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Nifedipine: Drug information

Nifedipine: Drug information
(For additional information see "Nifedipine: Patient drug information" and see "Nifedipine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Adalat CC [DSC];
  • Procardia XL;
  • Procardia [DSC]
Brand Names: Canada
  • Adalat XL;
  • AG-Nifedipine ER;
  • APO-Nifed PA [DSC];
  • DOM-NIFEdipine;
  • JAMP-Nifedipine ER;
  • M-Nifedipine ER;
  • MYLAN-NIFEdipine;
  • PMS-NIFEdipine ER
Pharmacologic Category
  • Antianginal Agent;
  • Antihypertensive;
  • Calcium Channel Blocker;
  • Calcium Channel Blocker, Dihydropyridine
Dosing: Adult

Note: The use of IR sublingual nifedipine is not recommended for any indication due to safety concerns. When switching from IR (oral administration) to ER formulations, use same total daily dose.

Anal fissure

Anal fissure (off-label use):

Note: Administered topically as a local vasodilator in conjunction with supportive measures. Ointment and gel are not commercially available and must be prepared by a licensed compounding facility (Ref).

Peri-anal: 0.2% to 0.3% ointment or gel: After cleansing, apply around fissure(s) 2 to 4 times daily for 4 weeks (Ref).

Angina pectoris

Angina pectoris:

Chronic stable angina (alternative agent):

Note: A beta-blocker is the preferred initial therapy; if there are ongoing symptoms on beta-blocker therapy, a long-acting dihydropyridine calcium channel blocker (eg, ER nifedipine) may be added; ER nifedipine may also be used as an alternative therapy if there are contraindications or unacceptable adverse effects with beta-blockade (Ref). Use of immediate-release nifedipine (oral or sublingual) is not recommended due to increased adverse effects (hypotension and reflex tachycardia), particularly in absence of a beta-blocker.

Oral: Extended release: Initial: 30 or 60 mg once daily; increase as needed to effective antianginal dose over 1 to 2 weeks. Doses >90 mg/day are rarely needed; maximum: 120 mg/day.

Vasospastic angina:

Note: May be used alone or in combination with nitrates (Ref). Use of immediate-release nifedipine (oral or sublingual) is not recommended due to increased adverse effects (hypotension and reflex tachycardia).

Oral: Extended release: Initial: 30 or 60 mg once daily; increase as needed to effective antianginal dose over 1 to 2 weeks. Doses >90 mg/day are rarely needed; maximum: 120 mg/day.

High-altitude pulmonary edema

High-altitude pulmonary edema (adjunctive therapy) (off-label use):

Prevention: Note: May use as an adjunct to gradual ascent in high-risk individuals (eg, history of high-altitude pulmonary edema) (Ref).

Oral: Extended release: 30 mg every 12 hours starting 24 hours prior to ascent; continue for 4 to 5 days after reaching maximal altitude; can extend for up to 7 days in individuals who ascend faster than recommended (Ref).

Treatment: Note: Adjunctive to nonpharmacologic measures (eg, oxygen supplementation, portable hyperbaric chamber, gradual descent) or as monotherapy if nonpharmacologic measures are not possible (Ref).

Oral: Extended release: 30 mg every 12 hours; continue until descent is complete, symptoms resolve, and oxygenation is normal for the altitude (Ref).

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). IR nifedipine (oral or sublingual) should not be used for acute BP lowering due to risk of hypotension and ischemic complications. However, may consider extended release for severe asymptomatic hypertension (eg, to lower BP over hours) if there is concern that severe BP elevation will precipitate an acute cardiovascular event, such as in patients with known aortic or intracranial aneurysms (Ref).

Oral: Extended release: Initial: 30 or 60 mg once daily; evaluate response after ~2 to 4 weeks and titrate dose as needed up to 90 mg once daily; if additional blood pressure control is needed, consider combination therapy. Patients with severe asymptomatic hypertension and no signs of acute end organ damage should be evaluated for medication adjustment within 1 week (Ref).

Hypertensive emergency in pregnancy or postpartum

Hypertensive emergency in pregnancy or postpartum (including acute-onset severe hypertension in preeclampsia/eclampsia) (off-label use):

Note: For acute-onset, severe, persistent hypertension (eg, systolic BP ≥160 mm Hg or diastolic BP ≥110 mm Hg) (Ref).

Oral: Extended release: Initial: 30 mg; repeat 30 mg after 1 to 2 hours if target BP is not achieved; if systolic or diastolic BP remains above threshold after the second dose, another class of agents should be considered (Ref).

Oral: Immediate release (alternative agent): Note: Generally reserved for use when IV access is not available. Some experts avoid use of immediate-release formulations unless immediate BP lowering is warranted (eg, <30 minutes), as it may be associated with precipitous drops in BP (Ref). Do not puncture capsule or administer sublingually.

