Tocainide

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• CISAPRIDE/TOCAINIDE
• DOFETILIDE/TOCAINIDE

This is not a complete list of Tocainidedrug interactions. Ask your doctor or pharmacist for more information.

Take tocainide exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Tocainide dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Tocainide is available in the following doses:

• Tocainide 400 Mg Oral Tablet
• Tocainide 600 Mg Oral Tablet

Tocainide is available in the following forms:

• Oral Tablet

Tocainide belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm.

Tocainide produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive.

Tocainide is available only with your doctor's prescription.

It is important that your doctor check your progress at regular visits to make sure the medicine is working properly. This will allow changes to be made in the amount of medicine you are taking, if necessary.

Your doctor may want you to carry a medical identification card or bracelet stating that you are using tocainide.

Tocainide may cause some people to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to tocainide before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking tocainide.

Applies to tocainide: oral tablet

General

Tocainide is generally well tolerated. Minor, transient, dose-dependent side effects have occurred frequently (up to 80%) and usually involved nervous system or gastrointestinal symptoms. Approximately 21% of patients discontinued tocainide because of adverse effects. The incidence of side effects increased when plasma tocainide concentrations exceeded 10 mcg/mL. Tremor may indicate that the maximum dosage is being approached.

General adverse reactions affecting the body as a whole included fatigue (0.8% to 1.6%) and hot or cold sensations (0.5% to 1.5%). Cinchonism, asthenia, and malaise have been reported in less than 1% of patients.[Ref]

Gastrointestinal

Gastrointestinal side effects are the most frequently observed. Nausea, vomiting, and anorexia have occurred in 15% to 35% of patients. Dosage reductions or administration with food, which will not affect tocainide plasma concentrations, helps minimize these side effects. Diarrhea has been reported in 6.8% of patients. Pancreatitis, abdominal discomfort, constipation, dysphagia, stomatitis, taste alteration, dry mouth and thirst were reported in less than 1% of patients.[Ref]

Nervous system

Nervous system side effects have occurred in 15% to 25% of patients on chronic therapy. Lightheadedness/dizziness/vertigo (8% to 25.3%), tremors (2.9% to 21.6%), paresthesia (3.5% to 9.2%), coordination difficulties (1.2%), and headache (2.1% to 4.6%) have been reported. Neurologic side effects are usually dose-related and resolve with dosage reductions. Adverse effects such as coma, seizures, myasthenia gravis, dysarthria, decreased mental acuity/impaired memory, increased stuttering/slurred speech, and local anesthesia have been reported in less than 1% of patients.[Ref]

Tocainide, like lidocaine, crosses the blood-brain barrier and may produce neurotoxicity, including seizures. Tremor and paresthesias indicate a maximum tolerable dosage.[Ref]

Cardiovascular

Cardiovascular side effects such as exacerbation of old or induction of new arrhythmias, including ventricular tachycardia or fibrillation, have occurred in 16% of patients. Although tocainide has a minimal effect on the sinus node, cases of sinus arrest and SA block have been reported, particularly in patients with sick sinus syndrome. Exacerbation of congestive heart failure occurred in 1% to 5% of patients. Bradycardia (1.8%), hypotension (3.4%), and chest pain (1.6%) have been reported. Angina, hypertension, claudication, increased QRS duration, extension of acute myocardial infarction, vaso-vagal episodes, syncope, and edema have occurred.[Ref]

Hematologic

Tocainide-associated blood dyscrasias have been reported most often during the first 2 to 12 weeks of therapy.[Ref]

Hematologic side effects of tocainide have been rare (0.2% of patients), but serious reactions and death have occurred. Aplastic anemia and agranulocytosis have been associated with tocainide, some were irreversible and resulted in death. Weekly complete blood count analysis is recommended during the first three months of therapy and monthly, thereafter. Bone marrow depression and granuloma, hemolytic anemia, anemia, leukopenia, neutropenia, thrombocytopenia, and eosinophilia have been associated with tocainide therapy in less in 1% of patients. Septicemia and septic shock have been reported.[Ref]

