Product Details
TELMISARTAN-AMLODIPINE 80MG-5MG TAB 30
Manufacturer: Mylan
MFG#: 00378-1077-93
NDC: 00378-1077-93
PID: 319513
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Product Properties:
| Description | N |
|---|---|
| Description | - |
| DESI Drug Ind | $3.79; 04/01/2017 |
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| Drug Category | N |
| Drug Category | USES: This product is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications: telmisartan and amlodipine. Telmisartan is an angiotensin receptor blocker (ARB) and amlodipine is a calcium channel blocker. They both work differently to relax the blood vessels so that blood can flow more easily. These medications are used together when one drug is not controlling your blood pressure. Your doctor may direct you to start taking the individual medications first, and then switch you to this combination product if it is the best dose combination for you. |
| Drug Type Code | COMMON BRAND NAME(S): Twynsta |
| Drug Type Code | 1 |
| FDA Approval Date | 08/26/2014 |
| FDA Therap Equiv | AB |
| HCPCS | 1 |
| HCPCS | - |
| Market Entry Date | 10/07/2014 |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (TEL-mi-SAR-tan/am-LOE-di-peen) |
| Termination Date | - |
| Unit | TAB |
| Units Per Pkg | 1 |
| Active Ingredients | 3673 amlodipine besylate 111470996; 7683 telmisartan 144701484 |
| Active Ingredients | 3673 amlodipine besylate 111470996; 7683 telmisartan 144701484 |
| AHFS Class | 24320800 ANGIOTENSIN II RECEPTOR ANTAGONISTS; 24084408 ANGIOTENSIN II RECEPTOR ANTAGON.(HYPOTN); 24280800 DIHYDROPYRIDINES; 24081208 DIHYDROPYRIDINES (ANTIHYPERTENSIVE); 24280000 CALCIUM-CHANNEL BLOCKING AGENTS; 24129200 VASODILATING AGENTS, MISCELLANEOUS |
| AHFS Class | 24320800 ANGIOTENSIN II RECEPTOR ANTAGONISTS; 24084408 ANGIOTENSIN II RECEPTOR ANTAGON.(HYPOTN); 24280800 DIHYDROPYRIDINES; 24081208 DIHYDROPYRIDINES (ANTIHYPERTENSIVE); 24280000 CALCIUM-CHANNEL BLOCKING AGENTS; 24129200 VASODILATING AGENTS, MISCELLANEOUS |
| 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 | 65748 telmisartan/amlodipine ORAL TABLET 80 MG-5 MG |
| Gen Code and Des | 65748 telmisartan/amlodipine ORAL TABLET 80 MG-5 MG |
| Inactive Ingredients | 10138 blue dye; 2272 mannitol 69658; 2537 povidone 9003398 |
| Inactive Ingredients | 10138 blue dye; 2272 mannitol 69658; 2537 povidone 9003398 |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 80MG-5MG |
| Strength | 80MG-5MG |
| Common Brand Name | - |
| Common Brand Name | COMMON BRAND NAME(S): Twynsta |
| Drug Interaction | - |
| Drug Interaction | DRUG INTERACTIONS: See also Precautions 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: aliskiren, lithium, drugs that may increase the level of potassium in the blood (such as sparsentan, ACE inhibitors including benazepril/lisinopril, birth control pills containing drospirenone). Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen). |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 48 |
| Case Quantity | 48 |
| 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 | 20 Cool-Store Cont Temp |
| Temp Zone | 20 Cool-Store Cont Temp |
| Unit | EA |
| Unit | EA |
| Unit Size | 30 |
| Unit Size | 30 |
| How to Use | - |
| How to Use | HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking telmisartan/amlodipine 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. The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick. It may take up to 4 weeks before you get the full benefit of this drug. Tell your doctor if your condition does not improve or if it worsens (such as your blood pressure readings remain high or increase). |
| 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 | 1 |
| Notes | TAB |
| Notes | NOTES: Do not share this medication with others. Lab and/or medical tests (such as potassium levels, kidney function) 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 stress reduction programs, exercise, and dietary changes. Talk to your doctor or pharmacist about lifestyle changes that might benefit you. Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor. |
| 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. Symptoms of overdose may include: severe dizziness, fainting, fast heartbeat. |
| Overdose | AB |
| Phonetic Pronunciation | - |
| Phonetic Pronunciation | (TEL-mi-SAR-tan/am-LOE-di-peen) |
| Precautions | - |
| Precautions | PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to either telmisartan or amlodipine; or to other calcium channel blockers (such as nifedipine); 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, high level of potassium in the blood, dehydration, heart disease (such as aortic stenosis, heart failure), bile duct blockage. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist. Older adults may be more sensitive to the side effects of this drug, especially dizziness and change in the amount of urine (kidney problems). Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using telmisartan/amlodipine. Telmisartan may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. (See also Warning section.) It is unknown if telmisartan passes into breast milk. Amlodipine passes into breast milk. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. Swelling hands/ankles/feet or flushing may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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: fainting, fast/pounding/irregular heartbeat, signs of kidney problems (such as change in the amount of urine), symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat). Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating). 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 | - |
| Storage | STORAGE: Store at room temperature away from light and moisture. Do not remove the medication from the blister pack until right before using. 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 | 08/26/2014 |
| Uses | USES: This product is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications: telmisartan and amlodipine. Telmisartan is an angiotensin receptor blocker (ARB) and amlodipine is a calcium channel blocker. They both work differently to relax the blood vessels so that blood can flow more easily. These medications are used together when one drug is not controlling your blood pressure. Your doctor may direct you to start taking the individual medications first, and then switch you to this combination product if it is the best dose combination for you. |
| Uses | - |
Frequently Asked Questions (FAQs)
The cost of TELMISARTAN-AMLODIPINE 80MG-5MG TAB 30 is $available for registerd members only
TELMISARTAN-AMLODIPINE 80MG-5MG TAB 30 is manufactured by Mylan.
You can purchase TELMISARTAN-AMLODIPINE 80MG-5MG TAB 30 on our website at https://supplies.pipelinemedical.com/product/detail/telmisartan-amlodipine-80mg-5mg-tab-30-319513