Initial: 10 mg once; if systolic or diastolic BP remains above target at 20 minutes, give a second dose of 10 or 20 mg orally depending on initial response. Reassess BP again 20 minutes after the second dose; if not at target, give a third dose of 10 or 20 mg depending on previous response. If target BP is not achieved 20 minutes after the third dose, another class of agents should be considered; maximum cumulative dose: 50 mg/treatment episode or 180 mg/day (Ref).

Pulmonary arterial hypertension

Pulmonary arterial hypertension (group 1) (off-label use):

Note: Only used for rigorously selected group 1 pulmonary arterial hypertension patients with a positive vasoreactivity test and under the care of a pulmonary hypertension specialist (Ref). European guidelines recommend a 12-hour, sustained-release formulation that is not available in the United States; dosing is provided empirically for the ER formulation.

Oral: Extended release: Initial: 30 to 60 mg once daily; titrate gradually and with close hemodynamic monitoring; reported dose range: 120 to 240 mg/day (Ref).

Raynaud phenomenon

Raynaud phenomenon (off-label use):

Oral: Extended release: Initial: 30 mg once daily; if needed, may increase dose gradually, usually once every 4 weeks, but not more frequently than once every 7 to 10 days; monitor blood pressure closely with each dose increase; usual effective dose: 30 to 120 mg/day (Ref).

Oral: Immediate release: Note: Only for short-term use in hospitalized patients with severe digital ischemia. Initial: 10 mg 3 times daily; may titrate by 10 mg increments as needed based on response and tolerability, up to 30 mg 3 times daily; transition to an ER formulation for maintenance therapy (Ref).

Tocolysis

Tocolysis (off-label use):

Oral: Immediate release: Initial: 20 to 30 mg as a loading dose, followed by 10 to 20 mg every 3 to 8 hours for up to 48 hours; maximum dose: 180 mg/day (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: Mild to severe impairment: No dosage adjustment necessary (systemic clearance minimally affected by kidney dysfunction); however, use of lower initial doses and more frequent monitoring is recommended in severe impairment (eg, CrCl <30 mL/minute) as these patients are more sensitive to nifedipine's BP lowering effects (Ref).

Hemodialysis, intermittent (thrice weekly): Not significantly dialyzed (Ref): No supplemental dose or dosage adjustment necessary; however, use of lower initial doses and more frequent monitoring is recommended as these patients are more sensitive to nifedipine's BP lowering effects (Ref).

Peritoneal dialysis: Not significantly dialyzed: No dosage adjustment necessary (Ref); however, use of lower initial doses and more frequent monitoring is recommended as these patients are more sensitive to nifedipine's BP lowering effects (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling (has not been studied); use with caution. Clearance of nifedipine is reduced in cirrhotic patients, which may lead to increased systemic exposure; monitor closely for adverse effects/toxicity and consider dose adjustments.

Dosing: Pediatric

(For additional information see "Nifedipine: Pediatric drug information")

Hypertension, severe

Hypertension, severe: Limited data available:

Note: Use should be under the supervision of a specialist experienced in the management of pediatric hypertension in the inpatient tertiary setting and used only after other alternatives have been shown to be ineffective. Current pediatric blood pressure guidelines do not recommend nifedipine for the management of acute severe hypertension, as other safe and effective alternatives are available for use in the pediatric population (eg, hydralazine, isradipine) (Ref). If treatment with nifedipine is deemed appropriate and necessary, then administration should occur in the inpatient setting where blood pressure and other hemodynamic parameters can be closely monitored.

Children and Adolescents: Immediate release: Oral: 0.04 to 0.25 mg/kg/dose; maximum single dose: 10 mg/dose; may repeat if needed every 4 to 6 hours; monitor carefully; maximum daily dose: 1 to 2 mg/kg/day (Ref).

Hypertension, chronic

Hypertension, chronic: Limited data available: Children and Adolescents (able to swallow whole tablet): Extended release: Oral: Initial: 0.2 to 0.5 mg/kg/day once daily or divided in 2 doses every 12 hours; do not exceed initial adult daily dose of 30 to 60 mg/day; titrate dose to effect; maximum daily dose: 3 mg/kg/day up to 120 mg/day (Ref); some centers use a higher maximum dose: 3 mg/kg/day up to 180 mg/day (Ref). Note: In adults, doses are usually titrated upward over 7 to 14 days; may increase over 3 days if clinically necessary (Ref).

High altitude pulmonary edema, treatment

High altitude pulmonary edema, treatment: Limited data available: Note: Reserve treatment with NIFEdipine for unsatisfactory response to oxygen and/or altitude descent:

Children and Adolescents:

Immediate release: Oral: 0.5 mg/kg/dose every 8 hours; maximum dose: 20 mg/dose (Ref).

