THE MERCK MANUAL: The Merck Manual of Diagnosis and Therapy
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NIFEdipine Drug Information Provided by Lexi-Comp

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This information has been developed and provided by an independent third-party source. Merck & Co., Inc. does not endorse and is not responsible for the accuracy of the content, or for practices or standards of non-Merck sources.

Pronunciation

(nye FED i peen)

Generic Available (U.S.)

Yes

Brand Names: U.S.

  • Adalat® CC
  • Afeditab® CR
  • Nifediac CC®
  • Nifedical XL®
  • Procardia XL®
  • Procardia®

Brand Names: Canada

  • Adalat® XL®
  • Apo-Nifed PA®
  • Mylan-Nifedipine Extended Release
  • Nu-Nifed
  • Nu-Nifedipine-PA
  • PMS-Nifedipine

Pharmacologic Category

  • Antianginal Agent
  • Calcium Channel Blocker
  • Calcium Channel Blocker, Dihydropyridine

Pharmacologic Category Synonyms

  • CCB
  • Dihydropyridine Calcium Channel Blocker

Use: Labeled Indications

Management of chronic stable or vasospastic angina; treatment of hypertension (sustained release products only)

Use: Unlabeled

Management of pulmonary hypertension, preterm labor, and Raynaud's phenomenon; prevention and treatment of high altitude pulmonary edema

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies. Nifedipine crosses the placenta. Use in pregnancy only when clearly needed and when the benefits outweigh the potential hazard to the fetus. Hypotension, IUGR reported. IUGR probably related to maternal hypertension. May be used for the treatment of preterm labor.

Lactation

Enters breast milk/not recommended (AAP considers "compatible"; AAP 2001 update pending)

Contraindications

Hypersensitivity to nifedipine or any component of the formulation; concomitant use with strong CYP3A4 inducers (eg, rifampin); cardiogenic shock; immediate release preparation for treatment of urgent or emergent hypertension (Chobanian, 2003); acute MI (Antman, 2004)

Warnings/Precautions

Concerns related to adverse effects:

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

• Hypotension/syncope: Symptomatic hypotension with or without syncope can rarely occur; blood pressure must be lowered at a rate appropriate for the patient's clinical condition. The use of immediate release nifedipine (sublingually or orally) in hypertensive emergencies and urgencies is neither safe nor effective. Serious adverse events (eg, death, cerebrovascular ischemia, syncope, stroke, acute myocardial infarction, and fetal distress) have been reported. Immediate release nifedipine should not be used for acute blood pressure reduction.

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

Disease-related concerns:

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

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

• Heart failure (HF): Use with caution in patients with HF; may cause worsening of symptoms.

• Hepatic impairment: Use with caution in patients with hepatic impairment. Clearance of nifedipine is reduced in cirrhotic patients leading to increased systemic exposure; monitor closely for adverse effects/toxicity and consider dose adjustments.

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

Concurrent drug therapy issues:

• Potential for interactions: Use with caution in patients taking CYP3A4 inhibitors; may result in increased nifedipine concentrations; monitor for adverse effects/toxicity and consider dose adjustments. Use with strong CYP3A4 inducers (eg, rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, St John's wort) is contraindicated due to reduced bioavailability and efficacy.

Special populations:

• Elderly: Short-acting nifedipine may be inappropriate in this age group due to potential to cause hypotension and constipation (Beers Criteria).

Dosage form specific issues:

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

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

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

Other warnings/precautions:

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

• Withdrawal: Abrupt withdrawal may cause rebound angina in patients with CAD.

