Nifedipine (Monograph)
Brand names: Adalat CC, Afeditab CR, Nifedical XL, Procardia XL, Procardia
Drug class: Dihydropyridines
Introduction
Calcium-channel blocking agent; dihydropyridine derivative.284 307 342 343
Uses for Nifedipine
Angina
Management of Prinzmetal variant angina and chronic stable angina.a
A drug of choice for the management of Prinzmetal variant angina (used alone or in combination with nitrates).1100
β-Blockers are recommended as the anti-ischemic drugs of choice in most patients with chronic stable angina; calcium-channel blockers may be substituted or added in patients who do not tolerate or respond adequately to β-blockers.1101
Also has been used in patients with unstable angina† [off-label]; however, nondihydropyridine calcium-channel blockers (e.g., diltiazem, verapamil) generally recommended.1100
The potential risks of short-acting (conventional, immediate-release) nifedipine should be considered.242
Hypertension
Management of hypertension, alone or in combination with other classes of antihypertensive agents.126 309 342 343 344 345 348 351 1200
Only extended-release formulations currently are recommended for management of hypertension.121 126 178 181 183 184 191 192 193 197 201 202 204 205 206 207 208 209 210 211 212 213 225 226 264 309 342 344 348 1200 (See Cautions.)
Calcium-channel blockers are recommended as one of several preferred agents for the initial management of hypertension according to current evidence-based hypertension guidelines; other preferred options include ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics.501 502 503 504 1200 While there may be individual differences with respect to recommendations for initial drug selection and use in specific patient populations, current evidence indicates that these antihypertensive drug classes all generally produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes.501 502 503 504 1200 1213
Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).501 502 503 504 515 1200 1201
A 2017 ACC/AHA multidisciplinary hypertension guideline classifies BP in adults into 4 categories: normal, elevated, stage 1 hypertension, and stage 2 hypertension.1200 (See Table 1.)
Source: Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13-115.
Individuals with SBP and DBP in 2 different categories (e.g., elevated SBP and normal DBP) should be designated as being in the higher BP category (i.e., elevated BP).
|
Category |
SBP (mm Hg) |
DBP (mm Hg) |
|
|---|---|---|---|
|
Normal |
<120 |
and |
<80 |
|
Elevated |
120–129 |
and |
<80 |
|
Hypertension, Stage 1 |
130–139 |
or |
80–89 |
|
Hypertension, Stage 2 |
≥140 |
or |
≥90 |
The goal of hypertension management and prevention is to achieve and maintain optimal control of BP.1200 However, the BP thresholds used to define hypertension, the optimum BP threshold at which to initiate antihypertensive drug therapy, and the ideal target BP values remain controversial.501 503 504 505 506 507 508 515 523 526 530 1200 1201 1207 1209 1222 1223 1229
The 2017 ACC/AHA hypertension guideline generally recommends a target BP goal (i.e., BP to achieve with drug therapy and/or nonpharmacologic intervention) <130/80 mm Hg in all adults regardless of comorbidities or level of atherosclerotic cardiovascular disease (ASCVD) risk.1200 In addition, an SBP goal of <130 mm Hg generally is recommended for noninstitutionalized ambulatory patients ≥65 years of age with an average SBP of ≥130 mm Hg.1200 These BP goals are based upon clinical studies demonstrating continuing reduction of cardiovascular risk at progressively lower levels of SBP.1200 1202 1210
Previous hypertension guidelines generally have based target BP goals on age and comorbidities.501 504 536 Guidelines such as those issued by the JNC 8 expert panel generally have targeted a BP goal of <140/90 mm Hg regardless of cardiovascular risk, and have used higher BP thresholds and target BPs in elderly patients501 504 compared with those recommended by the 2017 ACC/AHA hypertension guideline.1200
