Felodipine
Tablet, Extended Release · Oral
Uses
Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.
Dosage and administration
The recommended starting dose is 5 mg once a day. Depending on the patient's response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. The recommended dosage range is 2.5-10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events (see ADVERSE REACTIONS ). Modification of the recommended dosage is usually not required in patients with renal impairment. Felodipine extended-release tablets should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism ). Felodipine extended-release tablets should be swallowed whole and not crushed or chewed. Geriatric Use - Patients over 65 years of age are likely to develop higher plasma concentrations of felodipine (see CLINICAL PHARMACOLOGY ). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment. Patients with Impaired Liver Function - Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of felodipine extended-release tablets; therefore, patients should have their blood pressure monitored closely during dosage adjustment of felodipine extended-release tablets (see CLINICAL PHARMACOLOGY ).
Contraindications
Felodipine extended-release tablets are contraindicated in patients who are hypersensitive to this product.
Precautions
General Hypotension - Felodipine, like other calcium antagonists, may occasionally precipitate significant hypotension and, rarely, syncope. It may lead to reflex tachycardia which in susceptible individuals may precipitate angina pectoris. (See ADVERSE REACTIONS .) Heart Failure - Although acute hemodynamic studies in a small number of patients with NYHA Class II or III heart failure treated with felodipine have not demonstrated negative inotropic effects, safety in patients with heart failure has not been established. Caution, therefore, should be exercised when using felodipine extended-release tablets in patients with heart failure or compromised ventricular function, particularly in combination with a beta-blocker. Patients with Impaired Liver Function - Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of felodipine extended-release tablets; therefore, a starting dose of 2.5 mg once a day is recommended. These patients should have their blood pressure monitored closely during dosage adjustment of felodipine extended-release tablets. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION .) Peripheral Edema - Peripheral edema, generally mild and not associated with generalized fluid retention, was the most common adverse event in the clinical trials. The incidence of peripheral edema was both dose and age dependent. Frequency of peripheral edema ranged from about 10% in patients under 50 years of age taking 5 mg daily to about 30% in those over 60 years of age taking 20 mg daily. This adverse effect generally occurs within 2-3 weeks of the initiation of treatment. Information for Patients Patients should be instructed to take felodipine extended-release tablets whole and not to crush or chew the tablets. They should be told that mild gingival hyperplasia (gum swelling) has been reported. Good dental hygiene decreases its incidence and severity. NOTE: As with many other drugs, certain advice to patients being treated with felodipine extended-release tablets are warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Drug Interactions CYP3A4 Inhibitors - Felodipine is metabolized by CYP3A4. Co-administration of CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, grapefruit juice, cimetidine) with felodipine may lead to several-fold increases in the plasma levels of felodipine, either due to an increase in bioavailability or due to a decrease in metabolism. These increases in concentration may lead to increased effects, (lower blood pressure and increased heart rate). These effects have been observed with co-administration of itraconazole (a potent CYP3A4 inhibitor). Caution should be used when CYP3A4 inhibitors are co-administered with felodipine. A conservative approach to dosing felodipine should be taken. The following specific interactions have been reported: Itraconazole - Co-administration of another extended release formulation of felodipine with itraconazole resulted in approximately 8-fold increase in the AUC, more than 6-fold increase in the C max , and 2-fold prolongation in the half-life of felodipine. Erythromycin - Co-administration of felodipine with erythromycin resulted in approximately 2.5-fold increase in the AUC and C max , and about 2-fold prolongation in the half-life of felodipine. Grapefruit Juice - Co-administration of felodipine with grapefruit juice resulted in more than 2-fold increase in the AUC and C max , but no prolongation in the half-life of felodipine. Cimetidine - Co-administration of felodipine with cimetidine (a non-specific CYP-450 inhibitor) resulted in an increase of approximately 50% in the AUC and the C max , of felodipine. Beta-Blocking Agents - A pharmacokinetic study of felodipine in conjunction with metoprolol demonstrated no significant effects on the pharmacokinetics of felodipine. The AUC and C max of metoprolol, however, were increased approximately 31 and 38%, respectively. In controlled clinical trials, however, beta blockers including metoprolol were concurrently administered with felodipine and were well tolerated. Digoxin - When given concomitantly with felodipine extended-release tablets the pharmacokinetics of digoxin in patients with heart failure were not significantly altered. Anticonvulsants - In a pharmacokinetic study, maximum plasma concentrations of felodipine were considerably lower in epileptic patients on long-term anticonvulsant therapy (e.g. phenytoin, carbamazepine, or phenobarbital) than in healthy volunteers. In such patients, the mean area under the felodipine plasma concentration-time curve was also reduced to approximately 6% of that observed in healthy volunteers. Since a clinically significant interaction may be anticipated, alternative antihypertensive therapy should be considered in these patients. Tacrolimus - Felodipine may increase the blood concentration of tacrolimus. When given concomitantly with felodipine, the tacrolimus blood concentration should be followed and the tacrolimus dose may need to be adjusted. Other Concomitant Therapy - In healthy subjects there were no clinically significant interactions when felodipine was given concomitantly with indomethacin or spironolactone. Interaction with Food - See CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism . Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in rats fed felodipine at doses of 7.7, 23.1 or 69.3 mg/kg/day (up to 61 times 1 the maximum recommended human dose on a mg/m 2 basis), a dose-related increase in the incidence of benign interstitial cell tumors of the testes (Leydig cell tumors) was observed in treated male rats. These tumors were not observed in a similar study in mice at doses up to 138.6 mg/kg/day (61 times 1 the maximum recommended human dose on a mg/m 2 basis).
