Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)
NCS HealthCare of KY, Inc dba Vangard Labs
AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE 200 mg
ORAL
PRESCRIPTION DRUG
Because of its life-threatening side effects and the substantial management difficulties associated with its use (see WARNINGS below), amiodarone hydrochloride tablets are indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. 1. Recurrent ventricular fibrillation. 2. Recurrent hemodynamically unstable ventricular tachycardia. As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hydrochloride tablets favorably affects survival. Amiodarone hydrochloride tablets should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambul
Amiodarone Hydrochloride Tablets, for oral administration are available as 200 mg Round, flat-faced, beveled edge, yellow tablets debossed “ E” over bisect, “144” below bisect, plain on the reverse side and supplied as: NDC 0615-4545-39 Blistercards of 30 NDC 0615-4545-05 Blistercards of 15 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, with a child-resistant closure as required. Protect from light. KEEP TIGHTLY CLOSED. This product’s label may have been updated. For current full prescribing information, please visit www.us.sandoz.com or call our customer service department toll-free at 1-800-525-8747. Distributed by Sandoz Inc. Princeton, NJ 08540 46061724 Rev. June 2016 MF0144REV06/16
Abbreviated New Drug Application
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET NCS HealthCare of KY, Inc dba Vangard Labs ---------- MEDICATION GUIDE Amiodarone Hydrochloride Tablets (am-ee-OH-dah-rohn) Read the Medication Guide that comes with Amiodarone Hydrochloride Tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about Amiodarone Hydrochloride Tablets? Amiodarone Hydrochloride Tablets can cause serious side effects that can lead to death including: • lung damage • liver damage • worse heartbeat problems • thyroid problems Call your doctor or get medical help right away if you have any of the following symptoms during treatment with amiodarone hydrochloride tablets: • shortness of breath, wheezing, or any other trouble breathing; coughing, chest pain or spitting up of blood • nausea or vomiting, brown or dark-colored urine, feel more tired than usual, yellowing of your skin or the whites of your eyes (jaundice), or right upper stomach pain • heart pounding, skipping a beat, beating fast or very slowly, feel light-headed or faint • weakness, weight loss or weight gain, heat or cold intolerance, hair thinning, sweating, changes in your menses, swelling of your neck (goiter), nervousness, irritability, restlessness, decreased concentration, depression in the elderly, or tremor. Amiodarone Hydrochloride Tablets should only be used in people with life-threatening heartbeat problems called ventricular arrhythmias, for which other treatments did not work or were not tolerated. Amiodarone Hydrochloride Tablets can cause other serious side effects. See “What are the possible side effects of Amiodarone Hydrochloride Tablets?” If you get serious side effects during treatment you may need to stop Amiodarone Hydrochloride Tablets, have your dose changed, or get medical treatment. Talk with your doctor b Přečtěte si celý dokument
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- AMIODARONE HYDROCHLORIDE TABLETS RX ONLY DESCRIPTION Amiodarone hydrochloride tablets are a member of a new class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams’ classification) effects, available for oral administration as yellow, scored tablets. Each tablet for oral administration contains 200 mg of amiodarone hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone, and D&C yellow No. 10 aluminum lake. Amiodarone hydrochloride tablets are a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows: C H I NO • HCl Molecular Weight: 681.8 Amiodarone hydrochloride is a white to cream-colored crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. CLINICAL PHARMACOLOGY ELECTROPHYSIOLOGY/MECHANISMS OF ACTION In animals, amiodarone hydrochloride is effective in the prevention or suppression of experimentally induced arrhythmias. The antiarrhythmic effect of amiodarone hydrochloride may be due to at least two major properties: 1. a prolongation of the myocardial cell-action potential duration and refractory period and 2. non-competitive antagonism of α- and β-adrenoceptors. Amiodarone hydrochloride prolongs the duration of the action potential of all cardiac fibers while causing minimal reduction of dV/dt (maximal upstroke velocity of the action potential). The refractory period is prolonged in all cardiac tissues. Amiodarone hydrochloride increases the cardiac refractory period without influencing resting membrane potential, except in automatic cells where the slope of the prepotential is reduced, generally reducing automaticity. These electrophysiologic effects are reflected in a decr Přečtěte si celý dokument