Dilt-CD

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:

• 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

• 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

• 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:

• Sneezing
• stuffy nose

• 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

• 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.

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 120 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO 007” is imprinted on each capsule in black ink. They are supplied as bottles of 30 (NDC 60505-0007-2), bottles of 90 (NDC 60505-0007-4) and bottles of 500 (NDC 60505-0007-8).

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 180 mg are available for oral administration as hard gelatin capsules with a white opaque body and a light blue opaque cap. “APO 008” is imprinted on each capsule in black ink. They are supplied as bottles of 30 (NDC 60505-0008-2), bottles of 90 (NDC 60505-0008-4) and bottles of 500 (NDC 60505-0008-8).

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 240 mg are available for oral administration as hard gelatin capsules with a white opaque body and a light blue opaque cap. “APO 009” is imprinted on each capsule in black ink. They are supplied as bottles of 30 (NDC 60505-0009-2), bottles of 90 (NDC 60505-0009-4) and bottles of 500 (NDC 60505-0009-8).

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 300 mg are available for oral administration as hard gelatin capsules with a white opaque body and a light gray opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as bottles of 30 (NDC 60505-0010-2), bottles of 90 (NDC 60505-0010-4) and bottles of 500 (NDC 60505-0010-8).

Storage Conditions:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Dispense in a tight, light-resistant container [see USP].

APOTEX INC.

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 

120 mg, 180 mg, 240 mg and 300 mg

Manufactured by:                  Manufactured for:

Apotex Inc.                           Apotex Corp.

Toronto, Ontario                   Weston, Florida

Canada M9L 1T9                  33326

Revised: January 2013

Rev. 3

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-0007-2

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage)

120 mg

Rx

30 count

You should not use diltiazem if you have very low blood pressure, a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), or if you have recently had a heart attack and you have a build-up of fluid in your lungs.

Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure.

Diltiazem may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop taking this medication without first talking to your doctor. If you stop taking diltiazem suddenly, your condition may become worse.

Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your diet, medication, and exercise routines very closely.

If you are being treated for high blood pressure, keep using diltiazem even if you feel well. High blood pressure often has no symptoms.

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.

More frequently reported side effects include: dizziness, edema, asthenia, headache, and vasodilatation. See below for a comprehensive list of adverse effects.

Applies to diltiazem: oral capsule extended release, oral capsule extended release 12 hr, oral capsule extended release 24 hr, oral tablet, oral tablet extended release

Other dosage forms:

• intravenous powder for solution, intravenous solution

Along with its needed effects, diltiazem 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 while taking diltiazem:

• 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

• 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

• 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 of diltiazem 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:

• Sneezing
• stuffy nose

• 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

• Hair loss or thinning of the hair

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

No adjustment recommended; use with caution.

• May be used for the treatment of high blood pressure (hypertension), alone or in combination with other agents for high blood pressure.
• May be used as an ongoing treatment to relieve symptoms such as chest pain in people with chronic stable angina, or angina due to coronary artery spasm. Will not relieve acute episodes of angina (other medications such as sublingual nitroglycerin are used for this purpose).
• Available as a tablet, an extended-release (long-acting) tablet, and an extended-release capsule.
• Can improve a person's tolerance to exercise and keep their blood pressure at acceptable levels during exercise. Heart rate at maximal exercise does not change or is slightly reduced.
• Does not weaken how hard the heart contracts (does not have a negative inotropic effect).
• Lowers blood pressure in both the standing and the sitting position. Does not tend to cause as much of a drop in blood pressure as some other blood pressure lowering agents when going from a lying down to standing position. Does not cause a reflex tachycardia (a compensatory fast heart rate that often occurs when blood pressure drops).
• Generic diltiazem is available.