HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use amlodipine besylate safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine besylate tablets for oral administrationInitial U.S. Approval: 1987INDICATIONS AND USAGE Hypertension (1.1) Coronary Artery Disease (1.2) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% DOSAGE AND ADMINISTRATION Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. (2.1) Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. (2.1) Pediatric starting dose: 2.5 mg to 5 mg once daily. (2.2) Important Limitation: 2.2DOSAGE FORMS AND STRENGTHS 2.5 mg, 5 mg, and 10 mg Tablets (3) CONTRAINDICATIONS Known sensitivity to amlodipine (4) WARNINGS AND PRECAUTIONS Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, because of the gradual onset of action, acute hypotension is unlikely. (5.1) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. (5.2) Titrate slowly when administering calcium channel blockers to patients with severe hepatic impairment. (5.4) Side Effects6To report SUSPECTED ADVERSE REACTIONS, contact at or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchUSE IN SPECIFIC POPULATIONS Pregnancy: Use only if the potential benefit justifies the potential risk. (8.1) Nursing: Discontinue when administering amlodipine besylate. (8.3) Pediatric: Effect on patients less than 6 years old is not known. (8.4) Geriatric: Start dosing at the low end of the dose range, due to the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. (8.5)
FULL PRESCRIBING INFORMATION: CONTENTS*
- 1 INDICATIONS & USAGE
- 2 DOSAGE & ADMINISTRATION
- 3 DOSAGE FORMS & STRENGTHS
- 4 AMLODIPINE BESYLATE CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
- 6 AMLODIPINE BESYLATE ADVERSE REACTIONS
- 7 DRUG INTERACTIONS
- 8 USE IN SPECIFIC POPULATIONS
- 10 OVERDOSAGE
- 11 AMLODIPINE BESYLATE DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
- 13 NONCLINICAL TOXICOLOGY
- 14 CLINICAL STUDIES
- 16 HOW SUPPLIED/STORAGE AND HANDLING
- PATIENT PACKAGE INSERT
- PRINCIPAL DISPLAY PANEL - 5 mg Tablets
FULL PRESCRIBING INFORMATION
1 INDICATIONS & USAGE
1.2 Coronary Artery Disease (CAD)
Chronic Stable Angina
Vasospastic Angina (Prinzmetal's or Variant Angina)
Angiographically Documented CAD
2 DOSAGE & ADMINISTRATION
[see Adverse Reactions (6)].
[see Clinical Studies (14.4)]
[see Clinical Pharmacology (12.4), Clinical Studies (14.1)]
3 DOSAGE FORMS & STRENGTHS
5 WARNINGS AND PRECAUTIONS
5.2 Increased Angina or Myocardial Infarction
5.3 Beta-Blocker Withdrawal
5.4 Patients with Hepatic Failure
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
|Adverse Event||2.5 mg||5.0 mg||10.0 mg||Placebo|
|Adverse Event||Amlodipine (%)||Placebo (%)|
Central and Peripheral Nervous System:
Skin and Appendages:1 1
Autonomic Nervous System:
Metabolic and Nutritional:
[see Clinical Studies (14.4)]
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 In Vitro Data
7.3 Grapefruit Juice
7.4 Magnesium and Aluminum Hydroxide Antacid
7.8 Ethanol (Alcohol)
7.10 Drug/Laboratory Test Interactions
8 USE IN SPECIFIC POPULATIONS
2 2 2
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
[see Dosage and Administration (2.1)]
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics and Metabolism
12.4 Pediatric Patients
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
2 3 2 3
14 CLINICAL STUDIES
14.1 Effects in Hypertension
14.2 Effects in Chronic Stable Angina
14.3 Effects in Vasospastic Angina
14.4 Effects in Documented Coronary Artery Disease
Figure 1 -Kaplan-Meier Analysis of Composite Clinical Outcomes for Amlodipine versus Placebo
Figure 2 – Effects on Primary Endpoint of Amlodipine versus Placebo across Sub-Groups
|Composite CV Endpoint
|Hospitalization for Angina*
|*Total patients with these events
14.5 Studies in Patients with Heart Failure
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 2.5 mg Tablets
16.2 5 mg Tablets
16.3 10 mg Tablets
ALKEM LABORATORIES LTD.
PATIENT PACKAGE INSERT
AMLODIPINE BESYLATE TABLETS 2.5 mg, 5 mg, and 10 mg
What is amlodipine besylate?
High Blood Pressure (hypertension)
Who should not use amlodipine besylate?
What should I tell my doctor before taking amlodipine besylate?
- 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. Do not breast-feed while taking amlodipine besylate. You can stop breast-feeding or take a different medicine.
How should I take amlodipine besylate?
- Take amlodipine besylate tablets once a day, with or without food. You can take amlodipine besylate with most drinks, including grapefruit juice.
- 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 breast-feed. It is not known if amlodipine besylate 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?
- swelling of your legs or ankles
- tiredness, extreme sleepiness
- stomach pain, nausea
- flushing (hot or warm feeling in your face)
- arrhythmia (irregular heartbeat)
- heart palpitations (very fast heartbeat)
How do I store amlodipine besylate tablets?
General advice about amlodipine besylate
ALKEM LABORATORIES LTD.
PRINCIPAL DISPLAY PANEL - 5 mg Tablets
AMLODIPINE BESYLATE TABLET
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!