Colestipol Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

Colestipol is used along with a proper diet to lower cholesterol in the blood. Lowering cholesterol helps decrease the risk for strokes and heart attacks.In addition to a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.This medication is known as a bile acid-binding resin. It works by removing bile acid from the body. In people with high cholesterol, this causes the liver to make more bile acid by using cholesterol in the blood. This helps to lower the cholesterol levels.

How to use colestipol oral

Take this medication by mouth as directed by your doctor, usually 1 to 2 times a day. If your dose is more than 1 tablet, take the tablets one at a time. Do not try to swallow more than one tablet at once. Take each tablet with plenty of liquid (such as water, juice). Swallow each tablet whole. Do not crush, chew, or break the tablets. If you have difficulty swallowing the tablet whole, consult your doctor.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully. It may take several weeks before you get the full benefit of this drug.

Colestipol may decrease your absorption of other medications. Take your other medications as directed by your doctor, usually at least 1 hour before or 4 to 6 hours after colestipol. Ask your doctor or pharmacist for more information or if you have any questions.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. Keep taking this medication even if you feel well. Most people with high cholesterol do not feel sick.

Side Effects

Constipation, stomach/abdominal pain, gas, nausea, and vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: difficulty swallowing, chest pain/pressure, severe stomach/abdominal pain, unusual bleeding/bruising, rapid breathing, confusion.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking colestipol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: swallowing problems, constipation, hemorrhoids, kidney disease.

Because this drug can interfere with the absorption of certain nutrients (such as folic acid, fat-soluble vitamins including A, D, E, K), your doctor may direct you to take a multivitamin supplement. Consult your doctor for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially constipation.

During pregnancy, this medication should be used only when clearly needed. It may affect the absorption of certain nutrients. Discuss the risks and benefits with your doctor.

This medication is unlikely to pass into breast milk. However, it may affect the absorption of certain nutrients. Consult your doctor before breast-feeding.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: “blood thinners” (such as warfarin), mycophenolate, raloxifene.

Does colestipol oral interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach/abdominal pain.

Do not share this medication with others.

Lab and/or medical tests (such as blood cholesterol/triglyceride levels, vitamin levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

colestipol 1 gram tablet

Color: yellowShape: ovalImprint: CZ

This medicine is a yellow, oval, film-coated, tablet imprinted with “CZ”.

colestipol 1 gram tablet

Color: yellowShape: ellipticalImprint: G 450

This medicine is a yellow, oval, film-coated, tablet imprinted with “CZ”.

colestipol 1 gram tablet

Color: off-whiteShape: ovalImprint: G

This medicine is a yellow, oval, film-coated, tablet imprinted with “CZ”.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Colestipol: MedlinePlus Drug Information

pronounced as (koe les’ ti pole)

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Colestipol is used along with diet changes to decrease the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol (‘bad cholesterol’) in certain people with high cholesterol. Colestipol is in a class of medications called bile acid sequestrants. It works by binding bile acids in your intestines to form a product that is removed from the body.

Colestipol comes as tablets and granules to take by mouth. The tablets are usually taken once or twice daily. The granules are usually taken one to six times daily. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take colestipol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Unless otherwise instructed, take all other medications at least 1 hour before or 4 hours after you take colestipol because it can interfere with their absorption.

Swallow the tablets whole with a glass of water or another liquid; do not chew, split, or crush them.

Your doctor may gradually increase your dose at 1 to 2 month intervals, depending on your response.

Continue to take colestipol even if you feel well. Do not stop taking colestipol without talking to your doctor.

Do not take the granules dry. Add them to at least 3 ounces (90 milliliters) of a liquid (e.g., fruit juice, water, milk, or soft drink) and stir until completely mixed. If you use a carbonated beverage, mix it slowly in a large glass to minimize foaming. After taking the dose, rinse the glass with a small amount of additional liquid and drink it to be sure that you receive the entire dose.

Colestipol also may be mixed with hot or regular breakfast cereals, thin soups (e.g., tomato and chicken noodle), or pulpy fruit (e.g., crushed pineapple, pears, peaches, and fruit cocktail).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking colestipol,

• tell your doctor and pharmacist if you are allergic to colestipol, any other medications, or any of the ingredients in colestipol preparations. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Pacerone), antibiotics, anticoagulants (‘blood thinners’) such as warfarin (Coumadin, Jantoven), digitoxin, digoxin (Lanoxin), diuretics (‘water pills’), iron, loperamide (Imodium), mycophenolate (Cellcept), oral diabetes medications, phenobarbital, phenylbutazone, propranolol (Inderal, Innopran), and thyroid medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had unusual bleeding, an underactive thyroid gland, heart or intestinal disease, or if you have hemorrhoids.
• if you are taking gemfibrozil (Lopid), take it 2 hours before or 2 hours after colestipol.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking colestipol, call your doctor.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Colestipol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• belching
• nausea
• vomiting
• gas

