Nifedipine Updated 2013 Jan 18 12:30:46 PM: Nifedipine brands data updatedShow more updates

 

Related Summaries: Management of angina Antihypertensive medication management Raynaud phenomenon

 

Warnings

Potentially Inappropriate Medication Use in Older Adults:  American Geriatrics Society (AGS) Beers Criteria recommends avoiding immediate

release nifedipine in elderly patients due to risk of hypotension and of precipitating myocardial ischemia (AGS Strong recommendation, High quality evidence) (2012 AGS Beers Criteria for potentially inappropriate medication use in older adults [J Am Geriatr Soc 2012 Apr;60(4):616])

General Information

Description:

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

Class:

Class: Dihydropyridines

Brands:

United States Brands: generic nifedipine available Adalat CC Afeditab CR Nifedical XL Procardia see also nifedipine in DailyMed

Canadian Brands: generic nifedipine available Adalat XL see also Health Canada Drug Product Database (DPD)

United Kingdom Brands: Adalat Adalat Retard Adipene Coracten Fortipine Nifedipress Nimodrel Tensipine Valni see also nifedipine in British National Formulary (BNF) or electronic Medicines

Compendium (eMC)Combination Products Containing This Drug (UK):

Beta-Adalat (atenolol, nifedipine) Tenif (atenolol, nifedipine)

Australian Brands: APO-Nifedipine XR Controlled release tablets (see MIMS Online) Adalat Oros Controlled release tablets (see MIMS Online) Adalat Tablets (see MIMS Online) Addos XR Controlled release tablets (see MIMS Online) Adefin 10 Tablets (see MIMS Online) Adefin 20 Tablets (see MIMS Online)

Adefin XL Controlled release tablets (see MIMS Online) Nifehexal Tablets (see MIMS Online) Nyefax Tablets (see MIMS Online)Uses and Efficacy

Uses:

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). 126 309 342 343 344 345 348 351 500

Only extended-release formulations currently are recommended for management of

hypertension.121 126 178 181 183 184 191 192 193 197 201 202 204 205 206 207 208 209 210 211 212 213 225 226 264 309 342 344 348 500 (See Cautions.)

Calcium-channel blockers are recommended as one of several preferred agents for the

initial management of hypertension; other options include ACE inhibitors, angiotensin II

receptor antagonists, and thiazide diuretics. 501 502 503 504 While there may be individual

differences with respect to specific outcomes, these antihypertensive drug classes all

produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and

renal outcomes. 501 502 503 504 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). 500 501 502 503 504 515

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). 500 501 504 However, diminished

response to these other drug classes is largely eliminated when administered

concomitantly with a calcium-channel blocker or thiazide diuretic. 500 504

The optimum BP threshold for initiating antihypertensive drug therapy is

controversial. 501 504 505 506 507 508 515 523 530 Further study needed to determine optimum BP

thresholds/goals; individualize treatment decisions. 501 503 507 515 526 530

JNC 7 recommends initiation of drug therapy in all patients with uncomplicated

hypertension and BP ≥140/90 mm Hg; 500 JNC 8 panel recommends SBP threshold of 150

mm Hg for patients ≥60 years of age. 501 Although many experts agree that SBP goal of

<150 mm Hg may be appropriate for patients ≥80 years of age, 502 504 505 530 application of

this goal to those ≥60 years of age is controversial, especially for those at higher

cardiovascular risk. 501 502 505 506 508 511 515

In the past, initial antihypertensive drug therapy was recommended for patients with

diabetes mellitus or chronic kidney disease who had BP ≥130/80 mm Hg; 309 500 503 current

hypertension management guidelines generally recommend a BP threshold of 140/90

mm Hg for these individuals (same as for the general population of patients without

these conditions), although a goal of <130/80 mm Hg may still be

considered. 501 502 503 504 520 530 535 536 541

Not recommended for management of hypertensive crises. 283 284 295 307 338 339 340 341 500

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 †, 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 pre

ferably 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

Other Potential Uses:

Urinary Stone Expulsion:

Nifedipine efficacy for urinary stone expulsion: nifedipine (plus corticosteroid) may increase and hasten stone expulsion

o based on 2 randomized trialso 96 patients with distal ureteral stones ≤ 1 cm were randomized to slow-

release nifedipine 30 mg/day for up to 4 weeks plus deflazacort 30 mg/day for up to 10 days vs. wait-and-watch control comparing combination vs. control

stone expulsion in 79% vs. 35% (p < 0.05, NNT 3) mean expulsion time 7 days vs. 20 days (p < 0.05)

