Colestipol Hcl 5gm Granules 500gm
It is used to lower cholesterol.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antilipemic Agent
Pharmacologic Class
Bile Acid Sequestrant
Pregnancy Category
Category C
FDA Approved
Aug 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Colestipol is a medication used to lower high cholesterol levels in your blood. It works by binding to certain substances in your gut called bile acids, which helps your body remove more cholesterol. This can reduce your risk of heart disease.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Take this medication exactly as directed.
Do not take the dry powder by itself. Instead, mix it with at least 3 ounces (90 mL) of water or another liquid, and then drink the mixture. After drinking, rinse the glass with more liquid and drink the rinse to ensure you get the full dose.
You can also mix this medication with soft foods like cereals, soups, or fruits such as applesauce or crushed pineapple. Follow the specific mixing instructions you have been given.
It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
* Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Take this medication exactly as directed.
Do not take the dry powder by itself. Instead, mix it with at least 3 ounces (90 mL) of water or another liquid, and then drink the mixture. After drinking, rinse the glass with more liquid and drink the rinse to ensure you get the full dose.
You can also mix this medication with soft foods like cereals, soups, or fruits such as applesauce or crushed pineapple. Follow the specific mixing instructions you have been given.
It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
* Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Follow a low-cholesterol, low-saturated fat diet as recommended by your doctor.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Do not take the granules dry. Always mix them with at least 90 mL (3 ounces) of water, juice, milk, or other non-carbonated liquid. You can also mix it with soft foods like applesauce or hot cereal.
- Stir well until completely dispersed and drink immediately. Rinse the glass with a small amount of liquid and drink to ensure full dose is taken.
- Maintain adequate fluid intake to help prevent constipation.
- Take other medications at least 1 hour before or 4-6 hours after colestipol to prevent drug interactions.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 5 grams once or twice daily. Maintenance: 5 to 30 grams per day, given once or in two divided doses.
Dose Range:
5 - 30 mg
Condition-Specific Dosing:
hypercholesterolemia:
Initial: 5 grams once or twice daily. May increase by 5 grams per day at 1-2 month intervals. Max: 30 grams/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not routinely recommended; safety and efficacy not established. If used, typically 10-20 grams/day in divided doses, titrated based on response and tolerability.
Adolescent:
Not routinely recommended; safety and efficacy not established. If used, typically 10-20 grams/day in divided doses, titrated based on response and tolerability.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed, as colestipol is not absorbed systemically.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Colestipol hydrochloride is an insoluble, non-absorbable anion-exchange resin that binds bile acids in the intestine, forming an insoluble complex. This complex is then excreted in the feces, preventing the reabsorption of bile acids. This interruption of the enterohepatic circulation of bile acids leads to an increased synthesis of bile acids from cholesterol in the liver. The increased demand for cholesterol in the liver results in an upregulation of hepatic LDL receptors, which increases the clearance of low-density lipoprotein cholesterol (LDL-C) from the blood.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (not absorbed)
Tmax:
Not applicable (not absorbed)
FoodEffect:
Can be taken with or without food, but usually mixed with liquid or food.
Distribution:
Vd:
Not applicable (not absorbed)
ProteinBinding:
Not applicable (not absorbed)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (not absorbed)
Clearance:
Not applicable (not absorbed)
ExcretionRoute:
Fecal (as insoluble complex)
Unchanged:
100%
Pharmacodynamics
OnsetOfAction:
Within 24-48 hours (lipid-lowering effects may take weeks)
PeakEffect:
Approximately 1 month for maximal LDL-C reduction
DurationOfAction:
Dependent on continued administration
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Difficulty swallowing
- Unexplained bruising or bleeding
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Heartburn
- Stomach cramps
- Gas
- Muscle or joint pain
- Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Difficulty swallowing
- Unexplained bruising or bleeding
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Heartburn
- Stomach cramps
- Gas
- Muscle or joint pain
- Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent constipation
- Severe abdominal pain
- Unusual bleeding or bruising (may indicate vitamin K deficiency)
- Vision changes, especially at night (may indicate vitamin A deficiency)
- Muscle weakness or bone pain (may indicate vitamin D deficiency)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
To manage your condition effectively, follow the personalized diet and exercise plan recommended by your doctor. If you experience constipation, increasing your fluid intake, engaging in regular physical activity, or adding more fiber to your diet may help alleviate symptoms. However, consult with your doctor before making any changes.
When taking this medication, it is crucial to administer other medications at least 1 hour before or 4 hours after taking this drug to minimize potential interactions.
Long-term use of this medication may lead to low vitamin K levels, increasing the risk of bleeding. If you have concerns or questions, discuss them with your doctor. Additionally, if you have hemorrhoids, inform your doctor, as this medication may exacerbate the condition.
If you have phenylketonuria (PKU), consult with your doctor, as some products may contain phenylalanine.
It is vital to inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
To manage your condition effectively, follow the personalized diet and exercise plan recommended by your doctor. If you experience constipation, increasing your fluid intake, engaging in regular physical activity, or adding more fiber to your diet may help alleviate symptoms. However, consult with your doctor before making any changes.
When taking this medication, it is crucial to administer other medications at least 1 hour before or 4 hours after taking this drug to minimize potential interactions.
