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Felodipine is a brand name for Felodipine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's FDA label. Tap a section to expand.
DOSAGE AND ADMINISTRATION
The recommended starting dose is 5 mg once a day. 5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. 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 ).
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, USP; therefore, patients should have their blood pressure monitored closely during dosage adjustment of felodipine extended-release tablets, USP (see CLINICAL PHARMACOLOGY ).
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. 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.
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. 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, USP 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) *Patients in titration studies may have been exposed to more than one dose level of felodipine extended-release tablets.
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 is 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.
CONTRAINDICATIONS
Felodipine extended-release tablets, USP are contraindicated in patients who are hypersensitive to this product.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 ).
S. controlled study. Liver Enzymes One of two episodes of elevated serum transaminases decreased once drug was discontinued in clinical studies; no follow-up was available for the other patient.