Dilacor XR

Diltiazem is a prescription medication used to treat high blood pressure and control chest pain. It can also be used to control an irregular heartbeat.

Diltiazem belongs to a group of drugs called calcium channel blockers. These work by relaxing the blood vessels so the heart does not need to work as hard. Calcium channel blockers also increase the supply of blood and oxygen to the heart.

This medication comes in tablet, extended release tablet, and extended release capsule forms. The tablet is usually taken 3 to 4 times a day. The extended release tablet and capsule are usually taken 1 to 2 times a day. Each diltiazem product has different instructions for whether or not it should be taken with or without food, so ask your pharmacist for more information.

Do not chew, divide, or break diltiazem extended release tablets or capsules. Swallow the tablets and capsules whole.

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of ditiazem include headache, flushing, slow heartbeat, and nausea.

Diltiazem can also cause dizziness. Do not drive or operate heavy machinery until you know how diltiazem affects you.

Oral:

Diltiazem tablets and capsules are prescription medications used to treat high blood pressure and control chest pain.

Injectable:

Diltiazem injection is a prescription medication used to treat arrhythmias, which are problems with the rate or rhythm of the heartbeat.

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

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

• Atazanavir (Reyataz)
• Benzodiazepines such as
  • Midazolam (Versed)
  • Triazolam (Halcion)
• Beta blockers such as
  • Atenolol (Tenormin)
  • Metoprolol (Toprol XL, Lopressor)
  • Carvedilol (Coreg)
  • Bisoprolol (Zebeta)
  • Betaxolol (Kerlone)
  • Nebivolol (Bystolic)
  • Propranolol (Inderal)
  • Labetalol (Trandate)
  • Nadolol (Corgard)
• Buspirone (Buspar)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Digoxin (Lanoxin)
• Statins such as
  • Lovastatin (Altoprev, Mevacor)
  • Simvastatin (Zocor)
• Quinidine
• Rifampin 
• Clonidine (Catapres)

This is not a complete list of diltiazem drug interactions. Ask your doctor or pharmacist for more information.

Oral:

Take diltiazem exactly as prescribed.

Diltiazem comes in tablet, extended release tablet, and extended release capsule forms. The tablet is usually taken 3 to 4 times a day. The extended release tablet and capsule is usually taken 1 to 2 times a day. Each diltiazem product has different instructions for whether or not it should be taken with or without food, so ask your pharmacist for more information.

Do not chew, divide, or break diltiazem extended release tablets or capsules. Swallow the tablets and capsules whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of diltiazem at the same time.

Injectable:

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

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

If diltiazem 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.

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

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Hypotension (low blood pressure) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision, confusion, severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness. .

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loose skin, chills, cough, diarrhea, itching, joint or muscle pain, red skin lesions, often with a purple center, skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Cardiac Conduction: Diltiazem hydrochloride prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second, or third degree AV block (22 of 10,119 patients, or 0.2%); 41% of these 22 patients were receiving concomitant β-adrenoceptor antagonists versus 17% of the total group. Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal’s angina developed periods of asystole (2 to 5 seconds) after a single 60 mg dose of diltiazem.

Congestive Heart Failure: Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). An acute study of oral diltiazem in patients with impaired ventricular function (ejection fraction of 24% ± 6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/dt). Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function. Experience with the use of diltiazem hydrochloride in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.

Hypotension: Decreases in blood pressure associated with diltiazem hydrochloride therapy may occasionally result in symptomatic hypotension.

Acute Hepatic Injury: Mild elevations of serum transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. In rare instances, significant elevations in alkaline phoshatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions tended to occur early after therapy initiation (1 to 6 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to diltiazem is uncertain in some cases, but probable in some others. (See PRECAUTIONS.)

Serious adverse reactions to diltiazem hydrochloride have been rare in studies with other formulations, as well as with Dilacor XR®. It should be recognized, however, that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies.

Hypertension: The most common adverse events (frequency ≥1%) in placebo-controlled, clinical hypertension studies with Dilacor XR using daily doses up to 540 mg, are listed in the table below with placebo-treated patients included for comparison.

Angina: The most common adverse events (frequency ≥1%) in a placebo-controlled, short-term (2 week) clinical angina study with Dilacor XR are listed in the table below with placebo-treated patients included for comparison. In this trial, following a placebo phase, patients were randomly assigned to once daily doses of either 120, 240, or 480 mg of Dilacor XR.

Infrequent Adverse Events: The following additional events (COSTART Terms), listed by body system, were reported infrequently (less than 1%) in all subjects, hypertensive (n=425) or angina (n=318) patients who received Dilacor XR, or with other formulations of diltiazem.

Hypertension: Cardiovascular: First-degree AV block, arrhythmia, postural hypotension, tachycardia, pallor, palpitations, phlebitis, ECG abnormality, ST elevation.

Nervous System: Vertigo, hypertonia, paresthesia, dizziness, somnolence.

Digestive System: Dry mouth, anorexia, tooth disorder, eructation.

Skin and Appendages: Sweating, urticaria, skin hypertrophy (nevus).

Respiratory System: Epistaxis, bronchitis, respiratory disorder.

Urogenital System: Cystitis, kidney calculus, impotence, dysmenorrhea, vaginitis, prostate disease.

Metabolic and Nutritional Disorders: Gout, edema.

Musculoskeletal System: Arthralgia, bursitis, bone pain.

Hemic and Lymphatic System: Lymphadenopathy.

Body as a Whole: Pain, unevaluable reaction, neck pain, neck rigidity, fever, chest pain, malaise.

Special Senses: Amblyopia (blurred vision), ear pain.

Angina: Cardiovascular: Palpitations, AV block, sinus bradycardia, bigeminal extrasystole, angina pectoris, hypertension, hypotension, myocardial infarct, myocardial ischemia, syncope, vasodilatation, ventricular extrasystole.

Nervous System: Abnormal thinking, neuropathy, paresthesia.

Digestive System: Diarrhea, dyspepsia, vomiting, colitis, flatulence, GI hemorrhage, stomach ulcers.

Skin and Appendages: Contact dermatitis, pruritus, sweating.

Respiratory System: Respiratory distress.

Urogenital System: Kidney failure, pyelonephritis, urinary tract infection.

Metabolic and Nutritional Disorders: Weight increase.

Musculoskeletal System: Myalgia.

Body as a Whole: Chest pain, accidental injury, infection.

Special Senses: Eye hemorrhage, ophthalmitis, otitis media, taste perversion, tinnitus.

There have been post-marketing reports of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of diltiazem hydrochloride.

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.

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.

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