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Ezetimibe-Simvastatin 10-80 Mg Tab 30

  • Manufacturer Name : ASCEND LABORATO
  • MFG # : 67877051030
  • NDC : 67877051030
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
335211 UN
$34.89
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ezetimibe/simvastatin ORAL TABLET 10 MG-

Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind AB
DESI2 Drug Ind AB
Drug Category -
Drug Category -
Drug Type Code N
Drug Type Code N
FDA Approval Date 01/26/2018
FDA Approval Date 01/26/2018
FDA Therap Equiv TAB
FDA Therap Equiv TAB
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date 1
Unit 30
Unit 30
Units Per Pkg 12/22/2017
Units Per Pkg 12/22/2017
Active Ingredients 3621 simvastatin 79902639; 9817 ezetimibe 163222331
Active Ingredients 3621 simvastatin 79902639; 9817 ezetimibe 163222331
AHFS Class 24060500 CHOLESTEROL ABSORPTION INHIBITORS; 24060800 HMG-COA REDUCTASE INHIBITORS
AHFS Class 24060500 CHOLESTEROL ABSORPTION INHIBITORS; 24060800 HMG-COA REDUCTASE INHIBITORS
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 57864 ezetimibe/simvastatin ORAL TABLET 10 MG-80MG
Gen Code and Des 57864 ezetimibe/simvastatin ORAL TABLET 10 MG-80MG
Inactive Ingredients 2432 lactose 64044515
Inactive Ingredients 2432 lactose 64044515
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 10-80 MG
Strength 10-80 MG
Common Brand Name COMMON BRAND NAME(S): Vytorin
Common Brand Name COMMON BRAND NAME(S): Vytorin
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), cyclosporine, danazol, daptomycin, gemfibrozil. Other medications can affect the removal of simvastatin from your body, which may affect how simvastatin works. Examples include certain azole antifungals (such as itraconazole, ketoconazole, posaconazole, voriconazole), cobicistat, colchicine, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as nelfinavir), ritonavir, telithromycin, among others. Chinese people should not take niacin at doses used to lower cholesterol (1 gram or more) when taking this medication. Doing so may increase the risk of side effects (especially muscle problems). Talk with your doctor for details. Do not take any red yeast rice products while you are taking ezetimibe/simvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking ezetimibe/simvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.
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), cyclosporine, danazol, daptomycin, gemfibrozil. Other medications can affect the removal of simvastatin from your body, which may affect how simvastatin works. Examples include certain azole antifungals (such as itraconazole, ketoconazole, posaconazole, voriconazole), cobicistat, colchicine, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as nelfinavir), ritonavir, telithromycin, among others. Chinese people should not take niacin at doses used to lower cholesterol (1 gram or more) when taking this medication. Doing so may increase the risk of side effects (especially muscle problems). Talk with your doctor for details. Do not take any red yeast rice products while you are taking ezetimibe/simvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking ezetimibe/simvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.
Allocation Period -
Allocation Period -
Case Quantity 96
Case Quantity 96
Drug Form Pack Size 30
Drug Form Pack Size 30
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 30
Unit Size 30
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily in the evening. The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). The usual maximum dose for the simvastatin in this medication is 40 milligrams a day. If you have been instructed by your doctor to take more than 40 milligrams of simvastatin, continue on that same dose. However, promptly talk with him or her about the risks and benefits of your higher dose. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 2 hours before or at least 4 hours after taking these medications. These medications can react with this product, preventing its full absorption. Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. Keep taking this medication even if you feel well. Most people with high cholesterol or 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 4 weeks before you get the full benefit of this drug.
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily in the evening. The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). The usual maximum dose for the simvastatin in this medication is 40 milligrams a day. If you have been instructed by your doctor to take more than 40 milligrams of simvastatin, continue on that same dose. However, promptly talk with him or her about the risks and benefits of your higher dose. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 2 hours before or at least 4 hours after taking these medications. These medications can react with this product, preventing its full absorption. Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. Keep taking this medication even if you feel well. Most people with high cholesterol or 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 4 weeks before you get the full benefit of this drug.
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 blood cholesterol/triglyceride levels, liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as blood cholesterol/triglyceride levels, liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
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 (e-ZET-i-mibe/SIM-va-STAT-in)
Phonetic Pronunciation (e-ZET-i-mibe/SIM-va-STAT-in)
Precautions PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to ezetimibe or simvastatin; 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: liver disease, kidney disease, alcohol use. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this product. Ask your doctor or pharmacist for more information. Older adults may be more sensitive to the side effects of this medication, especially muscle problems. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to ezetimibe or simvastatin; 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: liver disease, kidney disease, alcohol use. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this product. Ask your doctor or pharmacist for more information. Older adults may be more sensitive to the side effects of this medication, especially muscle problems. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. 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. A very small number of people taking simvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor. Rarely, statins may cause or worsen diabetes. Talk to your doctor about the benefits and risks. This drug may rarely cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Older adults and Chinese people may be at higher risk. Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms last after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine). This medication may rarely cause liver problems. Tell your doctor right away if you develop symptoms of liver problems, including: nausea/vomiting that doesn't stop, yellowing eyes/skin, dark urine, stomach/abdominal pain. 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), 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. A very small number of people taking simvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor. Rarely, statins may cause or worsen diabetes. Talk to your doctor about the benefits and risks. This drug may rarely cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Older adults and Chinese people may be at higher risk. Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms last after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine). This medication may rarely cause liver problems. Tell your doctor right away if you develop symptoms of liver problems, including: nausea/vomiting that doesn't stop, yellowing eyes/skin, dark urine, stomach/abdominal pain. 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), 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. 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. 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: This combination medication 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. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Simvastatin belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. 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. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.
Uses USES: This combination medication 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. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Simvastatin belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. 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. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.

Frequently Asked Questions(FAQs)

The cost of EZETIMIBE-SIMVASTATIN 10-80 MG TAB 30 is $ 34.89.
EZETIMIBE-SIMVASTATIN 10-80 MG TAB 30 is manufactured by ASCEND LABORATO.
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