Adverse Reactions

>10%:

Cardiovascular: Flushing (10% to 25%; extended release products 3% to 4%), peripheral edema (dose related 7% to 30%)

Central nervous system: Dizziness/lightheadedness/giddiness (10% to 27%), headache (10% to 23%)

Gastrointestinal: Nausea/heartburn (10% to 11%)

≥1% to 10%:

Cardiovascular: Palpitation (≤2% to 7%), transient hypotension (dose related 5%), CHF (2%)

Central nervous system: Nervousness/mood changes (≤2% to 7%), fatigue (6%), shakiness (≤2%), jitteriness (≤2%), sleep disturbances (≤2%), difficulties in balance (≤2%), fever (≤2%), chills (≤2%)

Dermatologic: Dermatitis (≤2%), pruritus (≤2%), urticaria (≤2%)

Endocrine & metabolic: Sexual difficulties (≤2%)

Gastrointestinal: Diarrhea (≤2%), constipation (≤2%), cramps (≤2%), flatulence (≤2%), gingival hyperplasia (≤10%)

Neuromuscular & skeletal: Muscle cramps/tremor (≤2% to 8%), weakness (<3%), inflammation (≤2%), joint stiffness (≤2%)

Ocular: Blurred vision (≤2%)

Respiratory: Cough/wheezing (6%), nasal congestion/sore throat (≤2% to 6%), chest congestion (≤2%), dyspnea (≤2%)

Miscellaneous: Diaphoresis (≤2%)

<1% (Limited to important or life-threatening): Agranulocytosis, allergic hepatitis, alopecia, anemia, aplastic anemia, angina, angioedema, arrhythmia, arthritis with positive ANA, bezoars (Procardia XL®), cerebral ischemia, depression, dysosmia, epistaxis, EPS, erectile dysfunction, erythema multiforme, erythromelalgia, exanthematous pustulosis, exfoliative dermatitis, facial edema, gastroesophageal reflux, gastrointestinal obstruction (Procardia XL®), gastrointestinal ulceration (Procardia XL®), gynecomastia, hematuria, ischemia, leukopenia, memory dysfunction, migraine, myalgia, myoclonus, nocturia, paranoid syndrome, parotitis, periorbital edema, photosensitivity, polyuria, purpura, Stevens-Johnson syndrome, syncope, tachycardia, taste perversion, thrombocytopenia, tinnitus, toxic epidermal necrolysis, transient blindness, ventricular arrhythmia

Reported with use of sublingual short-acting nifedipine: Cerebrovascular ischemia, syncope, heart block, stroke, sinus arrest, severe hypotension, acute MI, ECG changes, and fetal distress

Metabolism/Transport Effects

Substrate of CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP1A2 (moderate), CYP2C9 (weak), CYP2D6 (weak), CYP3A4 (weak)

Drug Interactions

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

Alpha1-Blockers: May enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Amifostine: Antihypertensives may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, antihypertensive medications should be withheld for 24 hours prior to amifostine administration. If antihypertensive therapy can not be withheld, amifostine should not be administered. Risk D: Consider therapy modification

Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Calcium Channel Blockers. Risk D: Consider therapy modification

Antihypertensives: May enhance the hypotensive effect of other Antihypertensives. Risk C: Monitor therapy

ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole systemic exposure/affects with concomitant use of a weak CYP3A4 inhibitor. Decrease aripiprazole dose to 25% of the usual dose in patients receiving both a CYP3A4 and a CYP2D6 inhibitor (regardless of potencies). Risk C: Monitor therapy

ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult product labeling for specific recommendations. Risk C: Monitor therapy

Barbiturates: May increase the metabolism of Calcium Channel Blockers. Management: Monitor for decreased therapeutic effects of calcium channel blockers with concomitant barbiturate therapy. Calcium channel blocker dose adjustments may be necessary. Nimodipine Canadian labeling contraindicates concomitant use with phenobarbital. Risk C: Monitor therapy

Beta-Blockers: Calcium Channel Blockers (Dihydropyridine) may enhance the hypotensive effect of Beta-Blockers. Bradycardia and signs of heart failure have also been reported. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): Calcium Channel Blockers (Dihydropyridine) may enhance the hypotensive effect of Calcium Channel Blockers (Nondihydropyridine). Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

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

CarBAMazepine: May increase the metabolism of Calcium Channel Blockers (Dihydropyridine). Management: Consider calcium channel blocker (CCB) dose adjustments or alternative therapy in patients receiving concomitant carbamazepine. Nimodipine Canadian labeling contraindicates concurrent use with carbamazepine. Risk D: Consider therapy modification

