UpToDate - Nifedipina
UpToDate - Nifedipina
(For additional information see "Nifedipine: Patient drug information" and see "Nifedipine: Pediatric drug
information")
For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: US Adalat CC; Afeditab CR; Nifediac CC [DSC]; Nifedical XL [DSC]; Procardia; Procardia
XL
Brand Names: Canada Adalat XL; Apo-Nifed PA; Mylan-Nifedipine Extended Release; Nifedipine ER;
PMS-Nifedipine; PMS-Nifedipine ER
Dosing: Adult Dosage adjustments should occur at 7- to 14-day intervals to allow for adequate
assessment of new dose; however, if clinically indicated, titration may be done more rapidly with appropriate
monitoring; when switching from immediate-release to sustained-release formulations, use same total daily
dose.
Immediate release: Initial: 10 mg 3 times daily; usual dose: 10 to 20 mg 3 times daily; coronary
artery spasm may require up to 20 to 30 mg 3 to 4 times daily; single doses >30 mg and total daily
doses >120 mg are rarely needed; maximum: 180 mg daily; Note: Do not use for acute anginal
episodes; may precipitate myocardial infarction
Extended release: Initial: 30 or 60 mg once daily; titrate as clinically indicated. Doses >90 mg daily
should be used with caution and only if necessary (maximum: 120 mg daily)
Hypertension: Oral: Extended release: Initial: 30 or 60 mg once daily; usual dosage range (ASH/ISH
[Weber 2014]): 30 to 90 mg daily; maximum: 90 to 120 mg daily
Prevention: ER: 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 (WMS [Luks 2014]).
Pulmonary hypertension (off-label use): Oral: Note: Guidelines recommend the sustained-release
formulation, which is not available in the US; dosing is provided empirically for the ER formulation.
ER: Initial: 60 mg once daily (initiate after demonstrating acute vasoreactivity); may increase
cautiously to 120 to 240 mg/day (ESC [Galie 2016]; Taichman 2014).
Extended release: Dosage range: 30 to 120 mg once daily (Thompson 2005; Wigley 2002)
Ureteral calculi (distal) (off-label use): Oral: 10 to 30 mg 3 times daily for up to 4 weeks or until
expulsion of lower stones (Ye 2011; Zhang 2009)
Dosing: Pediatric
(For additional information see "Nifedipine: Pediatric drug information")
High altitude pulmonary edema (off-label use; Pollard, 2001): Oral: Note: Treatment with NIFEdipine is
only necessary if response to oxygen and/or descent is unsatisfactory; extended release preparation is
preferred, but with proper dose and frequency adjustment:
Hypertension (off-label use): Oral: Children 1 to 17 years: Extended release tablet: Initial: 0.2 to 0.5
mg/kg/day once daily or in 2 divided doses; maximum: 3 mg/kg/day up to 120 mg daily
Dosing: Geriatric Refer to adult dosing. In the management of hypertension, consider lower initial
doses and titrate to response (Aronow 2011).
Dosing: Renal Impairment There are no dosage adjustments provided in manufacturer's labeling
(has not been studied); the pharmacokinetics of nifedipine are not significantly influenced by the degree of
renal impairment (only trace amounts of unchanged drug are found in urine).
Dosing: Hepatic Impairment There are no dosage adjustments provided in manufacturer's labeling
(has not been studied); use with caution. Clearance of nifedipine is reduced in cirrhotic patients, which may
lead to increased systemic exposure; monitor closely for adverse effects/toxicity and consider dose
adjustments.
Dosage Forms Excipient information presented when available (limited, particularly for generics);
consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
Procardia: 10 mg
Generic: 10 mg, 20 mg
Administration
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.
Use Management of chronic stable or vasospastic angina; treatment of hypertension (ER products only)
Guideline recommendations:
Hypertension:
The 2014 guideline for the management of high blood pressure in adults (JNC 8) recommends
initiation of pharmacologic treatment to lower blood pressure for the following patients (JNC 8
[James, 2013]):
• Patients ≥60 years with systolic blood pressure (SBP) ≥150 mm Hg or diastolic blood
pressure (DBP) ≥90 mm Hg.
• Patients ≥18 years with diabetes with SBP ≥140 mm Hg or DBP ≥90 mm Hg.
• Patients ≥18 years with chronic kidney disease (CKD) with SBP ≥140 mm Hg or DBP ≥90
mm Hg.