Hypersensitivity

Hypersensitivity reactions manifesting as rash, fever, joint pain, eosinophilia, or abnormal liver function tests have been reported in up to 25% of patients. Stevens-Johnson syndrome has been associated with tocainide. Interstitial pneumonitis is a rare side effect of tocainide and may be initiated by a hypersensitivity mechanism.[Ref]

Dermatologic

Data from 21 reports of severe skin reactions between 1985 to 1986, indicated 67% of the reactions occurred during the first 3 weeks of therapy.[Ref]

Dermatologic side effects occurred in 12% to 28% of patients. Serious reactions have included Stevens-Johnson syndrome, erythema multiforme, rash with stomatitis, or rash requiring or prolonging hospitalization. Overall, the incidence of serious skin reactions is 0.5 to 3.8 per 100,000 prescriptions of tocainide, with fatalities in 0.9 per 100,000 prescriptions. Diaphoresis has been reported in up to 8.3% of patients.[Ref]

Psychiatric

Psychiatric side effects have included confusion/disorientation/hallucinations (2.1% to 11.2%), altered mood/awareness (1.5% to 11%), nervousness (11.5%), and anxiety (1.1% to 1.5%). Psychosis/disturbances, depression, agitation, insomnia/sleep disturbances, and dream abnormalities have been reported in less than 1% of patients.[Ref]

Respiratory

Respiratory side effects, although rare, have resulted in death. Tocainide-associated pulmonary fibrosis has occurred, most often in seriously ill patients. Symptoms of dyspnea and cough usually presented within 3 to 18 weeks of initiation of therapy. Interstitial infiltrates were seen on radiologic examination. Respiratory arrest, pulmonary edema, fibrosing alveolitis, pneumonia, interstitial pneumonitis (0.03%), dyspnea, hiccough, yawning, and smell alterations have been reported in less than 1% of patients.[Ref]

Evidence of a hypersensitivity mechanism has been reported for tocainide-associated pulmonary fibrosis.[Ref]

Hepatic

Hepatic side effects usually have been mild and transient, manifesting as slightly elevated liver function tests. Hepatitis and jaundice have been reported in less than 1% of patients.[Ref]

Immunologic

A 75-year-old man with a history of coronary artery bypass grafting and short runs of ventricular tachycardia was given tocainide 400 mg every 8 hours. Three weeks after initiation of therapy he developed unexplained malaise, chills, sweats, and fever and was given oral antibiotics. His physical exam was noncontributory; laboratory tests revealed a white blood cell count of 4,400/mm3. An evaluation of typical and atypical infectious pathogens was negative. A CT scan noted a right pleural effusion and hepatosplenomegaly. Bone marrow aspiration revealed numerous noncaseating granuloma, decreased iron stores, and 30% cellularity. A serum ANA was positive at 1:640 (speckled pattern). Resolution of all symptoms occurred within one week of discontinuing tocainide. Rechallenge was not attempted.[Ref]

Immunologic and clinical changes consistent with a lupus-like syndrome have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects such as arthritis/arthralgia (4.7%) and myalgia (1.7%), and ataxia (02.% to 10.8%) have been reported. Side effects occurring in less than 1% of patients included muscle cramps/twitches/spasms, neck pain or pain radiating from the neck, and shoulder pressure.[Ref]

Ocular

Ocular disturbances have included blurred vision in up to 10% of patients. Nystagmus occurred less frequently (1.1%).[Ref]

Other

Ototoxicity characterized by vertigo and tinnitus/hearing loss has occurred in 25.3% and 1.1% of patients, respectively. Rare incidences of earache have been reported.[Ref]

Genitourinary

Genitourinary side effects including urinary retention, polyuria, and increased diuresis have occurred in less than 1% of patients.[Ref]

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