Some clinicians continue to support previous target BPs recommended by JNC 8 due to concerns about the lack of generalizability of data from some clinical trials (e.g., SPRINT study) used to support the 2017 ACC/AHA hypertension guideline and potential harms (e.g., adverse drug effects, costs of therapy) versus benefits of BP lowering in patients at lower risk of cardiovascular disease.1222 1223 1224 1229
Consider potential benefits of hypertension management and drug cost, adverse effects, and risks associated with the use of multiple antihypertensive drugs when deciding a patient’s BP treatment goal.1200 1220 1229
For decisions regarding when to initiate drug therapy (BP threshold), the 2017 ACC/AHA hypertension guideline incorporates underlying cardiovascular risk factors.1200 1207 ASCVD risk assessment recommended by ACC/AHA for all adults with hypertension.1200
ACC/AHA currently recommend initiation of antihypertensive drug therapy in addition to lifestyle/behavioral modifications at an SBP ≥140 mm Hg or DBP ≥90 mm Hg in adults who have no history of cardiovascular disease (i.e., primary prevention) and a low ASCVD risk (10-year risk <10%).1200
For secondary prevention in adults with known cardiovascular disease or for primary prevention in those at higher risk for ASCVD (10-year risk ≥10%), ACC/AHA recommend initiation of antihypertensive drug therapy at an average SBP ≥130 mm Hg or an average DBP ≥80 mm Hg.1200
Adults with hypertension and diabetes mellitus, chronic kidney disease (CKD), or age ≥65 years of age are assumed to be at high risk for cardiovascular disease; ACC/AHA state that such patients should have antihypertensive drug therapy initiated at a BP ≥130/80 mm Hg.1200 Individualize drug therapy in patients with hypertension and underlying cardiovascular or other risk factors.502 1200
In stage 1 hypertension, experts state that it is reasonable to initiate drug therapy using the stepped-care approach in which one drug is initiated and titrated and other drugs are added sequentially to achieve the target BP.1200 Initiation of antihypertensive therapy with 2 first-line agents from different pharmacologic classes recommended in adults with stage 2 hypertension and average BP >20/10 mm Hg above BP goal.1200
Calcium-channel blockers may be preferred in hypertensive patients with certain coexisting conditions (e.g., ischemic heart disease)171 185 187 192 198 523 and in geriatric patients, including those with isolated systolic hypertension.181 183 220 221 222 227 502 510
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).501 504 1200 However, the combination of an ACE inhibitor or an angiotensin II receptor antagonist with a calcium-channel blocker or thiazide diuretic produces similar BP lowering in black patients as in other racial groups.1200
Nifedipine is not recommended for management of hypertensive crises.283 284 295 307 338 339 340 341
Nifedipine is recommended by ACOG and other experts as an appropriate drug of choice in pregnant women who require antihypertensive therapy.388 540
Raynaud’s Phenomenon
Drug of choice for the management of Raynaud’s phenomenon† [off-label],144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 296 297 298 305 306 preferably administered as extended-release formulations.296 297 305 306
Preterm Labor
Has been used in selected women to inhibit uterine contractions in preterm labor† [off-label] (tocolysis) and prolong gestation when beneficial.290 291 292 293 294 389
ACOG states that because of conflicting results, there is no clear first-line tocolytic agent;389 data from randomized, controlled studies suggest calcium-channel blockers (principally nifedipine) may be more effective than, and preferable to, other agents (e.g., magnesium sulfate, β-adrenergic agonists).390
Main benefit currently derived from tocolytic therapy may be to forestall labor providing time for patients to receive corticosteroids to increase fetal lung maturation and/or be transferred to other (e.g., tertiary-care) facilities; any other potential benefits of prolonging pregnancy are unclear.290 291 293 294 389 390 419 420 421
Acute MI
Used in the early treatment and secondary prevention of acute MI† [off-label]; an effective anti-ischemic agent, but mortality benefit not demonstrated.266 527 1100