Cimetidine: May increase the serum concentration of Calcium Channel Blockers. Management: Consider alternatives to cimetidine. If no suitable alternative exists, monitor for increased effects of calcium channel blockers following cimetidine initiation/dose increase, and decreased effects following cimetidine discontinuation/dose decrease. Risk D: Consider therapy modification

Cisapride: May increase the serum concentration of NIFEdipine. Reported with sustained release nifedipine product. Risk C: Monitor therapy

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

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Risk X: Avoid combination

CycloSPORINE: May decrease the metabolism of Calcium Channel Blockers (Dihydropyridine). Nicardipine may likewise inhibit the metabolism of cyclosporine. Cyclosporine dosage adjustments might be needed. Risk C: Monitor therapy

CycloSPORINE (Systemic): May decrease the metabolism of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

CYP1A2 Substrates: CYP1A2 Inhibitors (Moderate) may decrease the metabolism of CYP1A2 Substrates. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of NIFEdipine. Management: Consider alternatives to nifedipine for patients who are using strong CYP3A4 inducers. At least one specific brand of nifedipine (Adalat CC) lists this combination as contraindicated. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Antihypertensives. Risk C: Monitor therapy

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

Fluconazole: May decrease the metabolism of Calcium Channel Blockers. Risk C: Monitor therapy

FLUoxetine: May enhance the adverse/toxic effect of NIFEdipine. Risk C: Monitor therapy

Fosphenytoin: Calcium Channel Blockers may increase the serum concentration of Fosphenytoin. Management: Monitor for phenytoin toxicity with concomitant use of a calcium channel blocker (CCB) or decreased phenytoin effects with CCB discontinuation. Monitor for decreased CCB therapeutic effects. Nimodipine Canadian labeling contraindicates use with phenytoin. Risk D: Consider therapy modification

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

Herbs (CYP3A4 Inducers): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensives. Risk C: Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Antihypertensives. Risk C: Monitor therapy

Hypotensive Agents: May enhance the adverse/toxic effect of other Hypotensive Agents. Risk C: Monitor therapy

Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Macrolide Antibiotics: May decrease the metabolism of Calcium Channel Blockers. Management: Consider using a noninteracting macrolide. Monitor for increased therapeutic effects of calcium channel blockers if an interacting macrolide antibiotic is initiated, or decreased effects if a macrolide is discontinued. Exceptions: Azithromycin; Azithromycin (Systemic); Fidaxomicin; Spiramycin. Risk D: Consider therapy modification

Magnesium Salts: Calcium Channel Blockers may enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

MAO Inhibitors: May enhance the orthostatic hypotensive effect of Orthostatic Hypotension Producing Agents. Risk C: Monitor therapy

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

Nafcillin: May increase the metabolism of Calcium Channel Blockers. Risk D: Consider therapy modification

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

Nitroprusside: Calcium Channel Blockers may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Antihypertensives. Risk C: Monitor therapy

Phenytoin: Calcium Channel Blockers may increase the serum concentration of Phenytoin. Management: Monitor for phenytoin toxicity with concomitant use of a calcium channel blocker (CCB) or decreased phenytoin effects with CCB discontinuation. Monitor for decreased CCB therapeutic effects. Nimodipine Canadian labeling contraindicates use with phenytoin. Risk D: Consider therapy modification

Phosphodiesterase 5 Inhibitors: May enhance the antihypertensive effect of Antihypertensives. Risk C: Monitor therapy

Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination

Prostacyclin Analogues: May enhance the hypotensive effect of Antihypertensives. Risk C: Monitor therapy

Protease Inhibitors: May decrease the metabolism of Calcium Channel Blockers (Dihydropyridine). Risk D: Consider therapy modification

QuiNIDine: May increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Calcium Channel Blockers (Dihydropyridine) may decrease the serum concentration of QuiNIDine. Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of QuiNIDine. Risk C: Monitor therapy

Rifamycin Derivatives: May increase the metabolism of Calcium Channel Blockers. This primarily affects oral forms of calcium channel blockers. Management: The labeling for some U.S. and Canadian calcium channel blockers contraindicate use with rifampin however recommendations vary. Consult appropriate labeling. Risk D: Consider therapy modification

RiTUXimab: Antihypertensives may enhance the hypotensive effect of RiTUXimab. Risk D: Consider therapy modification

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

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

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

VinCRIStine: NIFEdipine may decrease the excretion of VinCRIStine. Risk C: Monitor therapy

Yohimbine: May diminish the antihypertensive effect of Antihypertensives. Risk C: Monitor therapy

Ethanol/Nutrition/Herb Interactions

Ethanol: Ethanol may increase CNS depression and may increase the effects of nifedipine. Management: Avoid ethanol.

