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Nisoldipine

Class: Dihydropyridines
- Calcium-Channel Blocking Agents, Dihydropyridine
- Calcium Antagonists
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
Brands: Sular

Medically reviewed by Drugs.com. Last updated on Mar 19, 2018.

Introduction

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

Uses for Nisoldipine

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 11 12 1200

Calcium-channel blockers are recommended as one of several preferred agents for the initial management of hypertension according to current evidence-based hypertension guidelines; other preferred options include ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics.501 502 503 504 1200 While there may be individual differences with respect to recommendations for initial drug selection and use in specific patient populations, current evidence indicates that these antihypertensive drug classes all generally produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes.501 502 503 504 1200 1213

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).501 502 503 504 515 1200 1201

A 2017 ACC/AHA multidisciplinary hypertension guideline classifies BP in adults into 4 categories: normal, elevated, stage 1 hypertension, and stage 2 hypertension.1200 (See Table 1.)

Source: Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13-115.

Individuals with SBP and DBP in 2 different categories (e.g., elevated SBP and normal DBP) should be designated as being in the higher BP category (i.e., elevated BP).

Table 1. ACC/AHA BP Classification in Adults1200

Category

SBP (mm Hg)

DBP (mm Hg)

Normal

<120

and

<80

Elevated

120–129

and

<80

Hypertension, Stage 1

130–139

or

80–89

Hypertension, Stage 2

≥140

or

≥90

The goal of hypertension management and prevention is to achieve and maintain optimal control of BP.1200 However, the BP thresholds used to define hypertension, the optimum BP threshold at which to initiate antihypertensive drug therapy, and the ideal target BP values remain controversial.501 503 504 505 506 507 508 515 523 526 530 1200 1201 1207 1209 1222 1223 1229

The 2017 ACC/AHA hypertension guideline generally recommends a target BP goal (i.e., BP to achieve with drug therapy and/or nonpharmacologic intervention) of <130/80 mm Hg in all adults regardless of comorbidities or level of atherosclerotic cardiovascular disease (ASCVD) risk.1200 In addition, an SBP goal of <130 mm Hg is recommended for noninstitutionalized ambulatory patients ≥65 years of age with an average SBP of ≥130 mm Hg.1200 These BP goals are based upon clinical studies demonstrating continuing reduction of cardiovascular risk at progressively lower levels of SBP.1200 1202 1210

Other hypertension guidelines generally have based target BP goals on age and comorbidities.501 504 536 Guidelines such as those issued by the JNC 8 expert panel generally have targeted a BP goal of <140/90 mm Hg regardless of cardiovascular risk and have used higher BP thresholds and target BPs in elderly patients501 504 536 compared with those recommended by the 2017 ACC/AHA hypertension guideline.1200

Some clinicians continue to support previous target BPs recommended by JNC 8 due to concerns about the lack of generalizability of data from some clinical trials (e.g., SPRINT study) used to support the 2017 ACC/AHA hypertension guideline and potential harms (e.g., adverse drug effects, costs of therapy) versus benefits of BP lowering in patients at lower risk of cardiovascular disease.1222 1223 1224 1229

Consider potential benefits of hypertension management and drug cost, adverse effects, and risks associated with the use of multiple antihypertensive drugs when deciding a patient's BP treatment goal.1200 1220 1229

For decisions regarding when to initiate drug therapy (BP threshold), the 2017 ACC/AHA hypertension guideline incorporates underlying cardiovascular risk factors.1200 1207 ASCVD risk assessment is recommended by ACC/AHA for all adults with hypertension.1200

ACC/AHA currently recommend initiation of antihypertensive drug therapy in addition to lifestyle/behavioral modifications at an SBP ≥140 mm Hg or DBP ≥90 mm Hg in adults who have no history of cardiovascular disease (i.e., primary prevention) and a low ASCVD risk (10-year risk <10%).1200

For secondary prevention in adults with known cardiovascular disease or for primary prevention in those at higher risk for ASCVD (10-year risk ≥10%), ACC/AHA recommend initiation of antihypertensive drug therapy at an average SBP ≥130 mm Hg or an average DBP ≥80 mm Hg.1200

Adults with hypertension and diabetes mellitus, chronic kidney disease (CKD), or age ≥65 years are assumed to be at high risk for cardiovascular disease; ACC/AHA state that such patients should have antihypertensive drug therapy initiated at a BP ≥130/80 mm Hg.1200 Individualize drug therapy in patients with hypertension and underlying cardiovascular or other risk factors.502 1200

In stage 1 hypertension, experts state that it is reasonable to initiate drug therapy using the stepped-care approach in which one drug is initiated and titrated and other drugs are added sequentially to achieve the target BP.1200 Initiation of antihypertensive therapy with 2 first-line agents from different pharmacologic classes recommended in adults with stage 2 hypertension and average BP >20/10 mm Hg above BP goal.1200

