Flecainide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
See full prescribing information for complete Boxed Warning.
Mortality:
Ventricular Pro-Arrhythmic Effects in Patients with Atrial Fibrillation/Flutter:
|
Overview
Flecainide is an antiarrhythmic that is FDA approved for the {{{indicationType}}} of paroxysmal supraventricular tachycardias (PSVT), paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms, sustained ventricular tachycardia (sustained VT). Fecainide is also indicated for the treatment of documented ventricular arrhythmias, such as sustained VT. There is a Black Box Warning for this drug as shown here. Common adverse reactions include palpitations, nausea, dizziness, headache, blurred vision, photopsia, dyspnea, and fatigue.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
- Dosing Information
- Dosage
Condition2
- Dosing Information
- Dosage
Condition3
- Dosing Information
- Dosage
Condition4
- Dosing Information
- Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Flecainide in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Flecainide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Flecainide in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Flecainide in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Flecainide in pediatric patients.
Contraindications
- Condition1
Warnings
|
See full prescribing information for complete Boxed Warning.
Mortality:
Ventricular Pro-Arrhythmic Effects in Patients with Atrial Fibrillation/Flutter:
|
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Flecainide in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Flecainide in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Flecainide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Flecainide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Flecainide with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Flecainide with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Flecainide with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Flecainide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Flecainide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Flecainide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Flecainide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Flecainide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Flecainide in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Flecainide in the drug label.
Condition1
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Flecainide in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Flecainide in the drug label.
Pharmacology
There is limited information regarding Flecainide Pharmacology in the drug label.
Mechanism of Action
- Flecainide has local anesthetic activity and belongs to the membrane stabilizing (Class 1) group of antiarrhythmic agents; it has electrophysiologic effects characteristic of the IC class of antiarrhythmics.
Electrophysiology
- In man, flecainide produces a dose-related decrease in intracardiac conduction in all parts of the heart with the greatest effect on the His-Purkinje system (H-V conduction). Effects upon atrioventricular (AV) nodal conduction time and intra-atrial conduction times, although present, are less pronounced than those on ventricular conduction velocity. Significant effects on refractory periods were observed only in the ventricle. Sinus node recovery times (corrected) following pacing and spontaneous cycle lengths are somewhat increased. This latter effect may become significant in patients with sinus node dysfunction.
- Flecainide causes a dose-related and plasma-level related decrease in single and multiple PVCs and can suppress recurrence of ventricular tachycardia. In limited studies of patients with a history of ventricular tachycardia, flecainide has been successful 30 to 40% of the time in fully suppressing the inducibility of arrhythmias by programmed electrical stimulation. Based on PVC suppression, it appears that plasma levels of 0.2 to 1 mcg/mL may be needed to obtain the maximal therapeutic effect. It is more difficult to assess the dose needed to suppress serious arrhythmias, but trough plasma levels in patients successfully treated for recurrent ventricular tachycardia were between 0.2 and 1 mcg/mL. Plasma levels above 0.7 to 1 mcg/mL are associated with a higher rate of cardiac adverse experiences such as conduction defects or bradycardia. The relation of plasma levels to proarrhythmic events is not established, but dose reduction in clinical trials of patients with ventricular tachycardia appears to have led to a reduced frequency and severity of such events.
Hemodynamics
- Flecainide does not usually alter heart rate, although bradycardia and tachycardia have been reported occasionally.
- In animals and isolated myocardium, a negative inotropic effect of flecainide has been demonstrated. Decreases in ejection fraction, consistent with a negative inotropic effect, have been observed after single administration of 200 to 250 mg of the drug in man; both increases and decreases in ejection fraction have been encountered during multidose therapy in patients at usual therapeutic doses.
Structure
- Flecainide acetate, USP is an antiarrhythmic drug available in tablets and is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is as follows:
This image is provided by the National Library of Medicine.
- Flecainide acetate, USP is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C.
- Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of flecainide acetate, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline celulose, pregelatinized starch and sodium stearyl fumarate.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Flecainide in the drug label.
Pharmacokinetics
- Following oral administration, the absorption of flecainide is nearly complete. Peak plasma levels are attained at about three hours in most individuals (range, 1 to 6 hours). Flecainide does not undergo any consequential presystemic biotransformation (first-pass effect). Food or antacid do not affect absorption. Milk, however, may inhibit absorption in infants. A reduction in flecainide dosage should be considered when milk is removed from the diet of infants.