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

Herb/Nutraceutical: St John's wort may decrease nifedipine levels. Some herbal medications (eg, licorice) may worsen hypertension; others may increase the antihypertensive effect of nifedipine (eg, shepherd's purse). Management: Avoid bayberry, blue cohosh, cayenne, ephedra, ginger, ginseng (American), kola, licorice, and yohimbe. Avoid black cohosh, California poppy, coleus, golden seal, hawthorn, mistletoe, periwinkle, quinine, and shepherd's purse.

Mechanism of Action

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

Pharmacodynamics/Kinetics

Onset of action: Immediate release: ~20 minutes

Protein binding (concentration dependent): 92% to 98%

Metabolism: Hepatic via CYP3A4 to inactive metabolites

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

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

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

Dosage

Oral:

Children 1-17 years:

High altitude pulmonary edema (unlabeled use; Pollard, 2001): Note: Treatment with nifedipine is only necessary if response to oxygen and/or descent is unsatisfactory; extended release preparation is preferred at equivalent dose with proper frequency adjustment:

Immediate release: 0.5 mg/kg/dose (maximum: 20 mg/dose) every 8 hours

Hypertension (unlabeled use): Extended release tablet: Initial: 0.25-0.5 mg/kg/day once daily or in 2 divided doses; maximum: 3 mg/kg/day up to 120 mg/day

Adults: Note: Dosage adjustments should occur at 7- to 14-day intervals, to allow for adequate assessment of new dose; when switching from immediate release to sustained release formulations, use same total daily dose.

Chronic stable or vasospastic angina:

Immediate release: Initial: 10 mg 3 times/day; usual dose: 10-20 mg 3 times/day; coronary artery spasm may require up to 20-30 mg 3-4 times/day; single doses >30 mg and total daily doses >120 mg are rarely needed; maximum: 180 mg/day; Note: Do not use for acute anginal episodes; may precipitate myocardial infarction

Extended release: Initial: 30 or 60 mg once daily; maximum: 120-180 mg/day

Hypertension: Extended release: Initial: 30 or 60 mg once daily; maximum: 90-120 mg/day

High altitude pulmonary edema (unlabeled use; Luks, 2010):

Prevention: Extended release: 30 mg every 12 hours starting the day before ascent and may be discontinued after staying at the same elevation for 5 days or if descent initiated

Treatment: Extended release: 30 mg every 12 hours

Pulmonary hypertension (unlabeled use; Galie, 2004): Extended release: Initial: 30 mg twice daily; may increase cautiously to 120-240 mg/day

Raynaud's phenomenon (unlabeled use; Wigley, 2002): Extended release: Dosage range: 30-120 mg once daily

Elderly: Hypertension: Consider lower initial doses and titrate to response (Aronow, 2011)

Hemodialysis: Supplemental dose is not necessary

Peritoneal dialysis effects: Supplemental dose is not necessary

Dosing adjustment in hepatic impairment: Clearance of nifedipine is reduced in cirrhotic patients leading to increased systemic exposure; monitor closely for adverse effects/toxicity and consider dose adjustments.

Administration: Oral

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

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

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

Monitoring Parameters

Heart rate, blood pressure, signs and symptoms of CHF, peripheral edema

Dietary Considerations

Avoid grapefruit juice with all products.

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

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

Patient Education

Do not crush or chew sustained release forms; swallow whole. Avoid grapefruit and grapefruit juice. When used to manage angina, consult prescriber before increasing exercise routine. May cause dizziness, gum pain and swelling, flushing, difficulties in balance, fatigue, or constipation. Notify prescriber of chest pain or palpitations, swelling of extremities, respiratory difficulty, rash, severe headache, or severe constipation.

