PLENDIL SUMMARY
PLENDIL (felodipine) is a calcium antagonist (calcium channel blocker).
PLENDIL is indicated for the treatment of hypertension.
PLENDIL may be used alone or concomitantly with other antihypertensive agents.
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NEWS HIGHLIGHTS
Published Studies Related to Plendil (Felodipine)
Pharmacokinetics of felodipine extended-release tablets in healthy Taiwanese subjects: a retrospective review. [2011] The objective of this study was to investigate the pharmacokinetics of felodipine (CAS 72509-76-3) in healthy male Taiwanese subjects. This is a retrospective review of five felodipine pharmacokinetic studies completed in Taiwan.Taiwanese subjects might have lower CYP3A4 activity to metabolize felodipine, which is similar to the phenomenon observed with nifedipine.
[Effect between felodipine plus irbesartan and felodipine plus metoprolol regimen on the sexual function in young and middle-aged women with hypertension]. [2010.08] OBJECTIVE: To compare the effects between felodipine plus irbesartan and felodipine plus metoprolol regimen on blood pressure and the sexual function in young and middle-aged hypertensive women... CONCLUSION: felodipine plus irbesartan or metoprolol for 24 weeks equally reduced blood pressure and the former regimen is superior to the latter on sexual function improvement in this patient cohort.
The calcium channel blocker felodipine attenuates the positive hemodynamic effects of the beta-blocker metoprolol in severe dilated cardiomyopathy--a prospective, randomized, double-blind and placebo-controlled study with invasive hemodynamic assessment. [2009.02.20] CONCLUSION: beta-blocker treatment in CHF patients improves left ventricular function and additionally invasive hemodynamic measurements both at rest and during exercise. In contrast, the combined therapy with the long-acting calcium antagonist felodipine neutralizes these beneficial effects of metoprolol therapy to almost placebo level, providing evidence based on hemodynamic measurements that this combination should be avoided in patients with CHF.
Comparative study of barnidipine and felodipine in Chinese patients with essential hypertension. [2006.07] This study evaluated the efficacy and safety of barnidipine for the treatment of mild-to-moderate essential hypertension in Chinese patients. A total of 131 patients were randomized to receive either barnidipine (10 -15 mg) or felodipine (5 - 10 mg) once daily for 4 weeks...
A furanocoumarin-free grapefruit juice establishes furanocoumarins as the mediators of the grapefruit juice-felodipine interaction. [2006.05] BACKGROUND: Grapefruit juice (GFJ) enhances the systemic exposure of numerous CYP3A4 drug substrates, including felodipine, by inhibiting intestinal (but not hepatic) first-pass metabolism. Furanocoumarins have been identified as major CYP3A4 inhibitors contained in the juice, but their contribution to the GFJ effect in vivo remains unclear. OBJECTIVE: To ascertain whether furanocoumarins mediate the GFJ-felodipine interaction, a furanocoumarin-free GFJ was created and tested against orange juice and the original GFJ with respect to the oral pharmacokinetics of felodipine... CONCLUSION: Furanocoumarins are the active ingredients in GFJ responsible for enhancing the systemic exposure of felodipine and probably other CYP3A4 substrates that undergo extensive intestinal first-pass metabolism.
Clinical Trials Related to Plendil (Felodipine)
Coffee Interaction With the Antihypertensive Drug Felodipine [Completed]
Hypertension affects an estimated 1. 5 billion people world-wide and is a chief contributor
to death, stroke, congestive heart failure, kidney disease, coronary artery disease and
dementia. A number of important causal environmental factors have been identified and
include excessive salt or alcohol consumption, physical inactivity, inadequate fruit,
vegetable and potassium intake and obesity. Although there have been significant
improvements in management, a high percentage of patients still do not achieve target blood
pressures.
Coffee is a popular beverage globally and elevates blood pressure variably among
individuals. Customers in the United States comprise more than half of the population over
the age of 18 years, consume an average of 1 cup (typical size: 270 ml) of coffee three
times per day and spend an estimated $ 40 billion on the purchase of it each year. A major
active constituent in coffee is caffeine, which is the most widely used pharmacological
substance in the world.
Drug therapy plays a major role in the management of hypertension. Concomitant intake of
coffee is likely substantial. However, the interaction between coffee or caffeine and blood
pressure lowering drugs has been assessed in only a few clinical studies conducted more than
two decades ago. Moreover, it appears to have the potential to confound the routine drug
management of hypertension.
This clinical investigation reports the actions of a customary amount of coffee on the
circulatory effects and blood concentrations of felodipine, a drug belonging to a class of
drugs commonly used to treat hypertension. Application of results from this study to
clinical practice has the possibility to improve the management of hypertension.
The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release in Chinese Patients. [Completed]
The purpose of this study is to evaluate the effects on blood pressure control, pulse wave
velocity, as well as safety and tolerability of felodipine single or combine with other
drugs in Chinese Hypertension patients.
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions [Completed]
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended
release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories,
Inc., NJ, 08901 with PLENDILŪ extended release tablets 10 mg (containing felodipine 10 mg)
manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP
Wilmington, DE 19850 in healthy, adult, male, human subjects under fasting condition.
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions [Completed]
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended
release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories
Inc., NJ, 08901 with PLENDILŪ extended release tablets 10 mg (containing felodipine 10 mg)
manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP
Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.
Felodipine Event Reduction Study [Completed]
FEVER is an investigator-designed, prospective, multicentre,double-bind, randomized,
placebo-controlled,parallel-group trial. The primary objective is to compare the long-term
effects on the incidence of fatal and non-fatal stroke (and secondarily of other
cardiovascular events) of administering a small dose of the calcium antagonist felodipine (5
mg once a day) or of a placebo, in hypertensive patients whose blood pressure had
preliminarily been reduced by administering a low-dose diuretic (hydrochlorothiazide,12. 5 mg
once a day) to be continued in association with felodipine or placebo, throughout the trial.
Reports of Suspected Plendil (Felodipine) Side Effects
Atrial Fibrillation (5),
Drug Ineffective (4),
Drug Hypersensitivity (3),
Cerebrovascular Accident (3),
Cardiac Disorder (2),
Cerebral Haemorrhage (2),
ECG Signs of Myocardial Ischaemia (2),
Anaphylactoid Reaction (2),
Acute Coronary Syndrome (2),
Myocardial Infarction (2), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Plendil has an overall score of 9. The effectiveness score is 6 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| Plendil review by medical professional caring for 30 year old male patient | | Rating |
Overall rating: | | |
Effectiveness: | | Moderately Effective |
Side effects: | | Mild Side Effects | | Treatment Info |
Condition / reason: | | hypertention |
Dosage & duration: | | 10 mg taken once daily for the period of 6 months |
Other conditions: | | nil |
Other drugs taken: | | nil | | Reported Results |
Benefits: | | blood pressure came to with in normal limits, overall feeling of well-being and reduced risk of longterm cardiovascular copmlications |
Side effects: | | headaches mainly |
Comments: | | tenormin 25 twice daily
felodipine 10 mg once daily
Losartan 50 mg and hydrochlorothiazide 12.5 mg once daily
Regular exercise
moderate salt restiction
smoking cessation and alcohol moderation
stress management techniques like yoga or meditation |
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Page last updated: 2011-12-09
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