Nisoldipine: Drug information

For additional information see "Nisoldipine: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Sular

Pharmacologic Category

Antihypertensive;
Calcium Channel Blocker;
Calcium Channel Blocker, Dihydropyridine

Dosing: Adult

Hypertension, chronic

Hypertension, chronic:

Note: For patients who warrant combination therapy (BP >20/10 mm Hg above goal or suboptimal response to initial monotherapy), may use in combination with another appropriate agent (eg, angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, thiazide diuretic) (Ref).

Sular (Geomatrix delivery system): Oral: Initial: 17 mg once daily; evaluate response after ~2 to 4 weeks and titrate dose as needed by 8.5 mg/dose up to 34 mg once daily; antihypertensive effect attenuates with higher doses and adverse effects may become more prominent; if additional BP control is needed, consider combination therapy. Patients with severe asymptomatic hypertension and no signs of acute end organ damage should be evaluated for medication titration within 1 week (Ref).

Nisoldipine ER tablet (original formulation): Oral: Initial: 20 mg once daily; evaluate response after ~2 to 4 weeks and titrate dose as needed by 10 mg/dose up to 40 mg once daily; antihypertensive effect attenuates with higher doses and adverse effects may become more prominent; if additional BP control is needed, consider combination therapy. Patients with severe asymptomatic hypertension and no signs of acute end organ damage should be evaluated for medication titration within 1 week (Ref).

Conversion from nisoldipine extended release (original formulation) to Sular Geomatrix delivery system:

**Nisoldipine Extended Release Dosing Equivalency**
Original ER Formulation	Sular Extended Release (Geomatrix delivery system)
10 mg	8.5 mg
20 mg	17 mg
30 mg	25.5 mg
40 mg	34 mg

Dosing: Kidney Impairment: Adult

Mild to moderate impairment: No dosage adjustment necessary .

Severe impairment: No dosage adjustment provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

Sular (Geomatrix delivery system): Oral: Initial dose should not exceed 8.5 mg once daily.

Nisoldipine extended release (original formulation): Oral: Initial dose should not exceed 10 mg once daily.

Dosing: Older Adult

Hypertension:

Sular (Geomatrix delivery system): Oral: Initial dose: 8.5 mg once daily.

Nisoldipine extended release (original formulation): Oral: Initial dose: 10 mg once daily.

Conversion from nisoldipine extended release (original formulation) to Sular Geomatrix delivery system: Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Peripheral edema (7% to 27%)

Nervous system: Headache (22%)

1% to 10%:

Cardiovascular: Chest pain (2%), exacerbation of angina pectoris (2%), palpitations (3%), vasodilation (4%)

Dermatologic: Skin rash (2%)

Gastrointestinal: Nausea (2%)

Nervous system: Dizziness (5% to 7%)

Respiratory: Pharyngitis (5%), sinusitis (3%)

Frequency not defined: Cardiovascular: Severe initial hypotension (or with upward titration)

Postmarketing:

Cardiovascular: Acute myocardial infarction (Estacio 1998), flushing (Friedel 1988), orthostatic hypotension (Friedel 1988), tachycardia (Campo 2001)

Dermatologic: Psoriasis (Song 2021), skin photosensitivity

Endocrine & metabolic: Weight gain (edematous) (Friedel 1988)

Gastrointestinal: Constipation (Friedel 1988), diarrhea (Friedel 1988), dyspepsia (Campo 2001), gingival hyperplasia (Tajani 2008), xerostomia (Friedel 1988)

Hepatic: Abnormal hepatic function tests

Hypersensitivity: Angioedema, hypersensitivity reaction

Nervous system: Anxiety (Friedel 1988), asthenia (Friedel 1988), fatigue (Friedel 1988), tremor (Friedel 1988)

Respiratory: Asthma (Friedel 1988), dyspnea (Friedel 1988)

Contraindications

Hypersensitivity to nisoldipine, any component of the formulation, or other dihydropyridine calcium channel blockers

Warnings/Precautions

Concerns related to adverse effects:

• Angina/MI: Increased angina and/or MI has occurred with initiation or dosage titration of dihydropyridine calcium channel blockers. Reflex tachycardia may occur resulting in angina and/or MI in patients with obstructive coronary disease, especially in the absence of concurrent beta-blockade.

• Hypotension/syncope: Symptomatic hypotension with or without syncope can rarely occur; blood pressure must be lowered at a rate appropriate for the patient's clinical condition. Monitor closely during initial dosing and with dosage adjustment.

