Cardizem CD

DRUG DESCRIPTION

Cardizem (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is:

CARDIZEM® CD (diltiazem HCl) Structural Formula Illustration

Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Cardizem CD (diltiazem hcl) is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg, 300 mg, or 360 mg diltiazem hydrochloride. The 120 mg, 180 mg, 240 mg, and 300 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, black iron oxide (300 mg), castor oil, ethylcellulose, FD&C Blue #1, fumaric acid, gelatin, silicon dioxide, simethicone, starch, stearic acid, sucrose, talc, titanium dioxide and white wax. The 360 mg capsule also contains: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, diethyl phthalate, FD&C Blue #1, gelatin, povidone, simethicone, sodium lauryl sulfate, starch, sucrose, talc and titanium dioxide.

For oral administration.

What are the precautions when taking diltiazem hcl (Cardizem CD)?

Before taking diltiazem, 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 types of heart rhythm problems (such as sick sinus syndrome/atrioventricular block unless you have a pacemaker).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart failure.

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

Read All Potential Precautions of Cardizem CD »


Cardizem CD Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, weakness, nausea, flushing, and headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower the risk of 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, slow/irregular/pounding/fast heartbeat, swelling ankles/feet, shortness of breath, unusual tiredness, unexplained/sudden weight gain, mental/mood changes (such as depression, agitation), unusual dreams.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, dark urine, persistent nausea/vomiting, yellowing eyes/skin.

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 diltiazem, 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 types of heart rhythm problems (such as sick sinus syndrome/atrioventricular block unless you have a pacemaker).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart failure.

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.

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

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.



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