Extended release (preferred if weight allows): Oral: 1.5 mg/kg/day once daily or divided in 2 doses per day; do not exceed adult dose of 30 mg every 12 hours. Note: Smallest extended-release dosage form available is 30 mg (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling (has not been studied); the pharmacokinetics of nifedipine are not significantly influenced by the degree of renal impairment (only trace amounts of unchanged drug are found in urine). Based on experience in adult dialysis patients, supplemental doses are not necessary with hemodialysis or peritoneal dialysis; however, more frequent monitoring may be necessary.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling (has not been studied); use with caution. Clearance of nifedipine is reduced in cirrhotic adult patients, which may lead to increased systemic exposure; monitor closely for adverse effects/toxicity and consider dose adjustments.

Dosing: Older Adult

Note: Avoid immediate-release formulation (Ref).

Refer to adult dosing. In the management of hypertension, consider lower initial doses and titrate to response (Ref).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Procardia: 10 mg [DSC]

Generic: 10 mg, 20 mg

Tablet Extended Release 24 Hour, Oral:

Adalat CC: 30 mg [DSC], 60 mg [DSC], 90 mg [DSC] [contains corn starch]

Procardia XL: 30 mg, 60 mg, 90 mg

Generic: 30 mg, 60 mg, 90 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Generic: 5 mg, 10 mg

Tablet Extended Release 12 Hour, Oral:

Generic: 10 mg [DSC], 20 mg [DSC]

Tablet Extended Release 24 Hour, Oral:

Adalat XL: 20 mg [DSC], 30 mg, 60 mg [DSC]

Generic: 30 mg, 60 mg

Administration: Adult

Oral:

Immediate release: In general, may be administered with or without food.

Extended release: Tablets should be swallowed whole; do not crush, split, or chew.

Adalat CC, Afeditab CR: Administer on an empty stomach (per manufacturer). Other extended release products may not have this recommendation; consult product labeling.

Bariatric surgery: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. IR capsule formulation is 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 IR formulation or alternative therapy is advised for cardiovascular and other high-risk labeled and off-label indications.

Administration: Pediatric

Oral:

Immediate release: In general, administer with or without food. If using extemporaneously compounded oral suspension, use calibrated device to accurately measure dose.

Extended release: Tablets should be swallowed whole; do not crush, break, chew, or divide.

Use: Labeled Indications

Angina: Management of chronic stable or vasospastic angina.

Hypertension, chronic: Management of hypertension (ER products only).

Use: Off-Label: Adult

Anal fissure; High-altitude pulmonary edema; Hypertensive emergency in pregnancy or postpartum (including acute-onset severe hypertension in preeclampsia/eclampsia); Pulmonary arterial hypertension (group 1); Raynaud phenomenon; Tocolysis

Medication Safety Issues
Sound-alike/look-alike issues:

NIFEdipine may be confused with niCARdipine, niMODipine, nisoldipine

Procardia XL may be confused with Cartia XT

Older Adult: High-Risk Medication:

Beers Criteria: Nifedipine (immediate release) is identified as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its potential to cause hypotension and risk for precipitating myocardial ischemia (Beers Criteria [AGS 2019]).

Pharmacy Quality Alliance (PQA): Nifedipine (immediate release) is identified as a high-risk medication in patients 65 years and older on the PQA’s Use of High-Risk Medications in the Elderly (HRM) performance measure, a safety measure used by the Centers for Medicare and Medicaid Services (CMS) for Medicare plans (PQA 2017).

International issues:

Depin [India] may be confused with Depen brand name for penicillamine [US]; Depon brand name for acetaminophen [Greece]; Dipen brand name for diltiazem [Greece]

Nipin [Italy and Singapore] may be confused with Nipent brand name for pentostatin [US, Canada, and multiple international markets]

Adverse Reactions (Significant): Considerations
Angina/Myocardial infarction

Exacerbation of angina pectoris and/or acute myocardial infarction (MI) have occurred with initiation or dosage titration of immediate release (IR) (orally or sublingually) nifedipine. Hypotension and reflex tachycardia may occur resulting in angina and/or MI in patients with coronary heart disease, especially in the absence of concurrent beta-blockade. Use of IR nifedipine has been associated with increased mortality in patients with coronary heart disease. In patients with unstable angina/non–ST-elevation myocardial infarction (STEMI), the use of IR nifedipine is not recommended in the absence of a beta-blocker and is contraindicated in patients with STEMI. Effects may be reversible upon discontinuation (Ref).

Mechanism: Dose-related; related to the pharmacologic action. Hypotension due to calcium channel blocking properties may cause a reflex increase in sympathetic activity, leading to ischemic effects. In addition, the IR nature of nifedipine may cause more marked fluctuations in hemodynamics compared to extended release (ER) formulations (Ref).

