Tiazac (Diltiazem Hcl)
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Tiazac (Diltiazem Hcl)

Tiazac®
(diltiazem hydrochloride) Extended-Release Capsules

DRUG DESCRIPTION

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

Tiazac®
(diltiazem hydrochloride) 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 and has a molecular weight of 450.98. Tiazac capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg.

Tiazac (diltiazem hcl) also contains: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium Dioxide.

For oral administration.

What are the possible side effects of diltiazem?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • a red, blistering skin rash;
  • swelling in your hands or feet;
  • trouble breathing;
  • slow heartbeats;
  • dizziness, fainting, fast or pounding heartbeat;
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction -- fever, sore...

Read All Potential Side Effects and See Pictures of Tiazac »

What are the precautions when taking diltiazem hcl (Tiazac)?

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 Tiazac »

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Hypertension

Tiazac (diltiazem hcl) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.

Chronic Stable Angina

Tiazac (diltiazem hcl) is indicated for the treatment of chronic stable angina.

DOSAGE AND ADMINISTRATION

Hypertension

Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, usual starting doses are 120 to 240 mg once daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 120 to 540 mg once daily. Current clinical experience with 540 mg dose is limited; however, the dose may be increased to 540 mg once daily.

Angina

Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 mg to 180 mg once daily. Individual patients may respond to higher doses of up to 540 mg once daily. When necessary, titration should be carried out over 7 to 14 days.

Concomitant use with Other Cardiovascular Agents

  1. Sublingual Nitroglycerin (NTG): May be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy.
  2. Prophylactic Nitrate Therapy: Diltiazem hydrochloride may be safely coadministered with short- and long-acting nitrates.
  3. Beta-blockers: (see WARNINGS and PRECAUTIONS.)
  4. Antihypertensives: Diltiazem hydrochloride has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other.

Hypertensive or anginal patients who are treated with other formulations of diltiazem can safely be switched to Tiazac (diltiazem hcl) capsules at the nearest equivalent total daily dose. Subsequent titration to higher or lower doses may, however, be necessary and should be initiated as clinically indicated.

Sprinkling the Capsule Contents on Food

Tiazac (diltiazem hydrochloride) Extended-release Capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the capsule contents. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. Any capsule contents/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a Tiazac (diltiazem hydrochloride) Extended-release Capsule is not recommended.

HOW SUPPLIED

Tiazac® (diltiazem hydrochloride) Extended-Release Capsules

Strength Description Quantity NDC#
120 mg #3 lavender/lavender capsule
imprinted: Tiazac 120
7's 0456-2612-07
30's 0456-2612-30
90's 0456-2612-90
1000's 0456-2612-00
HUD's 0456-2612-63
180 mg #2 white/blue-green capsule
imprinted: Tiazac 180
7's 0456-2613-07
30's 0456-2613-30
90's 0456-2613-90
1000's 0456-2613-00
HUD's 0456-2613-63
240 mg #1 blue-green/lavender capsule
imprinted: Tiazac 240
7's 0456-2614-07
30's 0456-2614-30
90's 0456-2614-90
1000's 0456-2614-00
HUD's 0456-2614-63
300 mg #0 white/lavender capsule
imprinted: Tiazac 300
7's 0456-2615-07
30's 0456-2615-30
90's 0456-2615-90
1000's 0456-2615-00
HUD's 0456-2615-63
360 mg #0 blue-green/blue-green capsule
imprinted: Tiazac 360
7's 0456-2616-07
30's 0456-2616-30
90's 0456-2616-90
1000's 0456-2616-00
HUD's 0456-2616-63
420 mg #00 white/white capsule
imprinted: Tiazac 420
7's 0456-2617-07
30's 0456-2617-30
90's 0456-2617-90
1000's 0456-2617-00

Storage conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity.

Manufactured by: Biovail Laboratories International SRL, Street B #34, Sabano Abajo Industrial Park, Carolina, PR 00983 OR Biovail Corporation, Mississauga, Ontario, Canada L5N 8M5. Manufactured for: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. Rev. 04/10

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Serious adverse reactions have been rare in studies with Tiazac (diltiazem hcl) , as well as with other diltiazem formulations. It should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. A total of 256 hypertensives were treated for between 4 and 8 weeks; a total of 207 patients with chronic stable angina were treated for 3 weeks with doses of Tiazac (diltiazem hcl) ranging from 120 to 540 mg once daily. Two patients experienced first-degree AV block at the 540 mg dose. The following table presents the most common adverse reactions, whether or not drug-related, reported in placebo-controlled trials in patients receiving Tiazac (diltiazem hcl) up to 360 mg and up to 540 mg with rates in placebo patients shown for comparison.

