VA Class:CV200
Nisoldipine is a 1,4-dihydropyridine-derivative calcium-channel blocking agent (calcium-channel blocker).1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 42, 45
Nisoldipine is used alone or in combination with other classes of antihypertensive agents in the management of hypertension.1, 11, 12, 1200
Calcium-channel blockers (e.g., nisoldipine) are considered one of several preferred antihypertensive drugs for the initial management of hypertension according to current evidence-based hypertension guidelines; other preferred options include angiotensin-converting enzyme (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, 504, 1200, 1213 (See Uses: Hypertension, in Amlodipine 24:28.08.)
Calcium-channel blockers may be beneficial in the management of hypertension in patients with certain coexisting conditions such as ischemic heart disease (e.g., angina)45, 523 and in geriatric patients, including those with isolated systolic hypertension.502, 510 (See Uses: Hypertension, in Amlodipine 24:28.08.)
In the Antihypertensive and Lipid-lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study, the long-term cardiovascular morbidity and mortality benefit of a long-acting dihydropyridine calcium-channel blocker (amlodipine), a thiazide-like diuretic (chlorthalidone), and an ACE inhibitor (lisinopril) were compared in a broad population of patients with hypertension at risk for coronary heart disease.73, 74, 82, 83 Although these antihypertensive agents were comparably effective in providing important cardiovascular benefit, apparent differences in certain secondary outcomes were observed.73, 74 Patients receiving the ACE inhibitor experienced higher risks of stroke, combined cardiovascular disease, GI bleeding, and angioedema, while those receiving the calcium-channel blocker were at higher risk of developing heart failure.82, 83 The ALLHAT investigators suggested that the favorable cardiovascular outcome may be attributable, at least in part, to the greater antihypertensive effect of the calcium-channel blocker compared with that of the ACE inhibitor, especially in women and black patients.82, 83 (See Clinical Benefits of Thiazides in Hypertension under Hypertension in Adults: Treatment Benefits, in Uses in the Thiazides General Statement 40:28.20.)
Interim analysis (mean follow-up: 5 years) of a prospective, randomized, double-blind study (the Appropriate Blood Pressure Control in Diabetes; [ABCD trial]) in hypertensive patients with type 2 (noninsulin-dependent) diabetes mellitus (NIDDM) indicated that use of nisoldipine was associated with a fivefold higher risk of fatal and nonfatal myocardial infarction than enalapril.55, 56, 60, 61, 62 However, these findings of increased cardiovascular risk should be interpreted with caution,55, 60, 61 since they were based on analysis of secondary clinical end-points.55, 60, 61, 62 The ABCD study originally was designed to compare the effects of moderate control of blood pressure (target diastolic pressure of 80-89 mm Hg) with those of intensive control of blood pressure (target diastolic pressure of 75 mm Hg) on the incidence and progression of complications of diabetes (i.e., renal function measured by the 24-hour creatinine clearance).55 Based on these findings, however, the trial's Data Safety and Monitoring Board recommended that the nisoldipine treatment arm be terminated prematurely (67 months after initiation of the study) and that such patients be switched to enalapril therapy.55, 61, 65 It is not known whether the higher incidence of myocardial infarction associated with the use of nisoldipine in this study resulted from a deleterious effect of the drug, a beneficial effect of enalapril, or a combination of these effects.55, 60, 61, 65 It also should be considered that many patients receiving enalapril also were receiving β-blockers, drugs known to have a beneficial effect on myocardial infarction.61 In addition, findings from the robust ALLHAT study revealed no difference in the primary outcome of combined fatal coronary heart disease or nonfatal myocardial infarction among thiazide diuretics (chlorthalidone), calcium-channel blockers (amlodipine), and ACE inhibitors (lisinopril).73, 74 (See Clinical Benefits of Thiazides in Hypertension under Hypertension in Adults: Treatment Benefits, in Uses in the Thiazides General Statement 40:28.20.)
