Diltiazem Hydrochloride 240 mg Capsule, Extended Release, 100-count
Other active recalls for Diltiazem Hydrochloride (different manufacturers) — 6 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Calcium Channel Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Diltiazem is used to treat high blood pressure and to control angina (chest pain). Diltiazem is in a class of medications called calcium-channel blockers. It works by relaxing the blood vessels so the heart does not have to pump as hard. It also increases the supply of blood and oxygen to the heart. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In...
Read the full MedlinePlus article ↗- Diltiazem is used for a few different heart and blood vessel conditions depending on the form you have. The oral extended-release tablets and capsules treat high blood pressure and...
- It depends on the specific product you have. Extended-release tablets like Matzim LA or Cardizem LA can be taken with or without food — food doesn't meaningfully affect their absor...
- Does it matter what time of day I take diltiazem, or whether I take it with food?
- No — please don't do that with extended-release forms of diltiazem. Crushing, chewing, or opening an extended-release capsule or tablet destroys the time-release mechanism, which m...
Patient education
Supplement & herbal interactions
Diltiazem may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 9DBA0SBB0L
A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII PN2ZH5LOQY
A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII MB5IUD6JUA
Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
13 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3502 | $35.02 / 100 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Diltiazem Hydrochloride 240 mg 00904-7219-61 | Major | 1 capsule | $0.197 | AB3 | Availability likely | — |
| Diltiazem Hydrochloride Extended-Release 240 mg 10370-0831-05 | Endo | 500 capsules | $0.197 | AB3 | Discontinued | — |
| Diltiazem Hydrochloride 240 mg 24979-0028-02 | Upsher-Smith | 500 capsules | $0.197 | AB3 | Availability likely | — |
| Diltiazem Hydrochloride Extended-Release 240 mg 60687-0217-01 | American | 1 capsule | $0.197 | AB3 | Availability likely | — |
| Cartia XT 240 mg 62037-0599-05 | Actavis | 500 capsules | $0.197 | AB3 | Availability likely | — |
| Diltiazem hydrochloride 240 mg 63304-0720-05 | Sun | 500 capsules | $0.198 | — | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 68682-0997-98 | OCEANSIDE | 90 capsules | $0.232 | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 47335-0671-13 | Sun | 500 capsules | $0.342 | — | FDA listed | — |
| Diltiazem Hydrochloride EXTENDED RELEASE 240 mg 68682-0369-90 | Oceanside | 90 capsules | $0.342 | AB4 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 16714-0525-01 | NORTHSTAR | 100 capsules | $0.491 | AB2 | Availability likely | — |
| Diltiazem Hydrochloride 240 mg 60505-0016-06 | Apotex | 100 capsules | $0.491 | AB2 | Availability likely | — |
| Diltiazem Hydrochloride 240 mg 62332-0817-31 | Alembic | 100 capsules | $0.491 | AB2 | Availability likely | — |
| Diltiazem Hydrochloride 240 mg 70436-0193-01 | Slate | 100 capsules | $0.491 | AB2 | Availability likely | — |
| Diltiazem Hydrochloride 240 mg 16729-0305-01 | Accord | 100 capsules | $0.520 | AB2 | Availability likely | — |
| Cardizem CD 240 mg 00187-0797-30 | Bausch | 30 capsules | — | AB3 | FDA listed | — |
| Tiazac Extended Release 240 mg 00187-2614-30 | Bausch | 30 capsules | — | AB4 | FDA listed | — |
| diltiazem hydrochloride 240 mg 00615-8381-39 | NCS | 30 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 33342-0523-02 | Macleods | 6 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 46708-0727-30 | Alembic | 30 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 240 mgthis 46708-0817-31 | Alembic | 100 capsules | — | AB2 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 47335-0677-13 | Sun | 500 capsules | — | — | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 50090-5452-00 | A-S | 30 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 50090-7815-00 | A-S | 30 capsules | — | AB3 | FDA listed | — |
| diltiazem hydrochloride 240 mg 50742-0250-05 | Ingenus | 500 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 51407-0475-90 | Golden | 90 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 55154-2627-00 | Cardinal | 1 capsule | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 62332-0727-30 | Alembic | 30 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride Extended-Release 240 mg 63629-2158-01 | Bryant | 30 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 240 mg 68071-4005-03 | NuCare | 30 capsules | — | AB3 | FDA listed | — |
