Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND)
Granules Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsule is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because doefetilide capsule can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter Dofetilide capsule is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsule has not been shown to be effective in patients with paroxysmal atrial fibrillation. Dofetilide is contraindicated i
Dofetilide capsules are supplied as: 125 mcg (0.125 mg): Hard gelatin capsule, orange opaque cap printed with "G125" and white opaque body printed with "024" contains white to off-white powder. Bottles of 60 Capsules NDC 70010-024-06 250 mcg (0.25 mg): Hard gelatin capsule, peach opaque cap printed with "G250" and peach opaque body printed with "025" contains white to off-white powder. Bottles of 60 Capsules NDC 70010-025-06 500 mcg (0.5 mg): Hard gelatin capsule, peach opaque cap printed with "G500" and white opaque body printed with "026" contains white to off-white powder. Bottles of 60 Capsules NDC 70010-026-06 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in a tight child-resistant container as defined in the USP. Rx only Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Rev. 09/2019
Abbreviated New Drug Application
DOFETILIDE 0.25MG- DOFETILIDE 0.25MG CAPSULE DOFETILIDE 0.5MG- DOFETILIDE 0.5MG CAPSULE Granules Pharmaceuticals Inc. ---------- SPL MEDGUIDE MEDICATION GUIDE Dofetilide (Do-fee-ti-lide) capsules Read the Medication Guide before you start taking dofetilide capsules and each time you get a refill. This information does not take the place of talking with your doctor about your condition or treatment. What is the most important information I should know about dofetilide capsules? Dofetilide capsules can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death. To establish the right dose of dofetilide capsules, treatment with dofetilide capsules must be started in a hospital where your heart rate and kidney function will be checked for the first 3 days of treatment. It is important that when you go home, you take the exact dose of dofetilide capsules that your doctor prescribed for you. While you take dofetilide capsules, always watch for signs of abnormal heartbeat. Call your doctor and go to the hospital right away if you: • feel faint • become dizzy, or • have a fast heartbeat What is dofetilide capsules? Dofetilide capsules is a prescription medicine that is used to treat an irregular heartbeat (atrial fibrillation or atrial flutter). It is not known if dofetilide capsules is safe and effective in children under 18 years of age. Who should not take dofetilide capsules? Do not take dofetilide capsules if you: • have an irregular heartbeat called long QT syndrome • have kidney problems or are on kidney dialysis • take any of these medicines: • cimetidine (TAGAMET, TAGAMET HB)* • verapamil (CALAN, CALAN SR, COVERA-HS, ISOPTIN, ISOPTIN SR, VERELAN, VERELAN PM, TARKA)* • ketoconazole (NIZORAL, XOLEGEL, EXTINA)* • trimethoprim alone (PROLOPRIM, TRIMPEX)* or the combination of trimethoprim and sulfamethoxazole (BACTRIM, SEPTRA SULFATRIM)* • prochlorperazine (COMPAZINE, COMPO)* • megestrol (MEGACE)* • dolutegravir (TIVICAY)* • hydro Przeczytaj cały dokument
DOFETILIDE 0.125MG- DOFETILIDE 0.125MG CAPSULE DOFETILIDE 0.25MG- DOFETILIDE 0.25MG CAPSULE DOFETILIDE 0.5MG- DOFETILIDE 0.5MG CAPSULE GRANULES PHARMACEUTICALS INC. ---------- DOFETILIDE CAPSULES 0.125MG,0.25MG,0.5MG RX ONLY To minimize the risk of induced arrhythmia, patients initiated or re-initiated on dofetilide should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION. DESCRIPTION Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C H N O S and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is: N-[4-[2-[methyl[2-[4- [(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2- ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, magnesium stearate, microcrystalline cellulose and titanium dioxide. The 125 mcg capsules contain FD & C Yellow # 6 and D & C yellow # 10. The 250 mcg and 500 mcg capsules contain FD & C Yellow # 6 and FD& C Red # 40. Dofetilide is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Dofetilide shows Vaughan Williams Class III antiarrhythmic activity. The mechanism of 19 27 3 5 2 action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, I . At Przeczytaj cały dokument