Chronic kidney disease (CKD) and hypertension: In patients with chronic kidney disease (CKD),
regardless of race or diabetes status, the use of an ACE inhibitor (ACEI) or angiotensin
receptor blocker (ARB) as initial therapy is recommended to improve kidney outcomes. In the
general nonblack population (without CKD) including those with diabetes, initial
antihypertensive treatment should consist of a thiazide-type diuretic, calcium channel blocker,
ACEI, or ARB. In the general black population (without CKD) including those with diabetes,
initial antihypertensive treatment should consist of a thiazide-type diuretic or a calcium
channel blocker instead of an ACEI or ARB.
Diabetes and hypertension: The American Diabetes Association (ADA) guidelines suggest that
for patients with hypertension and diabetes without albuminuria, any of the 4 classes of blood
pressure medications (eg, ACE inhibitors, angiotensin receptor blockers, thiazide-like diuretics,
dihydropyridine calcium channel blockers) may be used and have shown beneficial
cardiovascular outcomes (ADA 2017a).
Use: Off-Label
Achalasia; High altitude pulmonary edema (prevention and treatment); Hypertensive emergency in
pregnancy; Preterm labor; Pulmonary hypertension; Raynaud phenomenon; Ureteral calculi (distal)
Sound-alike/look-alike issues:
International issues:
Depin [India] may be confused with Depen brand name for penicillamine [US]; Depon brand name
for acetaminophen [Greece]; Dipen brand name for diltiazem [Greece]
Nipin [Italy and Singapore] may be confused with Nipent brand name for pentostatin [US, Canada,
and multiple international markets]
Adverse Reactions
>10%:
Cardiovascular: Flushing (10% to 25%; extended release: 3% to 4%), peripheral edema (7% to 30%)
1% to 10%:
Central nervous system: Mood changes (≤7%), nervousness (≤7%), fatigue (6%), chills (≤2%),
disturbed sleep (≤2%), equilibrium disturbance (≤2%), jitteriness (≤2%), shakiness (≤2%)
Gastrointestinal: Gingival hyperplasia (≤10%), sore throat (≤6%), abdominal cramps (≤2%),
constipation (≤2%), diarrhea (≤2%), flatulence (≤2%)
Neuromuscular & skeletal: Muscle cramps (≤8%), tremor (≤8%), weakness (<3%), joint stiffness
(≤2%)
Respiratory: Cough (≤6%), nasal congestion (≤6%), wheezing (≤6%), chest congestion (≤2%),
dyspnea (≤2%)
Contraindications
Hypersensitivity to nifedipine or any component of the formulation
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. In patients with unstable angina/non-STEMI, the use of immediate-release nifedipine is
not recommended except with concomitant beta-blockade (ACCF/AHA [Anderson, 2013]).
• 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 led to bezoar formation with extended
release forms.
• Heart failure (HF): The ACCF/AHA heart failure guidelines recommend to avoid use in patients
with heart failure due to lack of benefit and/or worse outcomes with calcium channel blockers in
general (Yancy, 2013).
• 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.
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency
adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug
interactions database for more detailed information.
• Extended release formulation: Consists of drug within a nondeformable matrix; following drug
release/absorption, the matrix/shell is expelled in the stool. The use of nondeformable products in
patients with known stricture/narrowing of the GI tract (eg, severe gastrointestinal narrowing, colon
cancer, obstruction, bowel resection, gastric bypass, vertical banded gastroplasty) has been
associated with symptoms of obstruction (pharmacobezoar).
• Immediate release formulation: Immediate release formulations should not be used to manage
primary hypertension, adequate studies to evaluate outcomes have not been conducted.
• Lactose: Adalat CC tablets contain lactose; do not use with galactose intolerance, 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.
Alcohol (Ethyl): May increase the serum concentration of NIFEdipine. Risk C: Monitor therapy
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
Alpha1-Blockers: May enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor
therapy
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine.
Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications
should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy
cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification
Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor
therapy
Antifungal Agents (Azole Derivatives, Systemic): May enhance the adverse/toxic effect of Calcium
Channel Blockers. Specifically, itraconazole may enhance the negative inotropic effects of verapamil or
diltiazem. Antifungal Agents (Azole Derivatives, Systemic) may decrease the metabolism of Calcium
Channel Blockers. Fluconazole and isavuconazonium likely exert weaker effects than other azoles and
are addressed in separate monographs. Management: Concurrent use of felodipine or nisoldipine with
itraconazole is specifically contraindicated. Frequent monitoring is warranted with any such
combination; calcium channel blocker dose reductions may be required. Exceptions: Fluconazole;
Isavuconazonium Sulfate. Risk D: Consider therapy modification
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the
hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy
Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk
C: Monitor therapy
Atosiban: Calcium Channel Blockers may enhance the adverse/toxic effect of Atosiban. Specifically,
there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy
Barbiturates: May 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
Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
Beta-Blockers: NIFEdipine may enhance the hypotensive effect of Beta-Blockers. NIFEdipine may
enhance the negative inotropic effect of Beta-Blockers. Risk C: Monitor therapy
Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk
C: Monitor therapy
Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance
the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C:
Monitor therapy
Calcium Salts: May diminish the therapeutic effect of Calcium Channel Blockers. Risk C: Monitor therapy
Cimetidine: May increase the serum concentration of Calcium Channel Blockers. 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 (High risk with Inhibitors).