Calcium-channel blockers generally are used for their anti-ischemic and BP-reducing properties in the MI setting, and only when β-blockers (which have been shown to reduce mortality after MI) are ineffective, not tolerated, or contraindicated.527 702 1100
Experts state that calcium-channel blockers may be used to relieve ischemic symptoms, lower BP, or control rapid ventricular response rate associated with atrial fibrillation in patients with ST-segment-elevation MI (STEMI) who are intolerant to β-blockers.527
Experts recommend a nondihydropyridine calcium-channel blocker for ongoing or recurrent ischemia in patients with non-ST-segment-elevation MI (NSTEMI) who have a contraindication to β-blockers and who do not have clinically important left ventricular dysfunction, increased risk of cardiogenic shock, or AV block.1100
Use of immediate-release nifedipine generally contraindicated because of possible hypotension and reflex sympathetic activation.527 1100
Nifedipine Dosage and Administration
General
BP Monitoring and Treatment Goals
-
Monitor BP regularly (i.e., monthly) during therapy and adjust dosage of the antihypertensive drug until BP controlled.1200
-
If unacceptable adverse effects occur, discontinue drug and initiate another antihypertensive agent from a different pharmacologic class.1200 1216
-
If adequate BP response not achieved with a single antihypertensive agent, either increase dosage of single drug or add a second drug with demonstrated benefit and preferably a complementary mechanism of action (e.g., ACE inhibitor, angiotensin II receptor antagonist, thiazide diuretic).1200 1216 Many patients will require at least 2 drugs from different pharmacologic classes to achieve BP goal; if goal BP still not achieved, add a third drug.1200 1216
Administration
Oral Administration
Conventional Capsules
Administer capsules orally 3 times daily.284
Swallow capsules whole.284
Extended-release Tablets
Administer orally once daily.126 342
Extended-release tablets should be swallowed intact and should not be chewed, crushed, or broken.126 342
Manufacturer recommends that Adalat CC be administered on an empty stomach.342
The shell of the extended-release tablet does not dissolve and may be passed in the stool.342 343
Whenever extended-release tablets are dispensed or administered, care should be taken to ensure that the extended-release dosage form actually was prescribed.126
Dosage of extended-release nifedipine tablets should be decreased gradually with close clinical supervision when discontinuance of the drug is required.126 342
Extemporaneously Compounded Oral Liquid
Extemporaneously compounded oral liquid formulations of nifedipine have been prepared.98
Standardize 4 Safety
Standardized concentrations for nifedipine have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care.99 Because recommendations from the S4S panels may differ from the manufacturer’s prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label.99 For additional information on S4S (including updates that may be available), see [Web].99
|
Concentration Standards |
|---|
|
4 mg/mL |
Dosage
Manufacturer states that two 30-mg Adalat CC extended-release tablets may be interchanged with one 60-mg Adalat CC extended-release tablet; however, three 30-mg Adalat CC extended-release tablets should not be considered interchangeable with one 90-mg Adalat CC extended-release tablet.342
Pediatric Patients
Hypertension† [off-label]
Extended-release Tablets
OralInitially, 0.2–0.5 mg/kg daily given in 1 dose or 2 divided doses recommended by some experts.1150 Initiate drug at the low end of the dosage range; may increase dosage every 2–4 weeks until BP controlled, maximum dosage reached (3 mg/kg [up to 120 mg] daily, given in 1 or 2 divided doses), or adverse effects occur.1150
Adults
Angina
Conventional Capsules
OralInitially, 10 mg 3 times daily.284 307
Increase dosage gradually at 7- to 14-day intervals until optimum control of angina is obtained.a
May increase more rapidly to 90 mg daily in increments of 30 mg daily over a 3-day period if symptoms so warrant and patient’s tolerance and response to therapy are frequently assessed.284 307
