Amlodipine Besylate (Page 5 of 5)

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

5 mg Tablets

Amlodipine besylate tablets, USP 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white to off white, round, flat-faced, beveled edge tablets ‘210’ debossed on one side and plain on the other side and supplied as follows:


NDC 43063-564-30 Bottle of 30
NDC 43063-564-90 Bottle of 90

Storage

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature), and dispense in tight, light resistant container (USP).

PATIENT PACKAGE INSERT


AMLODIPINE BESYLATE TABLETS, USP 2.5 mg, 5 mg, and 10 mg
Read this information carefully before you start taking amlodipine besylate tablets, USP 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, USP, ask your doctor. Your doctor will know if amlodipine besylate tablets, USP is 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?
Do not use amlodipine besylate 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?
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 is the best treatment for you.
  • are breast-feeding. Amlodipine passes into your milk.

How should I take amlodipine besylate tablets, USP?

  • Take amlodipine besylate tablets, USP 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 at a time.
  • If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate 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 together. If you take nitroglycerin for angina, don’t stop taking it while you are taking amlodipine besylate.
  • While you are taking amlodipine besylate, 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, 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?

  • 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?
Amlodipine besylate 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 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. For a complete list, ask your doctor or pharmacist.

How do I store amlodipine besylate tablets, USP?
Keep amlodipine besylate tablets, USP away from children. Store amlodipine besylate tablets, USP at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Keep amlodipine besylate tablets, USP out of the light. Do not store in the bathroom. Keep amlodipine besylate tablets, USP in a dry place.
General advice about amlodipine besylate tablets, USP
Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use amlodipine besylate tablets, USP the way your doctor told you to. Do not give amlodipine besylate tablets, USP 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, USP.
Manufactured in India by:
ALKEM LABORATORIES LTD.
H.O.: ALKEM HOUSE,
Senapati Bapat marg, Lower Parel, Mumbai — 400 013.
Distributed by:
Ascend Laboratories, LLC
Parsippany, NJ 07054
Revised Date: October,2017
PT1453-06

PRINCIPAL DISPLAY PANEL — 5 mg Tablets

image
(click image for full-size original)

AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-564(NDC:67877-198)
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
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (OFF-WHITE) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 210
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-564-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43063-564-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078925 10/20/2010
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-564)

Revised: 08/2020 PD-Rx Pharmaceuticals, Inc.

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