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FENOFIBRATE 145 MG TAB 100 UD

  • Manufacturer Name : Mylan
  • MFG # : 51079060820
  • NDC : 51079060820
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind -
DESI2 Drug Ind AB
Drug Category N
Drug Category NJ
Drug Type Code N
Drug Type Code 1
FDA Approval Date 12/07/2012
FDA Approval Date 05/14/2013
FDA Therap Equiv AB
FDA Therap Equiv TAB
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date 05/14/2013
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date 1
Unit 1
Unit TAB
Units Per Pkg 12/07/2012
Units Per Pkg 1
Active Ingredients 11658 fenofibrate nanocrystallized
Active Ingredients 11658 fenofibrate nanocrystallized
AHFS Class 24060600 FIBRIC ACID DERIVATIVES
AHFS Class 24060600 FIBRIC ACID DERIVATIVES
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 61200 fenofibrate nanocrystallized ORAL TABLET 145 MG
Gen Code and Des 61200 fenofibrate nanocrystallized ORAL TABLET 145 MG
Inactive Ingredients 13405 soy; 2432 lactose 64044515; 2537 povidone 9003398; 2598 sucrose 57501
Inactive Ingredients 13405 soy; 2432 lactose 64044515; 2537 povidone 9003398; 2598 sucrose 57501
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 145MG
Strength 145MG
Common Brand Name COMMON BRAND NAME(S): Tricor, Triglide
Common Brand Name COMMON BRAND NAME(S): Tricor, Triglide
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: "blood thinners" (such as warfarin). Fenofibrate is very similar to fenofibric acid. Do not use medications containing fenofibric acid while using fenofibrate.
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: "blood thinners" (such as warfarin). Fenofibrate is very similar to fenofibric acid. Do not use medications containing fenofibric acid while using fenofibrate.
Allocation Period -
Allocation Period -
Case Quantity 10
Case Quantity 10
Drug Form Pack Size 100
Drug Form Pack Size 100
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 100
Unit Size 100
How to Use HOW TO USE: Take this medication by mouth as directed by your doctor, usually once daily. Fenofibrate comes in different types of capsules and tablets which provide different amounts of the medication. Do not switch between different forms or brands of this medication unless directed by your doctor. Some forms of this drug should be taken with food but others may be taken with or without food. Ask your pharmacist about your brand of fenofibrate. It is important to take this medication correctly so that the drug has the greatest benefit. The dosage is based on your medical condition and response to treatment. If you are also taking certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take fenofibrate at least 1 hour before or at least 4 to 6 hours after taking these medications. These medications can bind to fenofibrate, preventing your body from fully absorbing the drug. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your cholesterol/triglycerides level will not lower faster, and your risk of side effects will increase. Keep taking this medication even if you feel well. Most people with high cholesterol/triglycerides do not feel sick. It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 2 months before you get the full benefit of this medication.
How to Use HOW TO USE: Take this medication by mouth as directed by your doctor, usually once daily. Fenofibrate comes in different types of capsules and tablets which provide different amounts of the medication. Do not switch between different forms or brands of this medication unless directed by your doctor. Some forms of this drug should be taken with food but others may be taken with or without food. Ask your pharmacist about your brand of fenofibrate. It is important to take this medication correctly so that the drug has the greatest benefit. The dosage is based on your medical condition and response to treatment. If you are also taking certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take fenofibrate at least 1 hour before or at least 4 to 6 hours after taking these medications. These medications can bind to fenofibrate, preventing your body from fully absorbing the drug. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your cholesterol/triglycerides level will not lower faster, and your risk of side effects will increase. Keep taking this medication even if you feel well. Most people with high cholesterol/triglycerides do not feel sick. It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 2 months before you get the full benefit of this medication.
Missed Dose MISSED DOSE: 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.
Missed Dose MISSED DOSE: 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.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as cholesterol/triglyceride levels, kidney/liver function, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. (See also Side Effects section.)
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as cholesterol/triglyceride levels, kidney/liver function, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. (See also Side Effects section.)
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.
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 (fen-oh-FYE-brate)
Phonetic Pronunciation (fen-oh-FYE-brate)
Precautions PRECAUTIONS: Before taking fenofibrate, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibric acid); or if you have any other allergies. This product may contain inactive ingredients (such as soy), 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: kidney disease, gallbladder disease, liver disease (such as biliary cholangitis, hepatitis), alcohol use. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 5 days after stopping the drug. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking fenofibrate, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibric acid); or if you have any other allergies. This product may contain inactive ingredients (such as soy), 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: kidney disease, gallbladder disease, liver disease (such as biliary cholangitis, hepatitis), alcohol use. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 5 days after stopping the drug. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: 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. This medication may rarely cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor right away: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. This drug may rarely cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine). Rarely, this medication has caused severe lowering of HDL ("good" cholesterol) levels. This is the opposite of what should happen to your HDL levels (paradoxical reaction). Your HDL cholesterol levels should be checked regularly. Keep all of your laboratory appointments. Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, unusual tiredness. Get medical help right away if you have any very serious side effects, including: chest pain, sudden pain/redness/swelling usually in the leg, signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough). 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: 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. This medication may rarely cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor right away: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. This drug may rarely cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine). Rarely, this medication has caused severe lowering of HDL ("good" cholesterol) levels. This is the opposite of what should happen to your HDL levels (paradoxical reaction). Your HDL cholesterol levels should be checked regularly. Keep all of your laboratory appointments. Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, unusual tiredness. Get medical help right away if you have any very serious side effects, including: chest pain, sudden pain/redness/swelling usually in the leg, signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough). 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.
Storage STORAGE: Store at room temperature away from light and moisture. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. 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 STORAGE: Store at room temperature away from light and moisture. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. 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.
Uses USES: Fenofibrate is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibrate belongs to a group of drugs known as "fibrates." Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibrate might not lower your risk of a heart attack or stroke. Talk to your doctor about the risks and benefits of fenofibrate. In addition to eating 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.
Uses USES: Fenofibrate is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibrate belongs to a group of drugs known as "fibrates." Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibrate might not lower your risk of a heart attack or stroke. Talk to your doctor about the risks and benefits of fenofibrate. In addition to eating 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.

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FENOFIBRATE 145 MG TAB 100 UD is manufactured by Mylan.
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