Some side effects can be serious. If you experience the following symptom, call your doctor immediately:

• unusual bleeding (such as bleeding from the gums or rectum)

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www. fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

• Colestid^®
• Colestid^® Flavored Granules
• Colestid^® Granules

Last Revised – 09/15/2018

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Description of COLESTIPOL indications, dosages, contraindications of the active substance COLESTIPOL

Fenofibrate – description of the substance, pharmacology, use, contraindications, formula

Contents

• Structural formula

• Russian name

• English name

• Latin name

• chemical name

• Gross formula

• Pharmacological group of the substance Fenofibrate

• Nosological classification

• CAS code

• pharmachologic effect

• Characteristic

• Pharmacology

• The use of the substance Fenofibrate

• Contraindications

• Application restrictions

• Use during pregnancy and lactation

• Side effects of Fenofibrate

• Interaction

• Overdose

• Dosage and administration

• Precautionary measures

• Trade names with the active substance Fenofibrate

Structural formula

Russian name

Fenofibrate

English name

Fenofibrate

Latin name

Fenofibratum (born Fenofibrati)

Chemical name

2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid 1-methylethyl ester

General formula

C ₂₀ H ₂₁ ClO ₄

Pharmacological group of the substance Fenofibrate

Fibrates

Nosological classification

ICD-10 code list

• E78. 0 Pure hypercholesterolemia

• E78.1 Pure hyperglyceridemia

• E78.2 Mixed hyperlipidemia

• E78.5 Hyperlipidemia, unspecified

CAS code

49562-28-9

Pharmacological action

Pharmacological action –

antiplatelet , hypolipidemic , uricosuric .

Description

Lipid-lowering agent.

White, practically insoluble in water; soluble in acetone, ether, benzene, chloroform. Molecular weight 360.83.

Pharmacology

By activating PPARα receptors (peroxisome proliferator-activated alpha receptors), fenofibric acid (the active metabolite of fenofibrate) enhances lipolysis and plasma clearance of atherogenic high triglyceride lipoproteins by activating lipoprotein lipase and reducing the synthesis of apolipoprotein CIII. Activation of PPARα also leads to increased synthesis of apolipoproteins AI and AII.

The effects on lipoproteins described above lead to a decrease in the content of the LDL and VLDL fraction, which include apolipoprotein B, and an increase in the content of the HDL fraction, which include apolipoproteins AI and AII.

By correcting impaired VLDL synthesis and catabolism, fenofibrate increases LDL clearance and reduces the content of dense and small LDL particles, which increase in patients with an atherogenic lipid phenotype (a common disorder in patients at risk of coronary artery disease).

In clinical studies, fenofibrate has been shown to reduce total cholesterol by 20-25% and triglycerides by 40-55% while increasing HDL-cholesterol by 10-30%. In patients with hypercholesterolemia, in whom LDL-cholesterol levels decreased by 20-35%, the use of fenofibrate led to a decrease in the ratios: “total cholesterol / HDL-cholesterol”, “LDL-cholesterol / HDL-cholesterol” and “Apo B / Apo AI ”, which are markers of atherogenic risk.

Given the effect on LDL-cholesterol and triglycerides, the use of fenofibrate is effective in patients with hypercholesterolemia, both accompanied and not accompanied by hypertriglyceridemia, including secondary hyperlipoproteinemia, incl. in type 2 diabetes mellitus. In addition, it reduces elevated plasma levels of fibrinogen and uric acid; with long-term therapy reduces extravascular cholesterol deposits.

After oral administration, fenofibrate is rapidly hydrolyzed by esterases. In plasma, only the main active metabolite of fenofibrate is found – fenofibric acid, T _max which is achieved in plasma within 2-3 hours. The binding of fenofibric acid to plasma proteins is about 99%, ss “> C _ss is achieved within 1 week. Fenofibrate and fenofibric acid do not undergo oxidative metabolism with the participation of cytochrome P450 . 1/2 “> T _1/2 fenofibric acid – approximately 20 hours. Excreted mainly by the kidneys (fenofibric acid and its glucuronide). Does not accumulate.

Clearance of fenofibric acid after a single dose of fenofibrate orally does not change depending on age and is 1.2 l/h in elderly patients (77–87 years), and 1.1 l/h in young patients.

In patients with severe renal insufficiency (Cl creatinine <30 ml / min), the exposure of fenofibric acid increases by 2.7 times and cumulation is observed with repeated administration. With impaired renal function of mild to moderate severity (Cl creatinine 30–80 ml / min), 1/2 "> T _1/2 fenofibric acid increases.

