Amlodipine Besylate (Page 5 of 6)

14.5 Studies in Patients with Heart Failure

Amlodipine besylate has been compared to placebo in four 8 to 12 week studies of patients with NYHA Class II/III heart failure, involving a total of 697 patients. In these studies, there was no evidence of worsened heart failure based on measures of exercise tolerance, NYHA classification, symptoms, or left ventricular ejection fraction. In a long-term (follow-up at least 6 months, mean 13.8 months) placebo-controlled mortality/morbidity study of amlodipine 5 to 10 mg in 1153 patients with NYHA Classes III (n=931) or IV (n=222) heart failure on stable doses of diuretics, digoxin, and ACE inhibitors, amlodipine besylate had no effect on the primary endpoint of the study which was the combined endpoint of all-cause mortality and cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure), or on NYHA classification, or symptoms of heart failure. Total combined all-cause mortality and cardiac morbidity events were 222/571 (39%) for patients on amlodipine besylate and 246/583 (42%) for patients on placebo; the cardiac morbid events represented about 25% of the endpoints in the study.

Another study (PRAISE-2) randomized patients with NYHA Class III (80%) or IV (20%) heart failure without clinical symptoms or objective evidence of underlying ischemic disease, on stable doses of ACE inhibitors (99%), digitalis (99%), and diuretics (99%), to placebo (n=827) or amlodipine besylate (n=827) and followed them for a mean of 33 months. There was no statistically significant difference between amlodipine besylate and placebo in the primary endpoint of all-cause mortality (95% confidence limits from 8% reduction to 29% increase on amlodipine besylate). With amlodipine besylate there were more reports of pulmonary edema.

16 HOW SUPPLIED/STORAGE AND HANDLING

Amlodipine Besylate Tablets, USP equivalent to 2.5 mg of amlodipine are supplied as white to off-white, round, flat, radial-edged tablets debossed with ‘Z’ on one side and ’7′ on the other side and are supplied as follows:

NDC 65841-620-16 in bottle of 90 tablets

NDC 65841-620-01 in bottle of 100 tablets

NDC 65841-620-05 in bottle of 500 tablets

NDC 65841-620-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

Amlodipine Besylate Tablets, USP equivalent to 5 mg of amlodipine are supplied as white to off-white, round, flat, radial-edged tablets debossed with ‘Z’, ’3′ on one side and plain on the other side and are supplied as follows:

NDC 65841-621-16 in bottle of 90 tablets

NDC 65841-621-01 in bottle of 100 tablets

NDC 65841-621-05 in bottle of 500 tablets

NDC 65841-621-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

Amlodipine Besylate Tablets, USP equivalent to 10 mg of amlodipine are supplied as white to off-white, round, flat, radial-edged tablets debossed with ‘Z’, ’5′ on one side and plain on the other side and are supplied as follows:

NDC 65841-622-16 in bottle of 90 tablets

NDC 65841-622-01 in bottle of 100 tablets

NDC 65841-622-05 in bottle of 500 tablets

NDC 65841-622-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from light.

Dispense in a tight, light-resistant container.

Manufactured by:

Cadila Healthcare Ltd.

India

Rev.: 12/17

Patient Information Leaflet

Amlodipine Besylate

(am-LOW-duh-PEEN BEH-sih-LATE)

Tablets , USP

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, ask your doctor. Your doctor will know if amlodipine besylate tablets are right for you.

What is amlodipine besylate?

Amlodipine besylate is 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 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 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. Do not breast feed while taking amlodipine besylate tablets. You can stop breast feeding or take a different medicine.

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 tablet 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 breast feed. It is not known if amlodipine besylate tablets will pass through your milk.
  • 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.

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.

How do I store amlodipine besylate?

Keep amlodipine besylate away from children. Store amlodipine besylate tablets at room temperature between 20°C (68°F) and 25°C (77°F). Keep amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep amlodipine besylate in a dry place.

General advice about amlodipine besylate

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 you can visit MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

This product’s package insert may have been updated. For current package insert, please visit www.zydususa.com.

Manufactured by:

Cadila Healthcare Ltd.

India

Rev.: 12/17

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.