Amlodipine Besylate
FULL PRESCRIBING INFORMATION: CONTENTS*
- AMLODIPINE BESYLATE DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- PHARMACODYNAMICS
- CLINICAL STUDIES
- INDICATIONS & USAGE
- AMLODIPINE BESYLATE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- AMLODIPINE BESYLATE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- SPL PATIENT PACKAGE INSERT
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
AMLODIPINE BESYLATE DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of ActionExertional Angina
Vasospastic Angina
PHARMACOKINETICS
Pharmacokinetics and MetabolismPediatric Patients
PHARMACODYNAMICS
PharmacodynamicsHemodynamics
Electrophysiologic Effects
CLINICAL STUDIES
CLINICAL STUDIESEffects in Hypertension
Adult patients
Pediatric patients
Effects in Chronic Stable Angina
Effects in Vasospastic Angina
Effects in Documented Coronary Artery Disease
Studies in Patients With Congestive Heart Failure
INDICATIONS & USAGE
1. Hypertension2. Coronary Artery Disease (CAD)
Chronic Stable Angina
AMLODIPINE BESYLATE CONTRAINDICATIONS
CONTRAINDICATIONSWARNINGS
WARNINGSIncreased Angina and/or Myocardial Infarction
PRECAUTIONS
GeneralUse in Patients With Congestive Heart Failure
Beta-Blocker Withdrawal
Patients With Hepatic Failure
DRUG INTERACTIONS
Drug InteractionsEffect of Other Agents on Amlodipine Besylate Tablets
Effect of Amlodipine Besylate Tablets on Other Agents
DRUG & OR LABORATORY TEST INTERACTIONS
Drug/Laboratory Test InteractionsCARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Carcinogenesis, Mutagenesis, Impairment of FertilityPREGNANCY
Teratogenic EffectsPregnancy category C
NURSING MOTHERS
Nursing MothersPEDIATRIC USE
Pediatric UseGERIATRIC USE
Geriatric UseAMLODIPINE BESYLATE ADVERSE REACTIONS
ADVERSE REACTIONSOVERDOSAGE
OVERDOSAGEDOSAGE & ADMINISTRATION
AdultsPediatric Patients
Coadministration With Other Antihypertensive and/or Antianginal Drugs
HOW SUPPLIED
2.5 mg Tablets
5 mg Tablets
10 mg Tablets
STORAGE AND HANDLING
SPL PATIENT PACKAGE INSERT
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● ever had heart disease
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● ever had liver problems
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● are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets are the best treatment for you.
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● are breast-feeding. Do not breast-feed while taking amlodipine besylate tablets. You can stop breast-feeding or take a different medicine.
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● Take amlodipine besylate tablets once a day, with or without food. You can take amlodipine besylate tablets with most drinks, including grapefruit juice.
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● 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 at a time.
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● 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.
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● 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.
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● 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.
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● 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.
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● Do not breast-feed. It is not known if amlodipine will pass through your milk.
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● Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.
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● headache
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● swelling of your legs or ankles
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● tiredness, extreme sleepiness
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● stomach pain, nausea
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● dizziness
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● flushing (hot or warm feeling in your face)
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● arrhythmia (irregular heartbeat)
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● heart palpitations (very fast heartbeat)
INACTIVE INGREDIENT
INACTIVE INGREDIENTS:SILICON DIOXIDE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 2
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Amlodipine BesylateAmlodipine Besylate TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!