Colestipol Hydrochloride

WARNINGS TO AVOID ACCIDENTAL INHALATION OR ESOPHAGEAL DISTRESS, COLESTIPOL HYDROCHLORIDE GRANULES SHOULD NOT BE TAKEN IN ITS DRY FORM. ALWAYS MIX COLESTIPOL HYDROCHLORIDE GRANULES WITH WATER OR OTHER FLUIDS BEFORE INGESTING.

ADVERSE REACTIONS Gastrointestinal The most common adverse reactions are confined to the gastrointestinal tract. To achieve minimal GI disturbance with an optimal LDL-cholesterol lowering effect, a gradual increase of dosage starting with one dose/day is recommended. Constipation is the major single complaint and at times is severe. Most instances of constipation are mild, transient, and controlled with standard treatment. Increased fluid intake and inclusion of additional dietary fiber should be the first step; a stool softener may be added if needed. Some patients require decreased dosage or discontinuation of therapy. Hemorrhoids may be aggravated. Other, less frequent gastrointestinal complaints consist of abdominal discomfort (abdominal pain and cramping), intestinal gas, (bloating and flatulence), indigestion and heartburn, diarrhea and loose stools, and nausea and vomiting. Bleeding hemorrhoids and blood in the stool have been infrequently reported. Peptic ulceration, cholecystitis, and cholelithiasis have been rarely reported in patients receiving colestipol hydrochloride granules, and are not necessarily drug related. Transient and modest elevations of aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT) and alkaline phosphatase were observed on one or more occasions in various patients treated with colestipol hydrochloride. The following non-gastrointestinal adverse reactions have been reported with generally equal frequency in patients receiving colestipol hydrochloride granules or placebo in clinical studies: Cardiovascular Chest pain, angina, and tachycardia have been infrequently reported. Hypersensitivity Rash has been infrequently reported. Urticaria and dermatitis have been rarely noted in patients receiving colestipol hydrochloride granules. Musculoskeletal Musculoskeletal pain, aches and pains in the extremities, joint pains, arthritis, and backache have been reported. Neurologic Headache, migraine headache and sinus headache have been reported. Other infrequently reported complaints include dizziness, light-headedness, and insomnia. Miscellaneous Anorexia, fatigue, weakness, shortness of breath, and swelling of the hands or feet, have been infrequently reported.