Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND)
VGYAAN Pharmaceuticals LLC
ORAL
PRESCRIPTION DRUG
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide Capsules are 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 Dofetilide Capsules 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 Capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide Capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation. Dofetilide Capsules are contraind
Dofetilide Capsules 125 mcg (0.125 mg) have a light orange opaque cap imprinted with "VP" in black ink and white opaque body imprinted with "125" in black ink. They are available as follows: NDC 72664- 229 -60 in bottles of 60 capsules. Dofetilide Capsules 250 mcg (0.25 mg) have a peach opaque cap imprinted with "VP" in black ink and peach opaque body imprinted with "250" in black ink. They are available as follows: NDC 72664- 230 -60 in bottles of 60 capsules. Dofetilide Capsules 500 mcg (0.5 mg) have a peach opaque cap imprinted with "VP" in black ink and white opaque body imprinted with "500" in black ink. They are available as follows: NDC 72664- 231 -60 in bottles of 60 capsules. Store at 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP). Distributed by: VGYAAN Pharmaceuticals LLC Skillman, NJ 08558 Rev.: 11/2020
Abbreviated New Drug Application
VGYAAN Pharmaceuticals LLC ---------- MEDICATION GUIDE DOFETILIDE (DOE FET' I 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 are Dofetilide Capsules? Dofetilide Capsules are a prescription medicine that is used to treat an irregular heartbeat (atrial fibrillation or atrial flutter). It is not known if Dofetilide Capsules are 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)* • hydrochlorothiazide alone or in combination with other medicines (such as ESIDRIX, EZIDE, HYDRODIURIL, HYDRO- Citiți documentul complet
DOFETILIDE- DOFETILIDE CAPSULE VGYAAN PHARMACEUTICALS LLC ---------- DOFETILIDE CAPSULES RX ONLY To minimize the risk of induced arrhythmia, patients initiated or re-initiated on Dofetilide Capsules 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 Capsules are 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 USP is a white to almost-white powder. It is soluble in 0.1 N sodium hydroxide, acetone, and 0.1 N hydrochloric acid, very slightly soluble in water and in isopropyl alcohol. Dofetilide Capsules contain the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate. Additionally, the empty hard gelatin capsule shell contains: FD&C Yellow No. 6, titanium dioxide, gelatin and water. Each capsule is imprinted with black pharmaceutical ink which contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Dofetilide Capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules. CLINICAL PHARMACOLOGY 19 27 3 5 2 MECHANISM OF ACTION Dofetilide shows Vaughan Williams Class III antiarrhythmic activity. The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, I . At concentrations covering several orders of magnitude, dofetilide blocks only I with no relevant bloc Citiți documentul complet