Prevalite

Prevalite is part of the drug class:

• Bile acid sequestrants

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Although cholestyramine is usually taken once or twice per day, this medicine may be taken up to 6 times per day. Carefully follow your doctor's dosing instructions.

Mix the cholestyramine powder with at least 2 to 3 ounces of water or other non-carbonated beverage. You may also mix the powder with a brothy soup, crushed pineapple, or applesauce. Measure the powder using the scoop provided with your medication. Do not use any other scoop or measuring cup to measure your cholestyramine dose.

Cholestyramine works best if you take it with meals. However, your dosing schedule may depend on when you need to take any other medications. Cholestyramine should not be taken within 1 hour after or 4 hours before you take other medications.

Use cholestyramine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Cholestyramine can affect the surfaces of your teeth. Sipping the cholestyramine/liquid mixture slowly or holding the liquid in your mouth for too long may result in tooth discoloration, enamel erosion, or tooth decay. Be sure to brush your teeth regularly while you are using this medicine.

Drink extra fluids to prevent constipation while you are taking cholestyramine.

While using cholestyramine, you may need frequent blood tests.

Cholestyramine is only part of a complete program of treatment that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• ongoing or worsening constipation;

• severe stomach pain;

• blood in your urine;

• black, bloody, or tarry stools; or

• easy bruising, unusual bleeding.

Side effects such as constipation may be more likely in older adults.

Common side effects may include:

• mild constipation, diarrhea;

• stomach pain, nausea, loss of appetite;

• bloating or gas;

• irritation of your tongue; or

• itching or irritation around your rectal area.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• birth control pills or hormone replacement therapy;

• digoxin (digitalis);

• a diuretic or "water pill";

• penicillin G;

• phenobarbital;

• phenylbutazone;

• propranolol;

• spironolactone;

• tetracycline;

• thyroid medication such as levothyroxine (Synthroid and others); or

• warfarin (Coumadin, Jantoven).

This list is not complete. Other drugs may interact with cholestyramine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Very bad belly pain.
• Very hard stools (constipation).
• Very loose stools (diarrhea).

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

The recommended starting adult dose for Prevalite® (cholestyramine for oral suspension, USP) powder is one packet or one level scoopful (5.5 grams of Prevalite® [cholestyramine for oral suspension, USP] powder contain 4 grams of anhydrous cholestyramine resin) once or twice a day. The recommended maintenance dose for Prevalite® (cholestyramine for oral suspension, USP) powder is 2 to 4 packets or scoopfuls daily (8 to 16 grams anhydrous cholestyramine resin) divided into two doses. 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 Prevalite® (cholestyramine for oral suspension, USP) powder (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, Prevalite® (cholestyramine for oral suspension, USP) powder may be administered in 1 to 6 doses per day.

Prevalite® (cholestyramine for oral suspension, USP) powder should not be taken in its dry form. Always mix the dry powder with water or other fluids before ingesting. See Preparation Instructions.

Concomitant Therapy

Preliminary evidence suggests that the lipid-lowering effects of cholestyramine 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 therapy. See PRECAUTIONS, Drug Interactions for recommendations on administering concomitant therapy.

Preparation

The color of Prevalite® (cholestyramine for oral suspension, USP) powder 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 Prevalite® (cholestyramine for oral suspension, USP) powder in a glass or cup. Add at least 2 to 3 ounces of water or the beverage of your choice. Stir to a uniform consistency.

Prevalite® (cholestyramine for oral suspension, USP) powder may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

Prevalite® (cholestyramine for oral suspension, USP) powder is available in cartons of forty-two and sixty single-dose packets and in cans containing 231 grams. 5.5 grams of Prevalite® (cholestyramine for oral suspension, USP) powder contain 4 grams of anhydrous cholestyramine resin.

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

Applies to cholestyramine: oral powder for suspension, oral tablet

In some animal studies, cholestyramine (the active ingredient contained in Prevalite) was found to cause tumors. It is not known whether cholestyramine causes tumors in humans.

Along with its needed effects, cholestyramine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cholestyramine:

• Black, tarry stools
• stomach pain (severe) with nausea and vomiting

Check with your doctor as soon as possible if any of the following side effects occur while taking cholestyramine:

• Constipation

• Loss of weight (sudden)

Some side effects of cholestyramine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Heartburn or indigestion
• nausea or vomiting
• stomach pain

• Belching
• bloating
• diarrhea
• dizziness
• headache

Applies to cholestyramine: compounding powder, oral powder for reconstitution

General

The most frequently reported side effect is constipation.[Ref]

Gastrointestinal

Intestinal obstruction occurred rarely and 2 deaths in pediatric patients were reported.[Ref]

Very common (10% or more): Constipation
Uncommon (0.1% to 1%): Tongue irritation, irritation of perianal area, abdominal discomfort/pain/distention, flatulence, nausea, vomiting, diarrhea, heartburn, dyspepsia, steatorrhea
Rare (less than 0.1%): Intestinal obstruction
Frequency not reported: Rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccoughs, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis, eructation, dental bleeding, dental caries, calcification of gallbladder, tooth discoloration, erosion of tooth enamel[Ref]

Cardiovascular

Frequency not reported: Claudication, angina, arteritis, thrombophlebitis, myocardial infarction, myocardial ischemia, postprandial angina increased[Ref]

Musculoskeletal

Common (1% to 10%): Osteoporosis
Frequency not reported: Backache, arthritis, muscle/joint pain[Ref]

Hematologic

Uncommon (0.1% to 1%): Bleeding
Frequency not reported: Prothrombin time increased, prothrombin time decreased, anemia, hypoprothrombinemia[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, hyperchloremic acidosis, Vitamin A deficiency, Vitamin K deficiency[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, skin irritation
Frequency not reported: Ecchymosis, xanthoma of hands/fingers, urticaria[Ref]

Hepatic

Frequency not reported: Liver function test abnormal[Ref]

Nervous system

Frequency not reported: Headache, paresthesia, syncope, dizziness, drowsiness, femoral nerve pain[Ref]

Other

Frequency not reported: Vertigo, weight loss, weight gain, glands swollen, edema, chest pain, tinnitus[Ref]

Ocular

Frequency not reported: Arcus juvenilis, uveitis, night blindness[Ref]

Genitourinary

Frequency not reported: Hematuria, dysuria, burnt odor to urine, diuresis[Ref]

Respiratory

Frequency not reported: Asthma, wheezing, shortness of breath[Ref]

Psychiatric

Frequency not reported: Libido increased[Ref]

Some side effects of Prevalite may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.