Side effects
In controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation. The most common clinical adverse events reported with felodipine extended-release administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache. Peripheral edema was generally mild, but it was age and dose related and resulted in discontinuation of therapy in about 3% of the enrolled patients. Discontinuation of therapy due to any clinical adverse event occurred in about 6% of the patients receiving felodipine extended-release tablets, principally for peripheral edema, headache, or flushing. Adverse events that occurred with an incidence of 1.5% or greater at any of the recommended doses of 2.5 mg to 10 mg once a day (felodipine extended-release tablets, N = 861; Placebo, N = 334), without regard to causality, are compared to placebo and are listed by dose in the table below. These events are reported from controlled clinical trials with patients who were randomized to a fixed dose of felodipine extended-release tablets or titrated from an initial dose of 2.5 mg or 5 mg once a day. A dose of 20 mg once a day has been evaluated in some clinical studies. Although the antihypertensive effect of felodipine extended-release tablets is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects (see DOSAGE AND ADMINISTRATION ). Percent of Patients with Adverse Events in Controlled Trials* of Felodipine Extended-Release Tablets (N = 861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses) Body System Adverse Events Placebo N=334 2.5 mg N=255 5 mg N=581 10 mg N= 408 Body as a whole Peripheral Edema 3.3 (0.0) 2.0 (0.0) 8.8 (2.2) 17.4 (2.5) Asthenia 3.3 (0.0) 3.9 (0.0) 3.3 (0.0) 2.2 (0.0) Warm Sensation 0.0 (0.0) 0.0 (0.0) 0.9 (0.2) 1.5 (0.0) Cardiovascular Palpitation 2.4 (0.0) 0.4 (0.0) 1.4 (0.3) 2.5 (0.5) Digestive Nausea 1.5 (0.9) 1.2 (0.0) 1.7 (0.3) 1.0 (0.7) Dyspepsia 1.2 (0.0) 3.9 (0.0) 0.7 (0.0) 0.5 (0.0) Constipation 0.9 (0.0) 1.2 (0.0) 0.3 (0.0) 1.5 (0.2) Nervous Headache 10.2 (0.9) 10.6 (0.4) 11.0 (1.7) 14.7 (2.0) Dizziness 2.7 (0.3) 2.7 (0.0) 3.6 (0.5) 3.7 (0.5) Paresthesia 1.5 (0.3) 1.6 (0.0) 1.2 (0.0) 1.2 (0.2) Respiratory Upper Respiratory Infection 1.8 (0.0) 3.9 (0.0) 1.9 (0.0) 0.7 (0.0) Cough 0.3 (0.0) 0.8 (0.0) 1.2 (0.0) 1.7 (0.0) Rhinorrhea 0.0 (0.0) 1.6 (0.0) 0.2 (0.0) 0.2 (0.0) Sneezing 0.0 (0.0) 1.6 (0.0) 0.0 (0.0) 0.0 (0.0) Skin Rash 0.9 (0.0) 2.0 (0.0) 0.2 (0.0) 0.2 (0.0) Flushing 0.9 (0.3) 3.9 (0.0) 5.3 (0.7) 6.9 (1.2) *Patients in titration studies may have been exposed to more than one dose level of felodipine extended-release tablets. Adverse events that occurred in 0.5 up to 1.5% of patients who received felodipine extended-release tablets in all controlled clinical trials at the recommended dosage range of 2.5 mg to 10 mg once a day, and serious adverse events that occurred at a lower rate, or events reported during marketing experience (those lower rate events are in italics) are listed below. These events are listed in order of decreasing severity within each category, and the relationship of these events to administration of felodipine extended-release tablets are uncertain: Body as a Whole : Chest pain, facial edema, flu-like illness Cardiovascular : Myocardial infarction, hypotension, syncope, angina pectoris , arrhythmia , tachycardia, premature beats Digestive: Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation Endocrine: Gynecomastia Hematologic: Anemia Metabolic : ALT (SGPT) increased Musculoskeletal: Arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, hip pain Nervous/Psychiatric : Insomnia, depression, anxiety disorders, irritability, nervousness, somnolence, decreased libido Respiratory : Dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, respiratory infection Skin : Angioedema, contusion, erythema, urticaria , leukocytoclastic vasculitis Special Senses : Visual disturbances Urogenital : Impotence, urinary frequency, urinary urgency, dysuria, polyuria. Gingival Hyperplasia : Gingival hyperplasia, usually mild, occurred in < 0.5% of patients in controlled studies. This condition may be avoided or may regress with improved dental hygiene. (See PRECAUTIONS, Information for Patients .) Clinical Laboratory Test Findings Serum Electrolytes - No significant effects on serum electrolytes were observed during short- and long-term therapy (see CLINICAL PHARMACOLOGY:Renal/Endocrine Effects ). Serum Glucose - No significant effects on fasting serum glucose were observed in patients treated with felodipine extended-release tablets in the U.S. controlled study. Liver Enzymes - 1 of 2 episodes of elevated serum transaminases decreased once drug was discontinued in clinical studies; no follow-up was available for the other patient. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Overdosage
