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Dynacirc CR

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Dynacirc CR

DynaCirc CR®
(isradipine) Controlled Release Tablets

DRUG DESCRIPTION

DynaCirc CR® contains isradipine, a calcium antagonist. It is available for once-daily oral administration as a controlled release 5 mg and 10 mg tablet for DynaCirc CR® (isradipine). DynaCirc CR® is a registered trademark for isradipine GITS (Gastrointestinal Therapeutic System) tablets.

The structural formula of isradipine is:

DynaCirc CR (isradipine)  Structural Formula Illustration

Chemically, isradipine is 3,5-Pyridinedicarboxylic acid, 4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-, methyl 1-methylethyl ester. Isradipine is a yellow, fine crystalline powder which is odorless or has a faint characteristic odor. Isradipine is practically insoluble in water ( < 10 mg/L at 37°C), but is soluble in ethanol and freely soluble in acetone,chloroform and methylene chloride.

Active Ingredient: isradipine

Inactive Ingredients: butylated hydroxytoluene; cellulose acetate; hydroxypropyl methylcellulose; magnesium stearate; polyethylene glycol; polyethylene oxide; polysorbate 80; propylene glycol; red ferric oxide; silicon dioxide; sodium chloride; titanium dioxide; yellow ferric oxide.

System Components and Performance

Isradipine is delivered from the DynaCirc CR® (isradipine) Controlled Release Tablet as follows: a semipermeable membrane surrounds an osmotically active drug core.The core is composed of two layers: an "active"layer containing the drug, and a pharmacologically inert but osmotically active "push" layer. After ingestion, the tablet overcoating is quickly dissipated in the gastrointestinal tract,allowing water to enter the tablet through the semipermeable membrane. The polyethylene oxide polymer swells in the osmotic ("push") layer and exerts pressure against the "active"drug layer, releasing isradipine as a fine suspension through the laser-drilled tablet orifice which has been positioned on the "active" drug layer side. Drug delivery is essentially constant as long as the osmotic gradient remains constant and, after either 5 mg or 10 mg of isradipine is released, gradually falls to a negligible amount.The controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. The delivery of isradipine in DynaCirc CR® (isradipine) Controlled Release Tablets depends on the existence of an osmotic gradient between the contents of the bilayer core and the fluid in the GI tract.The biologically inert core of the tablet remains intact and,unless it becomes trapped, is eliminated in the feces.

What are the possible side effects of isradipine (Dynacirc, Dynacirc CR)?

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

Call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • feeling short of breath, even with mild exertion;
  • swelling in your hands and feet;
  • fast or pounding heartbeats; or
  • chest pain.

Less serious side effects may include:

  • dizziness;
  • warmth, redness, or tingly feeling under your...

Read All Potential Side Effects and See Pictures of Dynacirc CR »

What are the precautions when taking isradipine (Dynacirc CR)?

Before taking isradipine, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain structural heart problems (aortic stenosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, stomach/intestine problems (such as narrowing, blockage).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure...

Read All Potential Precautions of Dynacirc CR »

Last reviewed on RxList: 12/30/2008
This monograph has been modified to include the generic and brand name in many instances.

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Dynacirc CR - User Reviews

Dynacirc CR User Reviews

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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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