Prescription Drug Information: Amlodipine Besylate (Page 4 of 4)

14.5 Studies in Patients with Heart Failure

Amlodipine besylate tablets have 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 besylate tablets 5-10 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 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 tablets 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 tablets (n= 827) and followed them for a mean of 33 months. There was no statistically significant difference between amlodipine besylate tablets and placebo in the primary endpoint of all-cause mortality (95% confidence limits from 8% reduction to 29% increase on amlodipine). With amlodipine besylate tablets there were more reports of pulmonary edema.

16 HOW SUPPLIED/STORAGE AND HANDLING

2.5 mg Tablets

Amlodipine besylate-2.5 mg Tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat faced beveled edged tablets debossed with IG on one side and 237 on the other and supplied as follows:

NDC 76282-237-90 Bottle of 90
NDC 76282-237-05 Bottle of 500
NDC 76282-237-10 Bottle of 1000

5 mg Tablets

Amlodipine besylate-5 mg Tablets (amlodipine besylate, USP equivalent to 5 mg of amlodipine per tablet) are supplied as white, round, flat faced beveled edged tablets debossed with IG on one side and 238 on the other and supplied as follows:

NDC 76282-238-90 Bottle of 90
NDC 76282-238-05 Bottle of 500
NDC 76282-238-10 Bottle of 1000

10 mg Tablets

Amlodipine besylate-10 mg Tablets (amlodipine besylate, USP equivalent to 10 mg of amlodipine per tablet) are supplied as white, round, flat faced beveled edged tablets debossed with IG on one side and 239 on the other and supplied as follows:

NDC 76282-239-90 Bottle of 90
NDC 76282-239-05 Bottle of 500
NDC 76282-239-10 Bottle of 1000

Storage

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

Dispense in tight, light-resistant containers (USP).

Revised: 06/2020

SUMMARY OF INFORMATION ABOUT AMLODIPINE BESYLATE 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 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 tablets relax 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 tabletsif 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 taking amlodipine besylate tablets is the best treatment for you.
  • are breast-feeding. Amlodipine 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 many 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 tabletsmay 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 room temperature (store between 20° to 25°C (68° to 77°F). 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 you can visit exelan pharmaceuticals website at www.exelanpharma.com or call 1-866-604-3268.

Manufactured by:
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788


Manufactured for:
Exelan Pharmaceuticals, Inc.
Boca Raton, FL 33432

Rev: 06/20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2.5mg

NDC 76282-237-90
Amlodipine Besylate
Tablets, USP
2.5mg
EXELAN PHARMACEUTICALS, INC
Rx Only 90 Tablets

image2.5mg
(click image for full-size original)

NDC 76282-238-90
Amlodipine Besylate
Tablets, USP
5mg
EXELAN PHARMACEUTICALS, INC
Rx Only 90 Tablets

image5mg
(click image for full-size original)

NDC 76282-239-90
Amlodipine Besylate
Tablets, USP
10mg
EXELAN PHARMACEUTICALS, INC
Rx Only
90 Tablets

image10mg
(click image for full-size original)
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-237
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 237;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-237-90 90 TABLET in 1 BOTTLE None
2 NDC:76282-237-05 500 TABLET in 1 BOTTLE None
3 NDC:76282-237-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077955 11/02/2007
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-238
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 238;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-238-90 90 TABLET in 1 BOTTLE None
2 NDC:76282-238-05 500 TABLET in 1 BOTTLE None
3 NDC:76282-238-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077955 11/02/2007
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-239
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 239;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-239-90 90 TABLET in 1 BOTTLE None
2 NDC:76282-239-05 500 TABLET in 1 BOTTLE None
3 NDC:76282-239-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077955 11/02/2007
Labeler — Exelan Pharmaceuticals, Inc. (967795266)
Registrant — InvaGen Pharmaceuticals, Inc. (165104469)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals, Inc. 165104469 MANUFACTURE (76282-237), manufacture (76282-238), manufacture (76282-239), ANALYSIS (76282-237), analysis (76282-238), analysis (76282-239)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals, Inc 080334903 pack (76282-237), analysis (76282-237), pack (76282-238), analysis (76282-238), pack (76282-239), analysis (76282-239)

Revised: 03/2023 Exelan Pharmaceuticals, Inc.

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