chances [90:10 mmHg) was greater as the dose increased: 31%, 42%, 48%, and 69% with the 120, 240, 360, and 480 mg/day diltiazem groups, respectively. Similar findings were observed for standing systolic and diastolic blood pressures. The trough (24 hours after a dose) antihypertensive effect of Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) retained more than one-half of the response seen at peak (3-6 hours after administration). Significant reductions of mean supine blood pressure (at trough) in patients with mild to moderate hypertension were also seen in a short-term, double-blind, dose-escalation, placebo-controlled study after 2 weeks of once daily Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) 180 mg/day (diastolic: -6.1 mmHg; systolic: -4.7 mmHg) and again, 2 weeks after escalation to 360 mg/day (diastolic: -9.3 mmHg; systolic: -7.2 mmHg). However, a further increase in dose to 540 mg/day for 2 weeks provided only a minimal further increase in the antihypertensive effect (diastolic: -10.2 mmHg; systolic: -6.7 mmHg). Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage), given at 120 mg, 240 mg, and 480 mg/day, in a randomized, multicenter, double-blind, placebo-controlled, parallel group, dose-ranging study, in 189 patients with chronic angina, demonstrated a dose-related increase in exercise time by Exercise Tolerance Test (ETT) and a reduction in rates of anginal attacks (based on individual patient diaries). The improvement in total exercise time (using the Bruce protocol), measured at trough exercise periods, for placebo, 120 mg, 240 mg, and 480 mg, was 20, 37, 49, and 56 seconds, respectively. Pharmacokinetics and Metabolism: Diltiazem is well absorbed from the gastrointestinal tract, and is subject to an extensive first-pass effect. When given as an immediate release oral formulation, the absolute bioavailability (compared to intravenous administration) of diltiazem is approximately 40%. Diltiazem undergoes extensive hepatic metabolism in which 2% to 4% of the unchanged drug appears in the urine. Total radioactivity measurement following short IV administration in healthy volunteers suggests the presence of other unidentified metabolites which attain higher concentrations than those of diltiazem and are more slowly eliminated; half-life of total radioactivity is about 20 hours compared to 2 to 5 hours for 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, HCTZ, phenylbutazone, propranolol, salicylic acid, or warfarin. The plasma elimination half-life of diltiazem is approximately 3.0 to 4.5 hours. Desacetyldiltiazem, the major metabolite of diltiazem, which is also present in the plasma at concentrations of 10% to 20% of the parent drug, is approximately 25% to 50% as potent a coronary vasodilator as diltiazem. Therapeutic blood levels of diltiazem hydrochloride appear to be in the range of 40-200 ng/mL. There is a departure from linearity when dose strengths are increased; the half-life is slightly increased with dose. A study that compared patients with normal hepatic function to patients with cirrhosis found an increase in half-life and a 69% increase in bioavailability in the hepatically impaired patients. Patients with severely impaired renal function showed no difference in the pharmacokinetic profile of diltiazem compared to patients with normal renal function. Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) contain a degradable controlled-release tablet formulation designed to release diltiazem over a 24-hour period. Controlled absorption of diltiazem begins within 1 hour, with maximum plasma concentrations being achieved 4 to 6 hours after administration. The apparent steady-state half-life of diltiazem following once daily administration of Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) ranges from 5 to 10 hours. This prolongation of half-life is attributed to continued absorption of diltiazem rather than to alterations in its elimination. The absolute bioavailability of diltiazem from a single dose of Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) (compared to intravenous administration) is 41% ( 14). The value was shown to be similar to the 40% systemic availability reported following administration of an immediate release diltiazem HCl formulation. As the dose of Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) is increased from a daily dose of 120 mg to 240 mg, there is an increase in the AUC of 2.3 fold. When the dose is increased from 240 mg to 360 mg, AUC increases 1.6 fold and when increased from 240 mg to 480 mg, AUC increases 2.4 fold. In vivo release of diltiazem occurs throughout the gastrointestinal tract, with controlled release still occurring for up to 24 hours after administration, as determined by radio-labeled methods. As the once daily dose of Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) was increased, departures from linearity were noted. There were disproportionate increases in area under the curve for doses from 120 mg to 480 mg. The