Reference - Urology 2000 Oct 1;56(4):579o 86 patients with unilateral ureteral stones were randomized

to methylprednisolone 16 mg/day plus nifedipine 40 mg/day vs. methylprednisolone 16 mg/day for 45 days comparing combination vs. methylprednisolone alone

increased rate of stone passage (87% vs. 65%, p = 0.021, NNT 5) mean time to stone passage 11.2 days vs. 16.4 days (p = 0.036)

Reference - J Urol 1994 Oct;152(4):1095, editorial can be found in J Urol 1994 Oct;152(4):1099

Drug class efficacy for urinary stone expulsion: calcium channel blockers may facilitate passage of urinary stones (level 2 [mid-

level] evidence)o based on 2 systematic reviews of mostly randomized trials without blindingo systematic review of 22 randomized trials of alpha-antagonist or calcium channel

blocker reporting stone expulsion rates in adults only 1 trial had blinding, review did not report assessment of allocation

concealment calcium channel blockers associated with

increased stone expulsion rate in meta-analysis of 9 trials (risk ratio 1.5, 95% CI 1.34-1.68)

15.2% rate of adverse effects Reference - Ann Emerg Med 2007 Nov;50(5):552, commentary can be found in J

Fam Pract 2008 Apr;57(4):224 full-text, Evid Based Med 2008 Aug;13(4):111o systematic review of 9 randomized trials with 693 patients, results confounded by

additional medications

use of concomitant medications (such as corticosteroids) varied across trials, 7 trials also provided NSAIDs to treatment and control groups

treatment duration lasted 7 days to 6 weeks, follow-up ranged from 15 days to 48 days, only 12 dropouts across all 9 trials

stone passage rates higher with treatment than control in all 9 trials rates of stone passage ranged from 75% to 100% with treatment vs. 35% to

80% with control in 8 trials rate of stone passage 53% with treatment vs. 20% with control in 1 outlier

trial no significant heterogeneity in meta-analysis, NNT 4 to promote stone

passage effects of calcium channel blockers and alpha blockers could not be statistically

isolated from other medications used sensitivity analyses showed similar results with higher-quality trials Reference - Lancet 2006 Sep 30;368(9542):1171, editorial can be found in Lancet

2006 Sep 30;368(9542):1138, commentary can be found in Am Fam Physician 2006 Dec 15;74(12):2110, ACP J Club 2007 Jan-Feb;146(1):22

Comparative efficacy for urinary stone expulsion:  tamsulosin may reduce pain and time to expulsion of distal ureteral stones

compared to nifedipine (level 2 [mid-level] evidence)o based on 3 randomized trials without blindingo  tamsulosin associated with decreased time to expulsion compared to

nifedipine in adults with renal colic and single distal ureteric stone (level 2 [mid-level] evidence) based on randomized trial without blinding 3,189 adults aged 18-50 years with renal colic and single 4-7 mm distal ureteric

stone randomized to tamsulosin 0.4 mg orally once daily vs. nifedipine 10 mg orally 3 times daily

all patients had levofloxacin 0.2 g orally twice daily and analgesics on demand comparing tamsulosin vs. nifedipine

spontaneous stone expulsion in 95.9% vs. 73.5% (p < 0.01, NNT 4) median time to stone expulsion 78.4 hours vs. 137.9 hours (p < 0.01) median analgesic use 52.35 mg vs. 109.33 mg (p < 0.01)

no significant difference in side effects Reference - BJU Int 2011 Jul;108(2):276

o tamsulosin may reduce pain and time to expulsion of distal ureteral stones compared to nifedipine or phloroglucinol (level 2 [mid-level] evidence) based on randomized trial without blinding 210 patients with symptomatic distal ureteral calculi > 4 mm (mean 6.5 mm)

were randomized to 1 of 3 groups for up to 28 days tamsulosin  0.4 mg/day (alpha blocker) nifedipine 20 mg/day (calcium channel blocker) phloroglucinol (anticholinergic)

all patients treated with oral corticosteroids and diclofenac (NSAID) comparing tamsulosin vs. nifedipine vs. phloroglucinol

spontaneous passage of stone in 97% vs. 77% vs. 64% (p < 0.0001, NNT 3-5 favoring tamsulosin)

median time to stone passage 3 days vs. 5 days vs. 5 days unclear whether stone passage was documented by stone retrieval tamsulosin associated with superior control of renal colic pain and fewer