Calcium-channel blockers may be beneficial in hypertensive patients with certain coexisting conditions (e.g., ischemic heart disease)45 523 and in geriatric patients, including those with isolated systolic hypertension.502 510 1200

Calcium-channel blockers may be particularly useful in black patients with hypertension;80 81 1250 1251 1252 1253 1254 1255 such 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).501 504 1200 However, the combination of an ACE inhibitor or an angiotensin II receptor antagonist with a calcium-channel blocker or thiazide diuretic produces similar BP lowering in black patients as in other racial groups.1200

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

Nisoldipine Dosage and Administration

General

BP Monitoring and Treatment Goals

  • Monitor BP regularly (i.e., monthly) during therapy and adjust dosage of the antihypertensive drug until BP controlled.1200

  • If unacceptable adverse effects occur, discontinue drug and initiate another antihypertensive agent from a different pharmacologic class.1200 1216

  • If adequate BP response not achieved with a single antihypertensive agent, either maximize dosage of single drug or add a second drug with demonstrated benefit and preferably a complementary mechanism of action (e.g., ACE inhibitor, angiotensin II receptor antagonist, thiazide diuretic).1200 1216 Many patients will require at least 2 drugs from different pharmacologic classes to achieve BP goal; if goal BP still not achieved with 2 antihypertensive agents, add a third drug.1200 1216 1220

Administration

Oral Administration

Administer orally1 2 3 5 6 7 8 11 12 42 on an empty stomach (1 hour before or 2 hours after a meal);600 avoid concomitant administration with high-fat food.42 600

Extended-release tablets should be swallowed intact and should not be chewed, broken, or crushed.600

Dosage

Reformulated extended-release tablets containing 8.5 or 34 mg of nisoldipine are bioequivalent to original extended-release formulation (no longer commercially available) containing 10 or 40 mg, respectively.84

Adults

Hypertension
Extended-release Tablets
Oral

Manufacturer recommends initial dosage of 17 mg once daily.600

Increase as tolerated in increments of 8.5 mg daily at weekly or less frequent intervals up to 34 mg once daily.600 Monitor BP carefully during initial titration or subsequent upward adjustment in dosage.600

Usual maintenance dosage:17–34 mg once daily.600 1200

Prescribing Limits

Adults

Hypertension
Oral

Maximum 34 mg daily.600

Special Populations

Hepatic Impairment

Initially, 8.5 mg daily; monitor BP response closely with each dosage adjustment.600

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, 8.5 mg daily; monitor BP response closely with each dosage adjustment.600

Cautions for Nisoldipine

Contraindications

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

Warnings/Precautions

Warnings

Increased Angina and/or Acute MI

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

Sensitivity Reactions

Tartrazine Sensitivity

Some preparations may contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.600 Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.600

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

Heart Failure

Use with caution in patients with heart failure 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 Nisoldipine

Drugs Affecting Hepatic Microsomal Enzymes

Inducers of CYP3A4: Decreased plasma nisoldipine concentrations.1 601 Generally avoid concomitant use.600 601

Inhibitors of CYP3A4: Increased plasma nisoldipine concentrations.600 Generally avoid concomitant use.600

Specific Drugs and Foods

Drug or Food

Interaction

Comments

β-Adrenergic blocking agents

Increased risk of hypotension and exacerbation of heart failure1

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

Nisoldipine Pharmacokinetics

Absorption

Bioavailability

Relatively well absorbed from the GI tract following oral administration,600 601 with peak plasma concentrations attained in about 9.2 hours.600

Absolute bioavailability is low (about 5%), due to presystemic metabolism in the intestine; presystemic metabolism decreases from proximal to distal parts of intestine.1 600 601 602 Bioavailability of extended-release preparation is increased since nisoldipine is released in the colon where presystemic metabolism is reduced.1 601 602

Food

A high-fat meal increases peak plasma concentrations by up to 245%, but decreases AUC by 25%.600

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%.1 601

Elimination

Metabolism

Extensively metabolized; major pathway appears to involve hydroxylation.600 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 13.7 hours.600

Stability

Storage

Oral

Extended-Release Tablets

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; administer 1 hour before or 2 hours after a meal.600

  • 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 patients that some preparations may contain tartrazine.600

  • 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

Nisoldipine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, extended-release, film-coated

8.5 mg*

Nisoldipine Extended-release Tablets

Sular

Shionogi

17 mg*

Nisoldipine Extended-release Tablets

Sular

Shionogi

25.5 mg*

Nisoldipine Extended-release Tablets

34 mg*

Nisoldipine Extended-release Tablets

Sular

Shionogi

AHFS DI Essentials™. © Copyright 2019, Selected Revisions March 19, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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

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