Risk X: Avoid combination
CycloSPORINE (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum
concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum
concentration of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk
with Inducers). Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of NIFEdipine. Risk X: Avoid
combination
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with
Inhibitors). Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates (High risk with
Inhibitors). Risk D: Consider therapy modification
Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot
be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D:
Consider therapy modification
Dapoxetine: May enhance the orthostatic hypotensive effect of Calcium Channel Blockers. Risk C:
Monitor therapy
Dasatinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk
C: Monitor therapy
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Risk C: Monitor therapy
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
Digoxin: NIFEdipine may increase the serum concentration of Digoxin. Risk C: Monitor therapy
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk
C: Monitor therapy
Efavirenz: May decrease the serum concentration of Calcium Channel Blockers. Risk C: Monitor therapy
Fluconazole: May increase the serum concentration of Calcium Channel Blockers. Risk C: Monitor
therapy
FLUoxetine: May enhance the adverse/toxic effect of NIFEdipine. Risk C: Monitor therapy
Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Risk C: Monitor therapy
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with
Inhibitors). Risk X: Avoid combination
Grapefruit Juice: May increase the serum concentration of NIFEdipine. Risk X: Avoid combination
Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents.
Risk C: Monitor therapy
Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering
Agents. Risk C: Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect
of Hypotension-Associated Agents. Risk C: Monitor therapy
Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk
X: Avoid combination
Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Risk C:
Monitor therapy
Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C:
Monitor therapy
Macrolide Antibiotics: May decrease the metabolism of Calcium Channel Blockers. Management:
Consider using a noninteracting macrolide. Felodipine Canadian labeling specifically recommends
avoiding its use in combination with clarithromycin. Exceptions: Azithromycin (Systemic); Fidaxomicin;
Roxithromycin; 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
Melatonin: May diminish the antihypertensive effect of Calcium Channel Blockers (Dihydropyridine).
Risk C: Monitor therapy
Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor
therapy
MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Management: Minimize doses of CYP3A4 substrates, and monitor for increased
concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine,
dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Risk D:
Consider therapy modification
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
Nafcillin: May decrease the serum concentration of NIFEdipine. Risk D: Consider therapy modification
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Risk C: Monitor therapy
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside.
Risk C: Monitor therapy
Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management:
Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to
obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy
modification
Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Risk C: Monitor therapy
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
Phenytoin: NIFEdipine may increase the serum concentration of Phenytoin. Phenytoin may decrease the
serum concentration of NIFEdipine. Risk X: Avoid combination
Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk
C: Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering
Agents. Risk C: Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk
C: Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor
therapy
QuiNIDine: Calcium Channel Blockers (Dihydropyridine) may decrease the serum concentration of
QuiNIDine. Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of
QuiNIDine. QuiNIDine may increase the serum concentration of Calcium Channel Blockers
(Dihydropyridine). Risk C: Monitor therapy
Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk
C: Monitor therapy
Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Risk C: Monitor therapy
Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Risk C: Monitor therapy
St John's Wort: May decrease the serum concentration of NIFEdipine. Risk X: Avoid combination
Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow
therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any
CYP3A4 substrate used with stiripentol requires closer monitoring. Risk D: Consider therapy
modification
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 (High risk with Inducers).
Risk C: Monitor therapy
VinCRIStine: NIFEdipine may increase the serum concentration of VinCRIStine. Risk C: Monitor therapy
VinCRIStine (Liposomal): NIFEdipine may increase the serum concentration of VinCRIStine (Liposomal).
Risk C: Monitor therapy
Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor
therapy
Food Interactions Nifedipine serum levels may be decreased if taken with food. Food may decrease
the rate but not the extent of absorption of Procardia XL. Increased nifedipine concentrations resulting in
therapeutic and vasodilator side effects, including severe hypotension and myocardial ischemia, may occur
if nifedipine is taken by patients ingesting grapefruit. Management: Avoid grapefruit/grapefruit juice.
