Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)
AvKARE, Inc.
AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE 400 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. - Recurrent ventricular fibrillation. - 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 HCl 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 e
Amiodarone HCl Tablets, 100 mg are round, flat, beveled edge, white tablets; one side plain, the second side engraved with "TARO" at the top and "55" below. Bottles of 90 Tablets NDC 42291-118-90 Amiodarone HCl Tablets, 200 mg are round, flat, beveled edge, light orange tablets; one side plain, the second side scored and engraved with "TARO" above the score and "56" below the score line. Amiodarone HCl Tablets, 300 mg are round, flat, beveled edge, peach tablets; one side plain, the second side scored and engraved with "TARO" above the score and "58" below the score line. Amiodarone HCl Tablets, 400 mg are round, flat, beveled edge, light yellow tablets; one side plain, the second side scored and engraved with "TARO" above the score and "59" below the score line and are available as follows: Bottles of 30 Tablets NDC 42291-139-30 Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a light-resistant, tight container.
Abbreviated New Drug Application
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET AvKARE, Inc. ---------- MEDICATION GUIDE AMIODARONE HYDROCHLORIDE (A-MEE-OH-DA-RONE HYE-DROE-KLOR-IDE) TABLETS What is the most important information I should know about amiodarone HCl tablets? Amiodarone HCl 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 HCl 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 HCl 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 HCl tablets can cause other serious side effects. See " What are the possible side effects of amiodarone HCl tablets?" If you get serious side effects during treatment you may need to stop amiodarone HCl tablets, have your dose changed, or get medical treatment. Talk with your doctor before you stop taking amiodarone HCl tablets. You may still have side effects after stopping amiodarone HCl tablets because the medicine stays in your body months after treatment is stopped. Tell all your healthcare providers that you take or took amiodarone HCl tablets. What are amiodarone HCl tablets? Amiodarone HCl is a prescription medicine used to treat life-thre Belgenin tamamını okuyun
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET AVKARE, INC. ---------- AMIODARONE HCL TABLETS RX ONLY DESCRIPTION Amiodarone HCl is a member of a class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams' classification) effects, available for oral administration as white, tablets containing 100 mg of amiodarone hydrochloride, light orange, scored tablets containing 200 mg of amiodarone hydrochloride, peach, scored tablets containing 300 mg of amiodarone hydrochloride, and light yellow, scored tablets containing 400 mg of amiodarone hydrochloride. The inactive ingredients present are colloidal silicon dioxide, corn starch, D&C yellow No. 10 lake (200 and 400 mg only), FD&C yellow No. 6 lake (200 and 300 mg only), lactose anhydrous, magnesium stearate and povidone. 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 HCl 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 HCl 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. a prolongation of the myocardial cell-action potential duration and refractory period and 2. non-competitive antagonism of α- and β-adrenoceptors. 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 refle Belgenin tamamını okuyun