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED HYPERTENSION TRIALS*

Adverse Events (COSTART Term) Placebo Tiazac
n=57
# pts (%)
Up to 360 mg
n=149
# pts (%)
480 - 540mg
n=48
# pts (%)
edema, peripheral 1 (2) 8 (5) 7 (15)
dizziness 4 (7) 6 (4) 2 (4)
vasodilation 1 (2) 5 (3) 1 (2)
dyspepsia 0 (0) 7 (5) 0 (0)
pharyngitis 2 (4) 3 (2) 3 (6)
rash 0 (0) 3 (2) 0 (0)
infection 2 (4) 2 (1) 3 (6)
diarrhea 0 (0) 2 (1) 1 (2)
palpitations 0 (0) 2 (1) 1 (2)
nervousness 0 (0) 3 (2) 0 (0)
headache 1 (2) 13 (8) 4 (8)
edema, peripheral 1 (2) 3 (2) 5 (10)
pain 1 (2) 10 (6) 3 (6)
dizziness 0 (0) 5 (3) 5 (10)
asthenia 0 (0) 1 (1) 2 (4)
dyspepsia 0 (0) 2 (1) 3 (6)
dyspnea 0 (0) 1 (1) 3 (6)
bronchitis 0 (0) 1 (1) 2 (4)
AV block 0 (0) 0 (0) 2 (4)
infection 0 (0) 2 (1) 1 (2)
flu syndrome 0 (0) 0 (0) 1 (2)
cough increase 0 (0) 2 (1) 1 (2)
extrasystoles 0 (0) 0 (0) 1 (2)
gout 0 (0) 2 (1) 1 (2)
myalgia 0 (0) 0 (0) 1 (2)
impotence 0 (0) 0 (0) 1 (2)
conjunctivitis 0 (0) 0 (0) 1 (2)
rash 0 (0) 2 (1) 1 (2)
abdominal enlargement 0 (0) 0 (0) 1 (2)
* Adverse events occurring in treated patients at 2% or more than placebo-treated patients.

In addition, the following events have been reported infrequently (less than 2%) in clinical trials with other diltiazem products:

Cardiovascular: Angina, arrhythmia, AV block (second- or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.

Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor.

Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see WARNINGS, Acute Hepatic Injury), nausea, thirst, vomiting, weight increase.

Dermatological: Petechiae, photosensitivity, pruritus.

Other: Albuminuria, allergic reaction, amblyopia, asthenia, CPK increase, crystalluria, dyspnea, edema, epistaxis, eye irritation, headache, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, neck rigidity, nocturia, osteoarticular pain, pain, polyuria, rhinitis, sexual difficulties, gynecomastia.

In addition, the following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride: acute generalized exanthematous pustulosis, alopecia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), leukopenia, purpura, retinopathy, and thrombocytopenia. In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A number of well-documented cases of generalized rash, characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and diltiazem hydrochloride therapy is yet to be established.

Read the Tiazac (diltiazem hcl) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction (see WARNINGS). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with Tiazac (see WARNINGS). As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of the enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

Anesthetics

The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium channel blockers should be titrated carefully.

Benzodiazepines

Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4-fold and the Cmax by 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1.5-to 2.5-fold) during coadministration with diltiazem. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g., prolonged sedation) of both midazolam and triazolam.

Beta-blockers

Controlled and uncontrolled domestic studies suggest that concomitant use of diltiazem hydrochloride and beta-blockers is usually well tolerated, but available data are not sufficient to predict the effects of concomitant treatment in patients with left ventricular dysfunction or cardiac conduction abnormalities. Administration of diltiazem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see WARNINGS).

Buspirone

In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5-fold and Cmax 4.1-fold compared to placebo. The T½ and Tmax of buspirone were not significantly affected by diltiazem. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment.

Carbamazepine

Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated serum levels of carbamazepine (40% to 72% increase), resulting in toxicity in some cases. Patients receiving these drugs concurrently should be monitored for a potential drug interaction.

