Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)
Cardinal Health
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 is 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. 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 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 ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhy
Amiodarone Hydrochloride Tablets, 200 mg are white to off-white, round-shaped, flat beveled-edge, uncoated tablets with bisect on one side and other side is plain; one side of bisect is debossed with 'ZE' and other side is debossed with '65' and are supplied as follows: NDC 55154-4996-0 Overbagged with 10 tablets per bag. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
Cardinal Health ---------- MEDICATION GUIDE 8237101/1217 Medication Guide Amiodarone Hydrochloride (A-mi-OH-da-rone HYE-droe-KLOR-ide) Tablets Rx only 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 problems • liver problems • worsening 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 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 before you stop taking amiodarone. You may still have side effects after stopping amiodarone hydrochloride tablets because the medicine stays in your body months after treatment is stopped. Tell all your healthcare providers that you take or took amiodarone hydrochloride tablets. What are Amiodarone Hydrochloride Tablet Lesen Sie das vollständige Dokument
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET CARDINAL HEALTH ---------- AMIODARONE HYDROCHLORIDE TABLETS 8237101/1217 RX ONLY DESCRIPTION Amiodarone hydrochloride is a member of a class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams' classification) effects. Amiodarone is a benzofuran derivative: 2-butyl-3- benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows: Amiodarone hydrochloride, USP 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. Each amiodarone hydrochloride tablet intended 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 sodium starch glycolate. CLINICAL PHARMACOLOGY ELECTROPHYSIOLOGY/MECHANISMS OF ACTION: In animals, amiodarone is effective in the prevention or suppression of experimentally induced arrhythmias. The antiarrhythmic effect of amiodarone may be due to at least two major properties: 1. 2. Amiodarone 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 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 decreased sinus rate of 15 to 20%, increased PR and QT intervals of about 10%, the development of U- waves, and changes in T-wave contour. These changes should not require discontinuation of amiodarone as they are evidence of its pharmacological action, although amiodarone can cause marked a prolongation of the myocardial cell-a Lesen Sie das vollständige Dokument