In hospitalized patients who are closely monitored, dosage may be increased in 10-mg increments at 4- to 6-hour intervals, as necessary to control pain and arrhythmias caused by ischemia.284 307 Single doses usually should not exceed 30 mg.284 307
Some experts state usual maintenance dosage is 10–20 mg 3 times daily.a In some patients, especially those with evidence of coronary artery spasm, increased dosages of 20–30 mg 3 or 4 times daily and rarely, more than 120 mg daily may be necessary.a
Extended-release Tablets
OralInitially, 30 or 60 mg once daily.126
Increase dosage gradually at 7- to 14-day intervals until optimum control of angina is obtained.a
Dosage may be increased more rapidly to 90 mg daily in increments of 30 mg daily after steady state is achieved (usually achieved on the second day of therapy with a given dose) if symptoms so warrant and patient’s tolerance and response are frequently assessed.126
In some patients, especially those with evidence of coronary artery spasm, higher dosages may be necessary.a However, experience with antianginal dosages exceeding 90 mg once daily as extended-release tablets is limited and should be employed with caution and only when clinically necessary.126
Extended-release tablets can be substituted for the conventional capsules at the nearest equivalent total daily dose.126
Hypertension
Conventional Capsules
OralConventional capsules not recommended for use in the management of hypertension242 284 307 344 345 because of concerns about potential cardiovascular risks.240 241 242 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 266 284 307 344 345 346 347 348
Extended-release Tablets
OralInitially, 30 or 60 mg once daily.126
Increase dosage gradually at 7- to 14-day intervals until optimum control of BP is obtained.126 342 a
Dosage may be increased more rapidly, if symptoms so warrant and the patient’s tolerance and response to therapy are frequently assessed.126
Usual maintenance dosage is 30–90 mg once daily.1200
If unacceptable adverse effects occur, discontinue the drug and initiate another hypertensive agent from a different pharmacologic class.1200 1216
Prescribing Limits
Pediatric Patients
Hypertension†
Oral
Extended-release tablets: Maximum 3 mg/kg (up to 120 mg) daily.1150
Adults
Angina
Oral
Conventional liquid-filled capsules: Maximum 30 mg as a single dose.284 307 Maximum 180 mg daily.284
Extended-release tablets: Maximum 120 mg daily.126
Hypertension
Oral
Extended-release tablets: Maximum 90 mg (Adalat CC) or 120 mg (Procardia XL) once daily.126 342
Cautions for Nifedipine
Contraindications
Warnings/Precautions
Warnings
Excessive Hypotension
Risk of excessive, poorly tolerated hypotension in patients being treated for angina; usually occurs during initial dosage titration or subsequent upward titration and may be more likely in patients receiving concomitant β-blocker.114 126 129 284 286 307 Carefully monitor BP, especially during therapy initiation, titration, or dosage increase.126 284 342 a
Cardiovascular Effects with Conventional Preparations
Conventional (immediate-release) nifedipine formulations generally are contraindicated in the routine management of acute MI because of negative inotropic effects and reflex sympathetic activation, tachycardia, and hypotension associated with its use.242 284 307 527 Do not administer within first 1–2 weeks after MI and avoid in acute coronary syndrome when infarction may be imminent.284 307
Risk of profound hypotension, cerebrovascular ischemia or stroke, myocardial ischemia or infarction, and/or death with use of conventional preparations for management of hypertensive crises;119 283 284 288 295 300 302 303 304 307 308 similar effects reported in patients receiving such preparations for angina or pulmonary hypertension.283 286 287 310 Do not use short-acting preparations for acute BP reduction or for chronic hypertension management.284 307
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.126 284 342
β-Blocker Withdrawal
Possible increased angina in patients recently withdrawn from β-blockers after nifedipine initiation.126 284 342 Taper dosage of β-blockers before initiation of nifedipine.126 284 342 (See Interactions.)
