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

14.5 Studies in Patients with Heart Failure

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

16 HOW SUPPLIED/STORAGE AND HANDLING

2.5 mg Tablets

Amlodipine Besylate Tablets USP, 2.5 mg – (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as pink color mottled, round, flat-faced, beveled edged tablets debossed with “L” on one side and “28” on the other side and supplied as follows:

NDC 68180-719-09 Bottles of 90

5 mg Tablets

Amlodipine Besylate Tablets USP, 5 mg – (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are supplied as white to off white capsule shaped tablets debossed with “L” on one side and “29” on the other side and supplied as follows:

NDC 68180-720-09 Bottles of 90

NDC 68180-720-03 Bottles of 1000

10 mg Tablets

Amlodipine Besylate Tablets USP, 10 mg – (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are supplied as white to off white round, flat faced, beveled edged tablet debossed with “L” on one side and “32” on the other side and supplied as follows:

NDC 68180-721-09 Bottles of 90

NDC 68180-721-03 Bottles of 1000

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and dispense in tight, light-resistant containers (USP).

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

MADE IN INDIA.

Revised: May 2021

Amlodipine Besylate (am-LOE-di-peen BES-i-late)

Tablets USP

Rx Only

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 an amlodipine besylate tablet is right for you.

What is Amlodipine Besylate Tablet?

Amlodipine besylate tablet 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 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 tablet is the best treatment for you.
  • are breast-feeding. Amlodipine besylate tablet passes into your milk.

How should I take Amlodipine Besylate Tablets?

  • Takeamlodipine besylate tablet 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 ofamlodipine besylate tablets at a time.
  • If you miss a dose, take it as soon as you remember. Do not takeamlodipine 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 andamlodipine besylate tablets together. If you take nitroglycerin for angina, don’t stop taking it while you are takingamlodipine besylate tablets.
  • While you are takingamlodipine 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 muchamlodipine 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.

To report side effects, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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). 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 the Lupin website at www.lupinpharmaceuticals.com or call 1-800-399-2561.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

MADE IN INDIA.

Revised: May 2021 ID#: 267375

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMLODIPINE BESYLATE TABLETS USP

Rx only

2.5 mg

NDC 68180-750-09

90 Tablets

old-2.5 mg
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

2.5 mg

NDC 68180-719-09

90 Tablets

Image05
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

5 mg

NDC 68180-751-09

90 Tablets

old-5mg
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

5 mg

NDC 68180-720-09

90 Tablets

image-06
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

10 mg

NDC 68180-752-09

90 Tablets

old-10mg
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

10 mg

NDC 68180-721-09

90 Tablets

image-07
(click image for full-size original)
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-750
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape DIAMOND (Diamond) Size 8mm
Flavor Imprint Code LU;H11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-750-09 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/03/2007 06/30/2021
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-751
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape OCTAGON (8 SIDED) (Elongated octagon) Size 9mm
Flavor Imprint Code LU;H12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-751-09 90 TABLET in 1 BOTTLE None
2 NDC:68180-751-17 300 TABLET in 1 BOTTLE None
3 NDC:68180-751-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/03/2007 07/31/2021
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-752
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Round) Size 11mm
Flavor Imprint Code LU;H13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-752-09 90 TABLET in 1 BOTTLE None
2 NDC:68180-752-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/03/2007 06/30/2021
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-719
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
FD&C RED NO. 40
MAGNESIUM STEARATE
POVIDONE
SILICON DIOXIDE
Product Characteristics
Color PINK (pink color mottled) Score no score
Shape ROUND (Flat-faced, beveled edged) Size 7mm
Flavor Imprint Code L;28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-719-09 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 10/31/2018
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-720
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE
SILICON DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 8mm
Flavor Imprint Code L;29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-720-09 90 TABLET in 1 BOTTLE None
2 NDC:68180-720-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/15/2018
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-721
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE
SILICON DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Flat faced, beveled edged) Size 7mm
Flavor Imprint Code L;32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-721-09 90 TABLET in 1 BOTTLE None
2 NDC:68180-721-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/15/2018
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 MANUFACTURE (68180-750), MANUFACTURE (68180-751), MANUFACTURE (68180-752), PACK (68180-750), PACK (68180-751), PACK (68180-752)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 862272739 MANUFACTURE (68180-750), MANUFACTURE (68180-751), MANUFACTURE (68180-752), MANUFACTURE (68180-719), MANUFACTURE (68180-720), MANUFACTURE (68180-721), PACK (68180-750), PACK (68180-751), PACK (68180-752), PACK (68180-719), PACK (68180-720), PACK (68180-721)

Revised: 05/2021 Lupin Pharmaceuticals, Inc.

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