Amlodipine Besylate

Amlodipine Besylate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Amlodipine Besylate is an antihypertensive agent that is FDA approved for the treatment of hypertension, coronary artery disease. Common adverse reactions include edema, fatigue, nausea, abdominal pain, and somnolence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension

• Amlodipine besylate tablet, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including Amlodipine besylate tablet, USP.

• Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

• Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

• systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

• Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

• Amlodipine besylate tablet, USP may be used alone or in combination with other antihypertensive agents.

• Dosing information

• The usual initial antihypertensive oral dose of Amlodipine besylate tablet, USP is 5 mg once daily, and the maximum dose is 10 mg once daily.

• Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Amlodipine besylate tablet, USP to other antihypertensive therapy.

• Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

Coronary Artery Disease (CAD)

Chronic Stable Angina

• Amlodipine besylate tablet, USP is indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablet, USP may be used alone or in combination with other antianginal agents.
• Dosing information:

• The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg

Vasospastic Angina (Prinzmetal's or Variant Angina)

• Amlodipine besylate tablet, USP is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablet, USP may be used as monotherapy or in combination with other antianginal agents.
• Dosing information:

• The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.

Angiographically Documented CAD

• In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, Amlodipine besylate tablet, USP is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Amlodipine Besylate in adult patients.

Non–Guideline-Supported Use

• Congestive heart failure
• Diabetic nephropathy
• Disorder related to transplantation
• Kidney disease, Nondiabetic
• Left ventricular hypertrophy
• Raynaud's phenomenon
• Silent myocardial ischemia
• Systolic hypertension

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Amlodipine Besylate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Amlodipine Besylate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Amlodipine Besylate in pediatric patients.

Contraindications

There is limited information regarding Amlodipine Besylate Contraindications in the drug label.

Warnings

There is limited information regarding Amlodipine Besylate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Amlodipine Besylate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Amlodipine Besylate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Amlodipine Besylate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Amlodipine Besylate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Amlodipine Besylate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Amlodipine Besylate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Amlodipine Besylate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Amlodipine Besylate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Amlodipine Besylate in geriatric settings.

Gender

There is no FDA guidance on the use of Amlodipine Besylate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Amlodipine Besylate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Amlodipine Besylate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Amlodipine Besylate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Amlodipine Besylate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Amlodipine Besylate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Amlodipine Besylate Administration in the drug label.

Monitoring

There is limited information regarding Amlodipine Besylate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Amlodipine Besylate and IV administrations.

Overdosage

There is limited information regarding Amlodipine Besylate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Amlodipine Besylate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Amlodipine Besylate Mechanism of Action in the drug label.

Structure

There is limited information regarding Amlodipine Besylate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Amlodipine Besylate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Amlodipine Besylate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Amlodipine Besylate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Amlodipine Besylate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Amlodipine Besylate How Supplied in the drug label.

Storage

There is limited information regarding Amlodipine Besylate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Amlodipine Besylate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Amlodipine Besylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Amlodipine Besylate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Amlodipine Besylate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.