Onset: Varied; increase in mortality observed after 2 weeks (Muller 1984). However, hemodynamic effects (ie, decrease in blood pressure, increase in heart rate, ECG changes) observed as quickly as after 1 dose (Ref).

Risk factors:

• Acute MI (Ref)

• Coronary heart disease (Ref)

• Refractory angina (Ref)

Hypotension/syncope

Symptomatic hypotension with or without syncope may occur when using the immediate release (IR) formulation. The use of IR nifedipine (sublingually or orally) in hypertensive emergencies and urgencies is neither safe or effective and is associated with increased risk of adverse events such as acute myocardial infarction, cerebrovascular ischemia, fetal distress, and death when used to treat hypertension (Ref). IR nifedipine may be warranted for acute treatment in pregnant or postpartum women based on guidelines (Ref). Although hypotension should be reversible upon discontinuation, effects may be initially severe and resistant to treatment (Ref).

Mechanism: Dose-related; related to the pharmacologic action. Inhibits calcium channels in peripheral smooth muscle leading to vasodilation. IR nifedipine, compared to extended release (ER) nifedipine has a much faster rate of increase in plasma levels, leading to more adverse reactions (Ref).

Onset: Rapid; hemodynamic effects (ie, decrease in blood pressure, increase in heart rate) observed as quickly as after one dose (Ref).

Risk factors:

• Older patients (age 60 to 83 years) (Ref)

Peripheral edema

Peripheral edema is a common adverse reaction of calcium channel blockers, characterized by ankle and leg swelling independent of fluid retention (Ref). It is a bothersome adverse reaction for patients and may lead to discontinuation (Ref). Peripheral edema can be expected to subside within several days following intervention.

Mechanism: Dose- and time-related; related to the pharmacologic action. Calcium channel blocker-mediated peripheral edema is caused by arteriolar vasodilation that subsequently leads to increased hydrostatic pressure in the precapillary circulation and fluid movement from the capillary vasculature to the interstitial space (Ref). In addition, impaired postural vasoconstriction may contribute (Ref).

Onset: Varied; has been reported between 4 weeks to >6 months after initiation (Ref).

Risk factors:

• Dose-related (ie, higher doses) (Ref); however, may develop more frequently and at lower doses in patients with impaired postural autoregulation (eg, diabetes, arterial disease) (Ref).

• Duration-related (>6 months) (Ref)

• Dihydropyridine calcium channel blockers (DHPs) versus non-DHPs (Ref)

• Lipophilic DHPs (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidence may include data with concomitant beta-blocker therapy. ER = extended release; IR = immediate release.

>10%:

Cardiovascular: Flushing (IR: 25%; ER: <3%), peripheral edema (4% to 30%) (table 1)

Nifedipine: Adverse Reaction: Peripheral Edema

Drug (Nifedipine)

Placebo

Dose

Dosage Form

Number of Patients (Nifedipine)

Number of Patients (Placebo)

30%

N/A

180 mg per day

ER tablets

N/A

N/A

10%

N/A

N/A

ER tablets

N/A

N/A

13%

N/A

120 mg per day or more

IR capsules

N/A

N/A

7%

1%

N/A

IR capsules

226

235

4%

N/A

less than 60 mg per day

IR capsules

N/A

N/A

Gastrointestinal: Heartburn (IR: ≤11%), nausea (IR: ≤11%; ER: 3%)

Nervous system: Dizziness (IR: 27%), headache (16% to 23%)

Neuromuscular & skeletal: Asthenia (IR: 12%; ER: <3%)

1% to 10%:

Cardiovascular: Acute myocardial infarction (4%), cardiac failure (2%), palpitations (≤7%), transient hypotension (5%)

Dermatologic: Dermatitis (IR), diaphoresis, pruritus, skin rash (ER), urticaria

Gastrointestinal: Abdominal cramps (IR), abdominal pain (ER), constipation (≤3%), diarrhea, dyspepsia (ER), flatulence, xerostomia (ER)

Genitourinary: Impotence (ER), sexual difficulty (IR)

Nervous system: Balance impairment (IR), chills (IR), drowsiness (ER), fatigue (ER: 6%), insomnia (ER), jitteriness (IR), mood changes (IR: ≤7%), nervousness (≤7%), pain (ER), paresthesia (ER), shakiness (IR), sleep disturbance (IR)

Neuromuscular & skeletal: Arthralgia (ER), joint stiffness (IR), lower limb cramp (ER), muscle cramps (IR: ≤8%), tremor (IR: ≤8%; ER: <1%)

Ophthalmic: Blurred vision (IR)

Renal: Polyuria (ER: <3%; IR: <1%)

Respiratory: Chest congestion (IR), cough (IR: ≤6%; ER: <1%), dyspnea, nasal congestion (IR), pleuritic chest pain (ER), pulmonary edema (2%), wheezing (IR: ≤6%)

