Angina, chronic stable (alternative agent) (off-label use): Note: A beta-blocker is the preferred initial therapy; if there are ongoing symptoms on beta-blocker therapy, a long-acting dihydropyridine calcium channel blocker (eg, felodipine) may be added; felodipine may also be used as an alternative therapy if there are contraindications or unacceptable adverse effects with beta-blockade (Ref).
Oral: Initial: 5 mg once daily; may increase to 10 mg once daily as tolerated (Ref).
Hypertension, chronic: Note : For patients who warrant combination therapy (BP >20/10 mm Hg above goal or suboptimal response to monotherapy), may use with another appropriate agent (eg, angiotensin-converting enzyme [ACE] inhibitor, angiotensin II receptor blocker [ARB], or thiazide diuretic) (Ref).
Oral : Initial: 2.5 to 5 mg once daily; evaluate response after ~2 to 4 weeks and titrate dose, as needed, up to 10 mg once daily; if additional blood pressure control is needed, consider combination therapy (Ref); antihypertensive effect attenuates with higher doses and adverse effects may become more prominent. Patients with severe asymptomatic hypertension and no signs of acute end organ damage should be evaluated for medication titration within 1 week (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
Initial: 2.5 mg once daily; monitor blood pressure closely during titration.
Hypertension: Oral: 2.5 mg once daily and titrate at no less than 2-week intervals to response (Ref).
(For additional information see "Felodipine: Pediatric drug information")
Hypertension: Limited data available: Children ≥6 years and Adolescents: Oral: Initial: 2.5 mg once daily; may increase as needed at 2-week intervals to a maximum daily dose: 10 mg/day (Ref)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no pediatric specific recommendations available; based on experience in adult patients, no dosage adjustments necessary; use with caution.
There are no pediatric specific recommendations available; based on experience in adult patients, initial dosage adjustments suggested; monitor blood pressure closely during titration.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Peripheral edema (2% to 17%)
Central nervous system: Headache (11% to 15%)
1% to 10%: Cardiovascular: Flushing (4% to 7%), tachycardia (≤3%)
<1%, postmarketing, and/or case reports: Abdominal pain, acid regurgitation, anemia, angina pectoris, angioedema, anxiety disorder, arm pain, arthralgia, back pain, bronchitis, bruise, cardiac arrhythmia, cardiac failure, cerebrovascular accident, chest pain, constipation, decreased libido, depression, diarrhea, dizziness, drowsiness, dyspnea, dysuria, epistaxis, erythema, extrasystoles, facial edema, flatulence, flu-like symptoms, flushing, foot pain, gingival hyperplasia, gynecomastia, hip pain, hypersensitivity angiitis, hypotension, impotence, influenza, insomnia, irritability, knee pain, leg pain, muscle cramps, myalgia, myocardial infarction, nausea, nervousness, palpitations, paresthesia, pharyngitis, polyuria, psoriasis (Song 2021), respiratory tract infection, sinusitis, syncope, urinary frequency, urinary urgency, urticaria, visual disturbance, vomiting, xerostomia
Hypersensitivity to felodipine or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to other dihydropyridines; women of childbearing potential, in pregnancy, and during lactation.
Concerns related to adverse effects:
• Angina/MI: Increased angina and/or MI has 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.
• Peripheral edema: The most common side effect is peripheral edema (dose dependent); occurs within 2 to 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 ischemia.
• Heart failure: The ACC/AHA heart failure guidelines recommend to avoid use in patients with heart failure (HF) due to lack of benefit and/or worse outcomes with calcium channel blockers in general (AHA/ACC/HFSA [Heidenreich 2022]).
• Hepatic impairment: Use with caution in patients with hepatic impairment; may require lower starting dose.
• 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.
Special populations:
• Older adult: Initiate at a lower dose in the elderly.
