Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)
Mayne Pharma Inc.
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. - 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 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 electrophysio
Amiodarone HCl Tablets, 100 mg, are yellow colored, round, flat faced beveled edge tablets with debossings of “AS” on one side and “100” on the other side. Bottles of 30 tablets NDC 51862-154-30 Amiodarone HCl Tablets, 200 mg, are yellow colored, round, flat beveled edge tablets with “AS” and “200” debossed on either side of the break line on one side and plain on the other side. Bottles of 60 tablets NDC 51862-155-60 Amiodarone HCl Tablets, 400 mg, are yellow colored, oval, biconvex tablets with “AS” and “400” debossed on either side of the break line on one side and plain on the other side. Bottles of 30 tablets NDC 51862-156-30 Keep tightly closed. Store at Controlled Room Temperature, 20 ° to 25 °C (68 ° to 77 °F) (see USP Controlled Room Temperature). Protect from light and moisture. Dispense in a light-resistant, tight container with a child-resistant closure. This product’s label may have been revised after this copy was produced. For more information about the current full prescribing information, please visit www.maynepharma.com. Distributed by: MAYNE PHARMA GREENVILLE, NC 27834 Manufactured by: MURTY PHARMACEUTICALS, INC. LEXINGTON, KY 40509 Issued: October 2017 P069- 08
Abbreviated New Drug Application
AMIODARONE HCL- AMIODARONE HYDROCHLORIDE TABLET Mayne Pharma Inc. ---------- MEDICATION GUIDE Amiodarone HCl Tablets a MEE oh da rone hye droe KLOR ide Tablets Rx only Read the Medication Guide that comes with Amiodarone HCl 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 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 stoppi Izlasiet visu dokumentu
AMIODARONE HCL- AMIODARONE HYDROCHLORIDE TABLET MAYNE PHARMA INC. ---------- AMIODARONE AMIODARONE HCL TABLETS RX ONLY DESCRIPTION Amiodarone is a member of a class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams' classification) effects, available for oral administration, as yellow, round, flat faced beveled edge tablets containing 100 mg of amiodarone hydrochloride, and yellow, round, flat beveled edge, scored tablets containing 200 mg of amiodarone hydrochloride, and yellow, oval, biconvex, scored tablets containing 400 mg of amiodarone hydrochloride. The inactive ingredients present in 100 mg, 200 mg, and 400 mg tablets are: lactose monohydrate, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate, and Pigment D&C Yellow 10 Aluminum Lake. 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 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 reflected Izlasiet visu dokumentu