| diltiazem hydrochloride 240 mg 68382-0597-01 | Zydus | 100 capsules | — | AB3 | FDA listed | — |
| Tiadylt Er 240 mg 68382-0747-01 | Zydus | 100 capsules | — | AB4 | FDA listed | — |
| diltiazem hydrochloride 240 mg 70771-1032-01 | Zydus | 100 capsules | — | AB3 | FDA listed | — |
| Tiadylt Er 240 mg 70771-1037-00 | Zydus | 1000 capsules | — | AB4 | FDA listed | — |
| Diltiazem Hydrochloride Extended-Release 240 mg 71335-0009-01 | Bryant | 30 capsules | — | AB3 | Discontinued | — |
| Diltiazem Hydrochloride 240 mg 71335-0867-01 | Bryant | 30 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride EXTENDED RELEASE 240 mg 71335-1585-01 | Bryant | 30 capsules | — | AB4 | Discontinued | — |
| diltiazem hydrochloride 240 mg 71335-3091-01 | Bryant | 30 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride Extended Release 240 mg 72189-0248-90 | direct | 90 capsules | — | AB4 | FDA listed | — |
| diltiazem hydrochloride 240 mg 84677-0041-90 | Golden | 90 capsules | — | AB3 | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46708-0817-31 You're viewing this | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-817-31) | 2024-10-28 | Active |
| 46708-0817-71 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-817-71) | 2024-10-28 | Active |
| 46708-0817-91 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-817-91) | 2024-10-28 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 46708-0817-31?
What is the difference between NDC 46708-0817-31 and NDC 46708-0817-71?
What NDC number is used to bill for this package of Diltiazem Hydrochloride 240 mg Capsule, Extended Release?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Hypertensive or anginal patients who are treated with other formulations of diltiazem can safely be switched to diltiazem hydrochloride extended-release 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. Studies have shown a slight increase in the rate of absorption of diltiazem hydrochloride extended-release capsules when ingested with a high-fat breakfast; therefore, administration in the morning on an empty stomach is recommended.
Patients should be cautioned that the diltiazem hydrochloride extended-release capsules 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 diltiazem hydrochloride extended-release capsules 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.
⛔ Contraindications ▾
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 ▾
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 (22 of 10,119 patients, or 0.2%); 41% of these 22 patients were receiving concomitant β-adrenoceptor antagonists versus 17% of the total group. Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction.
A patient with Prinzmetal’s angina developed periods of asystole (2 to 5 seconds) after a single 60 mg dose of diltiazem. Congestive Heart Failure Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). An acute study of oral diltiazem in patients with impaired ventricular function (ejection fraction of 24% ± 6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/dt).
Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function. Experience with the use of diltiazem hydrochloride in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.
Hypotension Decreases in blood pressure associated with diltiazem hydrochloride therapy may occasionally result in symptomatic hypotension. Acute Hepatic Injury Mild elevations of serum transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment.
In rare instances, significant elevations in alkaline phosphatase, 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 .)
🤒 Adverse Reactions ▾
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. 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 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 Adverse Events (COSTART Term) D iltiazem Hydrochloride Extended-Release Capsules * n=303 # pts (%) Placebo n=87 # pts (%) rhinitis 29 (9.6) 7 (8) 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) 2 (2.3) flu syndrome 7 (2.3) 1 (1.1) edema, peripheral 7 (2.3) 0 (0) myalgia 7 (2.3) 0 (0) diarrhea 6 (2) 0 (0) vomiting 6 (2) 0 (0) sinusitis 6 (2) 1 (1.1) asthenia 5 (1.7) 0 (0) pain, back 5 (1.7) 2 (2.3) nausea 5 (1.7) 1 (1.1) dyspepsia 4 (1.3) 0 (0) vasodilatation 4 (1.3) 0 (0) injury, accident 4 (1.3) 0 (0) pain, abdominal 3 (1) 0 (0) arthrosis 3 (1) 0 (0) insomnia 3 (1) 0 (0) dyspnea 3 (1) 0 (0) rash 3 (1) 1 (1.1) tinnitus 3 (1) 0 (0) *Adverse events occurring in 1% or more of patients receiving diltiazem hydrochloride extended-release capsules.
