DILTIAZEM HCI 5 mg/mL
DILTIAZEM HCI · INJECTION · HF Acquisition Co LLC, DBA HealthFirst
DILTIAZEM HCI is a injection containing diltiazem hci at 5 mg/mL, taken intravenous. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- DILTIAZEM HCI
- Generic Name
- DILTIAZEM HCI
- NDC Code (Product)
51662-1335- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA078538
- Marketing Start
- 12/21/2018
Recall History
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Watson Pharmaceuticals
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE Diltiazem Hydrochloride Injection is indicated for the following: Atrial Fibrillation or Atrial Flutter Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. Paroxysmal Supraventricular Tachycardia Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium. For either indication and particularly when…
Dosage & Administration
DOSAGE & ADMINISTRATION Direct Intravenous Single Injections (Bolus) The initial dose of diltiazem hydrochloride injection should be 0.25 mg/kg actual body weight as a bolus 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 bolus dose of diltiazem hydrochloride injection 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 for each patient. Patients with low body weights should be dosed on a mg/kg basis. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Experience with this dose is limited. Continuous Intravenous Infusion For continued reduction of the heart rate (up to 24 hours) in patients with atrial fibrillation or atrial flutter, an intravenous infusion of diltiazem hydrochloride injection may be administered. Immediately following bolus administration of 20 mg (0.25 mg/kg) or 25 mg (0.35 mg/kg) diltiazem hydrochloride injection and reduction of heart rate, begin an intravenous…
Warnings
WARNINGS Cardiac Conduction Diltiazem prolongs AV nodal conduction and refractoriness that may rarely result in 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 PRECAUTIONS , Drug Interactions). If high-degree AV block occurs in sinus rhythm, intravenous diltiazem should be discontinued and appropriate supportive measures instituted (see OVERDOSAGE ). Congestive Heart Failure Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function and in patients with a compromised myocardium, such as severe CHF, acute MI, and hypertrophic cardiomyopathy, have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). Administration of oral diltiazem in patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission is contraindicated. Experience with the use of diltiazem hydrochloride injection in patients with impaired ventricular function is limited. Caution should be exercised when using the drug in such patients. …
Contraindications
CONTRAINDICATIONS Diltiazem hydrochloride injection is contraindicated in: Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. Patients with 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. Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome. As with other agents which slow AV nodal conduction and do not prolong the refractoriness of the accessory pathway (e.g., verapamil, digoxin), in rare instances patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract may experience a potentially life-threatening increase in heart rate accompanied by hypotension when treated with diltiazem hydrochloride injection. As such, the initial use of diltiazem hydrochloride injection should be, if possible, in a setting where monitoring and resuscit…
Adverse Reactions
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. Worldwide experience in over 1300 patients was similar. Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. Hypotension was the most commonly reported adverse event during clinical trials. Asymptomatic hypotension occurred in 4.3% of patients. Symptomatic hypotension occurred in 3.2% of patients. When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. Other events reported in at 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%): Cardiovascular Asystole, atrial flutter, AV block first degree, AV block second degree, bradycardia, chest pain, congestive heart failure, sin…
Frequently Asked Questions
What is DILTIAZEM HCI used for?
DILTIAZEM HCI contains DILTIAZEM HCI. It is a injection taken intravenous. Consult your doctor for specific uses.
Is DILTIAZEM HCI a controlled substance?
DILTIAZEM HCI is not classified as a controlled substance by the DEA.
What is the generic name for DILTIAZEM HCI?
The generic name for DILTIAZEM HCI is DILTIAZEM HCI. There are no other listed brand versions of DILTIAZEM HCI.
What is the NDC code for DILTIAZEM HCI 5 mg/mL?
The NDC (National Drug Code) for DILTIAZEM HCI 5 mg/mL is 51662-1335, listed by HF Acquisition Co LLC, DBA HealthFirst.
Other DILTIAZEM HCI Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)