Procardia XL (Nifedipine Extended Release) - Summary

PROCARDIA XL 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 >>

NEWS HIGHLIGHTS

Published Studies Related to Procardia XL (Nifedipine)

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.

Effect of nifedipine on anorectal sensorimotor functions in health and fecal incontinence. [2011.07]
The mechanisms of increased rectal stiffness in women with fecal incontinence (FI) and rectal urgency are not understood. Our hypothesis was that distention-induced activation of mechanosensitive L-type calcium channels in smooth muscle contributes to increased rectal stiffness in FI...

A multicentre, prospective, randomized trial: comparative efficacy of tamsulosin and nifedipine in medical expulsive therapy for distal ureteric stones with renal colic. [2011.07]
OBJECTIVE: * To determine the comparative efficacy of tamsulosin and nifedipine in medical expulsive therapy (MET) for distal ureteric stones with renal colic... CONCLUSIONS: * Administration of tamsulosin and nifedipine in MET was determined to be safe and effective for distal ureteric stones with renal colic. * Tamsulosin was significantly better than nifedipine in relieving renal colic and facilitating ureteric stone expulsion. (c) 2010 THE AUTHORS. BJU INTERNATIONAL (c) 2010 BJU INTERNATIONAL.

more studies >>

Clinical Trials Related to Procardia XL (Nifedipine)

The Pharmacokinetics of Nifedipine Controlled Release Tablets in Hypertensive Patients on Hemodialysis [Not yet recruiting]
This is a prospective, open, non-randomized, non-controlled study. 20 patients with hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients had mild to moderate hypertension and are receiving antihypertensive agents.

This study was designed to investigate effects of Adalat GITS on hemodialytic blood pressures in patients with chronic hemodialysis by using ABPM and measuring the drug plasma concentrations. For the purpose of investigating the influence of hemodialysis on the drug plasma concentration as well as its efficacy, it should be necessary to assign the subjects with the Adalat monotherapy. Since most patients in the hemodialysis center will be those who need and already receive combination therapy, it would be practical to start Adalat 60mg/day monotherapy to remain similar antihypertensive effect when discontinuing the previous treatment in this study population to be screened and enrolled. And taking into the consideration of clinical practice, few patients undergoing hemodialysis could be well controlled by low dose Adalat 30mg/day alone. So this study will evaluate the effect and safety of Adalat GITS 60mg/day alone and thereafter the influence of hemodialysis on the drug plasma concentration without any other possible drug interaction. The agents are given orally once a day at 08: 00h and patients are followed for at least 4 weeks. After that,the patients whose blood pressure are well controlled by Adalat GITS 60mg/day by office blood pressure would be enrolled for further ABPM assessment and plasma concentration evaluation.

Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension [Recruiting]
This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension. The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment. The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.

An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects [Recruiting]
This is an open label study. The study will consist of 1 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine, administered BID to subjects with chronic anal fissure.

Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension [Recruiting]
The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active

ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are

currently approved for use in patients with essential hypertension alone or together with other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS and candesartan used together in the treatment of essential hypertension has not been established yet. In this study patients will be treated with various doses of nifedipine GITS and/or candesartan or placebo. These different regimes will be administered once a day and will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood pressure) in subjects with mild to moderate essential hypertension.

FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry) [Recruiting]
To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan

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 >>