Most patients with hypertension, especially black patients, will require at least 2 antihypertensive drugs to achieve adequate blood pressure control.1200 Calcium-channel blockers may be particularly useful in the management of hypertension in black patients;80, 81, 1250, 1251, 1252, 1253, 1254, 1255 these patients tend to have greater blood pressure response to calcium-channel blockers and 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 blood pressure lowering in black patients as in other racial groups.1200 (See Race under Hypertension: Other Special Considerations for Antihypertensive Therapy, in Uses in Amlodipine 24:28.08.)
For additional information on the role of calcium-channel blockers in the management of hypertension, see Uses: Hypertension in Amlodipine 24:28.08. For information on overall principles and expert recommendations for treatment of hypertension, see Uses: Hypertension in Adults, in the Thiazides General Statement 40:28.20. For information on overall principles and expert recommendations for treatment of hypertension in pediatric patients, see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement 40:28.20.
Because of the slow onset of hypotensive effect with extended-release nisoldipine tablets,1, 2, 9 this dosage form is not suitable for use as acute therapy in rapidly reducing blood pressure in patients with hypertensive crises†, including those with severe hypertension in whom reduction of blood pressure is considered urgent† (I.e., hypertensive urgencies) or an emergency (hypertensive emergencies).46
Nisoldipine is administered orally.1, 2, 3, 5, 6, 7, 8, 11, 12, 42 The extended-release tablets should be swallowed intact; they should not be chewed, broken, or crushed.1
Nisoldipine extended-release tablets should be administered on an empty stomach (1 hour before or 2 hours after a meal);600 because high-fat food increases the peak concentration of nisoldipine, concomitant administration of the drug with such food should be avoided.42, 600 In addition, because grapefruit juice increases peak concentrations and oral bioavailability of the drug,1, 2, 42, 43, 44, 66, 67, 68 patients should be instructed to avoid grapefruit-containing foods and beverages for at least 1 hour before and after administration of a dose of nisoldipine.1, 44, 46 (See Drugs and Foods Affecting Hepatic Microsomal Enzymes: Grapefruit Juice, in Drug Interactions, in Cyclosporine 92:44.) The manufacturer also states that concomitant use of nisoldipine and any known inducer (e.g., phenytoin) or inhibitor of the cytochrome P-450 (CYP) 3A4 isoenzyme should be avoided and alternative antihypertensive therapy should be considered for patients receiving such agents.600 Concomitant use of nisoldipine and phenytoin reportedly has resulted in a reduction of plasma nisoldipine concentrations to undetectable levels.1 The possibility that nisoldipine may share the drug interaction potential of nifedipine, another 1,4-dihydropyridine derivative, also should be considered and the usual precautions observed. (See Drug Interactions in Nifedipine 24:28.08.)
