Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-Day Dosage) Strength Quantity NDC Number Description 120 mg 90 bottle 51407-473-90 Light turquoise blue opaque cap and light turquoise blue opaque body, imprinted T026 and 120 in black ink on the cap and the body respectively 180 mg 90 bottle 51407-474-90 Light blue opaque cap and light turquoise blue opaque body, imprinted T027 and 180 in black ink on the cap and the body respectively 240 mg 90 bottle 51407-475-90 Light blue opaque cap and light blue opaque body, imprinted T028 and 240 in black ink on the cap and the body respectively 300 mg 90 bottle 51407-476-90 Light blue opaque cap and grey opaque body, imprinted T029 and 300 in black ink on the cap and the body respectively Storage Conditions: Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Distributed by UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 Made in Taiwan LA-3057-04 Revised: 01/2025 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 51407-473-90OL - Diltiazem 120mg 90 ct - Rev. 1025.jpg 51407-474-90OL - Diltiazem 180mg 90 ct - Rev. 1025.jpg 51407-475-90OL - Diltiazem 240mg 90 ct - Rev. 1025.jpg 51407-476-90OL - Diltiazem 300mg 90 ct - Rev. 1025.jpg
- HOW SUPPLIED Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-Day Dosage) Strength Quantity NDC Number Description 120 mg 90 bottle 51407-473-90 Light turquoise blue opaque cap and light turquoise blue opaque body, imprinted T026 and 120 in black ink on the cap and the body respectively 180 mg 90 bottle 51407-474-90 Light blue opaque cap and light turquoise blue opaque body, imprinted T027 and 180 in black ink on the cap and the body respectively 240 mg 90 bottle 51407-475-90 Light blue opaque cap and light blue opaque body, imprinted T028 and 240 in black ink on the cap and the body respectively 300 mg 90 bottle 51407-476-90 Light blue opaque cap and grey opaque body, imprinted T029 and 300 in black ink on the cap and the body respectively Storage Conditions: Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Distributed by UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 Made in Taiwan LA-3057-04 Revised: 01/2025 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 51407-473-90OL - Diltiazem 120mg 90 ct - Rev. 1025.jpg 51407-474-90OL - Diltiazem 180mg 90 ct - Rev. 1025.jpg 51407-475-90OL - Diltiazem 240mg 90 ct - Rev. 1025.jpg 51407-476-90OL - Diltiazem 300mg 90 ct - Rev. 1025.jpg
Overview
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is: Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: ammonio methacrylate copolymer type B, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hydroxypropyl cellulose, iron oxide black, propylene glycol, shellac, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide and triethyl citrate. For oral administration. The USP Dissolution Test is pending. 03aa71a-dcc0-4a41-815d-42293e69e7a8
Indications & Usage
Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Dosage & Administration
Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) may be needed in some patients. Monitor patients closely. Subsequent titration to higher or lower doses may be necessary. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose. Hypertension: Adjust dosage to individual patient needs. When used as monotherapy, reasonable starting doses are 180 mg to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, schedule dosage adjustments accordingly. The usual dosage range studied in clinical trials was 240 mg to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. Angina: Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher 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 NTG: May be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy. Prophylactic Nitrate Therapy: Diltiazem hydrochloride may be safely coadministered with short- and long-acting nitrates. Beta-blockers: [See Wa rnings and P recautions.] Antihypertensives: Diltiazem hydrochloride have 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.
Warnings & Precautions
WARNINGS 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 3290 patients or 0.40%). 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 [see Adverse Reactions] . 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. Hypotension: Decreases in blood pressure associated with diltiazem hydrochloride therapy may result in symptomatic hypotension. 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, SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions tended to occur early after therapy initiation (l 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] .
Contraindications
Diltiazem hydrochloride extended-release capsules are 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 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.
Adverse Reactions
Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving diltiazem hydrochloride extended-release capsules up to 360 mg with rates in placebo patients shown for comparison. Diltiazem Hydrochloride Extended-Release CapsulesPlacebo-Controlled Angina and Hypertension Trials Combined Adverse Reactions Diltiazem Hydrochloride Extended-Release Capsules (n=607) Placebo ( n=301 ) Headache 5.4 % 5.0 % Dizziness 3.0 % 3.0% Bradycardia 3.3 % 1.3% AV Block First Degree 3.3 % 0.0% Edema 2.6 % 1.3% Asthenia 1.8 % 1.7% In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials: Cardiovascular: Congestive heart failure, palpitations, syncope, 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, dyspepsia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase [ see Warnings, Acute Hepatic Injury] , thirst, vomiting, weight increase. Dermatological: Petechiae, photosensitivity, pruritus, urticaria. Other: Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties. The following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, 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, some 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. To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.