Oral doses of 240 mg/kg and 264 mg/kg in male and female mice, respectively, and 2390 mg/kg and 2250 mg/kg in male and female rats, respectively, caused significant lethality. In a suicide attempt, one patient took 150 mg felodipine together with 15 tablets each of atenolol and spironolactone and 20 tablets of nitrazepam. The patient's blood pressure and heart rate were normal on admission to hospital; he subsequently recovered without significant sequelae. Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly bradycardia. If severe hypotension occurs, symptomatic treatment should be instituted. The patient should be placed supine with the legs elevated. The administration of intravenous fluids may be useful to treat hypotension due to overdosage with calcium antagonists. In case of accompanying bradycardia, atropine (0.5 mg -1 mg) should be administered intravenously. Sympathomimetic drugs may also be given if the physician feels they are warranted. It has not been established whether felodipine can be removed from the circulation by hemodialysis. To obtain up-to-date information about the treatment of overdose, consult your Regional Poison-Control Center. Telephone numbers of certified poison-control centers are listed in the Physicians' Desk Reference (PDR) . In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.
Description
Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2, 3-dichlorophenyl)-1, 4-dihydro-2, 6-dimethyl-3, 5-pyridinedicarboxylate. Its empirical formula is C 18 H 19 Cl 2 NO 4 and its structural formula is: Felodipine, USP is a light yellow to yellow, crystalline powder with molecular weight of 384.26. It is insoluble in water and is freely soluble in acetone and in methanol; very slightly soluble in heptane. Felodipine is a racemic mixture. Felodipine extended-release tablets, USP provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. Inactive ingredients are: polyoxyl 40 hydrogenated castor oil, magnesium aluminum silicate, hypromellose 2208, lactose monohydrate, hydroxypropyl cellulose, sodium stearyl fumarate, hypromellose 2910 5cP, titanium dioxide and PEG 400. The 2.5 mg tablet strength also contains Iron oxide yellow, D&C yellow #10 aluminum lake and the 5 mg tablet strength also contains Iron oxide yellow. USP dissolution test pending. Image
How supplied
Felodipine Extended-Release Tablets, USP are available containing 2.5 mg, 5 mg or 10 mg of felodipine, USP. The 2.5 mg tablet is a yellow colored, circular shaped, biconvex, film coated tablet de-bossed with 'I31' on one side and plain on other side. They are available as follows: NDC 23155-048-01 bottles of 100 tablets The 5 mg tablet is a light yellow colored, circular shaped, biconvex, film coated tablet de-bossed with 'I32' on one side and plain on other side. They are available as follows: NDC 23155-049-01 bottles of 100 tablets The 10 mg tablet is a white colored, circular shaped, biconvex, film coated tablet de-bossed with 'I33' on one side and plain on other side. They are available as follows: NDC 23155-050-01 bottles of 100 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: USV Private Limited Daman - 396210, India Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG(3784) Revised: 12/2022 logo
Label text from the FDA structured product label by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (revised Aug 11, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Felodipine in 51 products
Felodipine NDC products (51)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-1124 | Felodipine 10 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5870 | Felodipine 10 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 65862-673 | Felodipine 2.5 mg/1 Tablet, Film Coated, Extended Release | Aurobindo Pharma Limited | ANDA |
| 65862-674 | Felodipine 5 mg/1 Tablet, Film Coated, Extended Release | Aurobindo Pharma Limited | ANDA |
| 65862-675 | Felodipine 10 mg/1 Tablet, Film Coated, Extended Release | Aurobindo Pharma Limited | ANDA |
