Drugplain

Procainamide Hydrochloride 100 mg/mL

Procainamide Hydrochloride · INJECTION, SOLUTION · Sagent Pharmaceuticals

No Recall History
Plain English

Procainamide Hydrochloride is a injection, solution containing procainamide hydrochloride at 100 mg/mL, taken intramuscular. Manufactured by Sagent Pharmaceuticals.

Key Facts

Brand Name
Procainamide Hydrochloride
Generic Name
Procainamide Hydrochloride
NDC Code (Product)
25021-322
Manufacturer
Sagent Pharmaceuticals
Strength
100 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #
ANDA218135
Marketing Start
01/15/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective94 reports
off label use32 reports
atrial fibrillation21 reports
maternal exposure during pregnancy19 reports
systemic lupus erythematosus19 reports
ascites18 reports
drug ineffective for unapproved indication18 reports
electrocardiogram qt prolonged18 reports
fatigue18 reports
respiratory failure18 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see WARNINGS and Boxed Warning .)

Dosage & Administration

DOSAGE AND ADMINISTRATION Procainamide Hydrochloride Injection is useful for arrhythmias which require immediate suppression and for maintenance of arrhythmia control. Intravenous therapy allows most rapid control of serious arrhythmias, including those following myocardial infarction; it should be carried out in circumstances where close observation and monitoring of the patient are possible, such as in hospital or emergency facilities. Intramuscular administration is less apt to produce temporary high plasma levels but therapeutic plasma levels are not obtained as rapidly as with intravenous administration. Oral procainamide dosage forms are preferable for less urgent arrhythmias as well as for long-term maintenance after initial parenteral PA therapy. Intramuscular administration may be used as an alternative to the oral route for patients with less threatening arrhythmias but who are nauseated or vomiting, who are ordered to receive nothing by mouth preoperatively, or who may have malabsorptive problems. An initial daily dose of 50 mg per kg body weight may be estimated. This amount should be divided into fractional doses of one-eighth to one-quarter to be injected intramuscula…

Warnings

WARNINGS Mortality: In the National Heart, Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicentered, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously, an excessive mortality or non-fatal cardiac arrest rate (7.7%) was seen in patients treated with encainide or flecainide compared with that seen in patients assigned to matched placebo-treated group (3.0%). The average duration of treatment with encainide or flecainide in this study was ten months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarctions) is uncertain. Considering the known proarrhythmic properties of procainamide and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of procainamide as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias. Blood Dyscrasias: Agranulocytosis, bone marrow depression, neutropenia, hypoplastic anemia and thrombocytopeni…

Contraindications

CONTRAINDICATIONS Complete Heart Block: Procainamide should not be administered to patients with complete heart block because of its effects in suppressing nodal or ventricular pacemakers and the hazard of asystole. It may be difficult to recognize complete heart block in patients with ventricular tachycardia, but if significant slowing of ventricular rate occurs during PA treatment without evidence of A-V conduction appearing, PA should be stopped. In cases of second degree A-V block or various types of hemiblock, PA should be avoided or discontinued because of the possibility of increased severity of block, unless the ventricular rate is controlled by an electrical pacemaker. Idiosyncratic Hypersensitivity: In patients sensitive to procaine or other ester-type local anesthetics, cross sensitivity to PA is unlikely. However, it should be borne in mind, and PA should not be used if it produces acute allergic dermatitis, asthma, or anaphylactic symptoms. Lupus Erythematosus: An established diagnosis of systemic lupus erythematosus is a contraindication to PA therapy, since aggravation of symptoms is highly likely. Torsades de Pointes: In the unusual ventricular arrhythmia called "le…

Drug Interactions

Drug Interactions If other antiarrhythmic drugs are being used, additive effects on the heart may occur with PA administration, and dosage reduction may be necessary (see WARNINGS ). Anticholinergic drugs administered concurrently with PA may produce additive antivagal effects on A-V nodal conduction, although this is not as well documented for PA as for quinidine. Patients taking PA who require neuromuscular blocking agents such as succinylcholine may require less than usual doses of the latter, due to PA effects on reducing acetylcholine release.

Adverse Reactions

ADVERSE REACTIONS Cardiovascular System : Hypotension and serious disturbances of cardiorhythm such as ventricular asystole or fibrillation are more common with intravenous administration of PA than with intramuscular administration. Because PA is a peripheral vasodilator in concentrations higher than the usual therapeutic range, transient high plasma levels which may occur especially during intravenous administration may produce temporary but at times severe lowering of blood pressure (see OVERDOSAGE and PRECAUTIONS ). Multisystem: A lupus erythematosus-like syndrome of arthralgia, pleural or abdominal pain, and sometimes arthritis, pleural effusion, pericarditis, fever, chills, myalgia, and possibly related hematologic or skin lesions (see below) is fairly common after prolonged PA administration, perhaps more often in patients who are slow acetylators (See Boxed Warning and PRECAUTIONS ). While some series have reported less than 1 in 500, others have reported the syndrome in up to 30 percent of patients on long term oral PA therapy. If discontinuation of PA does not reverse the lupoid symptoms, corticosteroid treatment may be effective. Hematologic: Neutropenia, thrombocytopeni…

Frequently Asked Questions

What is Procainamide Hydrochloride used for?

Procainamide Hydrochloride contains Procainamide Hydrochloride. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.

Is Procainamide Hydrochloride a controlled substance?

Procainamide Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Procainamide Hydrochloride?

The generic name for Procainamide Hydrochloride is Procainamide Hydrochloride. There are 1 other brand versions of Procainamide Hydrochloride.

What is the NDC code for Procainamide Hydrochloride 100 mg/mL?

The NDC (National Drug Code) for Procainamide Hydrochloride 100 mg/mL is 25021-322, listed by Sagent Pharmaceuticals.

Product NDC

25021-322

Package NDC

25021-322-10

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