Diltiazem Hydrochloride 5 mg/mL
diltiazem hydrochloride · INJECTION, SOLUTION · Medical Purchasing Solutions, LLC
Diltiazem Hydrochloride is a injection, solution containing diltiazem hydrochloride at 5 mg/mL, taken intravenous. Manufactured by Medical Purchasing Solutions, LLC.
Key Facts
- Brand Name
- Diltiazem Hydrochloride
- Generic Name
- diltiazem hydrochloride
- NDC Code (Product)
71872-7345- Manufacturer
- Medical Purchasing Solutions, LLC
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA074617
- Marketing Start
- 06/01/2024
Recall History
Glenmark Pharmaceuticals Inc., USA
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Mckesson Packaging Services
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Glenmark Pharmaceuticals Inc., USA
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Teva Pharmaceuticals USA
GMP Deviation: lot not intended for commercial distribution.
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Teva Pharmaceuticals USA
Labelling: Incorrect Exp. Date
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Teva Pharmaceuticals USA Inc
Failed Dissolution Specifications: below specification limits for dissolution.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Dosage & Administration
DOSAGE AND ADMINISTRATION Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules, USP at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules, USP 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 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 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. Angina…
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 (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 repor…
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 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.
Drug Interactions
Drug Interactions Because of the potential for additive effects, slow titration is warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction (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 ). Diltiazem is both a substrate and an inhibitor of the cytochrome P450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels. 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, titrate anesth…
Adverse Reactions
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. 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. G astrointestinal: 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 …
Frequently Asked Questions
What is Diltiazem Hydrochloride used for?
Diltiazem Hydrochloride contains diltiazem hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Diltiazem Hydrochloride a controlled substance?
Diltiazem Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Diltiazem Hydrochloride?
The generic name for Diltiazem Hydrochloride is diltiazem hydrochloride. There are 5 other brand versions of diltiazem hydrochloride.
What is the NDC code for Diltiazem Hydrochloride 5 mg/mL?
The NDC (National Drug Code) for Diltiazem Hydrochloride 5 mg/mL is 71872-7345, listed by Medical Purchasing Solutions, LLC.