Cardene SR

DRUG DESCRIPTION

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:

 CARDENE® SR (nicardipine hydrochloride) Structural Formula Illustration

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
  • ...

Read All Potential Side Effects and See Pictures of Cardene SR »

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...

Read All Potential Precautions of Cardene SR »


Cardene SR Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, headache, flushing, or swelling ankles/feet may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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: fainting, fast/irregular/pounding heartbeat.

Tell your doctor immediately if this rare but very serious side effect occurs: 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 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 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.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Cardene SR Patient Information Including Side Effects

Brand Names: Cardene, Cardene SR

Generic Name: nicardipine (Pronunciation: nye KAR di peen)

  • What is nicardipine (Cardene SR)?
  • What are the possible side effects of nicardipine (Cardene SR)?
  • What is the most important information I should know about nicardipine (Cardene SR)?
  • What should I discuss with my healthcare provider before taking nicardipine (Cardene SR)?
  • How should I take nicardipine (Cardene SR)?
  • What happens if I miss a dose (Cardene SR)?
  • What happens if I overdose (Cardene SR)?
  • What should I avoid while taking nicardipine (Cardene SR)?
  • What other drugs will affect nicardipine (Cardene SR)?
  • Where can I get more information?

What is nicardipine (Cardene SR)?

Nicardipine is in a class of drugs called calcium channel blockers. Nicardipine relaxes (widens) your blood vessels, which makes it easier for the heart to pump and reduces its workload.

Nicardipine is used to treat hypertension (high blood pressure) and angina (chest pain).

Nicardipine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of nicardipine (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 may be more likely to occur. Continue to take nicardipine and talk to your doctor if you experience

  • unusual headache, fatigue, or tiredness;
  • dizziness;
  • flushing;
  • rash;
  • insomnia;
  • vivid or abnormal dreams;
  • increased urination;
  • dry mouth;
  • nausea or constipation; or
  • nervousness or tremor.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nicardipine (Cardene SR)?

Do not stop taking nicardipine without first talking to your doctor, even if you begin to feel better. If you stop taking the medication, your condition could become worse.

Do not crush, chew, or break the extended-release (SR) capsules. Swallow them whole. They are specially formulated to release the medication slowly in the body.

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