| 63629-2016 | Felodipine 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-2191 | Felodipine 10 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-2017 | Felodipine 2.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-2018 | Felodipine 5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-2195 | Felodipine 5 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-2196 | Felodipine 5 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1318 | Felodipine 5 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1486 | Felodipine 5 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2175 | Felodipine 5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-1158 | Felodipine 2.5 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1160 | Felodipine 10 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1742 | Felodipine 2.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-1743 | Felodipine 5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-1744 | Felodipine 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2568 | Felodipine 2.5 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 61442-433 | Felodipine 10 mg/1 Tablet, Film Coated | Carlsbad Technology, Inc. | ANDA |
| 61442-432 | Felodipine 5 mg/1 Tablet, Film Coated | Carlsbad Technology, Inc. | ANDA |
| 61442-431 | Felodipine 2.5 mg/1 Tablet, Film Coated | Carlsbad Technology, Inc. | ANDA |
| 62135-648 | Felodipine 10 mg/1 Tablet, Extended Release | Chartwell RX, LLC | ANDA |
| 62135-646 | Felodipine 2.5 mg/1 Tablet, Extended Release | Chartwell RX, LLC | ANDA |
| 62135-647 | Felodipine 5 mg/1 Tablet, Extended Release | Chartwell RX, LLC | ANDA |
| 0603-3582 | Felodipine 5 mg/1 Tablet, Extended Release | Endo USA, Inc. | ANDA |
| 0603-3583 | Felodipine 10 mg/1 Tablet, Film Coated, Extended Release | Endo USA, Inc. | ANDA |
| 0603-3581 | Felodipine 2.5 mg/1 Tablet, Extended Release | Endo USA, Inc. | ANDA |
| 68462-233 | Felodipine 2.5 mg/1 Tablet, Film Coated, Extended Release | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-234 | Felodipine 5 mg/1 Tablet, Film Coated, Extended Release | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-235 | Felodipine 10 mg/1 Tablet, Film Coated, Extended Release | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 51407-089 | Felodipine 10 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-088 | Felodipine 5 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 23155-048 | Felodipine 2.5 mg/1 Tablet, Extended Release | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-049 | Felodipine 5 mg/1 Tablet, Extended Release | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-050 | Felodipine 10 mg/1 Tablet, Extended Release | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 71205-920 | Felodipine 2.5 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-922 | Felodipine 10 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-921 | Felodipine 5 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 57237-109 | Felodipine 5 mg/1 Tablet, Film Coated, Extended Release | Rising Pharma Holdings, Inc. | ANDA |
| 57237-110 | Felodipine 10 mg/1 Tablet, Film Coated, Extended Release | Rising Pharma Holdings, Inc. | ANDA |
| 57237-108 | Felodipine 2.5 mg/1 Tablet, Film Coated, Extended Release | Rising Pharma Holdings, Inc. | ANDA |
| 13668-134 | Felodipine 10 mg/1 Tablet, Extended Release | Torrent Pharmaceuticals Limited | ANDA |
| 13668-133 | Felodipine 5 mg/1 Tablet, Extended Release | Torrent Pharmaceuticals Limited | ANDA |
| 13668-132 | Felodipine 2.5 mg/1 Tablet, Extended Release | Torrent Pharmaceuticals Limited | ANDA |
| 69367-265 | Felodipine 5 mg/1 Tablet, Extended Release | Westminster Pharmaceuticals, LLC | ANDA |
| 69367-264 | Felodipine 2.5 mg/1 Tablet, Extended Release | Westminster Pharmaceuticals, LLC | ANDA |
| 69117-0030 | Felodipine 10 mg/1 Tablet, Extended Release | Yiling Pharmaceutical Inc. | ANDA |
| 69117-0029 | Felodipine 5 mg/1 Tablet, Extended Release | Yiling Pharmaceutical Inc. | ANDA |
| 69117-0028 | Felodipine 2.5 mg/1 Tablet, Extended Release | Yiling Pharmaceutical Inc. | ANDA |
Felodipine recalls
- D-0108-2021 Dec 2, 2020 · Class III · Terminated
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Frequently asked questions
What is Felodipine used for?
Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control…
What are the side effects of Felodipine?
In controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation. The most common clinical adverse events reported with felodipine extended-release administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache.… See the full label for the complete list.
Who makes Felodipine?
Felodipine is listed by 14 labelers in the FDA NDC directory, including A-S Medication Solutions, Aurobindo Pharma Limited, Bryant Ranch Prepack, Carlsbad Technology, Inc..
Has Felodipine been recalled?
The FDA enforcement database lists 1 recall for Felodipine, most recently D-0108-2021 (class iii): Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity…