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(nicardipine hydrochloride) Sustained Release Capsules
CARDENE® SR (nicardipine hydrochloride sustained release capsules) is a sustained release formulation of CARDENE®. CARDENE SR capsules for oral administration each contain 30 mg, 45 mg or 60 mg of nicardipine hydrochloride. Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium entry blocker).
Nicardipine hydrochloride is a dihydropyridine derivative with the IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6 dimethyl- 4-(m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure:
Nicardipine hydrochloride is a greenish-yellow, odorless, crystalline powder that melts at about 169°C. It is freely soluble in chloroform, methanol and glacial acetic acid, sparingly soluble in anhydrous ethanol, slightly soluble in n-butanol, water, 0.01 M potassium dihydrogen phosphate, acetone and dioxane, very slightly soluble in ethyl acetate, and practically insoluble in benzene, ether and hexane. It has a molecular weight of 515.99.
CARDENE SR is available in hard gelatin capsules containing 30 mg, 45 mg or 60 mg nicardipine hydrochloride. All strengths contain a two component capsule fill. A powder component containing 25% of total nicardipine hydrochloride dose contains pregelatinized starch and magnesium stearate as inactive ingredients. A spherical granule component containing 75% of total nicardipine hydrochloride dose also contains microcrystalline cellulose, starch, lactose and methacrylic acid copolymer Type C as inactive ingredients.
The colorants used in the 30-mg capsules are titanium dioxide, FD& Red No. 40 and red iron oxide, and the colorants used in the 45-mg and 60-mg capsules are titanium dioxide and FD&C Blue No. 2.
What are the possible side effects of nicardipine (Cardene, Cardene SR)?
If you experience any of the following serious side effects, stop taking nicardipine and contact your doctor immediately or seek emergency medical treatment:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- unusually fast or slow heartbeats;
- fainting or severe dizziness;
- abnormal behavior or psychosis;
- chest pain or worsening angina;
- jaundice (yellowing of the skin or eyes); or
- swelling of the legs or ankles.
Other, less serious side effects...
What are the precautions when taking nicardipine hydrochloride sustained release capsules (Cardene SR)?
Before taking nicardipine, 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 a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain structural heart problem (aortic stenosis).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.
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...
Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Cardene SR Information
Cardene SR - User Reviews
Cardene SR 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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