presence of food did not affect the ability of Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) to maintain a controlled release of the drug and did not impact its sustained release properties over 24-hours after administration. However, simultaneous administration of Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) with a high-fat breakfast resulted in increases in AUC of 13% and 19%, and in C max by 37% and 51%, respectively. Indications and Usage for Dilt-XR Dilt-XR [Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage)] is indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Dilt-XR [Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage)] is indicated for the management of chronic stable angina. Contraindications Diltiazem hydrochloride 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 hypotension (less than 90 mmHg systolic); (4) patients who have demonstrated hypersensitivity to the drug; and (5) patients with acute myocardial infarction and pulmonary congestion as documented by X-ray on admission. Warnings Cardiac Condition: 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 condition. 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 .) Precautions General Diltiazem hydrochloride is extensively metabolized by the liver and is excreted by the kidneys and in bile. As with any drug given over prolonged periods, laboratory parameters 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. Caution should still be used in patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been no reports of obstructive symptoms in patients with known strictures in association with the ingestion of Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage). Information for Patients Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) should be taken on an empty stomach. Patients should be cautioned that the Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) should not be opened, chewed or crushed, and should be swallowed whole. Drug Interactions Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with any agents known to affect cardiac contractility and/or condition. (See WARNINGS . ) Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem hydrochloride. (See WARNINGS . ) As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem hydrochloride undergoes biotransformation by cytochrome P-450 mixed function oxidase. Co-administration of diltiazem hydrochloride with other agents which follow the same route of biotransformation may result in the competitive inhibition of metabolism. Especially in patients with renal and/or hepatic impairment, dosages of similarly metabolized drugs, particularly those of low therapeutic ratio such as cyclosporine, may require adjustment when starting or stopping concomitantly administer diltiazem hydrochloride to maintain optimum therapeutic blood levels. Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated plasma levels of carbamazepine, resulting in toxicity in some cases. 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 the bioavailability of propranolol was increased approximately 50%. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted. (See WARNINGS .) Cimetidine: A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and area-under-the-curve (53%) after a 1 week course of cimetidine at 1,200 mg per day and diltiazem 60 mg per day. 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. 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 effects 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 . ) 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. Carcinogenesis, Mutagenesis, Impairment of Fertility A 24-month study in rats and an 18-month study in mice 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 male or female rats at oral doses 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 once daily or 8 mg/kg once daily for a 60 kg patient) has resulted in embryo and fetal lethality. These studies have 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 diltiazem hydrochloride is deemed essential, an alternate method of infant feeding should be instituted. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Adverse Reactions Serious adverse reactions to diltiazem hydrochloride have been rare in studies with other formulations, as well as with Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage). 