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Flecainide Acetate 100 Mg Tabs 60 By Roxane.

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Flecainide Acetate 100 Mg Tabs 60 By Roxane.

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Flecainide Acetate 100 Mg Tabs 60 By Roxane. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD3458247/RXB10046647/RXA317032
Size : 60
Selling UoM : EA
NDC: 00054-0011-21
UPC Barcode : 300540011215Supplier: 0050000335 ROXANE LABS MULTISOURCE (PGN)
Supplier Material : 0011-21
Generic Code : 000263 FLECAINIDE ACETATE ORAL TABLET 100 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX

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Product Description.:

54 070
tablet , white , scored , round round

TAMBOCOR? (flecainide acetate) is an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis (2,2,2-trifluoroethoxy)-monoacetate.

Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37?C. TAMBOCOR tablets also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose and starch.

INDICATIONS

In patients without structural heart disease, TAMBOCOR is indicated for the prevention of

* paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms
* paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms

TAMBOCOR is also indicated for the prevention of

* documented ventricular arrhythmias, such assustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.

Use of TAMBOCOR for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of TAMBOCOR is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.

Because of the proarrhythmic effects of TAMBOCOR, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.

TAMBOCOR should not be used in patients with recent myocardial infarction. (See BOXED WARNINGS.)

Use of TAMBOCOR in chronic atrial fibrillation has not been adequately studied and is not recommended. (See BOXED WARNINGS.)

As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of TAMBOCOR favorably affects survival or the incidence of sudden death.

SIDE EFFECTS

In post-myocardial infarction patients with asymptomatic PVCs and non-sustained ventricular tachycardia, TAMBOCOR therapy was found to be associated with a 5.1% rate of death and non-fatal cardiac arrest, compared with a 2.3% rate in a matched placebo group. (See WARNINGS.)

Adverse effects reported for TAMBOCOR, described in detail in the Warnings section, were new or worsened arrhythmias which occurred in 1% of 108 patients with PSVT and in 7% of 117 patients with PAF and new or exacerbated ventricular arrhythmias which occurred in 7% of 1330 patients with PVCs, non-sustained or sustained VT. In patients treated with flecainide for sustained VT, 80% (51/64) of proarrhythmic events occurred within 14 days of the onset of therapy. 198 patients with sustained VT experienced a 13% incidence of new or exacerbated ventricular arrhythmias when dosage was initiated at 200 mg/day with slow upward titration, and did not exceed 300 mg/day in most patients. In some patients, TAMBOCOR treatment has been associated with episodes of unresuscitatable VT or ventricular fibrillation (cardiac arrest). (See WARNINGS.) New or worsened CHF occurred in 6.3% of 1046 patients with PVCs, non-sustained or sustained VT. Of 297 patients with sustained VT, 9.1% experienced new or worsened CHF. New or worsened CHF was reported in 0.4% of 225 patients with supraventricular arrhythmias. There have also been instances of second- (0.5%) or third-degree (0.4%) AV block. Patients have developed sinus bradycardia, sinus pause, or sinus arrest, about 1.2% altogether (see WARNINGS). The frequency of most of these serious adverse events probably increases with higher trough plasma levels, especially when these trough levels exceed 1.0μg/mL.

There have been rare reports of isolated elevations of serum alkaline phosphatase and isolated elevations of serum transaminase levels. These elevations have been asymptomatic and no cause and effect relationship with TAMBOCOR has been established. In foreign postmarketing surveillance studies, there have been rare reports of hepatic dysfunction including reports of cholestasis and hepatic failure, and extremely rare reports of blood dyscrasias. Although no cause and effect relationship has been established, it is advisable to discontinue TAMBOCOR in patients who develop unexplained jaundice or signs of hepatic dysfunction or blood dyscrasias in order to eliminate TAMBOCOR as the possible causative agent.