Procainamide injection

You should not receive this medication if you are allergic to procainamide, or if you have:

• a serious heart condition such as "AV block" (unless you have a pacemaker);

• lupus; or

• a history of "Long QT syndrome."

If possible before you receive procainamide, tell your doctor if you have:

• congestive heart failure;

• circulation problems;

• a history of heart attack or stroke (including "mini-stroke");

• a weak immune system;

• kidney disease;

• liver disease;

• myasthenia gravis;

• asthma or sulfite allergy;

• if you are allergic to aspirin; or

• if you have ever had an allergic reaction to a numbing medicine.

FDA pregnancy category C. It is not known whether procainamide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Procainamide can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using procainamide.

In an emergency situation, it may not be possible before you are treated with procainamide to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Overdose symptoms may include drowsiness, tremors, weak or shallow breathing, and fainting.

• Your doctor or pharmacist can provide more information about procainamide injection.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01.

Date modified: October 13, 2017
Last reviewed: September 20, 2011

Consult your pharmacist.

How to use Procainamide HCL Vial

Consult your pharmacist.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Applies to procainamide: compounding powder, injectable solution, oral capsule, oral tablet, oral tablet extended release

General

Some side effects of procainamide are related to serum levels of the parent compound and its metabolite, N-acetylprocainamide (NAPA). Side effects are uncommon at levels less than 4 mg per liter, more common at 7 to 8 mg per liter, and expected at 16 mg per liter. Side effects may be more likely and more severe in patients with renal insufficiency.[Ref]

Cardiovascular

Cardiovascular side effects may be acute and serious, such as hypotension, polymorphous ventricular tachycardia, or asystole. Administration of intravenous procainamide in dosages that do not exceed 20 mg/min minimizes the risk of hypotension, and should be considered in patients with low blood pressure and/or cardiac dysfunction. Procainamide may induce QT interval lengthening and torsades de pointes, although less commonly than with quinidine. The possible negative inotropic side effects of procainamide, especially with high serum levels, may be deleterious to some patients with compromised cardiac function.[Ref]

Procainamide may induce the formation of a circulating immunoglobulin directed against some coagulation factors, which has been associated with deep venous thrombosis. This may induce an elevation in the partial thromboplastin time.

A case of myocarditis without pericarditis and several cases of pericarditis associated with procainamide is reported in association with a lupus-like syndrome.[Ref]

Hematologic

Many of the cases of procainamide-induced agranulocytosis presented with complaints of sore throat, malaise, or fever. Prompt evaluation of the complete blood count and differential cell count is recommended since rare cases of serious infection, and even death, associated with this problem have been reported.

A case of pure red cell aplasia associated with procainamide, and confirmed by rechallenge, has been reported.[Ref]

Hematologic side effects are rare, but may be severe. The overall incidence of blood dyscrasias (1980 to 1992) was 0.0022% (90% of affected patients were receiving Procan SR). "Blood dyscrasia" was defined as any diagnosis of agranulocytosis, granulocytopenia, neutropenia, leukopenia, thrombocytopenia, pancytopenia, bone marrow suppression, or aplastic anemia--regardless of severity. These reversible dyscrasias do not appear to be related to drug levels. Periodic monitoring of the complete blood count and careful attention to even minor signs of infection during procainamide therapy is recommended. In addition, lupus anticoagulants, which are evident in 25% to 35% of patients with systemic lupus erythematosus, have been reported in patients treated with procainamide in the absence of other lupus-like symptoms. The presence of such immunoglobulins can lead to thromboembolic complications.[Ref]

Hypersensitivity

Hypersensitivity reactions include reports of angioedema, urticarial rash, and pruritus. Such reactions may be more likely in patients with a sulfite sensitivity. Though not proven, procainamide-induced hepatitis is believed to be hypersensitivity-mediated.[Ref]

Immunologic

Immunologic side effects include a lupus-like syndrome. Chronic use of procainamide may induce production of an antinuclear antibody (ANA) in up to 70% of asymptomatic patients after 6 weeks of therapy. This antibody may be associated with a reversible lupus-like syndrome (myalgias, arthralgias, arthritis, and pulmonary or pericardial serositis) in rare cases. Symptoms appear in only approximately 30% of affected patients. Checking the ANA titer every other month or quarterly is recommended, although many clinicians opt to continue the drug in some patients with a positive ANA titer, taking into account the need for procainamide therapy.[Ref]

The lupus-like syndrome may manifest as arthralgias (most common), fever, chills, myalgias, pericarditis, pleuritis, pleural effusion, hepatomegaly, and hemorrhagic cardiac tamponade. Nephritis and cerebritis are not reported. If periodic monitoring reveals a high antinuclear antibody (ANA) titer, or if the patient develops lupus-like symptoms, reevaluation of the use of procainamide and consideration of aspirin and/or corticosteroid therapy is recommended.