workdays lost nifedipine had lower analgesic use and fewer workdays lost compared with

phloroglucinol Reference - J Urol 2005 Jul;174(1):167

o tamsulosin may lead to slightly faster stone expulsion than nifedipine (level 2 [mid-level] evidence) based on small randomized trial without blinding 86 patients with lower ureteral stone 1 cm or smaller were randomized to 1 of 3

groups tamsulosin -based therapy (deflazacort 30 mg/day for up to 10

days, misoprostol 200 mcg twice daily and tamsulosin 0.4 mg once daily for up to 20 days)

nifedipine-based therapy (deflazacort 30 mg/day for up to 10 days, misoprostol 200 mcg twice daily and slow-release nifedipine 30 mg once daily for up to 28 days)

no-treatment control all 3 groups given diclofenac 75 mg injections as needed and advised to drink at

least 2 L of water daily 1 patient in each medication group dropped out due to side effects comparing nifedipine-based group vs. tamsulosin-based group vs. control

stone expulsion in 80% vs. 85% vs. 43% (significant comparing combined treatment groups vs. control)

mean expulsion time 9.3 days vs. 7.7 days vs. 12 days (significant comparing tamsulosin vs. control)

control patients received more diclofenac than medication groups Reference - J Urol 2004 Aug;172(2):568

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:

Oral:

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

hypertension 242 284 307 344 345 350 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

In pregnant women requiring urgent reduction of BP †, dose of 10–20 mg,

repeated after 30 minutes and then every 2–6 hours if necessary, has been used

in hospital setting.388

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. 500

If intolerable adverse effects occur, consider dosage reduction; if adverse effects

worsen or fail to resolve, may need to discontinue and switch to another

antihypertensive drug class. 501

General:

BP Monitoring and Treatment Goals: Carefully monitor BP during initial titration or subsequent upward adjustment in

dosage. 500 501

When available, use evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) to determine target dosages; target dosages usually can be achieved within 2–4 weeks but may take up to several months. 501

If adequate BP response not achieved with a single antihypertensive agent, add a second drug with demonstrated benefit; if goal BP still not achieved with optimal dosages of 2 antihypertensive agents, add a third drug. 501 May maximize dosage of the first drug before adding a second drug, or add a second drug before maximizing dosage of the initial drug. 501

Consider initiating antihypertensive therapy with a combination of drugs if patient's BP exceeds goal BP by >20/10 mm Hg. 500 501 503 504

Goal is to achieve and maintain optimal control of BP; individualize specific target BP based on consideration of multiple factors, including patient age and comorbidities, and currently available evidence from clinical studies. 500 501 (See Hypertension under Uses.)

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:

Oral:

Extended-release tablets: Maximum 90 mg (Adalat® CC) or 120 mg (Procardia XL®)

once daily. 126 342 350

Cautions and Adverse Effects

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 acute MI 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 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-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 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:

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

Metabolism:

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 arrhythmia a

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 control 342

Monitor glucose concentrations and adjust nifedipine dosage as needed 342

Alcohol Increased nifedipine bioavailability 236

Anticoagulants (e.g., coumarins) Possible increased PT 126 284 342

Antifungals, azoles (fluconazole, itraconazole, ketoconazole)

Possible increased plasma nifedipine concentrations 342

Monitor BP and adjust nifedipine dosage as needed 342

Antiretroviral agents (HIV protease inhibitors [amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir], nonnucleoside reverse transcriptase inhibitors [delavirdine])

Possible increased plasma nifedipine concentrations 342

Use concomitantly with caution; monitor patient carefully 342

Antituberculosis agents (rifabutin, rifampin)

Possible decreased plasma nifedipine concentrations 342 401 Adjust nifedipine dosage as needed 342

BenazeprilPossible attenuation of tachycardic effect of nifedipine 342

Candesartan Pharmacokinetic interaction unlikely 342

CarbamazepinePossible decreased plasma nifedipine concentrations 342 Adjust nifedipine dosage as needed 342

Clopidogrel Pharmacokinetic interaction unlikely 342

Digoxin Increased serum digoxin concentration 106 107126

Monitor serum digoxin concentrations when nifedipine therapy is initiated, discontinued, or dosage is adjusted in patients receiving digoxin 108 126 284 307342 Monitor for signs and symptoms of digoxin toxicity and reduce dosage if necessary 101 106 126 284 307