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 Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) using daily doses up to 540 mg, are listed in the table below with placebo-treated patients included for comparison. MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND, PLACEBO-CONTROLLED HYPERTENSION TRIALS Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage)* Placebo Adverse Events n=303 n=87 (COSTART Term) # pts (%) # pts (%) *Adverse events occurring in 1% or more of patients receiving Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage). rhinitis 29 (9.6) 7 (8.0) headache 27 (8.9) 12 (13.8) pharyngitis 17 (5.6) 4 (4.6) constipation 11 (3.6) 2 (2.3) cough increase 9 (3.0) 2 (2.3) flu syndrome 7 (2.3) 1 (1.1) edema, peripheral 7 (2.3) 0 (0.0) myalgia 7 (2.3) 0 (0.0) diarrhea 6 (2.0) 0 (0.0) vomiting 6 (2.0) 0 (0.0) sinusitis 6 (2.0) 1 (1.1) asthenia 5 (1.7) 0 (0.0) pain, back 5 (1.7) 2 (2.3) nausea 5 (1.7) 1 (1.1) dyspepsia 4 (1.3) 0 (0.0) vasodilatation 4 (1.3) 0 (0.0) injury, accident 4 (1.3) 0 (0.0) pain, abdominal 3 (1.0) 0 (0.0) arthrosis 3 (1.0) 0 (0.0) insomnia 3 (1.0) 0 (0.0) dyspnea 3 (1.0) 0 (0.0) rash 3 (1.0) 1 (1.1) tinnitus 3 (1.0) 0 (0.0) Angina: The most common adverse events (frequency 1%) in a placebo-controlled, short-term (2 week) clinical angina study with Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage) 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 Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage). MOST COMMON ADVERSE EVENTS IN A DOUBLE-BLIND, PLACEBO-CONTROLLED SHORT-TERM, ANGINA TRIALS Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage)* Placebo Adverse Events n=139 n=50 (COSTART Term) # pts (%) # pts (%) *Adverse events occurring in 1% or more of patients receiving Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage). asthenia 5 (3.6) 2 (4.0) headache 4 (2.9) 3 (6.0) pain, back 4 (2.9) 1 (2.0) rhinitis 4 (2.9) 1 (2.0) constipation 3 (2.2) 1 (2.0) nausea 3 (2.2) 0 (0.0) edema, peripheral 3 (2.2) 1 (2.0) dizziness 3 (2.2) 0 (0.0) cough, increased 3 (2.2) 0 (0.0) bradycardia 2 (1.4) 0 (0.0) fibrillation, atrial 2 (1.4) 0 (0.0) arthralgia 2 (1.4) 0 (0.0) dream, abnormal 2 (1.4) 0 (0.0) dyspnea 2 (1.4) 0 (0.0) pharyngitis 2 (1.4) 1 (2.0) 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 Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage), 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. OVERDOSAGE OR EXAGGERATED RESPONSE Several literature reports have identified cases of diltiazem hydrochloride overdose, some with multiple drug ingestion, with both fatal and non-fatal outcomes. The reported events affected multiple body systems including the cardiovascular system (bradycardia, complete heart block, asystole, cardiac failure, arrhythmia, atrial fibrillation, palpitations, hypotension, ischemia, ECG changes), respiratory system (respiratory failure, hypoxia, dyspnea, pulmonary edema), central nervous system (loss of consciousness, convulsions, dizziness, confusion, agitation), gastrointestinal system (nausea, vomiting), skin and appendages (increased sweating), and other systems (hypotonia, iliac artery thrombosis, metabolic acidosis, increased blood glucose). The administration of ipecac to induce vomiting and activated charcoal to reduce drug absorption have been advocated as initial means of intervention. In addition to gastric lavage, the following measures should also be considered: Bradycardia: administer atropine (0.6 mg to 1 mg). If there is no response to vagal blockade, 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 (dopamine or dobutamine) and diuretics. Hypotension: Vasopressors (e.g., dopamine or levarterenol bitartrate). Actual treatment and dosage should depend on the severity of the clinical situation as well as the judgment and experience of the treating physician. Due to extensive metabolism, plasma concentrations after a standard dose of diltiazem can vary over tenfold, which significantly limits their value in evaluating cases of overdosage. Charcoal hemoperfusion has been used successfully as an adjunct therapy to hasten drug elimination. Overdoses with as much as 10.8 grams of oral diltiazem have been successfully treated using appropriate supportive care. Dilt-XR Dosage and Administration Hypertensive or anginal patients who are treated with other formulations of diltiazem can safely be switched to Dilt-XR [Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage)] 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. Studies have shown a slight increase in the rate of absorption of Dilt-XR [Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage)] when ingested with a high-fat breakfast; therefore, administration in the morning on an empty stomach is recommended. Patients should be cautioned that the Dilt-XR [Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage)] should not be opened, chewed or crushed, and should be swallowed whole. Dosage: Hypertension: Dosages must be adjusted to each patient s needs, starting with 180 mg or 240 mg once daily. Based on the antihypertensive effect, the dose may be adjusted as needed. Individual patients, particularly 60 years of age, may respond to a lower dose of 120 mg. The usual dosage range studied in clinical trials was 180 mg to 480 mg once daily. Current clinical experience with the 540 mg dose is limited; the dose may be increased to 540 mg with little or no increased risk of adverse reactions. Doses should not exceed 540 mg once daily. While a dose of Dilt-XR [Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-day dosage)] given once daily may produce an antihypertensive effect similar to the same total daily