- The apparent plasma half-life averages about 20 hours and is quite variable (range, 12 to 27 hours) after multiple oral doses in patients with premature ventricular contractions (PVCs). With multiple dosing, plasma levels increase because of its long half-life with steady-state levels approached in 3 to 5 days; once at steady-state, no additional (or unexpected) accumulation of drug in plasma occurs during chronic therapy. Over the usual therapeutic range, data suggest that plasma levels in an individual are approximately proportional to dose, deviating upwards from linearity only slightly (about 10 to 15% per 100 mg on average).
- In healthy subjects, about 30% of a single oral dose (range, 10 to 50%) is excreted in urine as unchanged drug. The two major urinary metabolites are meta-O-dealkylated flecainide (active, but about one-fifth as potent) and the meta-O-dealkylated lactam of flecainide (non-active metabolite). These two metabolites (primarily conjugated) account for most of the remaining portion of the dose. Several minor metabolites (3% of the dose or less) are also found in urine; only 5% of an oral dose is excreted in feces. In patients, free (unconjugated) plasma levels of the two major metabolites are very low (less than 0.05 mcg/mL).
- In vitro metabolic studies have confirmed that cytochrome P450IID6 is involved in the metabolism of flecainide.
- When urinary pH is very alkaline (8 or higher), as may occur in rare conditions (e.g., renal tubular acidosis, strict vegetarian diet), flecainide elimination from plasma is much slower.
- The elimination of flecainide from the body depends on renal function (i.e., 10 to 50% appears in urine as unchanged drug). With increasing renal impairment, the extent of unchanged drug excretion in urine is reduced and the plasma half-life of flecainide is prolonged. Since flecainide is also extensively metabolized, there is no simple relationship between creatinine clearance and the rate of flecanide elimination from plasma.
- In patients with NYHA class III congestive heart failure (CHF), the rate of flecainide elimination from plasma (mean half-life, 19 hours) is moderately slower than for healthy subjects (mean half-life, 14 hours), but similar to the rate for patients with PVCs without CHF. The extent of excre- tion of unchanged drug in urine is also similar.
- Under one year of age, currently available data are limited but suggest that the half-life at birth may be as long as 29 hours, decreasing to 11to 12 hours by three months of age and 6 hours by one year of age. The pharmacokinetics in hydropic infants have not been studied, but case reports suggest prolonged elimination. In children aged 1 year to 12 years the half-life is approximately 8 hours. In adolescents (age 12 to 15) the plasma elimination half-life is approximately 11 to 12 hours. Since milk may inhibit absorption in infants, a reduction in flecainide dosage should be considered when milk is removed from the diet (e.g., gastroenteritis, weaning). Plasma trough flecainide levels should be monitored during major changes in dietary milk intake.
- From age 20 to 80, plasma levels are only slightly higher with advancing age; flecainide elimination from plasma is somewhat slower in elderly subjects than in younger subjects. Patients up to age 80+ have been safely treated with usual dosages.
- The extent of flecainide binding to human plasma proteins is about 40% and is independent of plasma drug level over the range of 0.015 to about 3.4 mcg/mL. Thus, clinically significant drug interactions based on protein binding effects would not be expected.
- Hemodialysis removes only about 1% of an oral dose as unchanged flecainide.
- Small increases in plasma digoxin levels are seen during coadministration of flecainide with digoxin. Small increases in both flecainide and propranolol plasma levels are seen during coadministration of these two drugs.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Flecainide in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Flecainide in the drug label.
Condition1
- Description
How Supplied
Storage
There is limited information regarding Flecainide Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Flecainide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Flecainide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Flecainide in the drug label.
Precautions with Alcohol
- Alcohol-Flecainide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Tambocor®[1]
Look-Alike Drug Names
- Tambocor® — Pamelor®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "FLECAINIDE ACETATE tablet".
- ↑ "http://www.ismp.org". External link in
|title=(help)
{{#subobject:
|Page Name=Flecainide |Pill Name=No image.jpg |Drug Name= |Pill Ingred=|+sep=; |Pill Imprint= |Pill Dosage= |Pill Color=|+sep=; |Pill Shape= |Pill Size (mm)= |Pill Scoring= |Pill Image= |Drug Author= |NDC=
}}
{{#subobject:
|Label Page=Flecainide |Label Name=Flecainide03.png
}}
{{#subobject:
|Label Page=Flecainide |Label Name=Flecainide04.png
}}
{{#subobject:
|Label Page=Flecainide |Label Name=Flecainide05.png
}}
{{#subobject:
|Label Page=Flecainide |Label Name=Flecainide06.png
}}