Cimetidine

A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and AUC (53%) after a 1-week course of cimetidine 1200 mg/day and a single dose of diltiazem 60 mg. Ranitidine produced smaller, nonsignificant increases. The effect may be mediated by cimetidine's known inhibition of hepatic cytochrome P-450, the enzyme system responsible for the first-pass metabolism of diltiazem. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. An adjustment in the diltiazem dose may be warranted.

Clonidine

Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. Monitor heart rate in patients receiving concomitant diltiazem and clonidine.

Cyclosporine

A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. In renal and cardiac transplant recipients, a reduction of cyclosporine dose ranging from 15% to 48% was necessary to maintain cyclosporine trough concentrations similar to those seen prior to the addition of diltiazem. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted, or discontinued.

The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.

Digitalis

Administration of diltiazem hydrochloride with digoxin in 24 healthy male subjects increased plasma digoxin concentrations approximately 20%. Another investigator found no increase in digoxin levels in 12 patients with coronary artery disease. Since there have been conflicting results regarding the effect of digoxin levels, it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing diltiazem hydrochloride therapy to avoid possible over- or under-digitalization (see WARNINGS).

Quinidine

Diltiazem significantly increases the AUC (0→∞) of quinidine by 51%, T½ by 36%, and decreases its CLoral by 33%. Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly.

Rifampin

Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered.

Statins

Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased with concomitant use of diltiazem. When possible, use a non-CYP3A4-metabolized statin together with diltiazem; otherwise, dose adjustments for both diltiazem and the statin should be considered along with close monitoring for signs and symptoms of any statin related adverse events.

In a healthy volunteer cross-over study (N=10), co-administration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. If co-administration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.

In a ten-subject randomized, open label, 4-way cross-over study, co-administration of diltiazem (120 mg BID diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and Cmax versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

  1. 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 (13 of 3007 patients or 0.43%). 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 dose of 60 mg of diltiazem.
  2. 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 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.
  3. Hypotension. Decreases in blood pressure associated with diltiazem hydrochloride therapy may occasionally result in symptomatic hypotension.
  4. Acute Hepatic Injury. Mild elevations of 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 enzymes such as alkaline phosphatase, LDH, SGOT, and SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to diltiazem hydrochloride is uncertain in some cases, but probable in some (see PRECAUTIONS).

PRECAUTIONS

General

Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. As with any drug given over prolonged periods, laboratory parameters of renal and hepatic function should be monitored at regular intervals. The drug should be used with caution in patients with impaired renal or hepatic function. In subacute and chronic dog and rat studies designed to produce toxicity, high doses of diltiazem were associated with hepatic damage. In special subacute hepatic studies, oral doses of 125 mg/kg and higher in rats were associated with histological changes in the liver which were reversible when the drug was discontinued. In dogs, doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing.

Dermatological events (see ADVERSE REACTIONS) may be transient and may disappear despite continued use of diltiazem hydrochloride. However, skin eruptions progressing to erythema multiforme and/or exfoliative dermatitis have also been infrequently reported. Should a dermatologic reaction persist, the drug should be discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24-month study in rats at oral dosage levels of up to 100 mg/kg/day and a 21-month study in mice at oral dosage levels of up to 30 mg/kg/day showed no evidence of carcinogenicity. There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. No evidence of impaired fertility was observed in a study performed in male and female rats at oral dosages of up to 100 mg/kg/day.

Pregnancy

Category C. Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from 4 to 6 times (depending on species) the upper limit of the optimum dosage range in clinical trials (480 mg/day or 8 mg/kg/day for a 60-kg patient) resulted in embryo and fetal lethality. These studies revealed, in one species or another, a propensity to cause abnormalities of the skeleton, heart, retina, and tongue. Also observed were reductions in early individual pup weights and pup survival, prolonged delivery and increased incidence of stillbirths. There are no well-controlled studies in pregnant women; therefore, use diltiazem hydrochloride in pregnant women only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of Tiazac (diltiazem hcl) is deemed essential, an alternative method of infant feeding should be instituted.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

The oral LD50's in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD50's in these species were 60 and 38 mg/kg, respectively. The oral LD50 in dogs is considered to be in excess of 50 mg/kg, while lethality was seen in monkeys at 360 mg/kg.

The toxic dose in man is not known. Due to extensive metabolism, blood levels after a standard dose of diltiazem can vary over tenfold, limiting the usefulness of blood levels in overdose cases. There have been 29 reports of diltiazem overdose in doses ranging from less than 1 gm to 10.8 gm. Sixteen of these reports involved multiple drug ingestions. Twenty-two reports indicated patients had recovered from diltiazem overdose ranging from less than 1 gm to 10.8 gm. There were seven reports with a fatal outcome; although the amount of diltiazem ingested was unknown, multiple drug ingestions were confirmed in six of the seven reports.