In clinical studies, two different forms of fenofibrate were compared – “micronized” and “non-micronized. ” Comparison of blood samples from healthy volunteers after ingestion of these forms showed that 67 mg of the “micronized” form was bioequivalent to 100 mg of the “non-micronized” form.0006

Use of the substance Fenofibrate

Hyperlipidemia type IIa, IV and V types, as well as type IIb and III with insufficient dietary efficacy, elevated blood cholesterol levels during dynamic examination and / or the presence of concomitant risk factors.

Contraindications

Hypersensitivity, liver failure (including biliary cirrhosis), severe renal failure (Cl creatinine <30 ml / min), gallbladder disease, photosensitivity or phototoxicity with treatment with fibrates or ketoprofen in history, age up to 18 years (adequate and good controlled studies have not been conducted).

Restrictions on use

Hepatic and/or renal insufficiency, hypothyroidism, alcoholism, old age, history of hereditary muscle diseases, concomitant use of oral anticoagulants, HMG-CoA reductase inhibitors.

Use in pregnancy and lactation

In pregnancy possible if the expected effect of therapy outweighs the potential risk to the fetus.

FDA Fetal Category C.

At the time of treatment, breastfeeding should be stopped.

Side effects of the substance Fenofibrate

From the side of the nervous system and sensory organs: dizziness, headache, fatigue.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): venous thromboembolism (pulmonary embolism, deep vein thrombosis), increased hemoglobin levels, leukocytosis.

From the digestive tract: abdominal pain, nausea, vomiting, diarrhea, flatulence, pancreatitis, cholelithiasis, increased levels of hepatic transaminases and creatine phosphokinase, hepatitis.

From the genitourinary system: acute renal failure, sexual dysfunction.

From the musculoskeletal system: myalgia, myositis, muscle spasm, muscle weakness, rhabdomyolysis.

Allergic reactions: skin rashes, itching, urticaria.

Other: interstitial pneumonia, photosensitivity, alopecia, hypercreatinemia, increased plasma urea.

Interaction

Fenofibrate enhances the effect of oral anticoagulants and may increase the risk of bleeding, which is associated with the displacement of the anticoagulant from the binding sites with blood plasma proteins (with simultaneous use, care should be taken). At the beginning of treatment with fenofibrate, it is recommended to reduce the dose of the anticoagulant by approximately 1/3, followed by a gradual dose adjustment under the control of the INR level.

Simultaneous treatment with fenofibrate and cyclosporine may reduce renal function (it is necessary to monitor the state of renal function in such patients and stop fenofibrate in case of a serious change in laboratory parameters). When coadministering fenofibrate and potentially nephrotoxic agents, the risks and benefits should be carefully assessed and fenofibrate should be used at the lowest effective dose.

When taking fenofibrate concomitantly with HMG-CoA reductase inhibitors or other fibrates, the risk of rhabdomyolysis, myopathy and acute renal failure is increased (combined use is not recommended). Bile acid sequestrants reduce the absorption of fenofibrate (fenofibrate should be taken 1 hour before or 4-6 hours after taking them).

In vitro studies”> in vitro showed that fenofibrate and fenofibric acid are not inhibitors of cytochrome P450 isoenzymes CYP3A4, CYP2D6, CYP2E1 and CYP1A2. At therapeutic concentrations, these compounds are weak inhibitors of CYP2C19 isoenzymesand CYP2A6 and weak or moderate inhibitors of CYP2C9.

Overdose

Cases of overdose have not been described.

Treatment: If an overdose is suspected, symptomatic and, if necessary, supportive treatment should be given. The specific antidote is unknown. Hemodialysis is ineffective.

Dosage and administration

Inside, 200-400 mg/day in 3 doses, micronized forms – 145-200 mg 1 time per day.

Precautions

Liver transaminases should be monitored every 3 months during the first year of therapy; with an increase in ALT by 2 times or more, the appearance of myalgia and muscle weakness, fenofibrate is canceled. In the first 3 months of treatment, it is recommended to determine the concentration of creatinine (in case of an increase in the concentration of creatinine by more than 50% above the upper limit of normal, treatment should be suspended).

Treatment should be carried out for a long time, in combination with a hypocholesterol diet and under the supervision of a physician. The effectiveness of therapy should be assessed by the content of lipids (total cholesterol, LDL, triglycerides) in the blood serum. In the absence of a therapeutic effect after 3–6 months of treatment, the advisability of prescribing concomitant or alternative therapy should be considered.

In patients with hyperlipidemia who are taking estrogens or hormonal contraceptives containing estrogens, it is necessary to determine whether the hyperlipidemia is primary or secondary in nature, since an increase in lipid levels may be caused by estrogens.