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Sular

Generic Name: Nisoldipine
Class: Dihydropyridines
VA Class: CV200
Chemical Name: Methyl 2-methylpropyl ester 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid
Molecular Formula: C20H24N2O6
CAS Number: 63675-72-9

Introduction

Calcium-channel blocking agent; dihydropyridine derivative.1 2 3 4 5 6 8 9 10 11 12 42 45

Uses for Sular

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 11 12 50

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One of several preferred initial therapies in hypertensive patients with a high risk of developing CAD, including those with diabetes mellitus.75

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.75

Should not be used for acute management of hypertensive crises.13 46 50

Sular Dosage and Administration

Administration

Oral Administration

Administer orally;1 2 3 5 6 7 8 11 12 42 avoid concomitant administration with high-fat food.1 42

Extended-release tablets should be swallowed intact and should not be chewed, broken, or crushed.1

Dosage

Adults

Hypertension
Extended-release Tablets
Oral

Initially, 20 mg once daily.1 42

Increase as tolerated in increments of 10 mg daily at ≥ weekly intervals up to 60 mg once daily.1 42 50 Monitor BP carefully during initial titration or subsequent upward adjustment in dosage.1 50

Usual maintenance dosage is 20–40 mg once daily;1 however, JNC 7 recommends a usual dosage range of 10–40 mg daily.75

Prescribing Limits

Adults

Hypertension
Oral

Maximum 60 mg daily.1

Special Populations

Hepatic Impairment

Initially, 10 mg daily; monitor BP response closely with each dosage adjustment.1 42

Reduce initial and maintenance dosages in patients with cirrhosis.1

Renal Impairment

Dosage modification not necessary in patients with mild to moderate renal impairment.1

Geriatric Patients

Initially, 10 mg daily; monitor BP response closely with each dosage adjustment.1 42

Cautions for Sular

Contraindications

  • Known hypersensitivity to nisoldipine or other dihydropyridine-derivative calcium channel blockers.1

Warnings/Precautions

Warnings

Increased Angina and/or AMI

Rarely, increased frequency, duration, and/or severity of angina or AMI, particularly in patients with severe obstructive CAD, upon initiation or dosage increase of calcium channel blockers.1

General Precautions

Hypotension

Risk of excessive, poorly tolerated hypotension; usually occurs during initial dosage titration or subsequent upward titration.1 Carefully monitor BP, especially during therapy initiation, titration, or dosage increase; closely observe patients currently receiving drugs known to lower BP.1

CHF

Use with caution in patients with CHF or compromised ventricular function, especially in those receiving concomitant β-adrenergic blocking agents.1

Specific Populations

Pregnancy

Category C.1

Lactation

Not known whether nisoldipine is distributed into milk.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

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

Hepatic Impairment

Use with caution in patients with severe hepatic impairment.1 Dosage reduction required.1 (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Peripheral edema, headache, dizziness, pharyngitis, vasodilation, sinusitis, palpitation, chest pain, nausea, rash.1

Interactions for Sular

Drugs Affecting Hepatic Microsomal Enzymes

Inducers of CYP3A4: Decreased plasma nisoldipine concentrations.1 a Avoid concomitant use.1 a

Specific Drugs and Foods

Drug or Food

Interaction

Comments

β-Adrenergic blocking agents

Increased risk of hypotension and exacerbation of CHF1

Digoxin

Pharmacokinetic interaction unlikely1

Grapefruit juice

Increased nisoldipine bioavailability1

Avoid grapefruit-containing foods and beverages for at least 1 hour before and after administration of a dose1 44 46

Histamine H2-receptor antagonists

Possible increased nisoldipine concentrations with cimetidine; no significant interaction with ranitidine1

Phenytoin

Decreased plasma concentrations of nisoldipine to undetectable levels1

Avoid concomitant use1

Quinidine

Possible decreased AUC of nisoldipine1

Clinical significance unknown1

Warfarin

Pharmacokinetic interaction unlikely1

Sular Pharmacokinetics

Absorption

Bioavailability

Relatively well absorbed from the GI tract following oral administration,1 a with peak plasma concentrations attained within 6–12 hours.1

Absolute bioavailability is low (about 5%), due to presystemic metabolism in the intestine; presystemic metabolism decreases from proximal to distal parts of intestine.1 a b Bioavailability of extended-release preparation is increased since nisoldipine is released in the colon where presystemic metabolism is reduced.1 a b

Food

A high-fat meal increases peak plasma concentrations by about 300%, but decreases extent of absorption by 25% (since more of the drug is released proximally).1

Special Populations

In geriatric patients, plasma concentrations increased about 2- to 3-fold.1

In patients with hepatic cirrhosis, plasma concentrations increased by 4–5 times.1

Distribution

Extent

Not known whether nisoldipine is distributed into milk.1

Plasma Protein Binding

>99%.1 a

Elimination

Metabolism

Thought to be metabolized principally by CYP isoenzymes.1 Precise enzymes responsible for metabolism are unknown, but other dihydropyridine-derivative calcium-channel blocking agents are metabolized by CYP3A4.1

Elimination Route

Excreted principally in urine (60–80%) as metabolites.1

Half-life

Approximately 7–12 hours.1 a

Stability

Storage

Oral

Extended-ReleaseTablets

Tight, light-resistant containers at 20–25°C.1 Protect from light and moisture.1

Actions

  • Inhibits transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells.1

  • Peripheral arterial vasodilator; acts directly on vascular smooth muscle causing reduction in peripheral vascular resistance (afterload) and BP.1

Advice to Patients

  • Importance of swallowing extended-release tablets whole; do not chew, crush, or break.1

  • Importance of avoiding administration with a high-fat meal.1

  • Importance of avoiding grapefruit-containing foods and beverages for at least 1 hour before and after administration of a dose.1 44 46

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

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

Nisoldipine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, extended-release, film-coated

10 mg

Sular

First Horizon

20 mg

Sular

First Horizon

30 mg

Sular

First Horizon

40 mg

Sular

First Horizon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Nisoldipine 17MG 24-hr Tablets (MYLAN): 30/$189.98 or 90/$539.96

Nisoldipine 20MG 24-hr Tablets (MYLAN): 30/$200.00 or 90/$575.95

Nisoldipine 25.5MG 24-hr Tablets (MYLAN): 30/$218.00 or 90/$623.99

Nisoldipine 30MG 24-hr Tablets (MYLAN): 30/$219.00 or 90/$614.97

Nisoldipine 40MG 24-hr Tablets (MYLAN): 30/$220.48 or 90/$616.47

Nisoldipine 8.5MG 24-hr Tablets (MYLAN): 30/$156.98 or 90/$438.95

Sular 17MG 24-hr Tablets (SHIONOGI PHARMA): 100/$1,000.01 or 300/$2,995.08

Sular 25.5MG 24-hr Tablets (SHIONOGI PHARMA): 100/$939.54 or 300/$2,807.02

Sular 34MG 24-hr Tablets (SHIONOGI PHARMA): 100/$905.00 or 300/$2,702.64

Sular 8.5MG 24-hr Tablets (SHIONOGI PHARMA): 100/$658.92 or 300/$1,959.49

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions March 1, 2007. 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.

References

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