat-soluble vitamins; accordingly, regular prenatal supplementation may not be adequate (see PRECAUTIONS: DRUG INTERACTIONS).

Nursing Mothers

Caution should be exercised when QUESTRAN is administered to a nursing mother. The possible lack of proper vitamin absorption described in the “Pregnancy” section may have an effect on nursing infants.

Pediatric Use

Although an optimal dosage schedule has not been established, standard texts^{(6, 7)} list a usual pediatric dose of 240 mg/kg/day of anhydrous cholestyramine resin in two to three divided doses, normally not to exceed 8 gm/day with dose titration based on response and tolerance.

In calculating pediatric dosages, 44.4 mg of anhydrous cholestyramine resin are contained in 100 mg of QUESTRAN powder and 80 mg of anhydrous cholestyramine resin are contained in 100 mg of QUESTRAN LIGHT.

The effects of long-term administration, as well as its effect in maintaining lowered cholesterol levels in pediatric patients, are unknown. (Also see ADVERSE REACTIONS.)

REFERENCES

5. The Lipid Research Clinics Investigators. The Lipid Research Clinics Coronary Primary Prevention Trial:Results of 6 Years of Post-Trial Follow-up. Arch Intern Med 1992;152:1399-1410.

6. Behrman RE et al (eds): Nelson, Textbook of Pediatrics, ed 15. Philadelphia, PA WB Saunders Company, 1996.

7. Takemoto CK et al (eds): Pediatric Dosage Handbook, ed 3. Cleveland/Akron, OH, Lexi-Comp, Inc., 1996-1997.

Overdosage with QUESTRAN 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.

QUESTRAN 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.

Actions

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.

QUESTRAN 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 QUESTRAN 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, QUESTRAN produces an increase in hepatic synthesis of cholesterol, plasma cholesterol levels fall. In patients with partial biliary obstruction, the reduction of serum bile acid levels by QUES-TRAN 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-CPPT¹, hypercholesterolemic subjects treated with QUESTRAN 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%, respec-tively. Over the seven-year study period the QUESTRAN 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% QUESTRAN and 8.6% placebo). The subjects included in the study were men aged 35-59 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 QUESTRAN monotherapy upon coronary atherosclerotic lesions using coronary arteriography. In the NHLBI Type II Coronary Intervention Trial², 116 patients (80% male) with coronary artery disease (CAD) documented by arteriography were randomized to QUESTRAN 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 QUESTRAN 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 QUESTRAN. 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 QUESTRAN (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 QUESTRAN group (p < 0.05). Thus in these randomized controlled clinical trials using coronary arteriography, QUESTRAN monotherapy has been demonstrated to slow progression^{2, 3} and promote regression³ 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 QUESTRAN and QUESTRAN LIGHT) 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.

REFERENCES

1. The Lipid Research Clinics Coronary Primary Prevention Trials Results: (l) Reduction in Incidence of Coronary Heart Disease; (ll) The Relationship of Reduction in Incidence of Coronary Heart Disease to Cholesterol Lowering. JAMA 1984; 251:351-374.

2. Brensike JF, Levy RI, Kelsey SF, et al.Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI type II coronary intervention study. Circulation 1984;69:313-24.

3. Watts, GF, Lewis B, Brunt JNH Lewis ES, et al.Effects on coronary artery disease of lipid-lowering diet, or diet plus cholestyramine. In the St. Thomas Atherosclerosis Regression Study (STARS). Lancet 1992;339:563-69.

