Loading…
PLENDIL is a brand name for Felodipine, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PLENDIL (felodipine) is indicated for: • the treatment of mild to moderate essential hypertension. The combination of PLENDIL with a thiazide diuretic or a beta-blocker has been found to be compatible and showed an additive antihypertensive effect. The safety and efficacy of concurrent use of PLENDIL with other…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a disproportionately higher incidence of peripheral edema and other vasodilatory adverse events. 2 Recommended Dose and Dosage Adjustment The usual recommended initial dose is 5 mg once daily.
Depending on the patient's response, the dosage should be adjusted accordingly. Dose adjustment, if necessary, should be done at intervals of not less than two weeks. 5 to 10 mg once daily. Use in the Elderly Patients over 65 years of age may develop elevated plasma concentrations of felodipine.
5 mg once daily is recommended. 4 WARNINGS and PRECAUTIONS, Special Populations, Geriatrics). 3 WARNINGS and PRECAUTIONS, Special Populations, Pediatrics). Use in Patients with Impaired Liver Function Patients with impaired liver function may develop elevated plasma concentrations of felodipine.
5 mg once daily is recommended. A dosage of 10 mg daily should not be exceeded (see 7 WARNINGS and PRECAUTIONS, Hepatic/Biliary/Pancreatic). Use in Patients with Renal Impairment Modification of the recommended dosage is usually not required in patients with renal impairment.
4 Administration PLENDIL should be swallowed whole and not crushed or chewed. 3 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions). 5 Missed Dose If the patient misses a dose of PLENDIL and remembers within 12 hours, then the usual dose should be taken as soon as possible.
The patient should then return to the regular schedule. If the patient remembers more than 12 hours later, then the missed dose should not be taken, but the next dose taken on time. A double dose of PLENDIL should never be taken to make up for missed tablets.
1 Adverse Reaction Overview Mild to moderate peripheral edema was the most common adverse event in the clinical trials. The incidence of peripheral edema was dose-dependent. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
5 to 10 mg PLENDIL (felodipine) as monotherapy in controlled clinical trials, the most common clinical adverse events were peripheral edema and headache. 5 mg to 10 mg once a day, without regard to causality, are listed by dose in Table 2 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 PLENDIL is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects (see 4 DOSAGE AND ADMINISTRATION).
0) * Some patients have been exposed to more than one dose level of PLENDIL. 5 to 10 mg once a day or during post- marketing experience are listed below. These events are listed in order of decreasing severity within each category regardless of relationship to PLENDIL therapy: Body as a Whole: Chest pain, facial edema, flu-like illness, fever; Cardiovascular: Tachycardia, premature beats, postural hypotension, bradycardia; Dermatologic: Pruritus, erythema multiforme, erythema nodosum, leucocytoclastic vasculitis, urticaria, photosensitivity reactions; Gastrointestinal: Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation, cholestatic hepatitis, gingival hyperplasia, salivary gland enlargement; Metabolic: ALT (SGPT) increased; Musculoskeletal: Arthralgia, muscle cramps, myalgia; Nervous/Psychiatric: Insomnia, depression, anxiety disorders, irritability, nervousness, somnolence, decrease in libido, tremor, confusion; Respiratory: Dyspnea, epistaxis; Special Senses: Visual disturbances; Urogenital: Impotence/sexual dysfunction, urinary frequency, urinary urgency, dysuria, polyuria.
Cardiovascular Congestive Heart Failure The safety and efficacy of PLENDIL in patients with heart failure have not been established. Caution should, therefore, be exercised when using PLENDIL in hypertensive patients with compromised ventricular function, particularly in combination with a beta-blocker.
Acute hemodynamic studies in a small number of patients with New York Heart Association Class II or III heart failure treated with felodipine have not demonstrated negative inotropic effects. Hypotension, Myocardial Ischemia PLENDIL may, occasionally, precipitate symptomatic hypotension and rarely syncope.
It may lead to reflex tachycardia which, particularly in patients with severe obstructive coronary artery disease, may result in myocardial ischemia. 5 mg tablet), lactose anhydrous, microcrystalline cellulose, polyethylene glycol, polyoxyl 40 hydrogenated castor oil, propyl gallate, sodium stearyl fumarate, titanium dioxide.
PLENDIL, felodipine Page 7 of 39 Care should be taken to avoid hypotension especially in patients with a history of cerebrovascular insufficiency, and in those taking medications known to lower blood pressure. Beta-Blocker Withdrawal PLENDIL gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be a gradual reduction of the dose of beta-blockers.
Outflow Obstruction PLENDIL should be used with caution in the presence of left ventricular outflow obstruction. Peripheral Edema Mild to moderate peripheral edema was the most common adverse event in the clinical trials. The incidence of peripheral edema was dose-dependent.
Frequency of peripheral edema ranged from about 10 percent in patients under 50 years of age taking 5 mg daily to about 30 percent 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.
PLENDIL (felodipine) is contraindicated: • In patients with a known hypersensitivity to felodipine or any other components of PLENDIL. • In patients with a known hypersensitivity to other dihydropyridines. • In women of childbearing potential, in pregnancy, and during lactation.
Fetal malformations and adverse effects on pregnancy have been reported in animals.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Felodipine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
5 percent) were myocardial infarction, hypotension, syncope, angina pectoris, arrhythmia and anemia. Isolated cases of angioedema have been reported. Angioedema may be accompanied by breathing difficulty. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings For the following laboratory values, statistically significant decreases were observed; bilirubin, red blood count, hemoglobin, and urate.
Statistically significant increases were found in erythrocyte sedimentation rate and thrombocyte count. In isolated cases, there were increased liver enzymes. None of the changes were considered to be of clinical significance.
Care should be taken to differentiate this peripheral edema from the effects of increasing left ventricular dysfunction. Dependence, Tolerance and/or Abuse Liability The potential for PLENDIL to cause dependence, tolerance and/or abuse has not been studied.
Driving and Operating Machinery PLENDIL can induce hypotension and visual disturbances that may impact the ability to drive or use machines. Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Gastrointestinal Gingival Hyperplasia PLENDIL can induce gingival enlargement in patients with pronounced gingivitis and periodontitis.
However, such changes may be avoided or reversed by measures of good oral hygiene and mechanical debridement of the teeth. In very rare instances, PLENDIL has also caused gingivitis. 3 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions).
These patients should have their blood pressure monitored closely during initial administration and after dosage adjustment of PLENDIL. 2 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment). PLENDIL, felodipine Page 8 of 39 Reproductive Health PLENDIL is contraindicated in women of childbearing potential and in pregnancy (see 2 CONTRAINDICATIONS).
Sensitivity/Resistance Lactose PLENDIL contains lactose and should not be given to patients with hereditary galactose intolerance or glucose-galactose malabsorption. Skin Dermatologic Lesion Along with leucocytoclastic vasculitis, other dermatologic events have been observed.
These include rash and flush. All cases of dermatologic lesions should be carefully diagnosed and monitored. 1 Pregnancy PLENDIL is contraindicated in women of childbearing potential and in pregnancy (see 2 CONTRAINDICATIONS). Fetal malformations and adverse effects on pregnancy have been reported in animals.
See 16 NON- CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology, for additional information on teratology observed in animals. 2 Breast-feeding PLENDIL is contraindicated during lactation (see 2 CONTRAINDICATIONS). 3 Pediatrics Pediatrics (≤ 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
3 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions). These patients should have their blood pressure monitored closely during initial administration and after dosage adjustment of PLENDIL. 2 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment).
PLENDIL, felodipine Page 9 of 39