Pregnancy Implications
Adverse events were observed in animal reproduction studies. Nifedipine crosses the placenta and small
amounts can be detected in the urine of newborn infants (Manninen 1991; Silberschmidt 2008). An increase
in perinatal asphyxia, cesarean delivery, prematurity, and intrauterine growth retardation have been reported
following maternal use. Untreated chronic maternal hypertension is also associated with adverse events in
the fetus, infant, and mother. If treatment for chronic hypertension during pregnancy is needed, nifedipine is
one of the preferred agents (ACOG 2013; SOGC [Magee 2014]). Nifedipine is also recommended for the
management of acute onset, severe hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥110 mm Hg)
with preeclampsia or eclampsia in pregnant and postpartum women (ACOG 2015; Magee 2014).
Nifedipine has also been evaluated for the treatment of preterm labor. Tocolytics may be used for the short-
term (48 hour) prolongation of pregnancy to allow for the administration of antenatal steroids and should
not be used prior to fetal viability or when the risks of use to the fetus or mother are greater than the risk of
preterm birth (ACOG 171 2016). Nifedipine is ineffective for maintenance tocolytic therapy (ACOG 171 2016;
Roos 2013).
Breast-Feeding Considerations
Nifedipine is excreted into breast milk.
The relative infant dose (RID) of nifedipine is 0.27% to 3.2% when calculated using the highest breast
milk concentration located and compared to an infant therapeutic dose of 0.25 to 3 mg/kg/day. In
general, breastfeeding is considered acceptable when the RID is <10%; when an RID is >25%
breastfeeding should generally be avoided (Anderson 2016; Ito 2000). Using the highest milk
concentration (53.35 ng/mL), the estimated daily infant dose via breast milk is 8 mcg/kg/day. This milk
concentration was obtained following maternal administration of oral nifedipine 30 mg three times daily
(Ehrenkrantz 1989).
Milk concentrations reached a peak within 1 hour of maternal administration of immediate release
capsules (Ehrenkrantz 1989; Penny 1989). The half-life of nifedipine in breast milk has been reported to
be ~3 hours (Ehrenkrantz 1989).
The use of nifedipine in breastfeeding women for the treatment of Raynaud phenomenon has been
described in case reports and case series; no adverse events were noted in the infants exposed to
nifedipine via breast milk (Anderson 2004; Barrett 2013; Garrison 2002; Page 2006; Wu 2012).
According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy
should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and
benefits of treatment to the mother.
The Academy of Breastfeeding Medicine recommends the use of nifedipine for the treatment of
Raynaud phenomenon of the nipple in breastfeeding mothers (Berens 2016).
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's
labeling). 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
Reference Range
Hypertension: The 2014 guideline for the management of high blood pressure in adults (Eighth Joint
National Committee [JNC 8]):
• Patients ≥60 years: Goal of therapy is SBP <150 mm Hg and DBP <90 mm Hg.
• Patients <60 years: Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.
• Patients ≥18 years with diabetes: Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.
• Patients ≥18 years with chronic kidney disease (CKD): Goal of therapy is SBP <140 mm Hg and
DBP <90 mm Hg.
Diabetes and hypertension: The American Diabetes Association (ADA) guidelines (ADA 2017a; ADA
2017b):
• Patients ≥18 to ≤65 years: Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.
• Patients ≥18 to ≤65 years and at high risk of cardiovascular disease: Goal of therapy is SBP <130
mm Hg and DBP <80 mm Hg (if can be achieved without undue treatment burden).
• Patients ≥65 years (healthy or complex/intermediate health): Goal of therapy is SBP <140 mm Hg
and DBP <90 mm Hg.
• Patients ≥65 years (very complex/poor health): Goal of therapy is SBP <150 mm Hg and DBP <90
mm Hg.
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%; Note: Protein-binding may be significantly
decreased in patients with renal or hepatic impairment
Bioavailability: Capsule: 40% to 77%; ER: 65% to 89% relative to immediate release capsules;
bioavailability increased with significant hepatic disease
Half-life elimination: Adults: Healthy: 2 to 5 hours; Cirrhosis: 7 hours; Elderly: 7 hours (extended release
tablet)
Pricing: US
Capsules (NIFEdipine Oral)
10 mg (100): $106.84
20 mg (100): $230.26
10 mg (100): $301.12
30 mg (100): $213.19
60 mg (100): $358.33
90 mg (100): $419.89
30 mg (100): $125.79
60 mg (100): $224.07
60 mg (100): $248.32
90 mg (100): $302.84
30 mg (100): $132.45
60 mg (100): $229.15
90 mg (100): $256.15
30 mg (100): $679.49
60 mg (100): $1175.84
90 mg (100): $1356.66
Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer
of the brand and/or generic product, respectively. The pricing data should be used for benchmarking
purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or
purchasing functions. Pricing data is updated monthly.
