DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE 1 mg/mL Injection, Solution
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 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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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 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 mL | 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1164 | $0.176 / J1164 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE 1 mg/mLthis 44567-0662-10 | WG | 100 ml | — | — | FDA listed | — |
| DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE 1 mg/mL 44567-0663-10 | WG | 250 ml | — | — | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 44567-0662-10 You're viewing this | 10 BAG in 1 CARTON (44567-662-10) / 100 mL in 1 BAG (44567-662-01) | 2025-03-21 | Active |
🧭 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Diltiazem Hydrochloride in Sodium Chloride Injection is a non-dihydropyridine calcium-channel blocker indicated for the following: • Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. ( 1.1) • Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. ( 1.2 )
1.1Atrial Fibrillation or Atrial Flutter Diltiazem Hydrochloride in Sodium Chloride Injection is indicated in adults for the temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter.
1.2Paroxysmal Supraventricular Tachycardia Diltiazem Hydrochloride in Sodium Chloride Injection is indicated in adults for rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Monitor ECG and blood pressure. The initial dose is 0.25 mg/kg or 20 mg intravenously over 2 minutes. If response is inadequate at 15 minutes, give one or more doses of 0.35 mg/kg or 25 mg intravenously over 2 minutes. Immediately following first bolus administration, begin intravenous infusion at 5 mg/hour. Increase by 5 mg/hour up to 15 mg/hour as needed and tolerated. ( 2.1 , 2.2 , 2.3 ) Do not mix with other drugs. ( 2.4 )
2.1General Considerations Administer intravenous diltiazem in a setting with continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available. Diltiazem Hydrochloride in Sodium Chloride Injection is a ready to administer product that requires no further dilution prior to infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
2.2Intravenous Single Injection The initial dose of diltiazem hydrochloride should be 0.25 mg/kg actual body weight administered over 2 minutes (20 mg is a reasonable dose for the average patient). If response is inadequate, a second dose may be administered after 15 minutes. The second dose of diltiazem hydrochloride should be 0.35 mg/kg actual body weight administered over 2 minutes (25 mg is a reasonable dose for the average patient).
Subsequent intravenous bolus doses should be individualized.
2.3Continuous Intravenous Infusion Immediately following bolus, the recommended initial infusion rate of diltiazem hydrochloride is 5 mg/hour. Adjust the infusion rate in 5 mg/hour increments up to a maximum of 15 mg/hour as needed to achieve satisfactory rate control. Infusions longer than 24 hours have not been studied. Patients should generally be transitioned to other antiarrhythmic agents within 24 hours [see Clinical Studies ( 14 )] .
2.4Physical Incompatibilities Do not mix diltiazem hydrochloride with any other drugs in the same container. If possible, use a dedicated line for diltiazem hydrochloride. Diltiazem hydrochloride has demonstrated physical incompatibilities with acetazolamide, acyclovir, aminophylline, ampicillin, ampicillin sodium/sulbactam sodium, cefamandole, cefoperazone, diazepam, furosemide, hydrocortisone sodium succinate, insulin (regular: 100 units/mL), methylprednisolone sodium succinate, mezlocillin, nafcillin, phenytoin, rifampin, and sodium bicarbonate.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: Clear, colorless solution in a single-dose bag for intravenous use. 100 mg per 100 mL (1 mg/mL) 250 mg per 250 mL (1 mg/mL) Injection: Clear, colorless solution in single-dose bag for intravenous use. 100 mg per 100 mL (1 mg/mL) and 250 mg per 250 mL (1 mg/mL) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Diltiazem Hydrochloride in Sodium Chloride Injection is contraindicated in the following situations: • Patients with sick sinus syndrome or second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. • Patients with severe hypotension or cardiogenic shock. • Patients who have demonstrated hypersensitivity to the drug. • Concomitant administration with IV beta-blockers. • Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome. • Patients with ventricular tachycardia. • Sick sinus syndrome or second- or third-degree AV block with no functioning ventricular pacemaker.
( 4 ) • Severe hypotension or cardiogenic shock. ( 4 ) • Demonstrated hypersensitivity to the drug. ( 4 ) • Atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW).
( 4 ) • Ventricular tachycardia. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hemodynamic deterioration and ventricular fibrillation if administered to patients with wide complex tachycardia of ventricular origin. ( 5.2 ) • Second-or third-degree AV block. ( 5.3 ) • Heart failure. ( 5.4 ) • Hypotension. ( 5.5 )
5.1Tachycardia and Hypotension in patients with AF/AFL and accessory bypass tract Diltiazem may cause ventricular fibrillation if given to patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome. Distinguish atrial fibrillation with aberrancy (bundle branch block) from pre-excited atrial fibrillation prior to diltiazem administration [see Contraindications (4)] .