Geriatric Considerations

Elderly may experience a greater hypotensive response. Theoretically, constipation may be more of a problem in elderly patients. The half-life of nifedipine is extended in elderly patients (6.7 hours) as compared to younger subjects (3.8 hours).

This medication is considered to be potentially inappropriate in this patient population (Beers Criteria severity: High).

Additional Information

When measuring smaller doses from the liquid-filled capsules, consider the following concentrations (for Procardia®) 10 mg capsule = 10 mg/0.34 mL; 20 mg capsule = 20 mg/0.45 mL; may be used preoperative to treat hypertensive urgency.

Considerable attention has been directed to potential increases in mortality and morbidity when short-acting nifedipine is used in treating hypertension. The rapid reduction in blood pressure may precipitate adverse cardiovascular events.

Short-acting nifedipine should not be used for acute anginal episodes since this may precipitate myocardial infarction. Extended-release formulations are preferred for the management of chronic or vasospastic angina (Poole-Wilson, 2004).

Equivalency of extended release formulation (Adalat® CC): The manufacturer states that it is acceptable to interchange two 30 mg tablets with one 60 mg tablet to effectively deliver a 60 mg dose. However, it is not recommended to substitute one 90 mg tablet with three 30 mg tablets, since the resulting Cmax is 29% higher compared to giving the single 90 mg tablet.

Cardiovascular Considerations

Considerable attention has been directed to potential increases in mortality and morbidity when short-acting nifedipine is used in treating hypertension. The rapid reduction in blood pressure may precipitate adverse cardiovascular events.

Short-acting nifedipine should not be used for acute anginal episodes since this may precipitate myocardial infarction. Extended-release formulations are preferred for the management of chronic or vasospastic angina (Poole-Wilson, 2004).

In the treatment of unstable angina/non-ST-segment elevation MI, a nondihydropyridine calcium antagonist (diltiazem or verapamil) may be considered in patients with continuing or frequently recurring ischemia when beta-blockers are contraindicated (Class I). Oral long-acting calcium antagonists may also be considered in addition to beta-blockers and nitrates (Class IIa).

Dental Health: Effects on Dental Treatment

Nifedipine has been reported to cause 10% incidence of gingival hyperplasia; effects from 30-100 mg/day have appeared after 1-9 months. Discontinuance results in complete disappearance or marked regression of symptoms; symptoms will reappear upon remedication. Marked regression occurs after 1 week and complete disappearance of symptoms has occurred within 15 days. If a gingivectomy is performed and use of the drug is continued or resumed, hyperplasia usually will recur. The success of the gingivectomy usually requires that the medication be discontinued or that a switch to a noncalcium channel blocker be made. If for some reason nifedipine cannot be discontinued, hyperplasia has not recurred after gingivectomy when extensive plaque control was performed. If nifedipine is changed to another class of cardiovascular agent, the gingival hyperplasia will probably regress and resolve. Switching to another calcium channel blocker may result in continued hyperplasia.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

Dizziness is common; may cause nervousness, sedation, or mood changes

Mental Health: Effects on Psychiatric Treatment

May cause leukopenia; use caution with clozapine and carbamazepine; concurrent use with propranolol may increase AV nodal effects; barbiturates may decrease effects of nifedipine

Nursing: Physical Assessment/Monitoring

Use caution in presence of obstructive coronary disease (aortic stenosis), severe hepatic impairment, or heart failure. Monitor for hypotension, peripheral edema, and constipation when starting, adjusting dose, or discontinuing. Teach patient orthostatic precautions.