Brand Names: International Adalat (AE, AR, AT, BE, BF, BH, BJ, BR, CH, CI, CL, CR, CZ, DE, DK, DO,
EE, EG, ES, ET, FI, GB, GH, GM, GN, GR, GT, HK, HN, HR, HU, ID, IE, IT, JO, JP, KE, KR, KW, LR, LU, MA, ML, MR,
MT, MU, MW, MX, MY, NE, NG, NI, NO, PA, PE, PH, PK, PL, PT, QA, RU, SA, SC, SD, SE, SL, SN, SV, TN, TR, TZ,
UA, UG, UY, VE, VN, ZA, ZM, ZW); Adalat 10 (AU); Adalat 20 (AU); Adalat CR (BG, CH, CY, GR, JP, RO, TH);
Adalat Crono (IT); Adalat GITS (CN, HK); Adalat GITS 30 (PH); Adalat L (JP); Adalat LA (BH, ET, GB, KW, LB,
LK, MT, MY, SG); Adalat LP (FR); Adalat Oros (AU, BB, BM, BR, BS, BZ, CL, CO, DK, EC, EE, ES, FI, GY, ID, IS, JM,
KR, LU, NL, NO, NZ, PE, PR, PY, SE, SI, SR, TT, TW, UY, VE); Adalat Retard (AE, AT, BF, BH, BJ, CI, CL, CR, CZ,
DE, EG, ES, ET, GB, GH, GM, GN, GR, GT, HK, HN, ID, IQ, IR, JO, KE, KW, LR, LU, LY, MA, ML, MR, MT, MU, MW,
MY, NE, NG, NI, OM, PA, PE, PH, PL, PY, QA, SA, SC, SD, SL, SN, SV, SY, TN, TZ, UG, YE, ZM, ZW); Adalate (FR);
Addos XR (AU); Adefin (AU); Adefin XL (AU); Adifen SR (MY); Adipine XL (GB); Alonix-S (TW); Altapres (PH);
Ampine (BD); Anifa (LK); Aprical (DE, LU); Atanaal Softcap (TW); Calcibloc (PH); Calcibloc OD (PH); Calcicor
(ET); Calcigard (IN, SG, TH); Calcigard Retard (ZW); Cardifen (ZA); Cardiiopine (AE); Chronadalate LP (FR);
Citilat (IT); Coracten (AE, BH, CY, DE, EG, GB, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Coral (IT); Cordaflex (BG,
HU, VN); Cordilat (MX); Cordipen (SG); Cordipen Retard (SG); Cordipin (HK, HR); Cordipin Retard (HR);
Cordipin XL (HR, LV); Corinfar (HU, LV); Corinfar Retard (LV); Corotrend (DE); Depin (IN); Depin-E Retard (TH);
Dignokonstant (DE); Dipinkor (ID); Duranifin (DE); Ecodipin (CH); Epilat (QA); 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, SA, SC, SD, SL, SN,
SY, TN, TZ, UG, YE, ZM, ZW); Glopir (GR); Hexadilat (DK); Huma-Nifedin (HU); Jutadilat (DE); Kin Ran (CN);
Kordypin (UA); Kordypin XL (UA); Myogard (AE, BH, CY, EG, IN, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Nedipin
(TW); Nelapine (PH); Nepin SR (LK); Nicardia (TH); Nicardia CD (TH); Nicardia Retard (TH); Nicardia XL (LK);
Nidipin (HU); Nifa (BD); 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); Nifecap (BD);
Nifecard (AE, AT, BH, HR, JO, SA); 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); Nifedipresc MR (GB); Nifedix SR (KR);
Nifehexal (LU, VN); Nifelan (EC); Nifelat (AR, ET, HK, MT, SG, TH, ZW); Nifelat Q (TR); Nifelat R (ZW); Nifelat-Q
(TH); Nifensar (PE); Nifensar Retard (PE); Niferon CR (KR); Nifeslow (LU); Nifestad (PH); Nifezzard (MX);
Nificard (CY, EG, IQ, IR, KW, LB, LY, OM, QA, SY, YE); Nifin (BD); Nifipen (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY,
OM, QA, SA, SY, YE); Nipen (BD); Noviken LP (MX); Nyefax (AU); Nyefax Retard (NZ); Odipin (PH); Orix (GR);
Osmo-Adalat (IL); Pidilat (DE); Pressolat (IL); Sepamit (JP); Servidipine (MY); Slow-Nifine (LU); Unidipin (HU,
LU); 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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