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 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. MOST COMMON ADVERSE EVENTS IN A DOUBLE-BLIND, PLACEBO-CONTROLLED SHORT-TERM, ANGINA TRIALS Adverse Events (COSTART Term) D iltiazem Hydrochloride Extended-Release Capsules* n=139 # pts (%) Placebo n=50 # pts (%) asthenia 5 (3.6) 2 (4) headache 4 (2.9) 3 (6) pain, back 4 (2.9) 1 (2) rhinitis 4 (2.9) 1 (2) constipation 3 (2.2) 1 (2) nausea 3 (2.2) 0 (0) edema, peripheral 3 (2.2) 1 (2) dizziness 3 (2.2) 0 (0) cough, increased 3 (2.2) 0 (0) bradycardia 2 (1.4) 0 (0) fibrillation, atrial 2 (1.4) 0 (0) arthralgia 2 (1.4) 0 (0) dream, abnormal 2 (1.4) 0 (0) dyspnea 2 (1.4) 0 (0) pharyngitis 2 (1.4) 1 (2) *Adverse events occurring in 1% or more of patients receiving diltiazem hydrochloride extended-release capsules.
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, 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, my…
🆘 Overdosage ▾
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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The therapeutic benefits of diltiazem hydrochloride are believed to be related to its ability to inhibit the influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscles. Mechanism of Action Hypertension Diltiazem hydrochloride extended-release capsule produces its antihypertensive effect primarily by relaxation of vascular smooth muscle with a 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 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 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.
In exercise tolerance studies in patients with ischemic heart disease, diltiazem reduces the double product (HR x SBP) 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. Increased heart failure has, however, been reported in occasional patients with pre-existing 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. Diltiazem hydrochloride extended-release capsule produces antihypertensive effects both in the supine and standing positions. Postural hypotension is infrequently noted upon suddenly assuming an upright position.
Diltiazem decreases vascular resistance, increases cardiac output (by increasing stroke volume), and produces a slight decrease or no change in heart rate. No reflex tachycardia is associated with the chronic antihypertensive effects. During dynamic exercise, increases in diastolic pressure are inhibited while maximum achievable systolic pressure is usually reduced.
Heart rate at maximum exercise does not change or is slightly reduced. Diltiazem antagonizes the renal and peripheral effects of angiotensin II. No increased activity of the renin-angiotensin-aldosterone axis has been observed.
Chronic therapy with diltiazem produces no change or an increase in plasma catecholamines. Hyperte…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Diltiazem hydrochloride extended-release capsules USP, 120 mg are pink opaque cap/light pink opaque body, hard gelatin capsules having imprinting “A250” in black ink on the cap. The capsule is filled with one white to off white oval shaped tablet. Bottle of 100 capsules with child-resistant closure, NDC 46708-815-31 Bottle of 500 capsules, NDC 46708-815-71 Bottle of 1000 capsules, NDC 46708-815-91 Diltiazem hydrochloride extended-release capsules USP, 180 mg are lavender opaque cap/pink opaque body, hard gelatin capsules having imprinting “A251” in black ink on the cap.
The capsule is filled with one white to off white oval shaped tablet. Bottle of 100 capsules with child-resistant closure, NDC 46708-816-31 Bottle of 500 capsules, NDC 46708-816-71 Bottle of 1000 capsules, NDC 46708-816-91 Diltiazem hydrochloride extended-release capsules USP, 240 mg are blue opaque cap/pink opaque body, hard gelatin capsules having imprinting “A252” in black ink on the cap. The capsule is filled with one white to off white oval shaped tablet.
Bottle of 100 capsules with child-resistant closure, NDC 46708-817-31 Bottle of 500 capsules, NDC 46708-817-71 Bottle of 1000 capsules, NDC 46708-817-91 Store at 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 tightly closed.
Keep out of the reach of children. Rx Only Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O.
Tajpura, Near Baska, Taluka-Halol, Panchmahal 389350, Gujarat, India. Revised: 09/2023
📋 Description ▾
DESCRIPTION Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5 H )one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C 22 H 26 N 2 O 4 S•HCl and its molecular weight is 450.98.
Its structural formula is as follows: Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period.
Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33.
The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. FDA approved dissolution test specifications differ from USP. diltiazem-str.jpg