JAMP-CHOLESTYRAMINE

1 Dosing Considerations • To familiarize the patient with JAMP-Cholestyramine and to minimize gastrointestinal side effects, it is desirable to begin all therapy with one dose daily. Dosage is then increased within a day or two to the desired level for effective control.

• Motivation of the patient to continue the prescribed regimen despite gastrointestinal problems is important. Physician encouragement and supervision are essential for successful management. • The colour of cholestyramine resin may vary somewhat from batch to batch, but this variation does not affect the performance of the product.

2 Recommended Dose and Dosage Adjustment Adults The recommended dose is 4 grams of cholestyramine resin, one to six times daily. Dosages may be adjusted as required to meet the patient's needs. 3 Pediatrics). 3 Reconstitution JAMP-Cholestyramine (Cholestyramine for Oral Suspension, USP) Page 6 of 27 • Place the contents of one pouch of JAMP-Cholestyramine on the surface of 120 mL - 180 mL of water, or non-carbonated beverage such as milk or fruit juice.

After 1-2 minutes mix thoroughly by stirring. • JAMP-Cholestyramine may also be mixed in highly fluid soups or pulpy fruits with high moisture content such as applesauce or crushed pineapple. 4 Administration • JAMP-Cholestyramine Light and Regular Powders (cholestyramine resin) are administered orally and should not be taken in its dry form; always mix the powder with water or other fluids before ingestion (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).

5 Missed Dose If a dose is missed, patients are advised to take the dose as soon as remembered, unless it is almost time for the next dose. Patients are advised not to take extra medicine to make up the missed dose.

5 Post-Market Adverse Reactions). When used as a cholesterol lowering agent, predisposing factors for most JAMP-Cholestyramine (Cholestyramine for Oral Suspension, USP) Page 10 of 27 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. [*] The percentage of complaints that are associated with these predisposing factors is unknown.

2 Clinical Trial Adverse Reactions The clinical trial data on which the original indication was authorized is not available. 5 Post-Market Adverse Reactions The following table presents a listing of post-market adverse reactions with their frequency of occurrence in patients treated with cholestyramine.

Adverse Reactions Categorized by System Organ Class Very Common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Blood and lymphatic system disorders Bleeding tendencies due to hypoprothrombinaemia (Vitamin K deficiency) ✓ Vitamin A and vitamin D deficiencies ✓ Night blindness ✓ Gastrointestinal disorders Constipation ✓ Abdominal discomfort ✓ Flatulence ✓ Nausea ✓ Vomiting ✓ Diarrhea ✓ Heartburn ✓ Dyspepsia ✓ Steatorrhea ✓ JAMP-Cholestyramine (Cholestyramine for Oral Suspension, USP) Page 11 of 27 Intestinal obstruction ✓ Metabolism and nutrition disorders Anorexia ✓ Musculoskeletal and connective tissue disorders Osteoporosis ✓ Skin and subcutaneous tissue disorders Rash and irritation of skin, tongue and perianal area ✓ The frequency of the following post-market adverse reactions is unknown.

• Gastrointestinal: gastrointestinal-rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccups, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis, eructation • Hematological: decreased or increased prothrombin time, ecchymosis, anemia, dental bleeding • Hypersensitivity: asthma, wheezing, shortness of breath • Monitoring and Laboratory Tests: liver function abnormalities • Musculoskeletal: backache, muscle and joint pain, arthritis • Neurological: headache, anxiety, vertigo, dizziness, fatigue, tinnitus, syncope, drowsiness, femoral nerve pain, paresthesia • Ophthalmologic: uveitis • Renal: hematuria, dysuria, burnt odour of urine, diuresis • Other: weight loss, weight gain, increased libido, swollen glands, edema, dental caries.

JAMP-Cholestyramine is contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

• with complete biliary obstruction where bile is not excreted into the intestine. JAMP-Cholestyramine (Cholestyramine for Oral Suspension, USP) Page 5 of 27