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Amlodipine-Olmesartan 5-20 Mg Tab 30

  • Manufacturer Name : Micro Labs Limited
  • MFG # : 42571023530
  • NDC : 42571023530
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind AB
Drug Category -
Drug Type Code N
FDA Approval Date 10/03/2018
FDA Therap Equiv TAB
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 1
Units Per Pkg 11/02/2017
Active Ingredients 3673 amlodipine besylate 111470996; 9635 olmesartan medoxomil 144689634
AHFS Class 24280800 DIHYDROPYRIDINES; 24081208 DIHYDROPYRIDINES (ANTIHYPERTENSIVE); 24280000 CALCIUM-CHANNEL BLOCKING AGENTS; 24320800 ANGIOTENSIN II RECEPTOR ANTAGONISTS; 24084408 ANGIOTENSIN II RECEPTOR ANTAGON.(HYPOTN); 24129200 VASODILATING AGENTS, MISCELLANEOUS; 24089200 HYPOTENSIVE AGENTS, MISCELLANEOUS
DEA Class NC
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 63179 amlodipine bes/olmesartan med ORAL TABLET 5 MG-20 MG
Inactive Ingredients -
OMP Family -
Product Category RX Pharmaceuticals
Strength 5-20 MG
Common Brand Name COMMON BRAND NAME(S): Azor
Drug Interaction DRUG INTERACTIONS: See also How to Use and Precautions sections. 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 -
Case Quantity 96
Drug Form Pack Size 30
Form TABLET
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 30
How to Use HOW TO USE: 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. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine, colesevelam, colestipol), take amlodipine/olmesartan at least 4 hours before any of these medications. Take 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 2 weeks before you get the full benefit of this drug. Tell your doctor if your condition does not improve or if it worsens (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.
Notes NOTES: Do not share this medication with others. 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. 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. 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.
Phonetic Pronunciation (am-LOE-di-peen/OL-me-SAR-tan)
Precautions PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to either amlodipine or olmesartan, 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: kidney disease, liver disease, a certain heart valve condition (aortic stenosis), dehydration, high level of potassium in the blood. 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. This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 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 this medication. Olmesartan 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. Amlodipine passes into breast milk. It is unknown if olmesartan 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. Headache 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: diarrhea that is severe or doesn't stop, swelling hands/ankles/feet, fainting, fast 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.
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 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: amlodipine and olmesartan. They both work by relaxing blood vessels so blood can flow more easily. Amlodipine is a calcium channel blocker and olmesartan is an angiotensin receptor blocker (ARB).

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Amlodipine-Olmesartan 5-20 Mg Tab 30 is manufactured by Micro Labs Limited.
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