Miscellaneous: Fever, inflammation (IR)

<1%:

Cardiovascular: Cardiac arrhythmia, cardiac conduction disorder, erythromelalgia, exacerbation of angina pectoris, facial edema, hypotension (may be severe hypotension), syncope, tachycardia, ventricular arrhythmia

Dermatologic: Alopecia, exfoliative dermatitis

Endocrine & metabolic: Decreased libido, gout, gynecomastia, hot flash, weight gain

Gastrointestinal: Dysgeusia, eructation, gastroesophageal reflux disease, gastrointestinal hemorrhage, gastrointestinal irritation, gingival hyperplasia, melena, vomiting

Genitourinary: Dysuria, hematuria, mastalgia, nocturia

Hematologic & oncologic: Anemia, leukopenia, purpuric disease, thrombocytopenia

Hepatic: Hepatitis (allergic)

Hypersensitivity: Angioedema

Nervous system: Anxiety, ataxia, depression, hypertonia, hypoesthesia, malaise, migraine, nightmares, paranoid ideation, rigors, vertigo

Neuromuscular & skeletal: Arthritis (with positive ANA), back pain, myalgia

Ophthalmic: Abnormal lacrimation, periorbital edema, transient blindness (at peak of plasma level; can be unilateral), visual disturbance

Otic: Tinnitus

Respiratory: Epistaxis, sinusitis, upper respiratory tract infection

Frequency not defined:

Endocrine & metabolic: Increased lactate dehydrogenase

Gastrointestinal: Cholecystitis

Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase

Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen

Postmarketing:

Dermatologic: Acute generalized exanthematous pustulosis (Roujeau 1991, Tripathy 2009), bullous skin disease (Morimoto 2021), erythema multiforme (Bewley 1993), psoriasis (Song 2021), skin photosensitivity (Seggev 1996; Thomas 1986; Zenarola 1991), Stevens-Johnson syndrome (Stern 1989), toxic epidermal necrolysis

Gastrointestinal: Bezoar formation, gastrointestinal obstruction (Juurlink 2014), gastrointestinal ulcer (Lavy 1999)

Hematologic & oncologic: Malignant neoplasm of lip (Friedman 2012), positive direct Coombs test

Contraindications

Hypersensitivity to nifedipine or any component of the formulation

Note: Considered contraindicated in patients with ST-elevation myocardial infarction (STEMI) (ACCF/AHA [O'Gara 2013]); avoid use (Elkayam 1990; FDA 2015).

Canadian labeling: Additional contraindications (not in US labeling): Severe hypotension; cardiovascular shock; breast-feeding; pregnancy or women of childbearing potential. Note: SOGC guidelines recommend nifedipine or oral labetalol as a preferred agent for maternal hypertension (SOGC [Magee 2014]). Extended release only: Hypersensitivity to other dihydropyridine calcium antagonists; Kock pouch (ileostomy after proctocolectomy); moderate or severe hepatic impairment; severe gastrointestinal obstructive disorders, concomitant use with rifampicin

Warnings/Precautions

Concerns related to adverse effects:

• Hypotension/syncope: IR nifedipine should not be used for acute BP reduction.

Disease-related concerns:

• Aortic stenosis: Use with extreme caution in patients with severe aortic stenosis; may reduce coronary perfusion resulting in myocardial ischemia.

• GI strictures: Alterations in GI anatomy (eg, severe GI narrowing, history of GI cancer, obstruction, bowel resection, gastric bypass, vertical banded gastroplasty) and underlying hypomotility disorders have led to bezoar formation with extended release forms.

• Heart failure: The American College of Cardiology/American Heart Association 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 hepatic impairment. Clearance of nifedipine is reduced in cirrhotic patients leading to increased systemic exposure; monitor closely for adverse effects/toxicity and consider dose adjustments.

• Hypertrophic cardiomyopathy (HCM) with outflow tract obstruction: Use with caution in patients with HCM and outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition.

Dosage form specific issues:

• Extended release formulation: Consists of drug within a nondeformable matrix; following drug release/absorption, the matrix/shell is expelled in the stool. The use of nondeformable products in patients with known stricture/narrowing of the GI tract (eg, severe gastrointestinal narrowing, colon cancer, obstruction, bowel resection, gastric bypass, vertical banded gastroplasty) has been associated with symptoms of obstruction (pharmacobezoar).

• Immediate release formulation: Immediate release formulations should not be used to manage primary hypertension, adequate studies to evaluate outcomes have not been conducted.

• Lactose: Adalat CC tablets contain lactose; do not use with galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption syndromes.

Other warnings/precautions:

• Surgery: Use with caution before major surgery. Cardiopulmonary bypass, intraoperative blood loss or vasodilating anesthesia may result in severe hypotension and/or increased fluid requirements. Consider withdrawing nifedipine (>36 hours) before surgery if possible.

