AMLODIPINE BESYLATE Amlodipine 5 MG Oral Tablet
1 INDICATIONS AND USAGE Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension ( 1.1 ) NORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Coronary Artery Disease ( 1.2 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents. 1.2 Coronary Artery Disease (CAD) Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
WOCKHARDT USA LLC.
OVAL WHITE W 422
W 422 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets Amlodipine Besylate Tablets - 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as white to off-white, triangle-shaped, flat-beveled debossed with "W" on one side and "421" on the other side and supplied as follows: NDC 64679-421-01 Bottle of 90 NDC 64679-421-02 Bottle of 1000 NDC 64679-421-03 Unit Dose package of 100 NDC 64679-421-04 Bottle of 100 5 mg Tablets Amlodipine Besylate Tablets - 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are supplied as white to off-white, caplet, flat-beveled, debossed with "W" on one side and "422" on the other side and supplied as follows: NDC 64679-422-01 Bottle of 90 NDC 64679-422-02 Bottle of 1000 NDC 64679-422-03 Unit Dose package of 100 NDC 64679-422-04 Bottle of 100 NDC 64679-422-05 Bottle of 300 10 mg Tablets Amlodipine Besylate Tablets - 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are supplied as white to off-white, round, flat-beveled, debossed with "W" 423 on one side and plain on the other side and supplied as follows: NDC 64679-423-01 Bottle of 90 NDC 64679-423-02 Bottle of 1000 NDC 64679-423-03 Unit Dose package of 100 NDC 64679-423-04 Bottle of 100 Storage Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature]. Protect from light and moisture. Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.190418 PATIENT INFORMATION LEAFLET Amlodipine Besylate (am-LOE-di-peen BES-i-late) Tablets Read this information carefully before you start taking amlodipine besylate tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about amlodipine besylate tablets , ask your doctor. Your doctor will know if amlodipine besylate tablets are right for you. What are amlodipine besylate tablets? Amlodipine besylate tablets are a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions. High Blood Pressure (hypertension) High blood pressure comes from blood pushing too hard against your blood vessels. Amlodipine besylate tablet relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack. Angina Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Amlodipine besylate tablets can relieve this pain. Who should not use amlodipine besylate tablets? Do not use amlodipine besylate tablets if you are allergic to amlodipine (the active ingredient in amlodipine besylate tablets ), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients. What should I tell my doctor before taking amlodipine besylate tablets? Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies. Tell your doctor if you: ever had heart disease ever had liver problems are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets are the best treatment for you. are breast-feeding. Amlodipine besylate passes into your milk. How should I take amlodipine besylate tablets? Take amlodipine besylate tablets once a day, with or without food. It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not take more than one dose of amlodipine besylate tablets at a time. If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time. Other medicines: You can use nitroglycerin and amlodipine besylate tablets together. If you take nitroglycerin for angina, don't stop taking it while you are taking amlodipine besylate tablets . While you are taking amlodipine besylate tablets, do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor. If you took too much amlodipine besylate tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away. What should I avoid while taking amlodipine besylate tablets? Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first. What are the possible side effects of amlodipine besylate tablets ? Amlodipine besylate tablets may cause the following side effects. Most side effects are mild or moderate: swelling of your legs or ankles tiredness, extreme sleepiness stomach pain, nausea dizziness flushing (hot or warm feeling in your face) arrhythmia (irregular heartbeat) heart palpitations (very fast heartbeat) muscle rigidity, tremor and/or abnormal muscle movement It is rare, but when you first start taking amlodipine besylate tablets or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room. Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of amlodipine besylate tablets. For a complete list, ask your doctor or pharmacist. How do I store amlodipine besylate tablets ? Keep amlodipine besylate tablets away from children. Store amlodipine besylate tablets at 20° to 25°C (68° to 77°F) (USP Controlled Room Temperature). Keep amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep amlodipine besylate tablets in a dry place. General advice about amlodipine besylate tablets Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use amlodipine besylate tablets the way your doctor told you to. Do not give amlodipine besylate tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about amlodipine besylate tablets, or call 1-800-346-6854. Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.190418
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