DiltiazemPossible increased plasma nifedipine concentrations 342 399

Dolasetron Pharmacokinetic interaction unlikely 342

ErythromycinPossible increased plasma nifedipine concentrations 342

Monitor BP and adjust nifedipine dosage as needed 342

Fentanyl Potential for severe hypotension a

If patient’s condition permits, temporarily withhold nifedipine for at least 36 hours before surgery if use of high-dose fentanyl is contemplated 126 284 342

FlecainideInsufficient clinical experience to recommend concomitant use 342

Grapefruit juiceIncreased nifedipine bioavailability 284 311 314323 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 therapy 342

Histamine H2-receptor antagonists (cimetidine, ranitidine)

Decreased clearance and increased plasma nifedipine concentrations and AUC with concomitant cimetidine or (to lesser extent) ranitidine 115 116 125 284 342

Cautiously titrate nifedipine dosage in patients receiving cimetidine; may need to reduce nifedipine dosage in patients stabilized on the drug if cimetidine therapy is initiated 115 125 284 342

Hypotensive agents (captopril, doxazosin, hydralazine, methyldopa) Increased incidence of severe hypotension a

Observe patient closely when nifedipine is added to existing antihypertensive regimen, especially during initial titration or upward adjustment of nifedipine dosage 126 284 342

Irbesartan Pharmacokinetic interaction unlikely 342

Metformin Possible increased absorption of metformin 342

NefazodonePossible increased plasma nifedipine concentrations 342

Monitor BP and adjust nifedipine dosage as needed 342

Omeprazole Pharmacokinetic interaction unlikely 342

Pantoprazole Pharmacokinetic interaction unlikely 342

PhenobarbitalPossible decreased plasma nifedipine concentrations 342 Adjust nifedipine dosage as needed 342

Phenytoin

Possible decreased phenytoin metabolism; 166167 possible decreased plasma nifedipine concentrations 342

Monitor plasma phenytoin concentrations when nifedipine is initiated or discontinued; 166 monitor BP and adjust nifedipine dosage as needed 342

Quinidine

Possible increased plasma nifedipine concentrations; 342 397 possible decreased serum quinidine concentrations 284 307 332 333334 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 accordingly 333 334 335 336 337

Quinupristin and dalfopristin

Possible increased plasma nifedipine concentrations 342 378

Monitor BP and adjust nifedipine dosage as needed 342

Sirolimus Pharmacokinetic interaction unlikely 342

St. John’s wortPossible decreased plasma nifedipine concentrations 342 Adjust nifedipine dosage as needed 342

TacrolimusPossible increased plasma tacrolimus concentrations 342

Monitor tacrolimus blood concentrations and adjust tacrolimus dosage as needed342

Tirofiban Pharmacokinetic interaction unlikely 342

Valproic acidPossible increased plasma nifedipine concentrations 342

Monitor BP and adjust nifedipine dosage as needed 342

VerapamilPossible increased plasma nifedipine concentrations 342

Monitor BP and adjust nifedipine dosage as needed 342

Mechanism of Action/Pharmacokinetics

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

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 cirrhosis 126 132 133 284 307 342 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 renal 126 133 139 284 307 342 or

hepatic 126 132 133 284 307 342 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 and Compatibility

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

Preparations

Tables of Preparations:

Routes Dosage FormsStrength

s Brand Names Manufacturer

OralCapsules, 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

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

Nifedipine:

Comparative Pricing:

This pricing information is subject to change at the sole discretion of DS Pharmacy. This

pricing information was updated 12/2014. For the most current and up-to-date pricing

information, please visit www.drugstore.com. 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

Medication Cost Assistance Programs: medication cost assistance programs for Nifedipine from NeedyMedsPatient Information

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.)

Guidelines and Resources

Guidelines:  American Geriatrics Society (AGS) Beers Criteria 2012 recommendation on potentially

inappropriate medication use in older adults can be found in J Am Geriatr Soc 2012 Apr;60(4):616 PDF or at National Guideline Clearinghouse 2012 Nov 5:37706

MEDLINE Search:

to search MEDLINE for (Nifedipine) with targeted search (Clinical Queries for therapy articles), click here

References

General References Used: Unless otherwise stated, source material derived from AHFS Drug Information

Essentials®. The AHFS Drug Information Essentials database is copyrighted by the American Society of Health-System Pharmacists, Inc. © 2010 ASHP, Bethesda, Maryland 20814. All Rights Reserved. Duplication must be expressly authorized by ASHP, unless such duplication consists of printing or downloading portions of the data inherent in the program for non-commercial use. Used with permission.