Inform your physician if you are pregnant or plan to become pregnant or are breastfeeding. Drink plenty of fluids and mix each 9 gram dose of QUESTRAN Powder in at least 2 to 6 ounces of fluid.Mix each 5 gram dose of QUESTRAN LIGHT in at least 2 to 6 ounces of fluid before taking.Sipping or holding the resin suspension in the mouth for prolonged periods may lead to changes in the surface of the teeth resulting in discoloration, erosion of enamel or decay; good oral hygiene should be maintained.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CHOLESTYRAMINE/SUCROSE - ORAL

(ko-less-TEER-uh-meen/SOO-krose)

COMMON BRAND NAME(S): Questran

USES: This medication is used alone or with another medication to treat high cholesterol levels in the blood (primary hypercholesterolemia). This medication should be used with an exercise program and a low-fat, low-cholesterol diet. Lowering cholesterol can decrease complications such as heart disease, heart attack, and stroke. Cholestyramine belongs to class of drugs called bile acid-binding resins. Bile acid is a natural body substance that the liver makes by using cholesterol. This medication works by causing more bile acid to pass out of the body. The liver will then make more bile acid, taking more cholesterol out of the body and lowering your cholesterol levels.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat the symptoms of severe itching in patients with a certain liver disease (primary biliary sclerosis with partial obstruction). With this disease, some of the bile acids produced by the body are deposited in the skin, causing the severe itching. Cholestyramine binds the bile acids in the intestines so that more of it passes out of the body, thereby decreasing bile acid levels and reducing itching.

HOW TO USE: Take this medication by mouth, usually 1-2 times daily with meals or as directed by your doctor. Carefully measure out your prescribed dose by using the dose packet(s), or measure out level scoopful(s) using the scoop provided. Use 2 to 6 ounces (60 to 180 milliliters) of water or other liquid for each scoop or packet. Place the prescribed amount of medication and liquid into a glass, stir the mixture thoroughly, and drink it immediately. Rinse the glass with more liquid, then drink the rinse liquid. Do not hold the mixture in your mouth since doing so can cause damage to your teeth over time. Brush your teeth and use dental floss regularly. Cholestyramine powder may also be mixed with watery soups, hot/cold cereals, applesauce, or crushed pineapple.

Dosage is based on your medical condition. Your doctor may gradually increase your dose over time based on your response to treatment. It may take 2 weeks to several months to see results of cholesterol lowering.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Take other medications at least 1 hour before or 4 hours after taking your cholestyramine dose.

SIDE EFFECTS: See also How to Use section.

Constipation is the most common side effect.

To help prevent constipation, drink plenty of fluids throughout the day (eight to twelve 8-ounce glasses). Consult your pharmacist about choosing a fiber supplement (e.g., psyllium) and/or a stool softener.

Other side effects may include gas, indigestion, upset stomach, pain/cramps in the stomach/abdomen, heartburn, diarrhea, nausea, vomiting, irritation of hemorrhoids, or blood in stools. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle aches, inability to swallow, inability to have a bowel movement, joint pain/stiffness, unusual bleeding/bruising, headache, loss of appetite, sore tongue, anal irritation.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast breathing even when resting, severe weakness/tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking cholestyramine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blocked intestines (intestinal obstruction), complete biliary obstruction.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: swallowing problems, problems with constipation, recent major intestinal surgery, treatment with thyroid medication, vitamin absorption problems, liver problems, certain bleeding problems (hypoprothrombinemia).

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the constipation effect.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: propranolol, furosemide, hydrochlorothiazide, gemfibrozil, chlorothiazide, tetracycline, penicillin G, phenobarbital, thyroid, levothyroxine, estrogens (e.g., estradiol, conjugated estrogens), progestins (e.g., medroxyprogesterone), digoxin, digitoxin, hydrocortisone, oral phosphate supplements.

Cholestyramine may partially interfere with the absorption of these medications if taken close to taking your cholestyramine dose.

Over time, cholestyramine may interfere with the absorption of certain vitamins (e.g., vitamins A, E, D, K) from the diet, causing deficiencies. Consult your doctor for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

Keep all laboratory and medical appointments.

Laboratory and/or medical tests (e.g., HDL/LDL cholesterol) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Talk with your doctor, pharmacist, or nutritionist about the risks of having high cholesterol. To further decrease the risk of heart disease and stroke, closely follow the low-cholesterol/low-fat diet prescribed by your doctor, and stop smoking if you are a smoker. If you have high blood pressure, talk with your doctor about treatment with medication.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.