Amlodipine Besylate: Package Insert and Label Information (Page 3 of 4)

14.2 Effects in Chronic Stable Angina

The effectiveness of 5 to 10 mg/day of amlodipine in exercise-induced angina has been evaluated in 8 placebo-controlled, double-blind clinical trials of up to 6 weeks duration involving 1038 patients (684 amlodipine, 354 placebo) with chronic stable angina. In 5 of the 8 studies, significant increases in exercise time (bicycle or treadmill) were seen with the 10 mg dose. Increases in symptom-limited exercise time averaged 12.8% (63 sec) for Amlodipine 10 mg, and averaged 7.9% (38 sec) for Amlodipine 5 mg. Amlodipine 10 mg also increased time to 1 mm ST segment deviation in several studies and decreased angina attack rate. The sustained efficacy of amlodipine in angina patients has been demonstrated over long-term dosing. In patients with angina, there were no clinically significant reductions in blood pressures (4/1 mmHg) or changes in heart rate (+0.3 bpm).

14.3 Effects in Vasospastic Angina

In a double-blind, placebo-controlled clinical trial of 4 weeks duration in 50 patients, amlodipine therapy decreased attacks by approximately 4/week compared with a placebo decrease of approximately 1/week (p<0.01). Two of 23 amlodipine and 7 of 27 placebo patients discontinued from the study due to lack of clinical improvement.

14.4 Effects in Documented Coronary Artery Disease

In PREVENT, 825 patients with angiographically documented coronary artery disease were randomized to amlodipine besylate tablets (5 to 10 mg once daily) or placebo and followed for 3 years. Although the study did not show significance on the primary objective of change in coronary luminal diameter as assessed by quantitative coronary angiography, the data suggested a favorable outcome with respect to fewer hospitalizations for angina and revascularization procedures in patients with CAD.

CAMELOT enrolled 1318 patients with CAD recently documented by angiography, without left main coronary disease and without heart failure or an ejection fraction <40%. Patients (76% males, 89% Caucasian, 93% enrolled at U.S. sites, 89% with a history of angina, 52% without PCI, 4% with PCI and no stent, and 44% with a stent) were randomized to double-blind treatment with either amlodipine besylate tablets (5 to 10 mg once daily) or placebo in addition to standard care that included aspirin (89%), statins (83%), beta-blockers (74%), nitroglycerin (50%), anti-coagulants (40%), and diuretics (32%), but excluded other calcium channel blockers. The mean duration of follow-up was 19 months. The primary endpoint was the time to first occurrence of one of the following events: hospitalization for angina pectoris, coronary revascularization, myocardial infarction, cardiovascular death, resuscitated cardiac arrest, hospitalization for heart failure, stroke/TIA, or peripheral vascular disease. A total of 110 (16.6%) and 151 (23.1%) first events occurred in the amlodipine besylate tablets and placebo groups, respectively, for a hazard ratio of 0.691 (95% CI: 0.540 to 0.884, p = 0.003). The primary endpoint is summarized in Figure 1 below. The outcome of this study was largely derived from the prevention of hospitalizations for angina and the prevention of revascularization procedures (see Table 1). Effects in various subgroups are shown in Figure 2.

In an angiographic substudy (n=274) conducted within CAMELOT, there was no significant difference between amlodipine and placebo on the change of atheroma volume in the coronary artery as assessed by intravascular ultrasound.

Figure 1 -Kaplan-Meier Analysis of Composite Clinical Outcomes for Amlodipine versus Placebo

Figure 1 -Kaplan-Meier Analysis of Composite Clinical Outcomes for Amlodipine versus Placebo
(click image for full-size original)

Figure 2 – Effects on Primary Endpoint of Amlodipine versus Placebo across Sub-Groups

Figure 2 – Effects on Primary Endpoint of Amlodipine versus Placebo across Sub-Groups
(click image for full-size original)

Table 1 below summarizes the significant composite endpoint and clinical outcomes from the composites of the primary endpoint. The other components of the primary endpoint including cardiovascular death, resuscitated cardiac arrest, myocardial infarction, hospitalization for heart failure, stroke/TIA, or peripheral vascular disease did not demonstrate a significant difference between amlodipine and placebo.

Table 1. Incidence of Significant Clinical Outcomes for CAMELOT
Clinical Outcomes N (%) Amlodipine (N=663) Placebo (N=655) Risk Reduction (p-value)
*
Total patients with these events

Composite CV Endpoint

110 (16.6)

151 (23.1)

31% (0.003)

Hospitalization for Angina *

51 (7.7)

84 (12.8)

42% (0.002)

Coronary Revascularization *

78 (11.8)

103 (15.7)

27% (0.033)

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 white to off white, round, flat-faced, beveled edge tablets ‘211’ debossed on one side and plain on the other side and supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-477-01

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:
Unit dose packages of 100 (10 x 10) NDC 60687-488-01

10 mg Tablets
Amlodipine besylate tablets, USP 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white to off white, round, flat-faced, beveled edge tablets ‘209’ debossed on one side and plain on the other side and supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-496-01

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).

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Ascend Laboratories, LLC as follows:
(2.5 mg / 100 UD) NDC 60687-477-01 packaged from NDC 67877-197
(5 mg / 100 UD) NDC 60687-488-01 packaged from NDC 67877-198
(10 mg / 100 UD) NDC 60687-496-01 packaged from NDC 67877-199

Distributed by:
American Health Packaging
Columbus, OH 43217

8447701/0619

PATIENT PACKAGE INSERT

8447701/0619

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.

Distributed by:
American Health Packaging Columbus, OH 43217

8447701/0619

Package/Label Display Panel – Carton – 2.5 mg

2.5 mg Amlodipine Besylate Tablets Carton
(click image for full-size original)

NDC 60687- 477 -01

AMLODIPINE BESYLATE
TABLETS, USP

2.5 mg*

100 Tablets (10 x 10)               Rx Only

*Each Tablet Contains:
Amlodipine besylate USP equivalent to 2.5 mg of amlodipine.

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children. In case of
accidental overdose, seek professional assistance or contact
a poison control center immediately.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 67877-197, Ascend Laboratories, LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

747701 0447701/0619

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