PROPAFENONE HYDROCHLORIDE- propafenone capsule, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

PROPAFENONE HYDROCHLORIDE (UNII: 33XCH0HOCD) (PROPAFENONE - UNII:68IQX3T69U)

Disponível em:

Mylan Pharmaceuticals Inc.

DCI (Denominação Comum Internacional):

PROPAFENONE HYDROCHLORIDE

Composição:

PROPAFENONE HYDROCHLORIDE 225 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: Propafenone hydrochloride extended-release capsules are contraindicated in the following circumstances: In the absence of studies in pregnant women, available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. Untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see Clinical Considerations). Propafenone and its metabolite, 5-OH-propafenone, cross the placenta in humans. In animal studies, propafenone was not teratogenic. At maternally toxic doses (ranging from 2 to 6 times the maximum recommended human dose [MRHD]

Resumo do produto:

Propafenone Hydrochloride Extended-Release Capsules, USP are available containing 225 mg, 325 mg or 425 mg of propafenone hydrochloride, USP. The 225 mg capsules are hard-shell gelatin capsules with a standard red opaque cap and white opaque body filled with white to off-white pellets. The capsules are axially printed with MYLAN over 1258 in black ink on the cap and body. They are available as follows: NDC 0378-1258-91 bottles of 60 capsules The 325 mg capsules are hard-shell gelatin capsules with a standard red opaque cap and pink opaque body filled with white to off-white pellets. The capsules are axially printed with MYLAN over 1259 in black ink on the cap and body. They are available as follows: NDC 0378-1259-91 bottles of 60 capsules The 425 mg capsules are hard-shell gelatin capsules with a standard red opaque cap and orange opaque body filled with white to off-white pellets. The capsules are axially printed with MYLAN over 1261 in black ink on the cap and body. They are available as follows: NDC 0378-1261-91 bottles of 60 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PROPAFENONE HYDROCHLORIDE- PROPAFENONE CAPSULE, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROPAFENONE HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PROPAFENONE
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.
PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: MORTALITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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INDICATIONS AND USAGE
Propafenone hydrochloride extended-release capsules are an
antiarrhythmic indicated to prolong the time to recurrence of
symptomatic atrial fibrillation (AF) in patients with episodic (most
likely paroxysmal or persistent) AF who do not have
structural heart disease. (1)
USAGE CONSIDERATIONS:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Capsules: 225 mg, 325 mg, 425 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
AN INCREASED RATE OF DEATH OR REVERSED CARDIAC ARREST RATE WAS SEEN IN
PATIENTS TREATED WITH ENCAINIDE
OR FLECAINIDE (CLASS IC ANTIARRHYTHMICS) COMPARED WITH THAT SEEN IN
PATIENTS ASSIGNED TO PLACEBO. AT
PRESENT, IT IS PRUDENT TO CONSIDER ANY IC ANTIARRHYTHMIC TO HAVE A
SIGNIFICANT RISK OF PROVOKING
PROARRHYTHMIC EVENTS IN PATIENTS WITH STRUCTURAL HEART DISEASE.
GIVEN THE LACK OF ANY EVIDENCE THAT THESE DRUGS IMPROVE SURVIVAL,
ANTIARRHYTHMIC AGENTS SHOULD
GENERALLY BE AVOIDED IN PATIENTS WITH NON-LIFE-THREATENING VENTRICULAR
ARRHYTHMIAS, EVEN IF THE
PATIENTS ARE EXPERIENCING UNPLEASANT, BUT NOT LIFE-THREATENING,
SYMPTOMS OR SIGNS.
Use in patients with permanent atrial fibrillation or with atrial
flutter or paroxysmal supraventricular tachycardia
(PSVT) has not been evaluated. Do not use to control ventricular rate
during atrial fibrillation. (1)
In patients with atrial fibrillation and atrial flutter, use
propafenone hydrochloride extended-release capsules with
drugs that