Product Details
Vascepa® Icosapent Ethyl 1 Gram Capsule 120 Capsules
Manufacturer: AMARIN PHARMA I
MFG#: 52937-0001-20
NDC: 52937-0001-20
PID: 272963
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Description
Indications and Usage:
VASCEPA® (icosapent ethyl) is indicated:
- as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (= 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.
- as an adjunct to diet to reduce TG levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia.
Limitations of Use::
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Product Properties:
| Description | - |
|---|---|
| Description | S |
| DESI Drug Ind | -; - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| Drug Category | USES: Icosapent ethyl is used along with certain other cholesterol medications ("statins" such as atorvastatin, simvastatin) to reduce the risk of heart attack, stroke, and certain types of heart problems that require treatment in a hospital. It is also used along with a proper diet to help lower fats (triglycerides) in the blood. Icosapent ethyl is a type of omega-3 fatty acid, a fat found in fish oil. It is thought to work by decreasing the amount of triglycerides made by the body. 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. |
| Drug Category | S |
| Drug Type Code | 1 |
| Drug Type Code | COMMON BRAND NAME(S): Vascepa |
| FDA Approval Date | 07/26/2012 |
| FDA Therap Equiv | NR |
| HCPCS | - |
| HCPCS | 1 |
| Market Entry Date | 01/03/2013 |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (eye-KOE-sa-pent ETH-il) |
| Termination Date | - |
| Unit | CAP |
| Units Per Pkg | 1 |
| Active Ingredients | 14642 icosapent ethyl 86227476 |
| Active Ingredients | 14642 icosapent ethyl 86227476 |
| AHFS Class | 24069200 ANTILIPEMIC AGENTS, MISCELLANEOUS |
| AHFS Class | 24069200 ANTILIPEMIC AGENTS, MISCELLANEOUS |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | CAPSULE |
| Dose Form | CAPSULE |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 69960 icosapent ethyl ORAL CAPSULE 1 G |
| Gen Code and Des | 69960 icosapent ethyl ORAL CAPSULE 1 G |
| Inactive Ingredients | 10095 maltitol 585886; 2549 gelatin 9000708; 2599 sorbitol 50704 |
| Inactive Ingredients | 10095 maltitol 585886; 2549 gelatin 9000708; 2599 sorbitol 50704 |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 1GM |
| Strength | 1GM |
| Common Brand Name | - |
| Common Brand Name | COMMON BRAND NAME(S): Vascepa |
| Drug Interaction | DRUG INTERACTIONS: 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. |
| Drug Interaction | - |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 24 |
| Case Quantity | 24 |
| Drug Form Pack Size | 120 |
| Drug Form Pack Size | 120 |
| Form | CAPSULES |
| Form | CAPSULES |
| 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 | 120 |
| Unit Size | 120 |
| How to Use | HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking icosapent ethyl and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually twice a day. Swallow the capsules whole. Do not crush, chew, open, or dissolve the capsules. Do not substitute other omega-3 fatty acids or fish oil products (such as nonprescription products, vitamins, supplements) for this product without talking with your doctor first. They may not contain the same amount and type of fatty acids. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Keep taking this medication even if you feel well. It is very important to continue to follow your doctor's advice about diet and exercise. |
| How to Use | - |
| Missed Dose | 1 |
| 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 | CAP |
| Notes | NOTES: Do not share this medication with others. Lab and/or medical tests (such as cholesterol/triglyceride levels) 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 | NR |
| Phonetic Pronunciation | - |
| Phonetic Pronunciation | (eye-KOE-sa-pent ETH-il) |
| Precautions | PRECAUTIONS: Before taking icosapent ethyl, tell your doctor or pharmacist if you are allergic to it; or to fish or shellfish products; 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, irregular heartbeat (such as atrial fibrillation). 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. This medication passes into breast milk. Consult your doctor before breast-feeding. |
| Precautions | - |
| Side Effects | - |
| Side Effects | SIDE EFFECTS: Joint/muscle pain or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. 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: fast/irregular heartbeat, easy bruising/bleeding, swelling ankles/feet/hands. 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 | 07/26/2012 |
| Storage | STORAGE: Store at room temperature away from light and moisture. 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 | USES: Icosapent ethyl is used along with certain other cholesterol medications ("statins" such as atorvastatin, simvastatin) to reduce the risk of heart attack, stroke, and certain types of heart problems that require treatment in a hospital. It is also used along with a proper diet to help lower fats (triglycerides) in the blood. Icosapent ethyl is a type of omega-3 fatty acid, a fat found in fish oil. It is thought to work by decreasing the amount of triglycerides made by the body. 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. |
Frequently Asked Questions (FAQs)
The cost of Vascepa® Icosapent Ethyl 1 Gram Capsule 120 Capsules is $available for registerd members only
Vascepa® Icosapent Ethyl 1 Gram Capsule 120 Capsules is manufactured by AMARIN PHARMA I.
You can purchase Vascepa® Icosapent Ethyl 1 Gram Capsule 120 Capsules on our website at https://supplies.pipelinemedical.com/product/detail/vascepa-1-gm-cap-120-272963