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COLESEVELAM HCL 625MG TAB 180

  • Manufacturer Name : Tris Pharma Inc
  • MFG # : 27808019001
  • NDC : 27808019001
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description N
Description -
Description N
DESI Drug Ind -; -
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind -
Drug Category USES: This medication is used along with a proper diet and exercise to lower cholesterol in people with high levels of cholesterol in the blood. Lowering cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. Colesevelam is also used along with a proper diet and exercise to lower high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Colesevelam belongs to a class of drugs called bile acid-binding resins. Bile acid is a natural substance the liver makes by using cholesterol. This medication works by removing bile acid from the body. This causes the liver to make more bile acid by using cholesterol, which reduces cholesterol levels in the blood. It is not known how colesevelam works in lowering blood sugar.
Drug Category N
Drug Category USES: This medication is used along with a proper diet and exercise to lower cholesterol in people with high levels of cholesterol in the blood. Lowering cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. Colesevelam is also used along with a proper diet and exercise to lower high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Colesevelam belongs to a class of drugs called bile acid-binding resins. Bile acid is a natural substance the liver makes by using cholesterol. This medication works by removing bile acid from the body. This causes the liver to make more bile acid by using cholesterol, which reduces cholesterol levels in the blood. It is not known how colesevelam works in lowering blood sugar.
Drug Type Code COMMON BRAND NAME(S): Welchol
Drug Type Code 1
Drug Type Code COMMON BRAND NAME(S): Welchol
FDA Approval Date 07/15/2020
FDA Therap Equiv AB
HCPCS -
HCPCS 1
HCPCS 1
Market Entry Date 03/16/2021
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date (KOE-le-SEV-e-lam)
Termination Date -
Termination Date (KOE-le-SEV-e-lam)
Unit TAB
Units Per Pkg 1
Active Ingredients 8853 colesevelam HCl 182815447
Active Ingredients 8853 colesevelam HCl 182815447
Active Ingredients 8853 colesevelam HCl 182815447
AHFS Class 24060400 BILE ACID SEQUESTRANTS; 68209200 ANTIDIABETIC AGENTS, MISCELLANEOUS
AHFS Class 24060400 BILE ACID SEQUESTRANTS; 68209200 ANTIDIABETIC AGENTS, MISCELLANEOUS
AHFS Class 24060400 BILE ACID SEQUESTRANTS; 68209200 ANTIDIABETIC AGENTS, MISCELLANEOUS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 46172 colesevelam HCl ORAL TABLET 625 MG
Gen Code and Des 46172 colesevelam HCl ORAL TABLET 625 MG
Gen Code and Des 46172 colesevelam HCl ORAL TABLET 625 MG
Inactive Ingredients -
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 625MG
Strength 625MG
Strength 625MG
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Welchol
Common Brand Name -
Drug Interaction DRUG 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: raloxifene, warfarin. Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs. Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.
Drug Interaction -
Drug Interaction -
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 12
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 180
Drug Form Pack Size 180
Drug Form Pack Size 180
Form TABLET
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 180
Unit Size 180
Unit Size 180
How to Use -
How to Use -
How to Use HOW TO USE: Take this medication by mouth with a meal as directed by your doctor, usually 1 to 2 times daily. Take the tablet form with a liquid (such as water, milk). If you have trouble swallowing the tablet, talk to your doctor about switching to the powder form of this medication. If you are using the powder form of this medication, pour the contents of one packet into a glass. Add one cup (8 ounces/240 milliliters) of water, fruit juice, or diet soda. Stir the mixture well and drink all of it. Do not take the powder without mixing it in liquid. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. It may take several weeks before you get the full benefit of this drug. Colesevelam may decrease the absorption of other products you may be taking. Some examples include cyclosporine, glipizide, glimepiride, glyburide, levothyroxine, and phenytoin, as well as birth control pills that contain ethinyl estradiol and norethindrone. Take other medications as directed by your doctor, usually at least 4 hours before taking your colesevelam dose. Ask your pharmacist if you are not sure when to take your medications.
Missed Dose 1
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember with a meal. 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.
Missed Dose 1
Notes TAB
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as blood cholesterol levels, blood sugar) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details. Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams. Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.
Notes TAB
Overdose AB
Overdose AB
Overdose 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.
Phonetic Pronunciation (KOE-le-SEV-e-lam)
Phonetic Pronunciation -
Phonetic Pronunciation -
Precautions -
Precautions -
Precautions PRECAUTIONS: Before taking colesevelam, 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: pancreatitis (caused by high triglyceride levels), high triglyceride levels, trouble swallowing, stomach/intestinal disorders (such as constipation, blockage, gastroparesis), recent major intestinal surgery, hemorrhoids. Because this drug can interfere with the absorption of certain vitamins (such as vitamins A, D, E, K) when used for a long period of time, your doctor may direct you to take a multivitamin supplement. Take the multivitamin at least 4 hours before taking your colesevelam dose. The powder form of this medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this medication safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if you are pregnant before using this medication. This medication is unlikely to pass into breast milk or harm a nursing infant. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Constipation and upset stomach 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: nausea/vomiting, stomach/abdominal pain, trouble swallowing, unusual bleeding/bruising. This medication does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications, or if you do not consume enough calories from food, or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal. Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased. 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.
Side Effects -
Side Effects -
Storage 07/15/2020
Storage STORAGE: 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.
Storage 07/15/2020
Uses -
Uses USES: This medication is used along with a proper diet and exercise to lower cholesterol in people with high levels of cholesterol in the blood. Lowering cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. Colesevelam is also used along with a proper diet and exercise to lower high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Colesevelam belongs to a class of drugs called bile acid-binding resins. Bile acid is a natural substance the liver makes by using cholesterol. This medication works by removing bile acid from the body. This causes the liver to make more bile acid by using cholesterol, which reduces cholesterol levels in the blood. It is not known how colesevelam works in lowering blood sugar.
Uses -

Frequently Asked Questions(FAQs)

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COLESEVELAM HCL 625MG TAB 180 is manufactured by Tris Pharma Inc.
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