• Withdrawal: Abrupt withdrawal may cause rebound angina in patients with coronary artery disease.

Warnings: Additional Pediatric Considerations

The "bite and swallow" method of administering immediate-release nifedipine is not recommended; variability of dose supplied via this method may lead to an overdose and result in significant side effects (eg, hypotension) in pediatric patients (Flynn 2003). An extemporaneous solution should be compounded to provide the most accurate dosing (see "Extemporaneous Preparations").

Metabolism/Transport Effects

Substrate of CYP2D6 (minor), 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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alcohol (Ethyl): May increase the serum concentration of NIFEdipine. Risk C: Monitor therapy

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

Alpha1-Blockers: May enhance the hypotensive effect of Calcium Channel Blockers. 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

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

Beta-Blockers: NIFEdipine may enhance the hypotensive effect of Beta-Blockers. NIFEdipine may enhance the negative inotropic effect of Beta-Blockers. 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

Cladribine: Inhibitors of Equilibrative Nucleoside (ENT1) and Concentrative Nucleoside (CNT3) Transport Proteins may increase the serum concentration of Cladribine. Management: Avoid concomitant use of ENT1 or CNT3 inhibitors during the 4 to 5 day oral cladribine treatment cycles whenever possible. If combined, consider an ENT1 or CNT3 inhibitor dose reduction and separation in the timing of administration. Risk D: Consider therapy modification

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 NIFEdipine. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of NIFEdipine. Management: Avoid coadministration of nifedipine with strong CYP3A4 inducers when possible and if combined, monitor patients closely for clinical signs of diminished nifedipine response. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of NIFEdipine. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of NIFEdipine. Management: Consider alternatives to this combination when possible. If combined, initiate nifedipine at the lowest dose available and monitor patients closely for increased nifedipine effects and toxicities (eg, hypotension, edema). Risk D: Consider therapy modification

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

Digoxin: NIFEdipine may increase the serum concentration of Digoxin. 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

FLUoxetine: May increase the serum concentration of NIFEdipine. Risk C: Monitor therapy

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

Grapefruit Juice: May increase the serum concentration of NIFEdipine. 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

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

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. 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

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

QuiNIDine: NIFEdipine may decrease the serum concentration of QuiNIDine. NIFEdipine may increase the serum concentration of QuiNIDine. QuiNIDine may increase the serum concentration of NIFEdipine. 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

VinCRIStine: NIFEdipine may increase the serum concentration of VinCRIStine. Risk C: Monitor therapy

VinCRIStine (Liposomal): NIFEdipine may increase the serum concentration of VinCRIStine (Liposomal). Risk C: Monitor therapy

Food Interactions

Nifedipine serum levels may be decreased if taken with food. Food may decrease the rate but not the extent of absorption of Procardia XL. Increased nifedipine concentrations resulting in therapeutic and vasodilator side effects, including severe hypotension and myocardial ischemia, may occur if nifedipine is taken by patients ingesting grapefruit. Management: Avoid grapefruit/grapefruit juice.

Pregnancy Considerations

Nifedipine crosses the placenta (Manninen 1991; Silberschmidt 2008).

An increase in perinatal asphyxia, cesarean delivery, prematurity, and intrauterine growth retardation have been reported following maternal use.

Chronic maternal hypertension may increase the risk of birth defects, low birth weight, preterm delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to duration and severity of maternal hypertension. Untreated hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes, MI, preeclampsia, stroke, and delivery complications (ACOG 2019a).

If treatment for chronic hypertension during pregnancy is needed, oral nifedipine is one of the preferred agents (ACOG 2019a; ESC [Regitz-Zagrosek 2018]). Oral immediate-release nifedipine is also recommended for the management of acute-onset, severe hypertension in pregnant and postpartum women, including those with preeclampsia or eclampsia (ACOG 2020; ESC [Cífková 2020]; ESC [Regitz-Zagrosek 2018]).

Nifedipine has also been evaluated for the treatment of preterm labor. Tocolytics may be used for the short-term (48-hour) prolongation of pregnancy to allow for the administration of antenatal steroids and should not be used prior to fetal viability or when the risks of use to the fetus or mother are greater than the risk of preterm birth (ACOG 2016). Nifedipine is ineffective for maintenance tocolytic therapy (ACOG 2016; Aggarwal 2018; Roos 2013; Verspyck 2017).

Breastfeeding Considerations

Nifedipine is present in breast milk.

The relative infant dose (RID) of nifedipine is 0.27% to 3.2% when calculated using the highest breast milk concentration located and compared to an infant therapeutic dose of 0.25 to 3 mg/kg/day.

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The RID of nifedipine was calculated using a milk concentration of 53.35 ng/mL, providing an estimated daily infant dose via breast milk of 8 mcg/kg/day.