Dosage Forms

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

Capsule, softgel, oral: 10 mg, 20 mg

Procardia®: 10 mg

Tablet, extended release, oral: 30 mg, 60 mg, 90 mg

Adalat® CC: 30 mg, 60 mg, 90 mg

Afeditab® CR: 30 mg, 60 mg

Nifediac CC®: 30 mg, 60 mg

Nifediac CC®: 90 mg [contains tartrazine]

Nifedical XL®: 30 mg, 60 mg

Procardia XL®: 30 mg, 60 mg, 90 mg

Pricing: U.S. (www.drugstore.com)

Capsules (NIFEdipine)

10 mg (90): $72.69

20 mg (90): $149.99

Capsules (Procardia)

10 mg (90): $115.38

Tablet, 24-hour (Adalat CC)

30 mg (30): $54.99

60 mg (30): $83.99

90 mg (30): $98.62

Tablet, 24-hour (Afeditab CR)

30 mg (30): $46.52

60 mg (30): $63.86

Tablet, 24-hour (Nifediac CC)

60 mg (30): $49.99

90 mg (30): $61.99

Tablet, 24-hour (NIFEdipine)

30 mg (100): $94.99

60 mg (90): $129.96

Tablet, 24-hour (NIFEdipine CR Osmotic)

30 mg (30): $37.99

60 mg (30): $59.99

90 mg (30): $75.99

Tablet, 24-hour (Procardia XL)

30 mg (30): $79.79

60 mg (30): $128.49

90 mg (30): $145.86

Extemporaneously Prepared

A 4 mg/mL oral suspension may be made with liquid capsules (Note: Concentration inside capsule may vary depending on manufacturer. Procardia®: 10 mg capsule contains a concentration of 10 mg/0.34 mL [29.4 mg/mL]). Puncture the top of twelve 10 mg liquid capsules with one needle to create a vent. Insert a second needle attached to a syringe and extract the liquid; transfer to a calibrated bottle and add sufficient quantity of a 1:1 mixture of Ora-Sweet® and Ora-Plus® to make 30 mL. Label "shake well". Stable 90 days under refrigeration or at room temperature.

Nahata MC, Morosco RS, and Willhite EA, "Stability of Nifedipine in Two Oral Suspensions Stored at Two Temperatures," J Am Pharm Assoc, 2002, 42(6):865-7.

References

American Academy of Pediatrics Committee on Drugs, "Transfer of Drugs and Other Chemicals Into Human Milk," Pediatrics, 2001, 108(3):776-89.

Anderson JL, Adams CD, Antman EM, et al, "2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines," Circulation, 2011, 123(18):e426-579.

Antman EM, Anbe DT, Armstrong PW, et al, “ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction),” Circulation, 2004, 110(9):e82-292.

Antman EM, Hand M, Armstrong PW, et al, “2007 Focused Update of the ACC/AHA 2004 Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines,” J Am Coll Cardiol, 2008, 51(2):210-49.

Aronow WS, Fleg JL, Pepine CJ, et al, “ACCF/AHA 2011 Expert Consensus Document on Hypertension in the Elderly: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents,” Circulation, 2011, 123(21):2434-506.

Badesch DB, Abman SH, Simonneau G, et al, “Medical Therapy for Pulmonary Arterial Hypertension: Updated ACCP Evidence-Based Clinical Practice Guidelines,” Chest, 2007, 131(6):1917-28.

Braunwald E, Antman EM, Beasley JW, et al, “ACC/AHA Guidelines for the Management of Patients With Unstable Angina and Non-ST-Segment Elevation Myocardial Infarction. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina),” J Am Coll Cardiol, 2000, 36(3):970-1062.

Chobanian AV, Bakris GL, Black HR, et al, “The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 Report,” JAMA, 2003, 289(19):2560-71.

Fraker TD, Fihn SD, Gibbons RJ, et al, “2007 Chronic Angina Focused Update of the ACC/AHA 2002 Guidelines for the Management of Patients With Chronic Stable Angina: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Writing Group to Develop the Focused Update of the 2002 Guidelines for the Management of Patients With Chronic Stable Angina,” Circulation, 2007, 116(23):2762-72.