dose given in divided doses, individual dose adjustment may be needed. Dosage: Angina: Dosages for the treatment of angina should be adjusted to each patient s needs, starting with a dose of 120 mg once daily, which may be titrated to doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7 to 14 day period. Concomitant Use with Other Cardiovascular Agents. Sublingual Nitroglycerin may be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy. Prophylactic Nitrate Therapy Diltiazem hydrochloride may be safely co-administered with short- and long-acting nitrates. Beta-blockers. (See WARNINGS and PRECAUTIONS . ) 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. How is Dilt-XR Supplied Strength Size NDC Color Markings 120 mg Bottles of 100 60505-0014-6 orange cap APO 014 Bottles of 500 60505-0014-8 white body 180 mg Bottles of 100 60505-0015-6 bright orange cap APO 015 Bottles of 500 60505-0015-8 white body 240 mg Bottles of 100 60505-0016-6 brown cap APO 016 Bottles of 500 60505-0016-8 white body Store at Controlled Room Temperature: 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Keep out of the reach of children Rx Only APOTEX INC. Manufactured for: Apotex Corp. Weston, Florida 33326 Manufactured by: Apotex Inc. Toronto, Ontario Canada, M9L 1T9 Rev: September 2005 Dilt-XR diltiazem hydrochloride capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60505-0014 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength diltiazem hydrochloride (diltiazem) diltiazem 120 mg Inactive Ingredients Ingredient Name Strength colloidal silicon dioxide hypromellose black SW-9008/SW-9009 red iron oxide yellow iron oxide magnesium stearate gelatin D&C Yellow No. 10 FD&C Red No. 40 D&C Red No. 28 titanium dioxide FD&C Blue No. 1 Product Characteristics Color WHITE, ORANGE Score no score Shape CAPSULE Size 22mm Flavor Imprint Code APO;014 Contains Coating false Symbol false Packaging # Item Code Package Description 1 NDC:60505-0014-6 100 CAPSULE (100 CAPSULE) in 1 BOTTLE 2 NDC:60505-0014-8 500 CAPSULE (500 CAPSULE) in 1 BOTTLE Dilt-XR diltiazem hydrochloride capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60505-0015 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength diltiazem hydrochloride (diltiazem) diltiazem 180 mg Inactive Ingredients Ingredient Name Strength colloidal silicon dioxide black SW-9008/SW-9009 hypromellose FD&C Blue No. 1 red iron oxide yellow iron oxide magnesium stearate gelatin D&C Yellow No. 10 FD&C Red No. 40 D&C Red No. 28 titanium dioxide Product Characteristics Color ORANGE, WHITE Score no score Shape CAPSULE Size 22mm Flavor Imprint Code APO;015 Contains Coating false Symbol false Packaging # Item Code Package Description 1 NDC:60505-0015-6 100 CAPSULE (100 CAPSULE) in 1 BOTTLE 2 NDC:60505-0015-8 500 CAPSULE (500 CAPSULE) in 1 BOTTLE Dilt-XR diltiazem hydrochloride capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60505-0016 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength diltiazem hydrochloride (diltiazem) diltiazem 240 mg Inactive Ingredients Ingredient Name Strength colloidal silicon dioxide black SW-9008/SW-9009 hypromellose FD&C Blue No. 1 red iron oxide yellow iron oxide magnesium stearate gelatin D&C Yellow No. 10 FD&C Red No. 40 D&C Red No. 28 titanium dioxide Product Characteristics Color BROWN, WHITE Score no score Shape CAPSULE Size 22mm Flavor Imprint Code APO;016 Contains Coating false Symbol false Packaging # Item Code Package Description 1 NDC:60505-0016-6 100 CAPSULE (100 CAPSULE) in 1 BOTTLE 2 NDC:60505-0016-8 500 CAPSULE (500 CAPSULE) in 1 BOTTLE Labeler - Apotex Corp. Revised: 03/2007 Apotex Corp. Next Interactions Print this page Add to My Med List More about Dilt-XR (diltiazem) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 1 Review Add your own review/rating Drug class: calcium channel blocking agents Consumer resources Dilt-XR Dilt-XR (Advanced Reading) Professional resources Diltiazem Hydrochloride (AHFS Monograph) Diltiazem Tablets (FDA) Other brands: Cardizem , Cartia XT , Taztia XT , Tiazac , ... +7 more Related treatment guides Angina Pectoris Prophylaxis Heart Failure High Blood Pressure]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturer Apotex Corp. Drug Class Calcium channel blocking agents Group IV antiarrhythmics Related Drugs calcium channel blocking agents amlodipine , diltiazem , Norvasc , nifedipine , verapamil , Cardizem group IV antiarrhythmics diltiazem , verapamil , Cardizem , Cartia XT , Taztia XT High Blood Pressure amlodipine , lisinopril , hydrochlorothiazide , furosemide , losartan , metoprolol , atenolol , More... Heart Failure amlodipine , lisinopril , furosemide , carvedilol , metoprolol , diltiazem , Lasix , spironolactone , More... Angina Pectoris Prophylaxis aspirin , metoprolol , atenolol , diltiazem , nitroglycerin , Nitrostat , nifedipine , More... Dilt-XR Rating 1 User Review 10 /10 1 User Review 10 Rate it!} } i assumed
at the present time Dilt-XR professional
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