Events observed following diltiazem overdose included bradycardia, hypotension, heart block, and cardiac failure. Most reports of overdose described some supportive medical measure and/or drug treatment. Bradycardia frequently responded favorably to atropine as did heart block, although cardiac pacing was also frequently utilized to treat heart block. Fluids and vasopressors were used to maintain blood pressure, and in cases of cardiac failure, inotropic agents were administered. In addition, some patients received treatment with ventilatory support, activated charcoal, and/or intravenous calcium. Evidence of the effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose was conflicting.

In the event of overdose or exaggerated response, appropriate supportive measures should be employed in addition to gastrointestinal decontamination. Diltiazem does not appear to be removed by peritoneal or hemodialysis. Based on the known pharmacological effects of diltiazem and/or reported clinical experiences, the following measures may be considered:

Bradycardia: Administer atropine (0.60 to 1.0 mg). If there is no response to vagal blockage, administer isoproterenol cautiously.

High-Degree AV Block: Treat as for bradycardia above. Fixed high-degree AV block should be treated with cardiac pacing.

Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics.

Hypotension: Vasopressors (e.g., dopamine or norepinephrine). Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.

In a few reported cases, overdose with calcium channel blockers has been associated with hypotension and bradycardia, initially refractory to atropine but becoming more responsive to this treatment when the patients received large doses (close to 1 gram/hour for more than 24 hours) of calcium chloride.

Due to extensive metabolism, plasma concentrations after a standard dose of diltiazem can vary over tenfold, which significantly limits their value in evaluation cases of overdosage.

Charcoal hemoperfusion has been used successfully as an adjunct therapy to hasten drug elimination. Overdoses with as much as 10.8 gm of oral diltiazem have been successfully treated using appropriate supportive care.

CONTRAINDICATIONS

Diltiazem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with severe hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

The therapeutic effects of diltiazem hydrochloride are believed to be related to its ability to inhibit the cellular influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle.

Mechanisms of Action

Hypertension

Diltiazem produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance. The magnitude of blood pressure reduction is related to the degree of hypertension: thus hypertensive individuals experience an antihypertensive effect, whereas there is only a modest fall in blood pressure in normotensives.

Angina

Diltiazem HCl has been shown to produce increases in exercise tolerance, probably due to its ability to reduce myocardial oxygen demand. This is accomplished via reductions in heart rate and systemic blood pressure at submaximal and maximal work loads.

Diltiazem has been shown to be a potent dilator of coronary arteries, both epicardial and subendocardial. Spontaneous and ergonovine-induced coronary artery spasms are inhibited by diltiazem.

In animal models, diltiazem interferes with the slow inward (depolarizing) current in excitable tissue. It causes excitation-contraction uncoupling in various myocardial tissues without changes in the configuration of the action potential. Diltiazem produces relaxation of the coronary vascular smooth muscle and dilation of both large and small coronary vascular smooth muscle and dilation of both large and small coronary arteries at drug levels which cause little or no negative inotropic effect. The resultant increases in coronary blood flow (epicardial and subendocardial) occur in ischemic and nonischemic models and are accompanied by dose-dependent decreases in systemic blood pressure and decreases in peripheral resistance.

Hemodynamic and Electrophysiologic Effects

Like other calcium channel antagonists, diltiazem decreases sinoatrial and atrioventricular conduction in isolated tissues and has a negative inotropic effect in isolated preparations. In the intact animal, prolongation of the AH interval can be seen at higher doses.

In man, diltiazem prevents spontaneous and ergonovine-provoked coronary artery spasm. It causes a decrease in peripheral vascular resistance and a modest fall in blood pressure in normotensive individuals and, in exercise tolerance studies in patients with ischemic heart disease, reduces the heart rate-blood pressure product for any given work load. Studies to date, primarily in patients with good ventricular function, have not revealed evidence of a negative inotropic effect; cardiac output, ejection fraction, and left ventricular end-diastolic pressure have not been affected. Such data have no predictive value with respect to effects in patients with poor ventricular function, and increased heart failure has been reported in patients with preexisting impairment of ventricular function. There are as yet few data on the interaction of diltiazem and beta-blockers in patients with poor ventricular function. Resting heart rate is usually slightly reduced by diltiazem.