• Peripheral edema: The most common side effect is peripheral edema; occurs within 2 to 3 weeks of starting therapy.

Disease-related concerns:

• Aortic stenosis: Use with caution in patients with severe aortic stenosis.

• Heart failure (HF): The ACC/AHA heart failure guidelines recommend to avoid use in patients with heart failure due to lack of benefit and/or worse outcomes with calcium channel blockers in general (FDA 2015).

• Hepatic impairment: Use with caution in patients with severe hepatic impairment; lower starting dose required.

• Hypertrophic cardiomyopathy and left ventricular outflow tract obstruction: Use with caution in patients with hypertrophic cardiomyopathy and left ventricular outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition (AHA/ACC [Ommen 2020]).

Dosage form specific issues:

• Tartrazine: Some dosage forms contain tartrazine, which may cause allergic reactions in certain individuals (eg, aspirin hypersensitivity).

Special populations:

• Older adult: Use with caution in patients >65 years of age; lower starting dose recommended.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Extended Release 24 Hour, Oral:

Sular: 8.5 mg

Sular: 17 mg [contains fd&c yellow #5 (tartrazine)]

Sular: 34 mg

Generic: 8.5 mg, 17 mg, 20 mg, 25.5 mg, 30 mg, 34 mg, 40 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablet, 24-hour (Nisoldipine ER Oral)

8.5 mg (per each): $6.14

17 mg (per each): $7.70

20 mg (per each): $16.45

25.5 mg (per each): $8.39

30 mg (per each): $17.94

34 mg (per each): $8.39

40 mg (per each): $17.94

Tablet, 24-hour (Sular Oral)

8.5 mg (per each): $37.93

17 mg (per each): $37.93

34 mg (per each): $37.93

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: Administer at the same time each day to ensure minimal fluctuation of serum levels. Avoid high-fat diet. Administer on an empty stomach (1 hour before or 2 hours after a meal). Swallow whole; do not crush, break, split, or chew.

Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. No alternative formulations are available. If safety and efficacy of nifedipine can be effectively monitored, no change in formulation or administration is required after bariatric surgery; however, selection of alternative therapy should be considered for off-label variant angina indication.

Use: Labeled Indications

Hypertension, chronic: Management of hypertension.

Medication Safety Issues

Sound-alike/look-alike issues:

Nisoldipine may be confused with NIFEdipine, niMODipine

Metabolism/Transport Effects

Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy

Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Atosiban: Calcium Channel Blockers may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination

Calcium Salts: May diminish the therapeutic effect of Calcium Channel Blockers. Risk C: Monitor therapy

Cimetidine: May increase the serum concentration of Calcium Channel Blockers. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Clopidogrel: Calcium Channel Blockers may diminish the therapeutic effect of Clopidogrel. Risk C: Monitor therapy

CycloSPORINE (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Nisoldipine. Risk X: Avoid combination

CYP3A4 Inducers (Strong): May decrease the serum concentration of Nisoldipine. Risk X: Avoid combination

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Nisoldipine. Risk X: Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Nisoldipine. Risk X: Avoid combination

Dantrolene: May enhance the hyperkalemic effect of Calcium Channel Blockers. Dantrolene may enhance the negative inotropic effect of Calcium Channel Blockers. Risk X: Avoid combination

Dapoxetine: May enhance the orthostatic hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Flunarizine: May enhance the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider therapy modification

Grapefruit Juice: May increase the serum concentration of Nisoldipine. Risk X: Avoid combination

Herbal Products with Blood Pressure Increasing Effects: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Iloperidone: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Indoramin: May enhance the hypotensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Inhalational Anesthetics: May enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Isocarboxazid: May enhance the antihypertensive effect of Antihypertensive Agents. Risk X: Avoid combination

Itraconazole: May increase the serum concentration of Nisoldipine. Risk X: Avoid combination

Ketoconazole (Systemic): May increase the serum concentration of Nisoldipine. Risk X: Avoid combination

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy

Loop Diuretics: May enhance the hypotensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the adverse/toxic effect of Calcium Channel Blockers (Dihydropyridine). Specifically, the risk of hypotension or muscle weakness may be increased. Risk C: Monitor therapy

Melatonin: May diminish the antihypertensive effect of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Prazosin: Antihypertensive Agents may enhance the hypotensive effect of Prazosin. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Silodosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification

Tacrolimus (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Terazosin: Antihypertensive Agents may enhance the hypotensive effect of Terazosin. Risk C: Monitor therapy

Urapidil: Antihypertensive Agents may enhance the hypotensive effect of Urapidil. Risk C: Monitor therapy

Food Interactions

Peak concentrations of nisoldipine may be significantly increased if taken with high-lipid foods; however, total exposure (AUC) may be reduced. Grapefruit juice has been shown to significantly increase the bioavailability of nisoldipine. Management: Take on an empty stomach 1 hour before or 2 hours after a meal. Avoid a high-fat diet. Avoid grapefruit products before and after dosing.

