Cardizem CD

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once and may increase your risk of side effects.Your doctor may gradually increase your dose. Follow your doctor's instructions carefully. Dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. For the treatment of high blood pressure, it may take 2 to 4 weeks before you get the full benefit of this drug.This medication must be taken regularly to prevent angina. It should not be used to treat angina when it occurs. Use other medications (such as nitroglycerin placed under the tongue) to relieve an angina attack as directed by your doctor. Consult your doctor or pharmacist for details.Tell your doctor if your condition worsens (for example, your chest pain worsens or your routine blood pressure readings increase).

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cardizem CD falls into category C. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Cardizem CD has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Cardizem CD, a choice should be made whether to stop nursing or to stop use of this medication. 

If you take too much Cardizem CD, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Cardizem CD is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

In the U.S.

• Cardizem
• Cardizem CD
• Cardizem LA
• Cartia XT
• Dilacor XR
• Dilt-CD
• Diltia XT
• Dilt-XR
• Diltzac
• Matzim LA
• Taztia XT
• Tiazac

Available Dosage Forms:

• Capsule, Extended Release
• Tablet, Extended Release
• Tablet
• Capsule, Extended Release, 24 HR
• Capsule, Extended Release, 12 HR

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Benzothiazepine

Diltiazem is used alone or together with other medicines to treat angina (severe chest pain) or hypertension (high blood pressure). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Diltiazem is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, diltiazem relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain
• congestion
• cough
• dryness or soreness of the throat
• fever
• hoarseness
• runny nose
• tender or swollen glands in the neck
• trouble swallowing
• voice changes

Less common

• Chest pain or discomfort
• chills
• diarrhea
• difficult or labored breathing
• feeling faint, dizzy, or lightheaded
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• shivering
• slow or irregular heartbeat
• sweating
• swelling of the hands, ankles, feet, or lower legs
• tightness in the chest
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Incidence not known

• Blistering, peeling, or loosening of the skin
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• no heartbeat
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots in the mouth or on the lips

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Sneezing
• stuffy nose

Less common

• Acid or sour stomach
• belching
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• degenerative disease of the joint
• difficulty with moving
• hearing loss
• heartburn
• indigestion
• lack or loss of strength
• muscle aching or cramping
• muscle pains or stiffness
• pain or tenderness around the eyes and cheekbones
• rash
• stomach discomfort, upset, or pain
• swollen joints

Incidence not known

• Hair loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Cardizem CD, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Cardizem CD. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Cardizem CD.

Review Date: October 4, 2017

NDC 0187-0799-42

Rx only

  Cardizem® CD
(diltiazem HCl)
ONCE-A-DAY DOSAGE

360 mg

90 Capsules

Valeant

Cardizem CD  diltiazem hydrochloride capsule, coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-0795 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 120 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE 300 mg FD&C BLUE NO. 1   MAGNESIUM STEARATE   ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)   POLYSORBATE 80   POVIDONE K30   SUCROSE STEARATE   TALC   TITANIUM DIOXIDE   GELATIN, UNSPECIFIED   HYPROMELLOSE, UNSPECIFIED   MICROCRYSTALLINE CELLULOSE

Product Characteristics Color BLUE (light turquoise blue,light turquoise blue) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code cardizem;CD;120;mg Contains

Packaging # Item Code Package Description 1 NDC:0187-0795-30 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2 NDC:0187-0795-42 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 3 NDC:0187-0795-49 10 BLISTER PACK in 1 BOX, UNIT-DOSE 3 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020062 04/11/2001

Cardizem CD  diltiazem hydrochloride capsule, coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-0796 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 180 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE 300 mg FD&C BLUE NO. 1   MAGNESIUM STEARATE   ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)   POLYSORBATE 80   POVIDONE K30   SUCROSE STEARATE   TALC   TITANIUM DIOXIDE   GELATIN, UNSPECIFIED   HYPROMELLOSE, UNSPECIFIED   MICROCRYSTALLINE CELLULOSE

Product Characteristics Color BLUE (Light turquoise blue, blue) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code cardizem;CD;180;mg Contains

Packaging # Item Code Package Description 1 NDC:0187-0796-30 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2 NDC:0187-0796-42 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 3 NDC:0187-0796-49 10 BLISTER PACK in 1 BOX, UNIT-DOSE 3 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK 4 NDC:0187-0796-50 5000 CAPSULE, COATED, EXTENDED RELEASE in 1 DRUM

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020062 04/11/2001

Cardizem CD  diltiazem hydrochloride capsule, coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-0797 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 240 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE 300 mg FD&C BLUE NO. 1   MAGNESIUM STEARATE   ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)   POLYSORBATE 80   POVIDONE K30   SUCROSE STEARATE   TALC   TITANIUM DIOXIDE   GELATIN, UNSPECIFIED   HYPROMELLOSE, UNSPECIFIED   MICROCRYSTALLINE CELLULOSE

Product Characteristics Color BLUE (blue, blue) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code cardizem;CD;240;mg Contains

Packaging # Item Code Package Description 1 NDC:0187-0797-30 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2 NDC:0187-0797-42 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 3 NDC:0187-0797-49 10 BLISTER PACK in 1 BOX, UNIT-DOSE 3 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020062 04/11/2001

Cardizem CD  diltiazem hydrochloride capsule, coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-0798 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 300 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE 300 mg FD&C BLUE NO. 1   MAGNESIUM STEARATE   ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)   POLYSORBATE 80   POVIDONE K30   SUCROSE STEARATE   TALC   TITANIUM DIOXIDE   GELATIN, UNSPECIFIED   HYPROMELLOSE, UNSPECIFIED   MICROCRYSTALLINE CELLULOSE

Product Characteristics Color GRAY (Light gray , BLUE (Light blue)) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code cardizem;CD;300;mg Contains

Packaging # Item Code Package Description 1 NDC:0187-0798-30 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2 NDC:0187-0798-42 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020062 04/11/2001

Cardizem CD  diltiazem hydrochloride capsule, coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-0799 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diltiazem Hydrochloride (Diltiazem) Diltiazem Hydrochloride 360 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE 300 mg FD&C BLUE NO. 1   MAGNESIUM STEARATE   ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)   POLYSORBATE 80   POVIDONE K30   SUCROSE STEARATE   TALC   TITANIUM DIOXIDE   GELATIN, UNSPECIFIED   HYPROMELLOSE, UNSPECIFIED   MICROCRYSTALLINE CELLULOSE

Product Characteristics Color BLUE (Light blue, WHITE (white)) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code cardizem;CD;360;mg Contains

Packaging # Item Code Package Description 1 NDC:0187-0799-42 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020062 04/11/2001

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Registrant - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Operations
Valeant Pharmaceuticals International, Inc.		253292734	MANUFACTURE(0187-0799, 0187-0795, 0187-0796, 0187-0797, 0187-0798)

Revised: 01/2017   Valeant Pharmaceuticals North America LLC