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Generic Name: Felodipine
Class: Dihydropyridines
VA Class: CV200
Chemical Name: 4-(2,3-Dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5 -pyridinedicarboxylic acid ethyl methyl ester
Molecular Formula: C18H19Cl2NO4
CAS Number: 72509-76-3

Introduction

Calcium-channel blocking agent; a 1,4-dihydropyridine derivative.1 2

Uses for Plendil

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 500

Calcium-channel blockers are recommended as one of several preferred agents for the initial management of hypertension; other options include ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics.501 502 503 504 While there may be individual differences with respect to specific outcomes, these antihypertensive drug classes all produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes.501 502 503 504 Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).500 501 502 503 504 515

Slideshow: Grapefruit and Medicines - A Possible Deadly Mix?

Grapefruit and grapefruit juice can react adversely with over 85 prescription medications.

Calcium-channel blockers may be preferred in hypertensive patients with certain coexisting conditions (e.g., ischemic heart disease)523 and in geriatric patients, including those with isolated systolic hypertension.502 510

Black hypertensive patients generally respond better to monotherapy with calcium-channel blockers or thiazide diuretics than to other antihypertensive drug classes (e.g., ACE inhibitors, angiotensin II receptor antagonists).500 501 504 However, diminished response to these other drug classes is largely eliminated when administered concomitantly with a calcium-channel blocker or thiazide diuretic.500 504

The optimum BP threshold for initiating antihypertensive drug therapy is controversial.501 504 505 506 507 508 515 523 530 Further study needed to determine optimum BP thresholds/goals; individualize treatment decisions.501 503 507 515 526 530

JNC 7 recommends initiation of drug therapy in all patients with uncomplicated hypertension and BP ≥140/90 mm Hg;500 JNC 8 panel recommends SBP threshold of 150 mm Hg for patients ≥60 years of age.501 Although many experts agree that SBP goal of <150 mm Hg may be appropriate for patients ≥80 years of age,502 504 505 530 application of this goal to those ≥60 years of age is controversial, especially for those at higher cardiovascular risk.501 502 505 506 508 511 515

In the past, initial antihypertensive drug therapy was recommended for patients with diabetes mellitus or chronic kidney disease who had BP ≥130/80 mm Hg;500 503 current hypertension management guidelines generally recommend a BP threshold of 140/90 mm Hg for these individuals (same as for the general population of patients without these conditions), although a goal of <130/80 mm Hg may still be considered.501 502 503 504 520 530 535 536 541

Plendil Dosage and Administration

General

BP Monitoring and Treatment Goals

  • Carefully monitor BP during initial titration or subsequent upward adjustment in dosage.500 501

  • When available, use evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) to determine target dosages; target dosages usually can be achieved within 2–4 weeks but may take up to several months.501

  • If adequate BP response not achieved with a single antihypertensive agent, add a second drug with demonstrated benefit; if goal BP still not achieved with optimal dosages of 2 antihypertensive agents, add a third drug.501 May maximize dosage of the first drug before adding a second drug, or add a second drug before maximizing dosage of the initial drug.501

  • Consider initiating antihypertensive therapy with a combination of drugs if patient's BP exceeds goal BP by >20/10 mm Hg.500 501 503 504

  • Goal is to achieve and maintain optimal control of BP; individualize specific target BP based on consideration of multiple factors, including patient age and comorbidities, and currently available evidence from clinical studies.500 501 (See Hypertension under Uses.)

Administration

Oral Administration

Administer once daily without food or with a light meal.1 Avoid concomitant administration with grapefruit juice.1 (See Specific Drugs and Foods under Interactions.)

Swallow extended-release tablets intact; do not chew or crush.1

Dosage

Pediatric Patients

Hypertension
Oral

Initially, 2.5 mg once daily.80 Increase dosage as necessary up to a maximum dosage of 10 mg once daily.80

Adults

Hypertension
Oral

Initially, 2.5–5 mg once daily.1 46

Manufacturer recommends usual maintenance dosage of 2.5–10 mg daily.1 Dosages >10 mg daily associated with increased BP response but also with exaggerated adverse vasodilatory effects (e.g, peripheral edema).1

Some experts have recommended usual dosage of 2.5–20 mg once daily.500

If intolerable adverse effects occur, consider dosage reduction; if adverse effects worsen or fail to resolve, may need to discontinue and switch to another antihypertensive drug class.501

Prescribing Limits

Pediatric Patients

Hypertension
Oral

Maximum 10 mg of felodipine daily.80

Special Populations

Hepatic Impairment

Usual initial dosage: 2.5 mg daily.1 68 Closely monitor BP response with each dosage adjustment.1

Renal Impairment

Dosage adjustment generally not required.1

Geriatric Patients

Usual initial dosage: 2.5 mg daily.1 68 Closely monitor BP response with each dosage adjustment.1

Risk of peripheral edema increased substantially with dosages >10 mg daily.1

Cautions for Plendil

Contraindications

  • Known hypersensitivity to felodipine or any ingredient in the formulation.1

Warnings/Precautions

General Precautions

Angina

Possible hypotension and/or syncope resulting in reflex tachycardia and precipitation of angina pectoris in susceptible patients.1

