Felodipine 2.5 mg/1
Felodipine Extended-release Tablets · TABLET, EXTENDED RELEASE · Yiling Pharmaceutical Inc.
Felodipine is a tablet, extended release containing felodipine extended-release tablets at 2.5 mg/1, taken oral. Manufactured by Yiling Pharmaceutical Inc..
Key Facts
- Brand Name
- Felodipine
- Generic Name
- Felodipine Extended-release Tablets
- NDC Code (Product)
69117-0028- Manufacturer
- Yiling Pharmaceutical Inc.
- Strength
- 2.5 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210847
- Drug Class
- Dihydropyridine Calcium Channel Blocker [EPC]
- Marketing Start
- 08/01/2019
Recall History
Mutual Pharmaceutical Company, Inc.
Chemical Contamination; benzophenone leached from the product label varnish
Mutual Pharmaceutical Company, Inc.
Chemical Contamination; benzophenone leached from the product label varnish
Heritage Pharmaceuticals Inc
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Mutual Pharmaceutical Company, Inc.
Chemical Contamination; benzophenone leached from the product label varnish
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 b…
Dosage & Administration
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 to 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, USP should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism ). Felodipine extended-release tablets, USP 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 thei…
Contraindications
CONTRAINDICATIONS Felodipine extended-release tablets, USP are contraindicated in patients who are hypersensitive to this product.
Drug Interactions
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-…
Adverse Reactions
ADVERSE REACTIONS 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, 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, 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, USP or titrated f…
Frequently Asked Questions
What is Felodipine used for?
Felodipine contains Felodipine Extended-release Tablets. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Felodipine a controlled substance?
Felodipine is not classified as a controlled substance by the DEA.
What is the generic name for Felodipine?
The generic name for Felodipine is Felodipine Extended-release Tablets. There are no other listed brand versions of Felodipine Extended-release Tablets.
What is the NDC code for Felodipine 2.5 mg/1?
The NDC (National Drug Code) for Felodipine 2.5 mg/1 is 69117-0028, listed by Yiling Pharmaceutical Inc..
Other Felodipine Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)