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Procardia XL (Nifedipine Extended Release) - Summary



Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. PROCARDIA XL® Extended Release Tablet is similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. The core itself is divided into two layers: an "active" layer containing the drug, and a "push" layer containing pharmacologically inert (but osmotically active) components. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and "pushes" against the drug layer, releasing drug through the precision laser-drilled tablet orifice in the active layer.

PROCARDIA XL is indicated for the following:

I. Vasospastic Angina

PROCARDIA XL is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. PROCARDIA XL may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.

II. Chronic Stable Angina
     (Classical Effort-Associated Angina)

PROCARDIA XL is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents.

In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete.

Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS.)

III. Hypertension

PROCARDIA XL is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

See all Procardia XL indications & dosage >>


Published Studies Related to Procardia XL (Nifedipine)

Vitamin D and nifedipine in the treatment of Chinese patients with grades I-II essential hypertension: a randomized placebo-controlled trial. [2014]
the treatment of patients with essential hypertension... CONCLUSIONS: Vitamin D supplementation can reduce blood pressure in patients with

Oral nifedipine or intravenous labetalol for hypertensive emergency in pregnancy: a randomized controlled trial. [2013]
hypertensive emergency of pregnancy... CONCLUSION: As administered in this trial, oral nifedipine lowered blood pressure

Effect of nifedipine on choroidal blood flow regulation during isometric exercise. [2012]
healthy subjects... CONCLUSIONS: In conclusion, the data of the present study suggest that nifedipine

Comparison of the efficacy of nifedipine and hydralazine in hypertensive crisis in pregnancy. [2011.11]
Intravenous hydralazine is a commonly administered arteriolar vasodilator that is effective for hypertensive emergencies associated with pregnancy...

Adjuvant Tamsulosin or Nifedipine After Extracorporeal Shock Wave Lithotripsy for Renal Stones: A Double Blind, Randomized, Placebo-controlled Trial. [2011.11]
OBJECTIVE: To evaluate the effects of the adjuvant use of tamsulosin or nifedipine after extracorporeal shock wave lithotripsy for nonlower pole kidney stones 5-20 mm in size... CONCLUSION: The stone-free rates after extracorporeal shock wave lithotripsy with adjuvant tamsulosin or nifedipine were significantly increased only for nonlower pole renal stones 10-20 mm in size compared with placebo. Nifedipine was associated with more adverse effects than placebo. Copyright A(c) 2011 Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Procardia XL (Nifedipine)

Nifedipine Pharmacokinetics and Pharmacodynamics When Used as a Tocolytic in Acute Threatened Preterm Labour [Recruiting]
Preterm birth is the leading cause of perinatal mortality and morbidity. According to WHO, 15 million children are born prematurely (gestational age < 37 weeks) in the world each year while 7% of them die because of complications associated with prematurity. Despite constant improvement of obstetrical care, the number of preterm births has increased over the last decades and prematurity is still the most frequent cause of prenatal hospitalization in industrialized countries. The American College of Obstetricians and Gynecologists as well as the Royal College of Obstetricians and Gynaecologists recommend nifedipine as a first-line tocolytic in case of acute threatened preterm labour. Clinical experience show however an important variability in treatment response among pregnant women. In spite of its large use in obstetrics as a tocolytic agent, nifedipine is prescribed off-label. As a consequence no international consensus on optimal dose schedule has so far been proposed. Small sample size and heterogeneousness of tocolysis administration protocols make it difficult to compare the little data available on the pharmacokinetics of nifedipine in pregnant women. Nevertheless an important interindividual variability in concentrations has been identified (CV=12-76%) but very few studies have investigated the possible reasons of this variability in pregnant women. Genetic and environmental factors involved in drug distribution and metabolism (e. g. enzymatic activity, CYP 3A5 genotype) might partially explain variability in drug levels and therefore differences in treatment response. The goal of this study is to quantify the variability in nifedipine pharmacokinetics and identify potential genetic and non-genetic sources of variability in nifedipine pharmacokinetics in pregnant women. The relationship between concentration and treatment response will be evaluated and will serve to propose optimal dosage regimen to improve efficacy and reduce side effects associated with this treatment.

Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed [Completed]
Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.

Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions [Completed]
The present study will be performed to investigate and to compare the in-vivo performance of the two investigational products Gen-nifedipine extended release, (previously referred to as Gen-Nifedipine XL (Genpharm ULC, Canada)) and Nifedipine(Bayer Healthcare AG manufactured as Adalat XL, Adalat LA, Adalat Crono, Adalat OROS) by comparing their pharmacokinetic parameters after oral single dose administrations in the fasted and fed state.

Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil [Not yet recruiting]
This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate control of blood pressure with candesartane alone. Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five weeks of the study to assess blood pressure control with candesartan given alone. Patients with an insufficient therapeutic response to candesartan alone (defined by mean seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last eight weeks

Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor [Recruiting]
This study looks at the effects of a mother's genes and other characteristics (mother's age, baby's age, race, and other diseases) on the ability of nifedipine to end contractions and prevent an early delivery. This information will be used to decide what amount of nifedipine women need to best treat preterm contractions.

more trials >>

Reports of Suspected Procardia XL (Nifedipine) Side Effects

Hypertension (23)Drug Ineffective (19)Headache (11)Death (11)Dizziness (10)Asthma (9)Blood Pressure Increased (9)Cerebrovascular Accident (9)Malaise (8)Asthenia (7)more >>

Page last updated: 2014-11-30

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