Heart Failure
Risk of heart failure, especially in those receiving concomitant β-blockers, particularly in patients with aortic stenosis.126 284 342
Sensitivity Reactions
Rash, dermatitis (including exfoliative dermatitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity reactions, pruritus, urticaria, allergic hepatitis, and angioedema, principally oropharyngeal edema and occasionally breathing difficulty, reported.126 284 342
General Precautions
Peripheral Edema
Consider possibility of deterioration in left ventricular function, especially in patients with heart failure, if peripheral edema develops.126 284 342
GI Disorders
Use extended-release tablets with caution in patients with preexisting GI narrowing; obstruction may occur.126
Specific Populations
Pregnancy
Lactation
Distributed into milk.165 342 Discontinue nursing or the drug.342
Pediatric Use
Safety and efficacy remain to be fully established in children;126 284 however, some experts have recommended dosages for hypertension based on clinical experience.1150
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.284 342 Select dosage with caution.284 342
Renal Impairment
Use Adalat CC extended-release nifedipine tablets with caution in patients with renal impairment due to the possibility of altered absorption of the drug.342
Common Adverse Effects
Dizziness, lightheadedness, giddiness, flushing, heat sensation, headache, tremor, nervousness, mood changes, weakness, fatigue, asthenia, muscle cramps, nausea, heartburn, peripheral edema, dyspnea, cough, wheezing, nasal congestion, sore throat.126 284 342
Drug Interactions
Metabolized by CYP isoenzymes, principally CYP3A.342 May inhibit CYP3A; does not appear to affect CYP2D6.342
Specific Drugs and Food
|
Drug or Food |
Interaction |
Comments |
|---|---|---|
|
β-Adrenergic blocking agents |
Increased risk of severe hypotension, exacerbation of angina, heart failure, and arrhythmiaa |
Monitor patient and adjust nifedipine dosage as needed;342 gradually reduce β-blocker dosage instead of abruptly withdrawing126 284 342 a |
|
Acarbose |
Possible loss of glycemic control342 |
Monitor glucose concentrations and adjust nifedipine dosage as needed342 |
|
Alcohol |
Increased nifedipine bioavailability236 |
|
|
Anticoagulants (e.g., coumarins) |
||
|
Antifungals, azoles (fluconazole, itraconazole, ketoconazole) |
Possible increased plasma nifedipine concentrations342 |
Monitor BP and adjust nifedipine dosage as needed342 |
|
Antiretroviral agents (HIV protease inhibitors [amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir], nonnucleoside reverse transcriptase inhibitors [delavirdine]) |
Possible increased plasma nifedipine concentrations342 |
Use concomitantly with caution; monitor patient carefully342 |
|
Antituberculosis agents (rifabutin, rifampin) |
Adjust nifedipine dosage as needed342 |
|
|
Benazepril |
Possible attenuation of tachycardic effect of nifedipine342 |
|
|
Candesartan |
Pharmacokinetic interaction unlikely342 |
|
|
Carbamazepine |
Possible decreased plasma nifedipine concentrations342 |
Adjust nifedipine dosage as needed342 |
|
Clopidogrel |
Pharmacokinetic interaction unlikely342 |
|
|
Digoxin |
Monitor serum digoxin concentrations when nifedipine therapy is initiated, discontinued, or dosage is adjusted in patients receiving digoxin108 126 284 307 342 Monitor for signs and symptoms of digoxin toxicity and reduce dosage if necessary101 106 126 284 307 |
|
|
Diltiazem |
||
|
Dolasetron |
Pharmacokinetic interaction unlikely342 |
|
|
Erythromycin |
Possible increased plasma nifedipine concentrations342 |
Monitor BP and adjust nifedipine dosage as needed342 |
|
Fentanyl |
Potential for severe hypotensiona |
If patient’s condition permits, temporarily withhold nifedipine for at least 36 hours before surgery if use of high-dose fentanyl is contemplated126 284 342 |
|
Flecainide |
Insufficient clinical experience to recommend concomitant use342 |
|
|
Grapefruit juice |
Increased nifedipine bioavailability284 311 314 323 324 342 371 372 373 |
Avoid concomitant use;284 314 342 371 372 373 discontinue grapefruit juice consumption at least 3 days prior to initiating nifedipine therapy342 |
|