Tiazac (diltiazem hcl) produces antihypertensive effects both in the supine and standing positions. Postural hypotension is infrequently noted upon suddenly assuming an upright position. No reflex tachycardia is associated with the chronic antihypertensive effects.

Diltiazem hydrochloride decreases vascular resistance, increases cardiac output (by increasing stroke volume), and produces a slight decrease or no change in heart rate. During dynamic exercise, increases in diastolic pressure are inhibited while maximum achievable systolic pressure is usually reduced. Chronic therapy with diltiazem hydrochloride produces no change or an increase in plasma catecholamines. No increased activity of the renin-angiotensin-aldosterone axis has been observed. Diltiazem hydrochloride reduces the renal and peripheral effects of angiotensin II. Hypertensive animal models respond to diltiazem with reductions in blood pressure and increased urinary output and natriuresis without a change in urinary sodium/potassium ratio. In man, transient natriuresis and kaliuresis have been reported, but only in high intravenous doses of 0.5 mg/kg of body weight.

Diltiazem-associated prolongation of the AH interval is not more pronounced in patients with first degree heart block. In patients with sick sinus syndrome, diltiazem significantly prolongs sinus cycle length (up to 50% in some cases). Intravenous diltiazem in doses of 20 mg prolongs AH conduction time and AV node functional and effective refractory periods by approximately 20%.

In two short term, double-blind, placebo-controlled studies in 256 hypertensive patients with doses up to 540 mg/day, Tiazac (diltiazem hcl) showed a clinically unimportant but statistically significant, dose-related increase in PR interval (0.008 seconds). There were no instances of greater than first-degree AV block in any of the clinical trials (see WARNINGS).

Pharmacodynamics

Hypertension

In short term, double blind, placebo-controlled clinical trials, Tiazac (diltiazem hcl) demonstrated a dose-related antihypertensive response among patients with mild to moderate hypertension. In one parallel-group study of 198 patients Tiazac (diltiazem hcl) was given for four weeks. The changes in diastolic blood pressure measured at trough (24 hours after the dose) for placebo, 90 mg, 180 mg, 360 mg and 540 mg were -5.4, 6.3, -6.2, -8.2, and -11.8 mm Hg, respectively. Supine diastolic blood pressure as well as standing diastolic and systolic blood pressures also showed statistically significant linear dose response effects.

In another clinical trial that followed a dose-escalation design, Tiazac (diltiazem hcl) also reduced blood pressure in a linear dose-related manner. Supine diastolic blood pressure measured following two-week intervals of treatment was reduced by -3.7 mm Hg with 120 mg/day versus -2.0 mm Hg with placebo, by -7.6 mm Hg after escalation to 240 mg/day versus -2.3 mm Hg with placebo, by -8.1 mm Hg after escalation to 360 mg/day versus -0.9 mm Hg with placebo, and by -10.8 mm Hg after escalation to 480/540 mg/day versus -2.2 mm Hg with placebo.

Angina

In a double-blind parallel group placebo-controlled trial (approximately 50 patients/group, in patients with chronic stable angina), Tiazac (diltiazem hcl) at doses of 120 to 540 mg/day increased exercise tolerance time. At trough, 24 hours after dosing, exercise tolerance times using a Bruce exercise protocol, increased by 14, 26, 41, 33 and 32 seconds over baseline for placebo and the 120 mg, 240 mg, 360 mg, and 540 mg treated patient groups, respectively. At peak, 8 hours after dosing, exercise tolerance times relative to baseline were statistically significantly increased by 13, 38, 64, 55 and 42 seconds for placebo and 120 mg, 240 mg, 360 mg, and 540 mg Tiazac (diltiazem hcl) treated patients, respectively. Compared to baseline, Tiazac (diltiazem hcl) treated patients experienced statistically significant reductions in anginal attacks and decreased nitroglycerin requirements when compared to placebo treated patients.

Pharmacokinetics and Metabolism

Diltiazem is well absorbed from the gastrointestinal tract but undergoes substantial hepatic first-pass effect. The absolute bioavailability of an oral dose of an immediate- release formulation (compared to intravenous administration) is approximately 40%. Only 2% to 4% of unchanged diltiazem appears in the urine. The plasma elimination half-life of diltiazem is approximately 3.0 to 4.5 h. Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. Therapeutic blood levels of diltiazem appear to be in the range of 40 to 200 ng/mL. There is a departure from linearity when dose strengths are increased; the half-life is slightly increased with dose.

