Felodipine Extended-Release Tablets, USP Rx only
DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of Action
Pharmacokinetics and Metabolism
Cardiovascular Effects
Renal/Endocrine Effects
Clinical Studies
| Study 1 (8 weeks) | ||||
| 2.5 mg | 68 | 9.4/4.7 | 2.7/2.5 | 29/53 |
| 5 mg | 69 | 9.5/6.3 | 2.4/3.7 | 25/59 |
| 10 mg | 67 | 18.0/10.8 | 10.0/6.0 | 56/56 |
| Study 2 (4 weeks) | ||||
| 10 mg | 50 | 5.3/7.2 | 1.5/3.2 | 33/40** |
| 20 mg | 50 | 11.3/10.2 | 4.5/3.2 | 43/34** |
INDICATIONS AND USAGE
CONTRAINDICATIONS
PRECAUTIONS
General
Information for Patients
Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Nursing Mothers
Pediatric Use
Geriatric Use:
ADVERSE REACTIONS
| 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) | |