Histamine H2-receptor antagonists (cimetidine, ranitidine) |
Decreased clearance and increased plasma nifedipine concentrations and AUC with concomitant cimetidine or (to lesser extent) ranitidine115 116 125 284 342 |
Cautiously titrate nifedipine dosage in patients receiving cimetidine; may need to reduce nifedipine dosage in patients stabilized on the drug if cimetidine therapy is initiated115 125 284 342 |
|
Hypotensive agents (captopril, doxazosin, hydralazine, methyldopa) |
Increased incidence of severe hypotensiona |
Observe patient closely when nifedipine is added to existing antihypertensive regimen, especially during initial titration or upward adjustment of nifedipine dosage126 284 342 |
|
Irbesartan |
Pharmacokinetic interaction unlikely342 |
|
|
Metformin |
Possible increased absorption of metformin342 |
|
|
Nefazodone |
Possible increased plasma nifedipine concentrations342 |
Monitor BP and adjust nifedipine dosage as needed342 |
|
Omeprazole |
Pharmacokinetic interaction unlikely342 |
|
|
Pantoprazole |
Pharmacokinetic interaction unlikely342 |
|
|
Phenobarbital |
Possible decreased plasma nifedipine concentrations342 |
Adjust nifedipine dosage as needed342 |
|
Phenytoin |
Possible decreased phenytoin metabolism;166 167 possible decreased plasma nifedipine concentrations342 |
Monitor plasma phenytoin concentrations when nifedipine is initiated or discontinued;166 monitor BP and adjust nifedipine dosage as needed342 |
|
Quinidine |
Possible increased plasma nifedipine concentrations;342 397 possible decreased serum quinidine concentrations284 307 332 333 334 335 336 337 396 397 |
Monitor heart rate and adjust nifedipine dosage as needed;342 monitor serum quinidine concentrations whenever nifedipine is initiated or discontinued; adjust quinidine dosage accordingly333 334 335 336 337 |
|
Quinupristin and dalfopristin |
Monitor BP and adjust nifedipine dosage as needed342 |
|
|
Sirolimus |
Pharmacokinetic interaction unlikely342 |
|
|
St. John’s wort |
Possible decreased plasma nifedipine concentrations342 |
Adjust nifedipine dosage as needed342 |
|
Tacrolimus |
Possible increased plasma tacrolimus concentrations342 |
Monitor tacrolimus blood concentrations and adjust tacrolimus dosage as needed342 |
|
Tirofiban |
Pharmacokinetic interaction unlikely342 |
|
|
Valproic acid |
Possible increased plasma nifedipine concentrations342 |
Monitor BP and adjust nifedipine dosage as needed342 |
|
Verapamil |
Possible increased plasma nifedipine concentrations342 |
Monitor BP and adjust nifedipine dosage as needed342 |
Nifedipine Pharmacokinetics
Absorption
Bioavailability
Following oral administration of conventional capsules, approximately 90% of a dose is absorbed with peak serum concentrations usually attained within 0.5–2 hours.a
Oral bioavailability of extended-release tablets is approximately 75–89% of that achieved with same doses as conventional capsules.126 130 342
Peak plasma concentrations for extended-release tablets are attained within about 2.5–6 hours.130 342
Food
Food decreases the rate but not extent of absorption from conventional capsules.140
Food can increase the early rate of GI absorption of extended-release tablets but does not affect overall bioavailability.126 342
Special Populations
Bioavailability is increased in patients with liver cirrhosis126 132 133 284 307 342 and may be particularly increased in those with portacaval shunts.132
Following oral administration of extended-release tablets (Adalat CC), , absorption of nifedipine may be altered in patients with renal impairment.342
Substantial reductions in GI retention time for prolonged periods (e.g., in patients with short-bowel syndrome) can result in decreased absorption from extended-release tablets.126
Increased mean peak plasma concentrations and average plasma concentrations compared with those in younger adults have been reported in healthy subjects >60 years of age receiving Adalat CC extended-release tablets.342
Distribution
Extent
Nifedipine is distributed into milk.165
Plasma Protein Binding
Special Populations
Plasma protein binding may be decreased in patients with renal126 133 139 284 307 342 or hepatic126 132 133 284 307 342 impairment.
