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Procardia XL

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Procardia XL

PROCARDIA XL®
(nifedipine) Extended Release Tablets

Procardia XL

DRUG DESCRIPTION

Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4(2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula:

PROCARDIA XL® (nifedipine)  Structural Formula Illustration

Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. PROCARDIA XL is a registered trademark for Nifedipine GITS. Nifedipine GITS (Gastrointestinal Therapeutic System) Tablet is formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine.

Inert ingredients in the formulations are: cellulose acetate; hydroxypropyl cellulose; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; red ferric oxide; sodium chloride; titanium dioxide.

System Components and Performance

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 Extended Release Tablet is designed to provide nifedipine at an approximately constant rate over 24 hours. This controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. PROCARDIA XL depends for its action on the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the gastrointestinal tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. Upon swallowing, the biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell.

What are the possible side effects of nifedipine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • worsening angina;
  • feeling like you might pass out;
  • feeling short of breath, swelling in your hands or feet;
  • fast or pounding heartbeats;
  • numbness or tingly feeling;
  • jaundice (yellowing of the skin or eyes); or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill...

Read All Potential Side Effects and See Pictures of Procardia XL »

What are the precautions when taking nifedipine extended release tablets (Procardia XL)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other calcium channel blockers (e.g., amlodipine, felodipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart diseases (e.g., congestive heart failure, aortic stenosis), liver problems, esophagus/stomach/intestine problems (e.g., narrowing/stricture, motility disorders, obstruction), kidney problems, a certain metabolic disorder (porphyria).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may...

Read All Potential Precautions of Procardia XL »

Last reviewed on RxList: 5/28/2014
This monograph has been modified to include the generic and brand name in many instances.

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Procardia XL - User Reviews

Procardia XL User Reviews

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Here is a collection of user reviews for the medication Procardia XL sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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