Heart Failure

Safety not established in patients with heart failure; use with caution in patients with heart failure or compromised ventricular function, particularly when used in combination with a β-adrenergic blocker.1

Peripheral Edema

Mild peripheral edema possible within 2–3 weeks of initiating therapy, particularly in older patients (e.g., >60 years of age) receiving higher felodipine dosages (e.g., 20 mg daily).1

Specific Populations

Pregnancy

Felodipine: Category C.1

Lactation

Not known whether felodipine is distributed into milk; discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy remain to be fully established in children;1 however, some experts have recommended dosages for hypertension based on current limited clinical experience.80

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.1 (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Felodipine clearance may be decreased.1 (See Special Populations under Pharmacokinetics.) Manufacturer recommends lower initial dosage in patients with hepatic impairment.1 (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Peripheral edema, headache, flushing.1

Interactions for Plendil

Metabolized by CYP3A4.1

Drugs Affecting Hepatic Microsomal Enzymes

CYP3A4 inhibitors: Potential for increased plasma felodipine concentrations, with possible reduction in BP and increase in heart rate; use with caution.1

Specific Drugs and Foods

Drug or Food

Interaction

Comment

Anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin)

Decreased plasma felodipine concentrations1

Consider use of alternative antihypertensive agents1

Antifungals, azoles (itraconazole, ketoconazole)

Increased plasma felodipine concentrations; decreased BP and increased heart rate reported with itraconazole1

Cimetidine

Increased plasma felodipine concentrations1

Digoxin

Pharmacokinetic interaction unlikely1

Erythromycin

Increased plasma felodipine concentrations1

Grapefruit juice

Increased oral bioavailability of felodipine1

Avoid concomitant use1

Indomethacin

Pharmacokinetic interaction unlikely1

Metoprolol

Increased plasma metoprolol concentrations1

Not considered clinically important1

Orange juice

Pharmacokinetic interaction unlikely1

Spironolactone

Pharmacokinetic interaction unlikely1

Tacrolimus

Increased plasma tacrolimus concentrations1

Monitor plasma tacrolimus concentrations1

Plendil Pharmacokinetics

Absorption

Bioavailability

Almost completely absorbed following oral administration but undergoes extensive first-pass metabolism.1

Systemic bioavailability of felodipine is approximately 20%.1

Onset

Antihypertensive effect evident within 2–5 hours.1

Duration

During chronic administration, substantial BP control lasts for 24 hours, with trough reductions in DBP approximately 40–50% of peak reductions.1

Food

High-fat or high-carbohydrate meal increases peak plasma concentrations but does not affect extent of absorption.1 A light meal (e.g., orange juice, toast, and cereal) does not alter felodipine pharmacokinetics.1

Distribution

Extent

Crosses the blood-brain barrier.51

Crosses the placenta in animals.1

Plasma Protein Binding

>99%.1

Elimination

Metabolism

Metabolized in the liver by CYP3A4.1

None of the 6 metabolites identified to date has substantial vasodilating activity.1

Elimination Route

Eliminated as metabolites, mainly in urine and to a lesser extent in feces.1

Half-life

Mean terminal half-life is approximately 11–16 hours following administration as an immediate-release formulation.1

Special Populations

Hepatic impairment: Clearance is decreased to about 60% of that observed in young healthy individuals.1

Geriatric patients: Felodipine clearance is decreased to about 45% of that observed in young healthy individuals.1

Stability

Storage

Oral

Tablets

Tightly closed container at <30°C.1 Protect from light.1

Actions

  • Inhibits the transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations.c

  • Hypotensive effect is principally a consequence of a dose-related reduction in peripheral vascular resistance, with a modest reflex increase in heart rate.1

  • Negative inotropic effects observed in vitro but not in intact animals.1

  • Has no substantial effect on cardiac conduction (PR, PQ, and HV intervals).1

Advice to Patients

  • Risk of mild gingival hyperplasia; importance of good dental hygiene.1

  • Importance of taking felodipine exactly as prescribed.1

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Felodipine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, extended-release

2.5 mg*

Felodipine Extended-release Tablets

Plendil

AstraZeneca

5 mg*

Felodipine Extended-release Tablets

Plendil

AstraZeneca

10 mg*

Felodipine Extended-release Tablets

Plendil

AstraZeneca

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2015. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Felodipine 10MG 24-hr Tablets (MYLAN): 100/$194.98 or 200/$388.98

Felodipine 2.5MG 24-hr Tablets (MYLAN): 30/$43.99 or 60/$87.98

Felodipine 5MG 24-hr Tablets (MYLAN): 30/$42.99 or 90/$119.98

Plendil 10MG 24-hr Tablets (ASTRAZENECA LP): 30/$89.99 or 90/$259.95

Plendil 2.5MG 24-hr Tablets (ASTRAZENECA LP): 30/$51.99 or 90/$137.97

AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions January 26, 2015. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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