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 (nifedipine extended release tablets) 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 (nifedipine extended release tablets) 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 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, or obstruction), kidney problems, a certain metabolic disorder (porphyria).

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

This drug...

Read All Potential Precautions of Procardia XL »


Procardia XL Consumer (continued)

SIDE EFFECTS: Headache, dizziness, nausea, flushing, constipation, leg/muscle cramps, or sexual problems may occur. To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

An empty tablet shell may appear in your stool. This is harmless since your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of the ankles/feet, shortness of breath, unusual weakness/tiredness.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast/slow/irregular heartbeat, fainting, mental/mood changes, swollen/tender gums, vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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, or 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 make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Nifedipine passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.



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