This milk concentration was obtained following maternal administration of oral nifedipine 30 mg three times daily for 48 hours to a woman following delivery at 26 weeks' gestation (Ehrenkranz 1989). Milk concentrations may be influenced by maternal ABCG2 genotype (Malfará 2019). Milk concentrations reached a peak within 1 hour of maternal administration of immediate-release capsules (Ehrenkranz 1989; Penny 1989). The half-life of nifedipine in breast milk has been reported to be ~3 hours (Ehrenkranz 1989).

The use of nifedipine in breastfeeding women for the treatment of Raynaud phenomenon has been described in case reports and case series; no adverse events were noted in the infants exposed to nifedipine via breast milk (Anderson 2004; Barrett 2013; Garrison 2002; Jansen 2019; Page 2006; Wu 2012).

Nifedipine is considered compatible with breastfeeding, although data following long-term use is limited (WHO 2002). According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

The Academy of Breastfeeding Medicine recommends the use of nifedipine for the treatment of Raynaud phenomenon of the nipple in breastfeeding mothers (Berens 2016).

Dietary Considerations

Avoid grapefruit juice with all products.

Immediate release: Capsule is rapidly absorbed orally if it is administered without food, but may result in vasodilator side effects; if flushing is problematic, administration with low-fat meals may decrease. In general, can take with or without food.

Monitoring Parameters

Heart rate, BP, signs and symptoms of heart failure, peripheral edema.

Reference Range

BP goals: May vary depending on clinical condition, different clinical practice guidelines, and expert opinion. Refer to clinical practice guidelines for specific treatment goals.

Mechanism of Action

Inhibits calcium ion from entering the “slow channels” or select voltage-sensitive areas of vascular smooth muscle and myocardium during depolarization, producing a relaxation of coronary vascular smooth muscle and coronary vasodilation; increases myocardial oxygen delivery in patients with vasospastic angina; also reduces peripheral vascular resistance, producing a reduction in arterial blood pressure.

Pharmacokinetics

Onset of action: Immediate release: ~20 minutes

Protein binding (concentration dependent): 92% to 98%; Note: Protein-binding may be significantly decreased in patients with renal or hepatic impairment

Metabolism: Hepatic via CYP3A4 to inactive metabolites

Bioavailability: Capsule: 40% to 77%; ER: 65% to 89% relative to immediate release capsules; bioavailability increased with significant hepatic disease

Half-life elimination: Adults: Healthy: 2 to 5 hours; Cirrhosis: 7 hours; Elderly: 7 hours (extended release tablet)

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

Pharmacokinetics: Additional Considerations

Older adult: Mean Cmax is 36% higher and plasma concentration is 70% greater in elderly patients.

Pricing: US

Capsules (NIFEdipine Oral)

10 mg (per each): $0.46 - $1.29

20 mg (per each): $0.99 - $2.30

Tablet, 24-hour (NIFEdipine ER Oral)

30 mg (per each): $0.41 - $1.39

60 mg (per each): $0.54 - $2.48

90 mg (per each): $0.67 - $3.03

Tablet, 24-hour (NIFEdipine ER Osmotic Release Oral)

30 mg (per each): $1.10 - $1.39

60 mg (per each): $1.83 - $3.50

90 mg (per each): $2.31 - $2.91

Tablet, 24-hour (Procardia XL Oral)

30 mg (per each): $7.77

60 mg (per each): $13.45

90 mg (per each): $15.52

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.