Patients should be advised that some commercially available preparations may contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.600 Although the incidence of tartrazine sensitivity is low, it frequently occurs in individuals who are sensitive to aspirin.600
The manufacturer states that safety and efficacy of nisoldipine in children have not been established.1
Although the hypotensive effect of nisoldipine usually is modest and well tolerated, excessive and poorly tolerated hypotension occasionally occurs.1 Because such exaggerated responses usually have been observed during initial titration or subsequent upward adjustment in dosage of the drug, careful monitoring of blood pressure during these periods is recommended.1 Close observation is particularly important in patients already receiving drugs known to lower blood pressure.1
The reformulated extended-release tablets of nisoldipine containing 8.5 or 34 mg of the drug are bioequivalent to the original extended-release formulation (no longer commercially available) containing 10 or 40 mg, respectively, of the drug.84
For the management of hypertension in adults, the manufacturer states that the usual initial dosage of nisoldipine extended-release tablets is 17 mg once daily.600 In geriatric patients older than 65 years of age, the initial dosage should not exceed 8.5 mg daily, and blood pressure response should be monitored closely with each dosage adjustment.600 If blood pressure response is inadequate with the initial dosage, nisoldipine dosage may be increased in increments of 8.5 mg daily at weekly or less frequent intervals up to a maximum of 34 mg once daily.600 The usual maintenance dosage of the drug is 17-34 mg once daily.600, 1200
Blood Pressure Monitoring and Treatment Goals
Blood pressure should be monitored regularly (i.e., monthly) during therapy and dosage of the antihypertensive drug adjusted until blood pressure is controlled.1200 If an adequate blood pressure response is not achieved with calcium-channel blocker monotherapy, the dosage may be increased or another antihypertensive agent with demonstrated benefit and preferably with a complementary mechanism of action (e.g., angiotensin-converting enzyme [ACE] inhibitor, angiotensin II receptor antagonist, thiazide diuretic) may be added; if target blood pressure is still not achieved, a third drug may be added.1200, 1216 (See Uses: Hypertension.) In patients who develop unacceptable adverse effects with nisoldipine, the drug should be discontinued and another antihypertensive agent from a different pharmacologic class should be initiated.1200, 1216
The goal of hypertension management and prevention is to achieve and maintain optimal control of blood pressure.1200 However, the optimum blood pressure threshold for initiating antihypertensive drug therapy and specific treatment goals remain controversial.505, 506, 507, 508, 515, 523, 530, 1201, 1207, 1209, 1222 A 2017 multidisciplinary hypertension guideline from the American College of Cardiology (ACC), American Heart Association (AHA), and a number of other professional organizations generally recommends a blood pressure goal of less than 130/80 mm Hg in all adults regardless of comorbidities or level of atherosclerotic cardiovascular disease (ASCVD) risk.1200, 1207 Many patients will require at least 2 drugs from different pharmacologic classes to achieve this blood pressure goal; the potential benefits of hypertension management and drug cost, adverse effects, and risks associated with the use of multiple antihypertensive drugs also should be considered when deciding a patient's blood pressure treatment goal.1200, 1220
For additional information on target levels of blood pressure and on monitoring therapy in the management of hypertension, see Blood Pressure Monitoring and Treatment Goals under Dosage: Hypertension, in Dosage and Administration in the Thiazides General Statement 40:28.20.
Dosage in Renal and Hepatic Impairment
Because patients with hepatic impairment may have substantially reduced nisoldipine clearance, the manufacturer recommends that the initial dosage not exceed 8.5 mg daily in such adult patients, and blood pressure response should be monitored closely with each dosage adjustment.600 Patients with cirrhosis generally require and tolerate lower than usual initial and maintenance dosages of the drug.1 Nisoldipine should be administered cautiously in patients with severe hepatic dysfunction.1
Since pharmacokinetics and bioavailability of nisoldipine are not altered substantially in patients with mild-to-moderate renal impairment, the manufacturer states that modification of nisoldipine dosage is not necessary in such patients.600
Nisoldipine is a 1,4-dihydropyridine-derivative calcium-channel blocking agent1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 42, 45 that is structurally related to nifedipine.2, 3, 4, 6, 11, 12, 42, 45, 49 Nisoldipine has pharmacologic actions similar to those of other dihydropyridine calcium-channel blocking agents (e.g., felodipine, nifedipine).1, 2, 3, 4, 5, 7, 42, 45, 48, 49 Nisoldipine currently is commercially available in the US only as extended-release tablets that contain nisoldipine in a hydrogel layer that provides for controlled drug release.600
Additional Information
SumMon® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the labeling be consulted for detailed information on the usual cautions, precautions, and contraindications.
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.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, extended-release, film-coated | 8.5 mg* | Nisoldipine Extended-release Tablets | |
17 mg* | Nisoldipine Extended-release Tablets | |||
Sular® | Shionogi | |||
25.5 mg* | Nisoldipine Extended-release Tablets | |||
34 mg* | Nisoldipine Extended-release Tablets | |||
Sular® | Shionogi |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
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