Dosage forms specific issues:
• Lactose: May contain lactose; if necessary, consider alternative agents in patients intolerant of lactose.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Extended Release 24 Hour, Oral:
Generic: 2.5 mg, 5 mg, 10 mg
Yes
Tablet, 24-hour (Felodipine ER Oral)
2.5 mg (per each): $1.22 - $1.58
5 mg (per each): $1.08 - $1.58
10 mg (per each): $2.18 - $3.72
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Extended Release 24 Hour, Oral:
Plendil: 2.5 mg, 5 mg, 10 mg
Generic: 2.5 mg, 5 mg, 10 mg
Oral: Swallow tablet whole; tablet should not be divided, crushed, or chewed. May be administered without food or with a small meal that is low in fat and carbohydrates.
Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. No IR formulation exists. Consider switching to a different dihydropyridine calcium channel blocker that is available in IR formulation.
Oral: Swallow tablet whole; do not divide, crush, or chew. May be administered without food or with a small meal that is low in fat and carbohydrates.
Hypertension: Management of hypertension
Angina, chronic stable
Plendil may be confused with Isordil, pindolol, Pletal, PriLOSEC, Prinivil
Substrate of CYP3A4 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP2D6 (Weak);
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification
Amphetamines: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor
Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Atosiban: Calcium Channel Blockers may increase adverse/toxic effects of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor
Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Brigatinib: May decrease antihypertensive effects of Antihypertensive Agents. Brigatinib may increase bradycardic effects of Antihypertensive Agents. Risk C: Monitor
Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid
Calcium Salts: May decrease therapeutic effects of Calcium Channel Blockers. Risk C: Monitor
Cardiac Glycosides: Felodipine may increase serum concentration of Cardiac Glycosides. Risk C: Monitor
Cimetidine: May increase serum concentration of Calcium Channel Blockers. Risk C: Monitor
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CycloSPORINE (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase serum concentration of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor
CYP3A4 Inducers (Moderate): May decrease serum concentration of Felodipine. Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Felodipine. Management: Consider alternatives to this combination when possible. If combined, monitor for reduced felodipine efficacy and the need for felodipine dose increases. Risk D: Consider Therapy Modification
CYP3A4 Inhibitors (Moderate): May increase serum concentration of Felodipine. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of Felodipine. Management: Consider using lower felodipine doses when combined with strong CYP3A4 inhibitors. Monitor patients for increased felodipine effects and toxicities (eg, hypotension, edema) when combined. Risk D: Consider Therapy Modification
Dantrolene: May increase hyperkalemic effects of Calcium Channel Blockers. Dantrolene may increase negative inotropic effects of Calcium Channel Blockers. Risk X: Avoid
Dapoxetine: May increase orthostatic hypotensive effects of Calcium Channel Blockers. Risk C: Monitor
Dexmethylphenidate: May decrease therapeutic effects of Antihypertensive Agents. Risk C: Monitor
Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor
Flunarizine: May increase therapeutic effects of Antihypertensive Agents. Risk C: Monitor
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Grapefruit Juice: May increase serum concentration of Felodipine. Risk C: Monitor
Herbal Products with Blood Pressure Increasing Effects: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor
Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor
Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Indoramin: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor
Inhalational Anesthetics: May increase hypotensive effects of Calcium Channel Blockers. Risk C: Monitor
Isocarboxazid: May increase antihypertensive effects of Antihypertensive Agents. Risk X: Avoid
Itraconazole: May increase serum concentration of Felodipine. Risk X: Avoid
Ketoconazole (Systemic): May increase serum concentration of Felodipine. Risk X: Avoid
Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor
Loop Diuretics: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor
Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Magnesium Sulfate: May increase adverse/toxic effects of Calcium Channel Blockers (Dihydropyridine). Specifically, the risk of hypotension or muscle weakness may be increased. Risk C: Monitor
Melatonin: May decrease antihypertensive effects of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor
Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor
Methylphenidate: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor
Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor
Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor
Obinutuzumab: May increase hypotensive effects 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
Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Perazine: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor
Phenobarbital-Primidone: May decrease serum concentration of Felodipine. Risk C: Monitor
Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor
Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Prazosin: Antihypertensive Agents may increase hypotensive effects of Prazosin. Risk C: Monitor
Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Sincalide: Drugs that Affect Gallbladder Function may decrease therapeutic effects of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider Therapy Modification
Tacrolimus (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase serum concentration of Tacrolimus (Systemic). Risk C: Monitor
Talazoparib: Felodipine may increase serum concentration of Talazoparib. Risk C: Monitor
Terazosin: Antihypertensive Agents may increase hypotensive effects of Terazosin. Risk C: Monitor
Thioridazine: CYP2D6 Inhibitors (Weak) may increase serum concentration of Thioridazine. Management: Consider avoiding concomitant use of thioridazine and weak CYP2D6 inhibitors. If combined, monitor closely for QTc interval prolongation and arrhythmias. Some weak CYP2D6 inhibitors list use with thioridazine as a contraindication. Risk D: Consider Therapy Modification
Urapidil: Antihypertensive Agents may increase hypotensive effects of Urapidil. Risk C: Monitor
Food: Compared to a fasted state, felodipine peak plasma concentrations are increased up to twofold when taken after a meal high in fat or carbohydrates. Grapefruit juice similarly increases felodipine Cmax by twofold. Increased therapeutic and vasodilator side effects, including severe hypotension and myocardial ischemia, may occur. Management: May be taken with a small meal that is low in fat and carbohydrates. Monitor hemodynamic response closely in patients consuming grapefruit juice concurrently; felodipine dosage adjustment and/or modification of grapefruit juice ingestion may be needed.
Medications considered acceptable for the treatment of chronic hypertension during pregnancy may generally be used in patients trying to conceive. Felodipine is generally not considered a preferred agent for use in pregnant patients (ACC/AHA [Whelton 2018]; ACOG 2019; NICE 2019); however, use of felodipine may be considered (ESC [Cífková 2020]).
Adverse events were observed in animal reproduction studies.
Chronic maternal hypertension is associated with adverse events in the fetus/infant. Chronic maternal hypertension may increase the risk of birth defects, low birth weight, premature delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to the duration and severity of maternal hypertension. Untreated chronic hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes, preeclampsia, delivery complications, stroke, and myocardial infarction (ACOG 2019).
Patients with preexisting hypertension may continue their medication during pregnancy unless contraindications exist (ESC [Regitz-Zagrosek 2018]). When treatment of hypertension is initiated during pregnancy, agents other than felodipine may be preferred (ACOG 2019; ESC [Regitz-Zagrosek 2018]; SOGC [Magee 2022]); however, use of felodipine may be considered (ESC [Cífková 2020]).
It is not known if felodipine is present in breast milk.
Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, considering the importance of treatment to the mother. Use of a calcium channel blocker other than felodipine may be preferred in lactating patients (ESC [Cífková 2020]).
May be taken with a small meal that is low in fat and carbohydrates.
BP; heart rate; peripheral edema.
Inhibits calcium ions 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
Onset of action: Antihypertensive: 2 to 5 hours
Duration of antihypertensive effect: 24 hours
Absorption: 100%; Absolute: 20% due to first-pass effect
Protein binding: >99%
Metabolism: Hepatic; CYP3A4 substrate (major); extensive first-pass effect
Half-life elimination: Immediate release: 11 to 16 hours
Time to peak: 2.5 to 5 hours
Excretion: Urine (70% as metabolites); feces 10%
Hepatic function impairment: Felodipine clearance is reduced about 60% in patients with hepatic impairment.
Older adult: Plasma concentrations of felodipine increase with advancing age. Clearance of felodipine in elderly hypertensive patients was 45% of that observed in young volunteers. Steady-state mean area under curve in young patients was 39% of that observed in elderly patients.