5.2Hemodynamic Deterioration in Patients with Wide Complex Tachycardia Diltiazem may cause hemodynamic deterioration and ventricular fibrillation if administered to patients with wide complex tachycardia of ventricular origin. Distinguish wide complex QRS tachycardia of supraventricular origin from that of ventricular origin prior to diltiazem administration [see Contraindications ( 4 )].
5.3AV Block Diltiazem prolongs AV nodal conduction and refractoriness that may cause second- or third-degree AV block in sinus rhythm. Concomitant use of diltiazem with agents known to affect cardiac conduction may result in additive effects [see Drug Interactions ( 7 )] . If high-degree AV block occurs in sinus rhythm, discontinue diltiazem and institute appropriate supportive measures [see Overdosage ( 10 )].
5.4Heart Failure Diltiazem is a negative inotrope and can cause decreased systolic function and heart failure. Do not initiate in patients with acute decompensated heart failure or cardiogenic shock. If heart failure develops during diltiazem treatment, discontinue treatment and treat heart failure appropriately.
5.5Hypotension Diltiazem can cause symptomatic hypotension. Patients with low blood pressure at baseline and those on concomitant medications that decrease blood pressure, intravascular volume, or myocardial contractility are at increased risk for hypotension.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reaction rates are based on the use of diltiazem hydrochloride injection in over 400 domestic clinical trial patients with atrial fibrillation/flutter or PSVT under double-blind or open-label conditions. Hypotension was the most commonly reported adverse event during clinical trials, with symptomatic hypotension occurring in 3.2% of patients. Other events reported in a least 1% of the diltiazem-treated patients were injection site reactions (e.g., itching, burning) - 3.9%, vasodilation (flushing) - 1.7%, and arrhythmia (junctional rhythm or isorhythmic dissociation) - 1%.
In addition, the following events were reported infrequently (less than 1%): Gastrointestinal - Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting Nervous System - Dizziness Other - dyspnea, edema, headache, Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: Dermatologic - Erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, petechiae, photosensitivity, purpura, pruritus, rash, urticaria, acute generalized exanthematous pustulosis, Gastrointestinal - Anorexia, dysgeusia, dyspepsia Other - Allergic reactions, angioedema (including facial or periorbital edema), gingival hyperplasia, hyperglycemia, impotence.
Most common adverse reactions are hypotension, itching and burning at injection site, vasodilation, and arrhythmia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 1. Clinically Relevant Interactions with Diltiazem Drug/Substance Class or Name Clinical implication Prevention/Management Agents Known to decrease peripheral resistance, cardiac contractility or conduction Increased risk of bradycardia, AV block, and heart failure. Monitor.
Beta-blockers Increased risk of bradycardia, AV block, and depression of contractility. Beta-blocker may need to be decreased [see Warnings and Precautions (5.1, 5.2)]. Anesthetics Depressed cardiac contractility, conductivity, and automaticity as well as the vascular dilation.
Monitor. Clonidine Increased risk of bradycardia. Monitor .
Drugs metabolized by Cytochrome P450 3A4 Diltiazem is both a substrate and an inhibitor of the cytochrome P450 3A4 enzyme system. Concomitant use with diltiazem can increase exposure of drugs that are substrates of CYP450 3A4. Drugs that are substrates of CYP450 3A4 may require dose adjustment to maintain optimum therapeutic blood levels.
Benzodiazepines Increased exposure likely. Monitor. Buspirone Carbamazepine Cyclosporine Quinidine Ranolazine Limit ranolazine to 500 mg twice daily.
Statins Increased risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4. When possible, use a non-CYP3A4-metabolized statin with diltiazem. Limit daily dose of simvastatin to 10 mg and diltiazem to 240 mg [see Clinical Pharmacology (12.3)].
Ivabradine May exacerbate bradycardia and conduction disturbances. Avoid concomitant use [see Clinical Pharmacology (12.3)] . Effect of other drugs on Diltiazem Cytochrome P450 3A4 Inhibitors/ Inducers Diltiazem is a substrate of the cytochrome P450 3A4 enzyme and inhibitors/inducers may change the pharmacological effect of diltiazem Monitor.
Strong or moderate CYP 3A inhibitors a Examples b : Ketoconazole, itraconazole, cimetidine Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with strong or moderate inhibitors of CYP3A4. An adjustment in the diltiazem dose may be warranted CYP inducers Examples b : Rifampin, carbamazepine CYP3A inducers can lower the plasma levels of diltiazem. Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered [see Clinical Pharmacology (12.3)]. a Strong and moderate inhibitors increase the AUC of sensitive substrates of CYP3A4 by ≥ 5 and ≥ 2-fold, respectively b These examples are a guide and not considered a comprehensive list of all possible drugs that may fit this category.
