FULL PRESCRIBING INFORMATION: CONTENTS*
- AMLODIPINE BESYLATE DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS AND METABOLISM
- CLINICAL STUDIES
- INDICATIONS & USAGE
- AMLODIPINE BESYLATE CONTRAINDICATIONS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- AMLODIPINE BESYLATE ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
AMLODIPINE BESYLATE DESCRIPTION
CLINICAL PHARMACOLOGYMechanism of Action
PHARMACOKINETICS AND METABOLISM
CLINICAL STUDIESEffects in Hypertension
Effects in Chronic Stable Angina:
Effects in Documented Coronary Artery Disease:
INDICATIONS & USAGE1. Hypertension
2. Coronary Artery Disease (CAD)
AMLODIPINE BESYLATE CONTRAINDICATIONS
WARNINGSIncreased Angina and/or Myocardial Infarction:
Use in Patients with Congestive Heart Failure:CLINICAL PHARMACOLOGY
Patients with Hepatic Failure:
Effect of other agents on amlodipine besylate tablets.
Effect of Amlodipine besylate tablets on other agents.
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
GERIATRIC USEDOSAGE AND ADMINISTRATION
AMLODIPINE BESYLATE ADVERSE REACTIONS
Central and Peripheral Nervous System:
Skin and Appendages:
Autonomic Nervous System:
Metabolic and Nutritional:
CLINICAL PHARMACOLOGYClinical Studies
DOSAGE & ADMINISTRATIONAdults:
CLINICAL PHARMACOLOGYClinical Studies
Co-administration with Other Antihypertensive and/or Antianginal Drugs:
HOW SUPPLIED2.5 mg Tablets
5 mg Tablets
10 mg Tablets
STORAGE AND HANDLING
Amlodipine Besylate Tablets
What are amlodipine besylate tablets?
High Blood Pressure (hypertension)
Who should not use amlodipine besylate tablets?
What should I tell my doctor before taking amlodipine besylate tablets?
●ever had heart disease
●ever had liver problems
●are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets are the best treatment for you.
●are breast-feeding. Do not breast-feed while taking amlodipine besylate tablets. You can stop breast-feeding or take a different medicine.
●Take amlodipine besylate tablets once a day, with or without food. You can take amlodipine besylate tablets 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 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 much amlodipine besylate tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.
●Do not breast-feed. It is not known if amlodipine besylate tablets will pass through your milk.
●Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.
Amlodipine besylate tablets
●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 tablets
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Amlodipine Besylate TABLET
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!