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Nifedipine

Pronunciation

Class: Dihydropyridines
VA Class: CV200
CAS Number: 21829-25-4
Brands: Adalat, Adalat CC, Nifedical XL, Procardia XL, Procardia

Introduction

Calcium-channel blocking agent; dihydropyridine derivative.284 307 342 343

Uses for Nifedipine

Angina

Used in the management of Prinzmetal variant angina and chronic stable angina pectoris.a

Calcium-channel blockers considered the drugs of choice in management of Prinzmetal variant angina.a

Appears to be as effective as β-adrenergic blocking agents (e.g., propranolol) and/or oral nitrates in the management of chronic stable angina pectoris; however, generally should be used only when the patient cannot tolerate adequate doses of or is refractory to these drugs.a

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).126 141 237 309 342 343 344 345 348 350 351

Only extended-release formulations currently are recommended for management of hypertension.121 126 141 178 181 183 184 191 192 193 197 201 202 204 205 206 207 208 209 210 211 212 213 225 226 237 264 309 342 344 348 350 (See Cautions.)

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One of several preferred initial therapies in hypertensive patients with a high risk of developing CAD, including those with diabetes mellitus.383

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.383

Not recommended for management of hypertensive crises.283 284 295 307 338 339 340 341 350 383

As an alternative to IV hydralazine, short-acting (conventional, immediate-release) nifedipine is included by JNC 7 for management of acute severe hypertension in pregnant women with preeclampsia when delivery is imminent.393 However, JNC 7 acknowledges that this use is controversial.393

Raynaud’s Phenomenon

Drug of choice for the management of Raynaud’s phenomenon,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 (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

Nifedipine Dosage and Administration

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

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
Extended-release Tablets
Oral

Initially, 0.25–0.5 mg/kg daily given in 1 dose or 2 divided doses.395 Increase dosage as necessary up to a maximum dosage of 3 mg/kg (up to 120 mg) daily, given in 1 dose or 2 divided doses.395

Adults

Angina
Conventional Capsules
Oral

Initially, 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

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

Initially, 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
Oral

Not recommended for use in the management of hypertension242 284 307 344 345 350 because of concerns about potential cardiovascular risks.240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 266 284 307 344 345 346 347 348

Extended-release Tablets
Oral

Initially, 30 or 60 mg once daily.126 350

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 30–60 mg once daily.342

Preeclampsia
Oral

Conventional capsules: 10 mg repeated at 20-minute intervals to a maximum total dosage of 30 mg.393 The drug should be used cautiously with magnesium sulfate since a precipitous drop in BP can occur.393

Prescribing Limits

Pediatric Patients

Hypertension
Oral

Extended-release tablets: Maximum 3 mg/kg (up to 120 mg) daily.395

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

Extended-release tablets: Maximum 90 mg (Adalat CC) or 120 mg (Procardia XL) once daily.126 342 350 However, JNC currently recommends a lower maximum dosage of 60 mg daily.383

Cautions for Nifedipine

Contraindications

  • Known hypersensitivity to nifedipine or any ingredient in the formulation.126 284 307 342 343

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-adrenergic blocking agent.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 AMI because of negative inotropic effects and reflex sympathetic activation, tachycardia, and hypotension associated with its use.242 284 307 352 391 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 AMI

Rarely, increased frequency, duration, and/or severity of angina or AMI, 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.)

CHF

Risk of CHF, especially in those receiving concomitant β-adrenergic blocking agents, 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 CHF, 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

Category C.126 284 342

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 current limited clinical experience.395

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

Interactions for Nifedipine

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, CHF, and arrhythmiaa

Monitor patient and adjust nifedipine dosage as needed;342 gradually reduce β-blocker dosage instead of abruptly withdrawing;126 284 342 a

Acarbose

Possible loss of glycemic control342

Monitor glucose concentrations and adjust nifedipine dosage as needed342

Alcohol

Increased nifedipine bioavailability236

Anticoagulants (e.g., coumarins)

Possible increased PT126 284 342

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)

Possible decreased plasma nifedipine concentrations342 401

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

Increased serum digoxin concentration106 107 126

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

Possible increased plasma nifedipine concentrations342 399

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

Possible increased plasma nifedipine concentrations342 378

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

Approximately 92–98%.126 284

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.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Nifedipine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, liquid-filled

10 mg*

Adalat

Bayer

Procardia

Pfizer

20 mg*

Adalat

Bayer

Procardia

Pfizer

Tablets, extended-release, film-coated

30 mg*

Adalat CC

Bayer

Nifedical XL

Teva

Nifedipine ER

Procardia XL

Pfizer

60 mg*

Adalat CC

Bayer

Nifedical XL

Teva

Nifedipine ER

Procardia XL

Pfizer

90 mg*

Adalat CC

Bayer

Nifedipine ER

Procardia XL

Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Adalat CC 30MG 24-hr Tablets (SCHERING): 30/$54.99 or 90/$140.97

Adalat CC 60MG 24-hr Tablets (SCHERING): 30/$83.99 or 90/$251.97

Adalat CC 90MG 24-hr Tablets (SCHERING): 30/$98.62 or 90/$269.89

Afeditab CR 30MG 24-hr Tablets (WATSON LABS): 30/$46.52 or 90/$116.29

Afeditab CR 60MG 24-hr Tablets (WATSON LABS): 30/$63.86 or 90/$181.50

Nifediac CC 60MG 24-hr Tablets (TEVA PHARMACEUTICALS USA): 30/$49.99 or 90/$125.96

Nifediac CC 90MG 24-hr Tablets (TEVA PHARMACEUTICALS USA): 30/$61.99 or 90/$171.96

NIFEdipine 10MG Capsules (ACTAVIS ELIZABETH): 90/$80.99 or 180/$148.98

NIFEdipine 20MG Capsules (ACTAVIS ELIZABETH): 90/$165.99 or 270/$482.99

NIFEdipine 30MG 24-hr Tablets (MYLAN): 100/$94.99 or 300/$259.95

NIFEdipine 60MG 24-hr Tablets (MYLAN): 90/$129.96 or 270/$339.93

NIFEdipine CR Osmotic 30MG 24-hr Tablets (MYLAN): 30/$37.99 or 90/$113.97

NIFEdipine CR Osmotic 60MG 24-hr Tablets (MYLAN): 30/$59.99 or 90/$179.98

NIFEdipine CR Osmotic 90MG 24-hr Tablets (MYLAN): 30/$75.99 or 90/$185.97

Procardia 10MG Capsules (PFIZER U.S.): 90/$115.38 or 270/$328.67

Procardia XL 30MG 24-hr Tablets (PFIZER U.S.): 30/$79.79 or 90/$211.01

Procardia XL 60MG 24-hr Tablets (PFIZER U.S.): 30/$135.99 or 90/$389.96

Procardia XL 90MG 24-hr Tablets (PFIZER U.S.): 30/$145.86 or 90/$416.73

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions January 11, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† 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.

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