The healthcare provider should consult appropriate references for comprehensive information. • Anesthetics: Further depression of cardiac contractility, conductivity, and automaticity as well as vascular dilation. ( 7 ) • Beta-Blockers: Monitor for bradycardia, AV block, and depression of contractility. ( 7 ) • Clonidine: Increased risk of bradycardia.
( 7 ) • CYP3A4 Inducers: Avoid concomitant use. ( 7 ) • CYP3A4 Inhibitors: Monitor diltiazem’s pharmacologic effect. ( 7 ) • CYP3A4: substrates: Increased exposure of substrates.
( 7 ) • Ivabradine: Avoid concomitant use. ( 7 ) • Ranolazine: Limit ranolazine to 500 mg twice daily. ( 7 ) • Statins: Avoid statins metabolized by CYP3A4.
( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary The available data from the published literature over decades of use with diltiazem during pregnancy have not identified a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, decreased embryo and fetal survival rates, and skeletal abnormalities have been observed at oral doses five to ten times the human oral antianginal therapeutic dose, and reduction in pup weights was also observed. At 20 times the human oral antianginal therapeutic dose, an increase in stillbirths was observed (see Data) .
The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.
Data Animal Data Reproduction studies have been conducted in mice, rats, and rabbits. Administration of oral doses ranging from five to ten times greater (on a mg/kg basis) than the human oral antianginal therapeutic dose has resulted in embryo and fetal lethality. These doses, in some studies, have been reported to cause skeletal abnormalities.
In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. There was an increased incidence of stillbirths at doses of 20 times the human oral antianginal therapeutic dose or greater.
8.2Lactation Risk Summary Published literature reports the presence of diltiazem in human milk. One report with oral diltiazem suggests that concentrations in breast milk may approximate serum levels. There are no data on the effects of diltiazem on the breastfed child or the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Diltiazem Hydrochloride Injection and any potential adverse effects on the breastfed child from Diltiazem Hydrochloride Injection or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric 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.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The available data from the published literature over decades of use with diltiazem during pregnancy have not identified a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, decreased embryo and fetal survival rates, and skeletal abnormalities have been observed at oral doses five to ten times the human oral antianginal therapeutic dose, and reduction in pup weights was also observed. At 20 times the human oral antianginal therapeutic dose, an increase in stillbirths was observed (see Data) .
The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.
Data Animal Data Reproduction studies have been conducted in mice, rats, and rabbits. Administration of oral doses ranging from five to ten times greater (on a mg/kg basis) than the human oral antianginal therapeutic dose has resulted in embryo and fetal lethality. These doses, in some studies, have been reported to cause skeletal abnormalities.
In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. There was an increased incidence of stillbirths at doses of 20 times the human oral antianginal therapeutic dose or greater.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage experience is limited. In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. Diltiazem does not appear to be removed by peritoneal or hemodialysis. Limited data suggest that plasmapheresis may hasten diltiazem elimination following overdose. The intravenous LD 50 's in mice and rats were 60 and 38 mg/kg, respectively. The toxic dose in humans is not known.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The therapeutic effects of diltiazem are believed to be related to inhibiting influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle. Paroxysmal Supraventricular Tachycardia: Diltiazem slows AV nodal conduction time and prolongs AV nodal refractoriness. Diltiazem exhibits frequency- (use-) dependent effects on AV nodal conduction such that it may selectively reduce the heart rate during tachycardias involving the AV node with little or no effect on normal AV nodal conduction at normal heart rates.
Atrial Fibrillation or Atrial Flutter : Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Diltiazem converts paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm by interrupting the reentry circuit in AV nodal reentrant tachycardias and reciprocating tachycardias. Diltiazem prolongs the sinus cycle length.
It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. Diltiazem has no significant electrophysiologic effect on tissues in the heart that are fast sodium channel dependent, e.g., His-Purkinje tissue, atrial and ventricular muscle, and extra nodal accessory pathways. Like other calcium channel antagonists, because of its effect on vascular smooth muscle, diltiazem decreases total peripheral resistance resulting in a decrease in both systolic and diastolic blood pressure.
12.2Pharmacodynamics Intravenous diltiazem hydrochloride 20 mg prolongs AH conduction time and AV node functional and effective refractory periods by approximately 20%. PR in healthy volunteers and HR in patients with atrial fibrillation and atrial flutter are dependent on plasma level of diltiazem. Based on this relationship, the mean plasma diltiazem concentration required to produce a 20%, 30% and 40% decrease in heart rate was determined to be 80 ng/mL, 130 ng/mL and 300 ng/mL, respectively.
