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 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. 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
Amiodarone hydrochloride tablets 200 mg are available as follows: Each round, pink tablet is scored and debossed with “93” and “9133” on one side, and plain and unscored on the other side available overbagged with 10 tablets per bag, NDC 55154-5492-0. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. This product’s label may have been updated. For current full prescribing information, please call 1-888-838-2872. Repackaged By: Cardinal Health Zanesville, OH 43701
Abbreviated New Drug Application
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET Cardinal Health ---------- MEDICATION GUIDE AMIODARONE HYDROCHLORIDE (A-mee-OH-da-rone HYE-droe-KLOR-ide) TABLETS Rx only 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 symptoms such as the following: • shortness of breath, wheezing, or any other trouble breathing; coughing, chest pain, or spitting up of blood • nausea or vomiting; passing brown or dark-colored urine; feel more tired than usual; your skin and whites of your eyes get yellow; or have stomach pain • heart pounding, skipping a beat, beating very 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. Because of these possible side effects, amiodarone hydrochloride tablets should only be used in adults 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 or reasonably likely side effects of amiodarone hydrochloride tablets?” for more information. If you get serious side effects during treatment with amiodarone hydrochloride tablets you may need to stop amiodarone hydrochloride tablets, have your dos Lesen Sie das vollständige Dokument
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET CARDINAL HEALTH ---------- AMIODARONE HYDROCHLORIDE TABLETS RX ONLY DESCRIPTION Amiodarone hydrochloride is a member of a class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams’ classification) effects, available for oral administration as pink, scored tablets containing 200 mg of amiodarone hydrochloride. The inactive ingredients present are: colloidal silicon dioxide, corn starch, FD&C Red 40, lactose monohydrate, magnesium stearate, and povidone. Amiodarone hydrochloride is 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 M.W. 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 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: • • 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 sinus bradycardia or sinus arrest and heart block. On rare occasi Lesen Sie das vollständige Dokument