flecainide acetate


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flecainide acetate

Apo-Flecainide (CA), Tambocor, Tambocor XL (UK)

Pharmacologic class: Cardiac benzamide local anesthetic

Therapeutic class: Antiarrhythmic (class IC)

Pregnancy risk category C

Action

Inhibits fast sodium channels of myocardial cell membrane. Also slows conduction, shortens action potential, stops paroxysmal reentrant supraventricular tachycardia, and decreases conduction in accessory pathways in Wolff-Parkinson-White syndrome.

Availability

Tablets: 50 mg, 100 mg, 150 mg

Indications and dosages

Supraventricular tachyarrhythmias (including paroxysmal supraventricular tachycardia and paroxysmal atrial fibrillation or flutter)

Adults: Initially, 50 mg P.O. q 12 hours, increased by 50 mg b.i.d. q 4 days until desired response occurs or maximum daily dosage of 300 mg is reached

Sustained, life-threatening ventricular tachycardia

Adults: Initially, 100 mg P.O. q 12 hours, increased by 50 mg b.i.d. q 4 days until desired response occurs or maximum daily dosage of 400 mg is reached

Dosage adjustment

• Heart failure

• Renal impairment

Off-label uses

• Ventricular arrhythmias

• Wolff-Parkinson-White syndrome

Contraindications

• Hypersensitivity to drug

• Preexisting atrioventricular block or right bundle-branch block

• Recent MI

• Cardiogenic shock

Precautions

Use cautiously in:

• heart failure, renal impairment

• patients taking concurrent amiodarone, beta-adrenergic blockers, disopyramide, or verapamil

• pregnant or breastfeeding patients

• children (safety not established).

Administration

• Initiate therapy only in hospital setting with trained personnel and continuous ECG monitoring.

• Before giving, correct hypokalemia or hyperkalemia.

• Be aware that dosage may be reduced once arrhythmias have been adequately controlled.

Adverse reactions

CNS: dizziness, anxiety, fatigue, headache, depression, malaise, tremor, weakness, hypoesthesia, paresthesia

CV: chest pain, palpitations, second- or third-degree heart block, heart failure, new or worsening arrhythmias

EENT: blurred vision, visual disturbances, corneal deposits

GI: nausea, vomiting, constipation, abdominal pain, dyspepsia, anorexia

Hepatic: hepatitis

Respiratory: dyspnea

Skin: rash, diaphoresis

Other: edema, fever

Interactions

Drug-drug. Acidifying drugs: increased renal elimination, decreased efficacy of flecainide (with urine pH below 5)

Alkalizing drugs: increased flecainide blood level, possible toxicity

Amiodarone: doubling of flecainide blood level

Beta-adrenergic blockers: increased blood levels of both drugs

Beta-adrenergic blockers, disopyramide, verapamil: additive myocardial depressant effect

Digoxin: 15% to 25% increase in digoxin blood level

Other antiarrhythmics (including calcium channel blockers): increased risk of arrhythmias

Drug-diagnostic tests. Alkaline phosphatase: increased level (with prolonged therapy)

Drug-food. Foods that decrease urine pH below 5 (such as acidic juices): increased renal elimination and possibly decreased efficacy of drug

Foods that increase urine рH above 7 (as in strict vegetarian diets): increased drug blood level

Drug-behaviors. Smoking: increased plasma clearance and decreased efficacy of drug

Patient monitoring

Monitor ECG for worsening arrhythmias.

• Measure pacing threshold 1 week before therapy starts and again after 1 week of therapy.

• Monitor potassium and flecainide blood levels.

• Assess respiratory status regularly.

• Monitor hepatic function tests.

Patient teaching

Instruct patient to immediately report cardiac or respiratory symptoms, unusual tiredness, or yellowing of skin or eyes.

• Tell patient drug may cause numbness. Advise him to avoid injury to areas with sensory impairment.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, and vision.

• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking adequate fluids.

• Tell female patient to inform prescriber if she is pregnant or breastfeeding.

• Inform patient that he'll undergo regular blood testing during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.

flecainide acetate

A drug used to treat severe heart irregularities. A brand name is Tambocor.
References in periodicals archive ?
The usual oral dosage for infants over 6 months old or over, toddlers, and children is 50-100 mg/m2 (body surface area) [0.5-1 g/m2 (body surface area) as fine granule] of flecainide acetate daily in two to three divided doses.
The usual oral dosage for infants under the age of 6 months is 50 mg/m2 (body surface area) [0.5 g/m2 (body surface area) as fine granule] of flecainide acetate daily in two to three divided doses.
According to ANI, Flecainide acetate tablets USP are also indicated for the prevention of documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.
Target: Approved NDA for Flecainide Acetate tablets
The recommended starting dose is 100 mg (1 g of fine granules) of flecainide acetate per day, taken orally and divided into two equally spaced doses.
Coadministration of flecainide acetate and sotalol during pregnancy: lack of teratogenic effects, passage across the placenta, and excretion in human breast milk.
Its ANDA for flecainide acetate tablets in 50,100 and 150 mg will compete in a market that the company said achieved $105.6 million in sales last year.
versions of the heart drug flecainide acetate under its own name.