Cardizem

Cardizem is a prescription medication used to control chest pain and treats high blood pressure.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Cardizem is part of the drug class:

• Benzothiazepine derivatives

Before taking Cardizem, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Cardizem or to any of its ingredients
• have or have had a myocardial infarction (heart attack)
• have or have had a blockage or condition of your digestive system that causes food to move through your digestive system slowly
• have or have had low blood pressure
• have or have had liver disease
• have or have had kidney disease
• have or have had heart disease or heart failure
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Store Cardizem at room temperature.
• Avoid excessive humidity.
• Keep this and all medicines out of the reach of children.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of diltiazem can be fatal.

Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting.

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

NDC 0187-0792-47

Rx only

Cardizem®
(diltiazem HCl)

120 mg

Swallow tablets whole.

Do not split, crush or chew tablets.

100 Tablets

VALEANT
Pharmaceuticals North America LLC

NDC 0187-0791-47

Cardizem®
(diltiazem HCl)

90 mg

100 Tablets

Swallow tablets whole.

Do not split, crush or chew tablets

Rx only

VALEANT
Pharmaceuticals North America LLC

Many drugs can interact with diltiazem, and your doctor may need to change your treatment plan if you use certain other medicines. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using. Give a list of all your medicines to any healthcare provider who treats you.

Applies to diltiazem: compounding powder, intravenous powder for injection, intravenous solution, oral capsule extended release, oral tablet, oral tablet extended release

General

The most commonly reported side effects include edema, headache, and dizziness.[Ref]

Cardiovascular

Very common (10% or more): Peripheral edema (up to 15%)
Common (1% to 10%): Bradycardia, ECG abnormality, first degree atrioventricular (AV) block, bundle branch block, palpitations, edema, asymptomatic/symptomatic hypotension, flushing, vasodilation, extrasystole/ventricular extrasystole, arrhythmia (junctional rhythm/isorhythmic dissociation)
Uncommon (0.1% to 1%): Orthostatic hypotension
Frequency not reported: Angina, AV block (second or third degree), development/aggravation of congestive heart failure, syncope, atrial flutter, sinus pause/arrest, sinus node dysfunction, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia/tachycardia
Postmarketing reports: Asystole/cardiac arrest, sinoatrial block, vasculitis, vasodilation symptoms (flushing, lower limb edema, sweating), myocardial infarction[Ref]

A patient with Prinzmetal's angina developed asystole after a single, 60 mg dose.

Myocardial infarction was not readily distinguishable from the natural history of the disease.

Vasodilatory events (e.g., peripheral edema, headache, flushing) are dose-related and may be more common in elderly patients.

First degree AV block and sinus bradycardia occurred more frequently with higher doses.[Ref]

Other

Common (1% to 10%): Asthenia, malaise, fatigue, infection, flu syndrome, pain
Frequency not reported: Malaise, tinnitus, thirst[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dyspepsia, gastric pain, abdominal enlargement, constipation
Uncommon (0.1% to 1%): Vomiting, diarrhea
Rare (0.01% to 0.1%): Dry mouth
Frequency not reported: Gastrointestinal disorder, gingivitis
Postmarketing reports: Gingival hyperplasia[Ref]

Dermatologic

Well-documented cases of rashes (as leukocytoclastic vasculitis) have been reported, but a definitive between these events and this drug have not been established.

Lichenoid keratosis and hyperpigmentation occurred in skin exposed to the sun.[Ref]

Common (1% to 10%): Flushing/hot flushes, rash, erythema
Rare (0.01% to 0.1%): Urticaria
Frequency not reported: Petechiae, photosensitivity (lichenoid keratosis), pruritus, hyperpigmentation, hyperhidrosis/sweating
Postmarketing reports: Alopecia, musculocutaneous reactions (simple erythema, desquamative erythema with/without fever), angioneurotic edema, erythema multiforme (Steven-Johnson's syndrome, toxic epidermal necrolysis), exfoliative dermatitis, leukocytoclastic vasculitis, allergic dermatitis, acute generalized exanthematous pustular dermatitis[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, increased cough, bronchitis
Frequency not reported: Dyspnea, epistaxis, sinus/nasal congestion[Ref]

Nervous system

Common (1% to 10%): Myalgia
Frequency not reported: Creatine phosphokinase (CPK) increase, muscle cramp, osteoarticular pain, myopathy, muscle pain, muscle weakness, neck rigidity[Ref]

Dizziness occurred more frequently with higher doses.[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia
Frequency not reported: Creatine phosphokinase (CPK) increase, muscle cramp, osteoarticular pain, myopathy, muscle pain, muscle weakness, neck rigidity[Ref]

Metabolic

Common (1% to 10%): Gout
Frequency not reported: Anorexia, weight increase, hyperglycemia, hyperuricemia[Ref]

Genitourinary

Common (1% to 10%): Impotence
Frequency not reported: Nocturia, polyuria, sexual difficulties, albuminuria, crystalluria[Ref]

Ocular

Common (1% to 10%): Conjunctivitis
Frequency not reported: Amblyopia, eye irritation
Postmarketing reports: Retinopathy[Ref]

Local

Common (1% to 10%): Injection site reactions (e.g., itching, burning)[Ref]

Psychiatric

Uncommon (0.1% to 1%): Nervousness, insomnia
Frequency not reported: Abnormal dreams, depression, hallucinations, personality change
Postmarketing reports: Mood changes (including depression)[Ref]

Hepatic

There were rare cases of clinical hepatitis that were reversible with discontinuation of this drug.[Ref]

Uncommon (0.1% to 1%): Increased hepatic enzymes (AST, ALT, LDH, ALP)
Frequency not reported: Clinical hepatitis/hepatitis[Ref]

Hematologic

Postmarketing reports: Hemolytic anemia, increased bleeding time, leukopenia, purpura, thrombocytopenia, lymphadenopathy, eosinophilia[Ref]

Hypersensitivity

Postmarketing reports: Allergic reactions, angioedema (including facial/periorbital edema)[Ref]

Endocrine

Postmarketing reports: Gynecomastia[Ref]

Some side effects of Cardizem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.