Reproductive Considerations

Medications considered acceptable for the treatment of chronic hypertension during pregnancy may generally be used in patients trying to conceive. Nisoldipine is not considered a preferred agent for use in pregnant patients; consider transitioning to a preferred agent in patients planning to become pregnant (ACC/AHA [Whelton 2018]; ACOG 2019; NICE 2019).

Pregnancy Considerations

Chronic maternal hypertension is associated with adverse events in the fetus/infant. Chronic maternal hypertension may increase the risk of birth defects, low birth weight, premature delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to the duration and severity of maternal hypertension. Untreated chronic hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes, preeclampsia, delivery complications, stroke, and myocardial infarction (ACOG 2019).

Patients with preexisting hypertension may continue their medication during pregnancy unless contraindications exist (ESC [Regitz-Zagrosek 2018]). When treatment of hypertension is initiated during pregnancy, agents other than nisoldipine may be preferred (ACOG 2019; ESC [Cífková 2020]; ESC [Regitz-Zagrosek 2018], SOGC [Magee 2022]).

Breastfeeding Considerations

It is not known if nisoldipine is present in breast milk.

The manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, considering the importance of treatment to the mother.

Dietary Considerations

Take on an empty stomach (1 hour before or 2 hours after a meal). Avoid grapefruit juice before and after dosing. Avoid grapefruit juice; avoid high-fat diet.

Monitoring Parameters

Blood pressure; heart rate; peripheral edema.

Mechanism of Action

As a dihydropyridine calcium channel blocker, structurally similar to nifedipine, nisoldipine impedes the movement of calcium ions into vascular smooth muscle and cardiac muscle. Dihydropyridines are potent vasodilators and are not as likely to suppress cardiac contractility and slow cardiac conduction as other calcium antagonists such as verapamil and diltiazem; nisoldipine is 5-10 times as potent a vasodilator as nifedipine.

Pharmacokinetics (Adult Data Unless Noted)

Duration: >24 hours

Absorption: Well absorbed. Peak concentrations significantly increased with high-lipid meals; however, AUC is reduced.

Protein binding: >99%

Metabolism: Extensively hepatic; 1 active metabolite (10% of activity of parent); first-pass effect

Bioavailability: ~5%

Half-life elimination: 9 to 18 hours

Time to peak: 4 to 14 hours

Excretion: Urine (60% to 80% as inactive metabolites); feces

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Dosage adjustments are not needed in patients with mild to moderate renal function impairment.

Hepatic function impairment: Liver cirrhosis: Increased plasma concentrations. Use lower starting and maintenance doses.

Older adult: Higher nisoldipine plasma concentrations (C_max and AUC) have been found in elderly patients.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AR) Argentina: Nisodipen;
(AT) Austria: Syscor;
(BE) Belgium: Sular | Syscor;
(BR) Brazil: Syscor;
(CH) Switzerland: Syscor | Syscor CC;
(CL) Chile: Corasol | Nivas | Syscor;
(CN) China: Ji ni le er | Ke di | Ni er xin | Yi li;
(DE) Germany: Baymycard | Syscor;
(EC) Ecuador: Nixoran;
(EE) Estonia: Syscor;
(ES) Spain: Cornel | Sular | Syscor;
(FI) Finland: Syscor;
(GB) United Kingdom: Syscor;
(GR) Greece: Syscor;
(HU) Hungary: Baymycard | Baymycard cc;
(IT) Italy: Syscor | Zadipina;
(JP) Japan: Baymycard | Nikameal | Ninobarucin | Nisomynard | Nisomynard nichiiko | Nisomynard yoshindo | Riohard;
(KR) Korea, Republic of: Nisoldine | Syscor;
(LU) Luxembourg: Sular | Syscor;
(LV) Latvia: Syscor;
(MX) Mexico: Sular;
(NL) Netherlands: Sular | Syscor;
(PR) Puerto Rico: Sular;
(TR) Turkey: Syscor;
(TW) Taiwan: Syscor | Syscor CC;
(UY) Uruguay: Nisodilat;
(ZA) South Africa: Syscor CC

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Nisoldipine: Drug information