The two primary metabolites of diltiazem are desacetyldiltiazem and desmethyldiltiazem. The desacetyl metabolite is approximately 25% to 50% as potent a coronary vasodilator as diltiazem and is present in plasma at concentrations of 10% to 20% of parent diltiazem. However, recent studies employing sensitive and specific analytical methods have confirmed the existence of several sequential metabolic pathways of diltiazem. As many as nine diltiazem metabolites have been identified in the urine of humans. Total radioactivity measurements following single intravenous dose administration in healthy volunteers suggest the presence of other unidentified metabolites. These metabolites are more slowly excreted (with a half-life of total radioactivity of approximately 20 hours), and attain concentrations in excess of diltiazem.

In vitro binding studies show diltiazem HCl is 70% to 80% bound to plasma proteins. Competitive in vitro ligand binding studies have also shown diltiazem HCl binding is not altered by therapeutic concentrations of digoxin, hydrochlorothiazide, phenylbutazone, propranolol, salicylic acid, or warfarin. A study that compared patients with normal hepatic function to patients with cirrhosis who received immediate-release diltiazem found an increase in diltiazem elimination half-life and a 69% increase in bioavailability in the hepatically impaired patients. Patients with severely impaired renal function (creatinine clearance < 50 mL/min) who received immediate-release diltiazem had modestly increased diltiazem concentrations compared to patients with normal renal function.

Tiazac (diltiazem hcl) Capsules

When compared to a regimen of immediate-release tablets at steady-state, approximately 93% of drug is absorbed from the Tiazac (diltiazem hcl) formulation. When Tiazac (diltiazem hcl) was coadministered with a high fat content breakfast, the extent of diltiazem absorption was not affected; Tmax, however, occurred slightly earlier. The apparent elimination half-life after single or multiple dosing is 4 to 9.5 hours (mean 6.5 hours).

Tiazac (diltiazem hcl) demonstrates non-linear pharmacokinetics. As the daily dose of Tiazac (diltiazem hcl) capsules is increased from 120 to 540 mg, there was a more than proportional increase in diltiazem plasma concentrations as evidenced by an increase of AUC, Cmax and Cmin of 6.8, 6 and 8.6 times, respectively, for a 4.5 times increase in dose.

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Tiazac Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DILTIAZEM SUSTAINED-ACTION - ORAL

(dill-TIE-uh-zem)

COMMON BRAND NAME(S): Tiazac

USES: Diltiazem is used to treat high blood pressure (hypertension) and prevent chest pain (angina). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. When used regularly, diltiazem can decrease the number and severity of episodes of chest pain from angina. It may help increase your ability to exercise.

Diltiazem is called a calcium channel blocker. It works by relaxing blood vessels in the body and heart so blood can flow more easily. Diltiazem also lowers your heart rate. These effects help the heart work less hard and lower blood pressure.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Diltiazem may also be used to control your heart rate if you have a fast/irregular heartbeat (such as atrial fibrillation).

HOW TO USE: 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.

If you have trouble swallowing the capsule, you may open the capsule and carefully sprinkle its contents on a spoonful of soft, cool applesauce just before you take it. Swallow all of the drug/food mixture immediately. Do not chew the mixture. Then rinse your mouth and swallow the rinse liquid to make sure that you have swallowed all of the medicine. Do not prepare a supply in advance.

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).

Disclaimer

Tiazac 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.

Read the Tiazac (diltiazem hcl) Side Effects Center for a complete guide to possible side effects »

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.

Disclaimer

Tiazac Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: amiodarone, digoxin.

Other medications can affect the removal of diltiazem from your body, which may affect how this medication works. Examples include atazanavir, cimetidine, quinidine, St. John's wort, azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, rifamycins including rifabutin and rifampin.

Diltiazem may also affect how your body gets rid of many drugs (such as buspirone, cyclosporine, sirolimus, certain statins including lovastatin, certain anti-seizure drugs including carbamazepine, certain benzodiazepines including triazolam and midazolam).

Check the labels on all your medicines (such as cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen for pain/fever reduction) because they may contain ingredients that could increase your blood pressure or heart rate. Ask your pharmacist about using those products safely.

Cimetidine is a nonprescription drug that is commonly used to treat extra stomach acid. Because cimetidine may interact with diltiazem, ask your pharmacist about other products to treat extra stomach acid.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Talk with your doctor about making changes to your lifestyle that may help this medication work better (such as stress reduction programs, exercise, and dietary changes).