Elimination
Metabolism
Extensively metabolized in the liver by CYP isoenzymes, including CYP3A, to highly water soluble, inactive metabolites.126 284 342 a
Elimination Route
Metabolites excreted in urine (60–80%) and feces (possibly via biliary elimination).126 342 a
Half-life
2 hours (conventional capsules); 7 hours (Adalat CC extended-release tablets).126 284 342 a
Special Populations
Elimination may be altered in patients with hepatic impairment.126 132 133 284 307 342 Elimination half-life of 7 hours reported in patients with cirrhosis.132 133
Following IV administration, decreased total body clearance in geriatric individuals compared with that in young adults .342
Stability
Storage
Oral
Capsules
Tight, light resistant containers at 15–25°C; protect from light and moisture.284
Extended-release Tablets
Tight, light resistant containers at <30°C; protect from light and moisture.126 342
Actions
-
Inhibits transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations.126 284 342
-
Peripheral arterial vasodilator; acts directly on vascular smooth muscle causing reduction in peripheral vascular resistance (afterload) and BP.126 284 342
Advice to Patients
-
Importance of swallowing extended-release tablets whole; do not chew, crush, or break.126 342
-
Importance of advising patients receiving extended-release tablets that tablet core may be excreted in stools without affecting drug efficacy.126
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.126 284 342
-
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.126 284 342
-
Importance of informing patients of other important precautionary information.126 284 342 (See Cautions.)
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
|
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
|---|---|---|---|---|
|
Oral |
Capsules, liquid-filled |
10 mg* |
NIFEdipine Capsules |
|
|
Procardia |
Pfizer |
|||
|
20 mg* |
NIFEdipine Capsules |
|||
|
Tablets, extended-release, film-coated |
30 mg* |
Adalat CC |
Bayer |
|
|
Afeditab CR |
Watson |
|||
|
Nifedical XL |
Teva |
|||
|
NIFEdipine ER |
||||
|
Procardia XL |
Pfizer |
|||
|
60 mg* |
Adalat CC |
Bayer |
||
|
Afeditab CR |
Watson |
|||
|
Nifedical XL |
Teva |
|||
|
NIFEdipine ER |
||||
|
Procardia XL |
Pfizer |
|||
|
90 mg* |
Adalat CC |
Bayer |
||
|
NIFEdipine ER |
||||
|
Procardia XL |
Pfizer |
AHFS DI Essentials™. © Copyright 2025, Selected Revisions June 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
Only references cited for selected revisions after 1984 are available electronically.
98. Nahata MC, Pai VB. Pediatric Drug Formulations. 6th ed. Harvey Whitney Books. Cincinnati, OH, 2011.
99. ASHP. Standardize 4 Safety: compounded oral liquid standards. Updated 2024 Mar. From ASHP website. Updates may be available at ASHP website. https://www.ashp.org/standardize4safety
100. Kleinbloesem CH, van Brummelen P, Woittiez AJ et al. Influence of haemodialysis on the pharmacokinetics and haemodynamic effects of nifedipine during continuous intravenous infusion. Clin Pharmacokinet. 1986; 11:316-22. https://pubmed.ncbi.nlm.nih.gov/3757391
101. Hansten PD. Drug interactions. 5th ed. Philadelphia: Lea & Febiger; 1985; 279-85.
102. Pedersen KE, Dorph-Pedersen A, Hvidt S et al. Effect of nifedipine on digoxin kinetics in healthy subjects. Clin Pharmacol Ther. 1982; 32:562-5. https://pubmed.ncbi.nlm.nih.gov/7127997
103. Schwartz JB, Migliore PJ. Effect of nifedipine on serum digoxin concentration and renal digoxin clearance. Clin Pharmacol Ther. 1984; 36:19-24. https://pubmed.ncbi.nlm.nih.gov/6734045
104. Schwartz JB, Raizner A, Akers S. The effect of nifedipine on serum digoxin concentrations in patients. Am Heart J. 1984; 107:669-73. https://pubmed.ncbi.nlm.nih.gov/6702561
105. Garty M, Shamir E, Ilfeld D et al. Noninteraction of digoxin and nifedipine in cardiac patients. J Clin Pharmacol. 1986; 26:304-5. https://pubmed.ncbi.nlm.nih.gov/3700685
106. Belz GG, Doering W, Munkes R et al. Interaction between digoxin and calcium antagonists and antiarrhythmic drugs. Clin Pharmacol Ther. 1983; 33:410-7. https://pubmed.ncbi.nlm.nih.gov/6831819
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