The lupus-like syndrome associated with procainamide shows no predilection for females, is reversible upon discontinuation of procainamide, and is more common among slow acetylators.[Ref]

Gastrointestinal

Gastrointestinal side effects are usually minor, and include nausea, vomiting, anorexia, and diarrhea.[Ref]

Nervous system

Nervous system side effects are uncommon, and include case reports of dizziness and tremors.[Ref]

Rare cases of reversible peripheral neuropathy have been associated with a procainamide-induced lupus-like syndrome.[Ref]

Musculoskeletal

Musculoskeletal weakness is unusual, but may be more likely in patients with underlying myasthenia gravis (MG). At least one case of respiratory failure due to necrotizing myopathy with diaphragmatic involvement in an elderly patient without evidence of MG has been reported.[Ref]

A 74-year-old man with post-coronary artery bypass grafting supraventricular arrhythmias developed upper body symmetrical muscle weakness and tenderness two weeks after beginning procainamide. Associated findings included a sterile, exudative pleural effusion, elevated creatinine kinase levels, and positive anti-double stranded DNA and anti-histone antibodies. Renal function and antinuclear antibodies were normal. Procainamide was withdrawn. The patient's weakness progressed over the next seven days. He developed diaphragmatic weakness, respiratory acidosis, and the need for mechanical ventilation. An extensive neuromuscular work-up revealed a necrotizing myopathy and no evidence of impaired neuromuscular junction transmission. The muscle biopsy showed no inflammatory infiltrates and antinuclear antibodies were not present. The patient recovered over the next month.[Ref]

Psychiatric

A case of reversible mania has been reported in a patient with nontoxic serum procainamide levels.

A 45-year-old female undergoing a mitral valve replacement and tricuspid valve repair began experiencing visual hallucinations and other symptoms suggestive of psychosis four days after beginning procainamide. Within 24 hours of discontinuing procainamide, the patient returned to normal sensorium.[Ref]

Psychiatric side effects include euphoria, hallucinations, psychosis, and mental depression.[Ref]

Hepatic

Only approximately five cases of procainamide-induced granulomatous hepatitis or intrahepatic cholestasis have been reported. Of the five reported cases, all experienced fever, two had vomiting, one pruritus, and none had lymphadenopathy. The onset of signs and symptoms of liver dysfunction began 1 to 17 days after drug administration, and normalized as soon as one day to as long as several months after drug withdrawal. While the mechanism of injury is not known, most believe procainamide-induced hepatitis to be hypersensitivity-mediated.[Ref]

Hepatic side effects are rare. Rare cases of reversible cholestatic jaundice associated with procainamide have been reported. These cases were thought to be due to hypersensitivity reactions. Frequent monitoring of liver function tests is recommended in patients with hepatic insufficiency.[Ref]

Some side effects of procainamide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Oral:
CrCl less than 10 mL/min: A dosing interval of every 8 to 24 hours is recommended.
CrCl 10 to 50 mL/min: A dosing interval of every 6 to 12 hours is recommended.

IV:
Reduce loading dose to 12 mg/kg in severe renal impairment.
Maintenance infusions should be reduced by one-third in patients with moderate renal impairment and by two-thirds in patients with severe renal impairment.

NARROW THERAPEUTIC INDEX:
-This drug should be considered a narrow therapeutic index (NTI) drug as small differences in dose or blood concentrations may lead to serious therapeutic failures or adverse drug reactions.
Recommendations:
- Generic substitution should be done cautiously, if at all, as current bioequivalence standards are generally insufficient for NTI drugs.
-Additional and/or more frequent monitoring should be done to ensure receipt of an effective dose while avoiding unnecessary toxicities.