Laboratory and/or medical tests (such as kidney/ liver function tests, pulse, blood pressure, EKG) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

There are different brands and types of this medication available. Many do not have the same effects. Do not change brands or types without consulting your doctor or pharmacist.

Have your blood pressure and pulse (heart rate) checked regularly while taking this medication. Learn how to check your own blood pressure and pulse at home, and share the results with your doctor.

MISSED DOSE: 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.

STORAGE: Store at room temperature at 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Different brands of this medication may have different storage needs. Ask your pharmacist about the brand you are using.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Tiazac Patient Information Including Side Effects

Brand Names: Cardizem, Cardizem CD, Cardizem LA, Cartia XT, Dilacor XR, Dilt-CD, Diltia XT, Diltiazem Hydrochloride CD, Diltiazem Hydrochloride SR, Diltiazem Hydrochloride XR, Diltiazem Hydrochloride XT, Dilt-XR, Diltzac, Taztia XT, Tiazac

Generic Name: diltiazem (Pronunciation: dil TYE a zem)

What is diltiazem (Tiazac)?

Diltiazem is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders.

Diltiazem may also be used for purposes not listed in this medication guide.

Cardizem CD 120 mg

turquoise, imprinted with Cardizem CD 120 mg

Cardizem CD 180 mg

blue/turquoise, imprinted with Cardizem CD 180 mg

Cardizem CD 240 mg

blue, imprinted with cardizem 240 mg

Cardizem CD 300 mg

blue/gray, imprinted with Cardizem CD 300 mg

Cardizem LA 120 mg

oblong, white, imprinted with B, 120, 120 MG

Cardizem LA 180 mg

oblong, white, imprinted with B, 180

Cardizem LA 240 mg

oblong, white, imprinted with B, 240

Cardizem LA 360 mg

oblong, white, imprinted with B, 360

Cardizem LA 420 mg

oblong, white, imprinted with B, 420 MG

Cartia XT 120 mg

orange/white, imprinted with 120 mg, Andryx 597

Cartia XT 180 mg

orange/yellow, imprinted with 180 mg, Andryx 598

Cartia XT 240 mg

brown/orange, imprinted with 240 mg, Andryx 599

Cartia XT 300 mg

orange, imprinted with 300 mg, Andryx 600

Dilacor XR 120 mg

gold/white, imprinted with rpr DILACOR XR 120 mg

Dilacor XR 180 mg per 24 hours-WAT

beige/lavender, imprinted with 180 mg DILACOR XR

Dilacor XR 180 mg

orange/white, imprinted with W DILACOR XR 180 mg

Dilacor XR 240 mg

brown/white, imprinted with Logo DILACOR XR 240 mg

Dilacor XR 240 mg-WAT

blue/pink, imprinted with Logo DILACOR 240 mg

Dilitazem 240 mg ER-EON

green, imprinted with R-2578

Diltia XT 180 mg

gray/white, imprinted with Andryx 549 180 mg

Diltiazem 120 mg-24-MYL

pink, imprinted with MYLAN 5220

Diltiazem 120 mg-MYL

oblong, white, imprinted with M525

Diltiazem 120 mg-TEV

oblong, orange, imprinted with 93 321

Diltiazem 180 mg-24-MYL

pink/purple, imprinted with MYLAN 5280

Diltiazem 240 mg-24-MYL

blue/pink, imprinted with MYLAN 5340

Diltiazem 30 mg-MYL

round, white, imprinted with M 23

Diltiazem 30 mg-TEV

round, peach, imprinted with 93 318

Diltiazem 60 mg-APH

round, yellow, imprinted with BMS, 55 50

Diltiazem 60 mg-MYL

round, yellow, imprinted with M 45

Diltiazem 60 mg-TEV

round, orange, imprinted with 93 319

Diltiazem 90 mg ER-MYL

pink/yellow, imprinted with MYLAN 6090

Diltiazem 90 mg-MYL

oblong, white, imprinted with M135

Diltiazem 90 mg-TEV

oblong, peach, imprinted with 93 320

Diltiazem 90 mg-WAT

oblong, blue, imprinted with WATSON 777

Diltiazem CD 120 mg-APO

white, imprinted with APO, 007

Diltiazem CD 180 mg-APO

blue/white, imprinted with APO, 008

Diltiazem CD 240 mg-APO

blue/white, imprinted with APO, 009

Diltiazem ER 120 mg-MYL

pink, imprinted with MYLAN 6120

Diltiazem ER 120 mg-TEV

green, imprinted with BVF 120

Diltiazem ER 180 mg-TEV

dark green/light green, imprinted with BVF 180

Diltiazem ER 180 mg-WAT

pink/white, imprinted with 180 mg WATSON 663

Diltiazem ER 240 mg-TEV

green, imprinted with BVF 240

Diltiazem ER 300 mg-TEV

green/white, imprinted with BVF 300

Diltiazem SR 120 mg-MYL

pink, imprinted with MYLAN 6120

Diltiazem SR 60 mg-MYL

pink/white, imprinted with MYLAN 6060

Diltiazem XR 120 mg-APO

orange/white, imprinted with APO 014

Diltiazem XR 180 mg-APO

orange/white, imprinted with APO 015

Diltiazem XR 240 mg-APO

brown/white, imprinted with APO 016

Diltzac 120 mg

blue, imprinted with APO, 120

Diltzac 180 mg

turquoise/white, imprinted with APO, 180

Diltzac 240 mg

blue/turquoise, imprinted with APO, 240

Diltzac 300 mg

blue/white, imprinted with APO, 300

Diltzac 360 mg