The American Society of Health-System Pharmacists, Inc. represents that the database provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such database and specifically disclaims all such warranties and representations. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the database is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug in the database. The information contained in the database is not a substitute for medical care.

Recommendation Grading Systems Used:  American Geriatrics Society (AGS) Beers Criteria grading system for recommendations

o strength of recommendation Strong - benefits clearly outweigh risks and burden, or risks and burden clearly

outweigh benefits Weak - benefits finely balanced with risks and burden Insufficient - insufficient evidence to determine net benefits or risks

o quality of evidence High - evidence includes consistent results from well-designed, well-conducted

studies in representative populations that directly assess effects on health outcomes, based on either ≥ 2 consistent, higher quality randomized controlled trials multiple, consistent observational studies with no significant methodological

flaws showing large effects Moderate - evidence sufficient to determine effects on health outcomes, but

strength of evidence limited by any of number, quality, size, or consistency of included studies generalizability to routine practice indirect nature of evidence on health outcomes

Low - evidence insufficient to assess effects on health outcomes due to any of limited number or power of studies large and unexplained inconsistency between higher quality studies important flaws in study design or conduct gaps in chain of evidence lack of information on important health outcomes

o Reference - AGS 2012 Beers Criteria for potentially inappropriate medication use in older adults (J Am Geriatr Soc 2012 Apr;60(4):616 full-text)

DynaMed Editorial Process: DynaMed topics are created and maintained by the DynaMed Editorial Team. Over 500 journals and evidence-based sources (DynaMed Content Sources) are

monitored directly or indirectly using a 7-Step evidence-based method for systematic literature surveillance. DynaMed topics are updated daily as newly discovered best available evidence is identified.

The participating members of the DynaMed Editorial Team have declared that they have no financial or other competing interests related to this topic.

The participating reviewers have declared that they have no financial or other competing interests related to this topic, unless otherwise indicated.

McMaster University is a partner that provides support in identifying Practice-Changing DynaMed Updates. Over 1,000 practicing physicians from 61 disciplines in 77 countries rate these articles to help you find the most useful new evidence affecting your practice.

F1000 is a partner that provides support in identifying Practice-Changing DynaMed Updates. Over 2,000 practicing clinicians from 20 disciplines in 60 countries rate these articles to help you find the most useful new evidence affecting your practice.

How to Cite: For attribution in other publications see How to Cite Information from DynaMed.

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181.Epstein M. Targeting antihypertensive therapy to the individual patient. J Clin Hypertens. 1986; 3:62-71S.

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191.Murphy MB, Bulpitt CJ, Dollery CT. Role of nifedipine in the treatment of resistant hypertension: comparison with hydralazine in hospital outpatients. Am J Med. 1984; 77:16-21. [IDIS 190958] [PubMed 6486124]

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196.Fadayomi MO, Akinroye KK, Ajao RO et al. Monotherapy with nifedipine for essential hypertension in adult blacks. J Cardiovasc Pharmacol. 1986; 8:466-9. [PubMed 2425159]

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198.Frishman WH, Charlap S, Kimmel B et al. Calcium-channel blockers for combined angina pectoris and systemic hypertension. Am J Cardiol. 1986; 57:22-9D.

199.Yagil Y, Kobrin I, Stessman J et al. Acute oral management of hypertension: blood pressure response to prazosin and nifedipine. Isr J Med Sci. 1983; 19:277-9. [PubMed 6853125]

200.Donnelly R, Elliott HL, Meredith PA et al. Nifedipine: individual responses and concentration-effect relationships. Hypertension. 1988; 12:443-9. [PubMed 3169952]

201.Ekelund LG. Nifedipine in combination therapy for chronic hypertension: a review. Am J Med. 1985; 79(Suppl 4A):41-3. [IDIS 207210] [PubMed 2864857]

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203.Buhler FR, Hulthen UL, Kiowski W et al. The place of the calcium antagonist verapamil in antihypertensive therapy. J Cardiovasc Pharmacol. 1982; (Suppl 3):350-7.

204.Bursztyn M, Grossman E, Rosenthal T. Nifedipine in antihypertensive therapy. Arch Intern Med. 1985; 145:953-4. [PubMed 3994476]

205.Evans MG Jr, Olanoff LS, Hurwitz G et al. Use of nifedipine as an adjunct to current antihypertensive therapy. Arch Intern Med. 1984; 144:985-7. [IDIS 184755] [PubMed 6143543]

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†.Use is not currently included in the labeling approved by the US Food and Drug Administration.

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