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International Brand Names

  • Adalat (AR, AT, BE, BF, BJ, BR, CH, CI, CN, CR, CZ, DE, DK, EE, ES, ET, FI, GB, GH, GM, GN, GR, GT, HK, HN, HR, HU, ID, IE, IT, JP, KE, KP, LR, LU, MA, ML, MR, MU, MW, MX, MY, NE, NG, NI, NO, PA, PE, PH, PK, PL, PT, RU, SC, SD, SE, SL, SN, SV, TN, TR, TZ, UG, UY, VE, ZA, ZM, ZW)
  • Adalat 10 (AU)
  • Adalat 20 (AU)
  • Adalat CR (BG, CH, GR, JP, TH)
  • Adalat Crono (IT)
  • Adalat GITS (CL, HK)
  • Adalat GITS 30 (PH)
  • Adalat L (JP)
  • Adalat LA (GB, MY)
  • Adalat LP (FR)
  • Adalat Oros (AU, BB, BM, BR, BS, BZ, CN, CO, DK, DO, EC, EE, ES, FI, GY, ID, JM, KP, NL, NO, NZ, PE, PR, PY, SE, SR, TT, TW, UY, VE)
  • Adalat Retard (AE, AT, BF, BH, BJ, BR, CI, CN, CR, CY, CZ, DE, EG, ES, ET, GB, GH, GM, GN, GR, GT, HK, HN, ID, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, MY, NE, NG, NI, OM, PA, PE, PH, PL, PY, QA, SA, SC, SD, SL, SN, SV, SY, TN, TZ, UG, YE, ZM, ZW)
  • Adalate (FR)
  • Addos XR (AU)
  • Adefin XL (AU)
  • Adifen SR (MY)
  • Adipine XL (GB)
  • Aprical (DE, LU)
  • Atanaal Softcap (TW)
  • Calcibloc (PH)
  • Calcibloc OD (PH)
  • Calcigard (IN, SG, TH)
  • Cardifen (ZA)
  • Chronadalate LP (FR)
  • Citilat (IT)
  • Coracten (AE, BH, CY, DE, EG, GB, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Coral (IT)
  • Cordaflex (BG, HU)
  • Cordilat (MX)
  • Cordipen (SG)
  • Cordipen Retard (SG)
  • Cordipin (HK, HR)
  • Corinfar (HU)
  • Coronpin (ID)
  • Corotrend (DE)
  • Depin (IN)
  • Depin-E Retard (TH)
  • Dignokonstant (DE)
  • Dipinkor (ID)
  • Duranifin (DE)
  • Ecodipin (CH)
  • Fenamon (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, MY, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW)
  • Ficor (ID)
  • Glopir (GR)
  • Hexadilat (DK)
  • Huma-Nifedin (HU)
  • Jutadilat (DE)
  • Myogard (AE, BH, CY, EG, IN, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Nedipin (TW)
  • Nelapine (PH)
  • Nicardia CD (TH)
  • Nidipin (HU)
  • Nifadil (HR)
  • Nifangin (FI)
  • Nifar (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW)
  • Nifar-GB (MX)
  • Nifdemin (FI)
  • Nifebene (AT)
  • Nifecard (AT, HR)
  • Nifecard XL (SG)
  • Nifecor (DE)
  • Nifedepat (DE)
  • Nifedicor (IT)
  • Nifedigel (MX)
  • NIfedilat (ZA)
  • Nifedilong (IL)
  • Nifedin (IT)
  • Nifedine (IN)
  • Nifedipin (HR)
  • Nifedipin AL (HU)
  • Nifedipin Pharmavit (HU)
  • Nifedipin Stada (LU)
  • Nifedipin-ratiopharm (LU)
  • Nifedix SR (KP)
  • Nifehexal (AU, LU)
  • Nifelat (AR, HK, TH)
  • Nifelat-Q (TH)
  • Nifensar (PE)
  • Nifensar Retard (PE)
  • Niferon CR (KP)
  • Nifeslow (LU)
  • Nifestad (PH)
  • Nifezzard (MX)
  • Nificard (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Nifipen (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Niften (IE)
  • Noviken LP (MX)
  • Nyefax (AU)
  • Nyefax Retard (NZ)
  • Odipin (PH)
  • Orix (GR)
  • Osmo-Adalat (IL)
  • Pidilat (DE)
  • Pressolat (IL)
  • Sepamit (JP)
  • Slow-Nifine (LU)
  • Stada Uno (SG)
  • Unidipin (HU, LU)
  • Vasdalat (ID)
  • Vasdalat Retard (ID)
  • Xin Ran (CL)
  • Zenusin (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW)

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