Felodipine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Overview
Felodipine is a Calcium Channel Blocker that is FDA approved for the {{{indicationType}}} of hypertension. Common adverse reactions include Peripheral edema， Flushing， Indigestion， Headache， Upper respiratory infection.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Felodipine
- Dosing information
- Recommended starting dosage: 5 mg PO qd.
- These adjustments should occur generally at intervals of not less than 2 weeks.
- The recommended dosage range is 2.5-10 mg PO qd, depending on the patient's response.
- 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).
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Felodipine sandbox in adult patients.
Non–Guideline-Supported Use
Angina
- Dosing information
- Initial dosage: 5 mg/day
- Following 10 weeks: 10 mg/day 9402450， 7526065， 3327683
- 2.5-5 mg PO bid or 10-20 mg PO qd 3327683
- 10 mg PO qd 2909138
- 20 mg PO qd 8013514
Arteriosclerotic vascular disease
- Dosing information
- Not applicable
chronic Cyclosporin A nephrotoxicity
- Dosing information
- 10 mg/day 9761517, 8743522
- 4 mg/day 9075128
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Felodipine sandbox in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Felodipine sandbox in pediatric patients.
Contraindications
Felodipine extended-release tablets are contraindicated in patients who are hypersensitive to this product.
Warnings
There is limited information regarding Felodipine Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Felodipine Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Felodipine Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Felodipine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Felodipine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Felodipine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Felodipine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Felodipine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Felodipine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Felodipine in geriatric settings.
Gender
There is no FDA guidance on the use of Felodipine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Felodipine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Felodipine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Felodipine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Felodipine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Felodipine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Felodipine Administration in the drug label.
Monitoring
There is limited information regarding Felodipine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Felodipine and IV administrations.
Overdosage
There is limited information regarding Felodipine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Felodipine Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Felodipine Mechanism of Action in the drug label.
Structure
There is limited information regarding Felodipine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Felodipine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Felodipine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Felodipine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Felodipine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Felodipine How Supplied in the drug label.
Storage
There is limited information regarding Felodipine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Felodipine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Felodipine sandbox interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Felodipine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Felodipine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- Dosing information
- Not applicable
- 10 mg/day 9761517, 8743522
- 4 mg/day 9075128
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Felodipine in women who are pregnant.