Generic Name: Nisoldipine
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
Calcium-channel blocking agent; dihydropyridine derivative.1 2 3 4 5 6 8 9 10 11 12 42 45
Uses for Sular
Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 11 12 500
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
Calcium-channel blockers may be preferred 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
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
Should not be used for acute management of hypertensive crises†.46
Sular Dosage and Administration
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.)
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
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
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
Manufacturer states usual maintenance dosage is 17–34 mg once daily.600
Experts have recommended usual dosage of 10–40 mg once daily as the original extended-release formulation (equivalent to 8.5–34 mg once daily as the reformulated extended-release tablets).84 500
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
Maximum 34 mg daily.600
Initially, 8.5 mg daily; monitor BP response closely with each dosage adjustment.600
Reduce initial and maintenance dosages in patients with cirrhosis.1
Dosage modification not necessary in patients with mild to moderate renal impairment.1
Initially, 8.5 mg daily; monitor BP response closely with each dosage adjustment.600
Cautions for Sular
Known hypersensitivity to nisoldipine or other dihydropyridine-derivative calcium channel blockers.1
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
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
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
Use with caution in patients with heart failure or compromised ventricular function, especially in those receiving concomitant β-adrenergic blocking agents.1
Not known whether nisoldipine is distributed into milk.1 Discontinue nursing or the drug.1
Safety and efficacy not established.1
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.)
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.1 601 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
β-Adrenergic blocking agents
Increased risk of hypotension and exacerbation of heart failure1
Pharmacokinetic interaction unlikely1
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
Decreased plasma concentrations of nisoldipine to undetectable levels1
Avoid concomitant use1
Possible decreased AUC of nisoldipine1
Clinical significance unknown1
Pharmacokinetic interaction unlikely1
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
A high-fat meal increases peak plasma concentrations by up to 245%, but decreases AUC by 25%.600
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
Not known whether nisoldipine is distributed into milk.1
Plasma Protein Binding
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
Excreted principally in urine (60–80%) as metabolites.1
Approximately 13.7 hours.600
Tight, light-resistant containers at 20–25°C.1 Protect from light and moisture.1
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.)
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
Tablets, extended-release, film-coated
Nisoldipine Extended-release Tablets
Nisoldipine Extended-release Tablets
Nisoldipine Extended-release Tablets
Nisoldipine Extended-release Tablets
AHFS DI Essentials. © Copyright 2017, Selected Revisions January 6, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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