Brand Names: International
  • Adalat (AE, AR, AT, BE, BF, BJ, BR, CH, CI, CL, CR, CZ, DE, DK, DO, EE, ES, ET, FI, GB, GH, GM, GN, GR, GT, HK, HN, HR, HU, ID, IE, IT, JO, JP, KE, KR, LR, LU, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NI, NO, NZ, PA, PE, PH, PK, PL, PT, QA, RU, SA, SC, SD, SE, SL, SN, SV, TN, TR, TZ, UG, UY, VE, ZA, ZM, ZW);
  • Adalat 10 (AU);
  • Adalat 20 (AU);
  • Adalat CC (BB);
  • Adalat CR (BG, CH, CY, GR, JP, RO, TH);
  • Adalat GITS (CN, HK);
  • Adalat GITS 30 (PH);
  • Adalat L (JP);
  • Adalat LA (BH, ET, GB, KW, LB, MT, MY, SG);
  • Adalat Oros (AU, BM, BS, BZ, CO, EC, EE, FI, GY, ID, IS, JM, KR, LU, NL, NO, NZ, PE, PR, PY, SI, SR, TT, TW, UY);
  • Adalat Retard (AE, AT, BF, BJ, CI, CR, CZ, DE, EG, ES, ET, GB, GH, GM, GN, GR, GT, HK, HN, ID, IQ, IR, JO, KE, LR, LU, LY, MA, ML, MR, MT, MU, MW, MY, NE, NG, NI, OM, PA, PE, PH, PL, PY, QA, SA, SC, SD, SL, SN, SV, SY, TN, TZ, UG, YE, ZM);
  • Adalat XL (ZW);
  • Adalate (FR);
  • Addos XR (AU);
  • Adefin (AU);
  • Adefin XL (AU);
  • Adifen SR (MY);
  • Adipine XL (GB);
  • Alonix-S (TW);
  • Altapres (PH);
  • Ampine (BD);
  • Aprical (DE, LU);
  • Atanaal Softcap (TW);
  • Calcibloc (PH);
  • Calcibloc OD (PH);
  • Calcicor (ET);
  • Calcigard (IN, SG, TH);
  • Calcigard Retard (ZW);
  • Cardicon (CL);
  • Cardifen (ZA);
  • Cardiiopine (AE);
  • Chronadalate LP (FR);
  • Citilat (IT);
  • Coracten (AE, CY, DE, GB, IQ, IR, JO, LY, OM, SA, SY, YE);
  • Coral (IT);
  • Cordafen (RU);
  • Cordaflex (BG, HU);
  • Cordilat (MX);
  • Cordipen (SG);
  • Cordipen Retard (SG);
  • Cordipin (CN, HK, HR);
  • Cordipin Retard (HR);
  • Cordipin XL (HR, LV);
  • Corinfar (HU, LV);
  • Corinfar Retard (LV);
  • Corotrend (DE);
  • Depin (IN);
  • Depin-E Retard (TH);
  • Dignokonstant (DE);
  • Dipinkor (ID);
  • Duranifin (DE);
  • Epilat (BH, EG, QA);
  • Fenamon (AE, BF, BJ, CI, CY, ET, GH, GM, GN, IQ, IR, JO, KE, LR, LY, MA, ML, MR, MU, MW, MY, NE, NG, OM, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM);
  • Glopir (GR);
  • Hexadilat (DK);
  • Huma-Nifedin (HU);
  • Hypan (BE);
  • Jutadilat (DE);
  • Kin Ran (CN);
  • Myogard (AE, CY, IN, IQ, IR, JO, LY, OM, SA, SY, YE);
  • Nedipin (TW);
  • Nelapine (PH);
  • Nepin SR (LK);
  • Nicardia (RU, TH);
  • Nicardia CD (TH);
  • Nicardia Retard (TH);
  • Nicardia XL (LK);
  • Nidelat (TR);
  • Nidipin (HU);
  • Nifa (BD);
  • Nifadil (HR);
  • Nifal (VE);
  • Nifangin (FI);
  • Nifar (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM);
  • Nifar-GB (MX);
  • Nifdemin (FI);
  • Nife-Par (ES);
  • Nifebene (AT);
  • Nifecap (BD);
  • Nifecard (AE, AT, BH, HR, JO, SA);
  • Nifecard XL (SG);
  • Nifecor (DE);
  • Nifedepat (DE);
  • Nifedicor (IT);
  • Nifedigel (MX);
  • NIfedilat (ZA);
  • Nifedilong (IL);
  • Nifedine (IN);
  • Nifedipin (HR);
  • Nifedipin AL (HU);
  • Nifedipin Pharmavit (HU);
  • Nifedipin Stada (LU);
  • Nifedipin-ratiopharm (LU);
  • Nifedipresc MR (GB);
  • Nifedix SR (KR);
  • Nifehexal (AU, LU, NZ);
  • Nifehexal 30 LA (VN);
  • Nifelan (EC);
  • Nifelat (BH, ET, HK, LB, MT, SG, TH, ZW);
  • Nifelat-Q (TH);
  • Nifenova (NO);
  • Nifensar (PE);
  • Nifensar Retard (PE);
  • Niferon CR (KR);
  • Nifeslow (LU);
  • Nifestad (PH);
  • Nifezzard (MX);
  • Nificard (CY, IQ, IR, LY, OM, QA, SY, YE);
  • Nifin (BD);
  • Nifipen (AE, BH, CY, IQ, IR, JO, LY, OM, QA, SA, SY, YE);
  • Nipen (BD);
  • Noviken LP (MX);
  • Nyefax Retard (NZ);
  • Odipin (PH);
  • Orix (GR);
  • Osmo-Adalat (IL);
  • Pidilat (DE);
  • Pressolat (IL);
  • Sepamit (JP);
  • Servidipine (MY);
  • Slow-Nifine (LU);
  • Tensopin (VE);
  • Tonorma (UA);
  • Unidipin (HU, LU);
  • Vasonipine (EG);
  • Zenusin (AE, BF, BJ, CI, CY, ET, GH, GM, GN, IQ, IR, JO, KE, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM)


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