Long-term use of this medication may lead to low vitamin K levels, increasing the risk of bleeding. If you have concerns or questions, discuss them with your doctor. Additionally, if you have hemorrhoids, inform your doctor, as this medication may exacerbate the condition.
If you have phenylketonuria (PKU), consult with your doctor, as some products may contain phenylalanine.
It is vital to inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe constipation
- Intestinal obstruction (rare)
What to Do:
Contact a poison control center or emergency medical services immediately. Call 1-800-222-1222. Treatment is generally supportive, focusing on managing constipation and maintaining hydration.
Drug Interactions
Major Interactions
- Digoxin (reduced absorption)
- Warfarin (reduced absorption, potential for altered INR)
- Thyroid hormones (e.g., levothyroxine, reduced absorption)
- Thiazide diuretics (e.g., hydrochlorothiazide, reduced absorption)
- Beta-blockers (e.g., propranolol, reduced absorption)
- Fat-soluble vitamins (A, D, E, K, reduced absorption with long-term use)
Moderate Interactions
- Folic acid (reduced absorption)
- Oral contraceptives (potential for reduced efficacy, though less common than with cholestyramine)
- Phenobarbital (reduced absorption)
- Ursodiol (reduced absorption)
Monitoring
Baseline Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess the severity of dyslipidemia.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST)
Rationale: Although not hepatically metabolized, baseline assessment is prudent for overall patient health.
Timing: Prior to initiation of therapy.
Routine Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Frequency: Every 4-6 weeks initially, then every 3-6 months once stable.
Target: LDL-C reduction goals vary by patient risk (e.g., <100 mg/dL, <70 mg/dL). Triglycerides should be monitored for potential increase.
Action Threshold: If LDL-C goals are not met, consider dose adjustment or combination therapy. If triglycerides significantly increase (>400 mg/dL), re-evaluate therapy.
Fat-soluble vitamin levels (A, D, E, K)
Frequency: Periodically, especially with long-term use or in patients with malabsorption issues.
Target: Within normal limits.
Action Threshold: Supplementation may be required if deficiencies are noted.
Prothrombin Time/INR (for patients on warfarin)
Frequency: More frequently when initiating or adjusting colestipol dose.
Target: Therapeutic range for warfarin.
Action Threshold: Adjust warfarin dose as needed.
Symptom Monitoring
- Constipation
- Abdominal pain or discomfort
- Bloating
- Flatulence
- Nausea
- Vomiting
- Heartburn
- Symptoms of fat-soluble vitamin deficiency (e.g., night blindness, easy bruising)
Special Patient Groups
Pregnancy
Category C. Colestipol is not absorbed systemically, so fetal exposure is minimal. However, it may interfere with the absorption of fat-soluble vitamins (A, D, E, K) which are essential for fetal development. Use only if clearly needed and the potential benefits outweigh the potential risks. Consider vitamin supplementation if used during pregnancy.
Trimester-Specific Risks:
First Trimester:
Low direct risk due to no systemic absorption; potential for vitamin deficiencies.
Second Trimester:
Low direct risk; potential for vitamin deficiencies.
Third Trimester:
Low direct risk; potential for vitamin deficiencies, particularly vitamin K, which could affect neonatal coagulation.
Lactation
L2 (Safer). Colestipol is not absorbed systemically and therefore is not expected to be excreted in breast milk. Risk to the infant is considered low. However, long-term use in the mother could theoretically lead to fat-soluble vitamin deficiencies, which could indirectly affect breast milk composition. Monitor maternal vitamin status.
Infant Risk:
Low risk
Pediatric Use
Safety and efficacy not established in pediatric patients. Use is generally not recommended for routine hypercholesterolemia in children, but may be considered in severe cases (e.g., familial hypercholesterolemia) under specialist supervision, with careful monitoring of growth, development, and fat-soluble vitamin levels.
Geriatric Use
No specific dose adjustment is required. Elderly patients may be more susceptible to constipation and other gastrointestinal side effects. Adequate fluid intake and fiber are important. Monitor for potential drug interactions due to polypharmacy.
Clinical Information
Clinical Pearls
- Colestipol is a non-systemic agent, making it a good option for patients who cannot tolerate or have contraindications to statins, or as an add-on therapy.
- The most common side effects are GI-related, particularly constipation. Advise patients on adequate fluid intake, dietary fiber, and potential use of stool softeners if needed.
- Crucial to educate patients on proper administration: always mix granules with liquid or soft food, never take dry, and ensure complete dispersion.
- Emphasize the importance of timing other medications to avoid malabsorption, typically 1 hour before or 4-6 hours after colestipol.
- Monitor for fat-soluble vitamin deficiencies with long-term use, especially in patients with poor dietary intake or malabsorption issues.
Alternative Therapies
- Cholestyramine (another bile acid sequestrant)
- Colesevelam (another bile acid sequestrant)
- Statins (HMG-CoA reductase inhibitors, e.g., atorvastatin, simvastatin)
- Ezetimibe (cholesterol absorption inhibitor)
- PCSK9 inhibitors (e.g., evolocumab, alirocumab)
- Fibrates (e.g., gemfibrozil, fenofibrate, primarily for triglycerides)
- Niacin (nicotinic acid, for various lipid abnormalities)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 500gm container
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.