turquoise, imprinted with APO, 360

Tiazac 120 mg

purple, imprinted with Tiazac 120

Tiazac 180 mg

turquoise/white, imprinted with Tiazac 180

Tiazac 240 mg

green/purple, imprinted with Tiazac 240

Tiazac 300 mg

blue/white, imprinted with Tiazac 300

Tiazac 360 mg

green, imprinted with Tiazac 360

Tiazac 420 mg

white, imprinted with Tiazac 420

What are the possible side effects of diltiazem?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • a red, blistering skin rash;
  • swelling in your hands or feet;
  • trouble breathing;
  • slow heartbeats;
  • dizziness, fainting, fast or pounding heartbeat;
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • headache;
  • dizziness, weakness, tired feeling;
  • upset stomach, nausea;
  • sore throat, cough, stuffy nose; or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Tiazac (diltiazem hcl) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about diltiazem?

Do not use this medication if you have certain heart conditions such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), low blood pressure, or if you have recently had a heart attack.

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 this medication even if you feel well. High blood pressure often has no symptoms.

Tiazac Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking diltiazem?

You should not use this medication if you are allergic to diltiazem, or if you have:

  • certain heart conditions, especially "sick sinus syndrome" or "AV block" (unless you have a pacemaker);
  • low blood pressure; or
  • if you have recently had a heart attack.

To make sure you can safely take diltiazem, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • liver disease;
  • congestive heart failure; or
  • if you are also taking clonidine (Catapres).

FDA pregnancy category C. It is not known whether diltiazem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Diltiazem can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take diltiazem?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take diltiazem with a full glass of water.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

If you have trouble swallowing a diltiazem capsule whole, ask your doctor or pharmacist if it is safe for you to open the capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Use diltiazem regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not stop taking this medication without first talking to your doctor. If you stop taking diltiazem suddenly, your condition may become worse.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

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.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood pressure will need to be checked often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

Tiazac Patient Information including If I Miss a Dose

What happens if I miss a dose?

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.

What happens if I overdose?

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, feeling light-headed, or fainting.

What should I avoid while taking diltiazem?

Diltiazem may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking alcohol while taking diltiazem.

Grapefruit and grapefruit juice may interact with diltiazem and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Avoid exposure to sunlight or tanning beds. Diltiazem can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect diltiazem?

Tell your doctor about all other medicines you use, especially:

  • amiodarone (Cordarone, Pacerone);
  • buspirone (BuSpar);
  • carbamazepine (Carbatrol, Tegretol);
  • cimetidine (Tagamet);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • digoxin (digitalis, Lanoxin, Lanoxicaps);
  • quinidine (Quin-G);
  • rifampin (Rifadin, Rimactane, Rifater);
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);
  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), miconazole (Oravig), or voriconazole (Vfend);
  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
  • cholesterol medications such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Mevacor, Altoprev, Advicor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin);
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), or ritonavir (Norvir, Kaletra); or
  • a sedative such as midazolam (Versed) or triazolam (Halcion).

This list is not complete and other drugs may interact with diltiazem. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about diltiazem.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 11.01. Revision date: 3/9/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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