In patients with cardiovascular disease, diltiazem hydrochloride administered intravenously in single bolus doses, followed in some cases by a continuous infusion, reduced blood pressure, systemic vascular resistance, the rate-pressure product, and coronary vascular resistance and increased coronary blood flow. In a limited number of studies of patients with compromised myocardium (severe congestive heart failure, acute myocardial infarction, hypertrophic cardiomyopathy), administration of intravenous diltiazem produced no significant effect on contractility, left ventricular end diastolic pressure, or pulmonary capillary wedge pressure.
The mean ejection fraction and cardiac output/index remained unchanged or increased. Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. However, in rare instances, worsening of congestive heart failure has been reported in patients with preexisting impaired ventricular function.
12.3Pharmacokinetics Based on the results of pharmacokinetic studies in healthy volunteers administered different oral diltiazem hydrochloride formulations, constant rate intravenous infusions of diltiazem hydrochloride at 3, 5, 7, and 11 mg/h are predicted to produce steady-state plasma diltiazem concentrations equivalent to 120-, 180-, 240-, and 360-mg total daily oral doses of diltiazem hydrochloride tablets and diltiazem hydrochloride extended-release capsules. Distribution The volume of distribution of diltiazem is approximately 305 L.
Diltiazem is 70% to 80% bound to plasma proteins. In vitro studies suggest alpha 1 -acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. Albumin appears to bind approximately 30% of the drug, while other constituents bind the remaining bound fraction.
Competitive in vitro ligand binding studies have shown that diltiazem hydrochloride binding is not altered by therapeutic concentrations of digoxin, phen…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The therapeutic effects of diltiazem are believed to be related to inhibiting influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle. Paroxysmal Supraventricular Tachycardia: Diltiazem slows AV nodal conduction time and prolongs AV nodal refractoriness. Diltiazem exhibits frequency- (use-) dependent effects on AV nodal conduction such that it may selectively reduce the heart rate during tachycardias involving the AV node with little or no effect on normal AV nodal conduction at normal heart rates.
Atrial Fibrillation or Atrial Flutter : Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Diltiazem converts paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm by interrupting the reentry circuit in AV nodal reentrant tachycardias and reciprocating tachycardias. Diltiazem prolongs the sinus cycle length.
It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. Diltiazem has no significant electrophysiologic effect on tissues in the heart that are fast sodium channel dependent, e.g., His-Purkinje tissue, atrial and ventricular muscle, and extra nodal accessory pathways. Like other calcium channel antagonists, because of its effect on vascular smooth muscle, diltiazem decreases total peripheral resistance resulting in a decrease in both systolic and diastolic blood pressure.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Diltiazem Hydrochloride in Sodium Chloride Injection is supplied as a clear, colorless solution in a single-dose bag with an aluminum overwrap available as: Total Strength per Total Volume Strength per mL Carton of 10 single-dose bags NDC Bag and Overwrap NDC 100 mg per 100 mL 1 mg/mL 44567-662-10 44567-662-01 250 mg per 250 mL 1 mg/mL 44567-663-10 44567-663-01 Discard any unused portion. Store under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze.
The single-dose bags in their original overwraps may be stored for up to one month at 20°C to 25°C [68°F to 77°F], [See USP Controlled Room Temperature] . The bag and port are not made with natural rubber latex, PVC, or DEHP. Product should be used within 28 days of removal from aluminum overwrap.
Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Made in Switzerland
📋 Description ▾
11 DESCRIPTION Diltiazem Hydrochloride in Sodium Chloride Injection is a non-dihydropyridine calcium channel-blocker. Diltiazem hydrochloride is 1,5-benzothiazepin-4(5 H )one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)- cis- with the molecular weight of 450.98 and structural formula: Molecular formula: C 22 H 26 N 2 0 4 S . HCl Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste soluble in water, methanol, and chloroform.
Diltiazem Hydrochloride in Sodium Chloride Injection is a clear, colorless, sterile, nonpyrogenic, isotonic solution for intravenous use only. It is packaged in single-dose bags containing 100 mg/100 mL and 250 mg/250 mL. Each mL contains: 1 mg diltiazem hydrochloride, USP (equivalent to 0.92 mg diltiazem), 0.15 mg citric acid monohydrate, USP, 7.2 mg sodium chloride, USP, 0.13 mg sodium citrate dihydrate, USP, 10 mg sorbitol, NF, and water for injection, USP.
Hydrochloric acid, NF and/or sodium hydroxide are added as needed to adjust pH to 4.5 - 5.5. Structural formula image