Colestipol Hydrochloride: Package Insert and Label Information (Page 2 of 2)

ADVERSE REACTIONS

Gastrointestinal

The most common adverse reactions are confined to the gastrointestinal tract. To achieve minimal GI disturbance with an optimal LDL-C lowering effect, a gradual increase of dosage starting with 2 grams, once or twice daily 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 COLESTID granules and are not necessarily drug related.

Difficulty swallowing and transient esophageal obstruction have been rarely reported in patients taking colestipol hydrochloride tablets.

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 nongastrointestinal adverse reactions have been reported with generally equal frequency in patients receiving colestipol hydrochloride tablets, COLESTID 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 COLESTID granules.

Musculoskeletal

Musculoskeletal pain, aches and pains in the extremities, joint pain and 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.

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc., at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Overdosage of colestipol hydrochloride tablets has not been reported. Should overdosage occur, however, 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.

DOSAGE AND ADMINISTRATION

For adults, colestipol hydrochloride tablets are recommended in doses of 2 grams/day to 16 grams/day given once or in divided doses. The starting dose should be 2 grams once or twice daily. Dosage increases of 2 grams, once or twice daily should occur at 1 month or 2 month intervals. Appropriate use of lipid profiles as per NCEP guidelines including LDL-C and triglycerides, is advised so that optimal but not excessive doses are used to obtain the desired therapeutic effect on LDL-C level. If the desired therapeutic effect is not obtained at a dose of 2 grams/day to 16 grams/day with good compliance and acceptable side effects, combined therapy or alternate treatment should be considered.

Colestipol hydrochloride tablets must be taken one at a time and be promptly swallowed whole, using plenty of water or other appropriate liquid. Do not cut, crush or chew the tablets. Patients should take other drugs at least one hour before or four hours after colestipol hydrochloride tablets to minimize possible interference with their absorption. (See Drug Interactions.)

Before Administration of Colestipol Hydrochloride Tablets

  1. Define the type of hyperlipoproteinemia, as described in NCEP guidelines.
  2. Institute a trial of diet and weight reduction.
  3. Establish baseline serum total and LDL-C and triglyceride levels.

During Administration of Colestipol Hydrochloride Tablets

  1. The patient should be carefully monitored clinically, including serum cholesterol and triglyceride levels. Periodic determinations of serum cholesterol levels as outlined in the NCEP guidelines should be done to confirm a favorable initial and long-term response.
  2. Failure of total or LDL-C to fall within the desired range should lead one to first examine dietary and drug compliance. If these are deemed acceptable, combined therapy or alternate treatment should be considered.
  3. Significant rise in triglyceride level should be considered as indication for dose reduction, drug discontinuation or combined or alternate therapy.

HOW SUPPLIED

Colestipol hydrochloride tablets, 1 g are light yellow to yellow colored, oval shaped, biconvex, film-coated tablets, one side debossed with “CZ” and plain on the other side and are supplied as follows:

NDC 70710-1467-7 in bottles of 120 tablets with child-resistant closure.

NDC 70710-1467-5 in bottles of 500 tablets

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture.

REFERENCES

  1. Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA 1993; 269(23):3015– 3023.
  2. Lipid Metabolism-Atherogenesis Branch, National Heart, Lung, and Blood Institute, Bethesda, MD: The Lipid Research Clinics Coronary Primary Prevention Trial Results. I. Reduction in Incidence of Coronary Heart Disease. JAMA 1984; 251:351–364.
  3. Parra HJ, et al. Differential electroimmunoassay of human LpA-I lipoprotein particles on ready-to-use plates. Clin. Chem. 1990; 36(8):1431–1435.
  4. Barbaras R, et al. Cholesterol efflux from cultured adipose cells is mediated by LpAI particles but not by LpAI:AII particles. Biochem. Biophys. Res. Comm. 1987; 142(1):63–69.
  5. Kane JP, et al. Normalization of low-density-lipoprotein levels in heterozygous familial hypercholesterolemia with a combined drug regimen. N Engl. J. Med. 1981; 304:251–258.
  6. Illingworth DR, et al. Colestipol plus nicotinic acid in treatment of heterozygous familial hypercholesterolemia. Lancet 1981; 1:296–298.
  7. Kuo PT, et al. Familial type II hyperlipoproteinemia with coronary heart disease: Effect of diet-colestipol-nicotinic acid treatment. Chest 1981; 79:286–291.
  8. Blankenhorn DH, et al. Beneficial Effects of Combined Colestipol-Niacin Therapy on Coronary Atherosclerosis and Coronary Venous Bypass Grafts. JAMA 1987; 257(23):3233–3240.
  9. Cashin-Hemphill L, et al. Beneficial Effects of Colestipol-Niacin on Coronary Atherosclerosis: A 4-Year Follow-up. JAMA 1990; 264:3013–3017.
  10. Brown G. et al. Regression of Coronary Artery Disease as a Result of Intensive Lipid-Lowering Therapy in Men with High Levels of Apolipoprotein B. N. Engl.J. Med. 1990; 323:1289–1298.
  11. Kane JP, et al. Regression of Coronary Atherosclerosis During Treatment of Familial Hypercholesterolemia with Combined Drug Regimens. JAMA 1990; 264:3007–3012.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The brand listed are trademarks of their respective owners.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 08/20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colestipol hydrochloride tablets, 1 g

120 tablets

NDC 70710-1467-7

Rx only

Zydus

image
(click image for full-size original)
COLESTIPOL HYDROCHLORIDE colestipol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1467
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESTIPOL HYDROCHLORIDE (COLESTIPOL) COLESTIPOL HYDROCHLORIDE 1 g
Inactive Ingredients
Ingredient Name Strength
CELLACEFATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE (120 .MU.M)
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE K90
SILICON DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW (light yellow to yellow) Score no score
Shape OVAL Size 20mm
Flavor Imprint Code CZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70710-1467-7 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70710-1467-5 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215223 05/04/2022
Labeler — Zydus Pharmaceuticals USA Inc. (156861945)
Registrant — Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70710-1467), MANUFACTURE (70710-1467)

Revised: 05/2022 Zydus Pharmaceuticals USA Inc.

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