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Amiodarone Hydrochloride (Amiodarone Hydrochloride)

Trade Name : Amiodarone Hydrochloride

Eon Labs, Inc.

TABLET

Strength 200 mg/1

AMIODARONE HYDROCHLORIDE Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amiodarone Hydrochloride (Amiodarone Hydrochloride) which is also known as Amiodarone Hydrochloride and Manufactured by Eon Labs, Inc.. It is available in strength of 200 mg/1 per ml. Read more

Amiodarone Hydrochloride (Amiodarone Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Amiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity n
  • Amiodarone hydrochloride can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the timen- Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when amiodarone therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months n
  • Amiodarone hydrochloride can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue amiodarone hydrochloride if the patient experiences signs or symptoms of clinical liver injury n
  • Amiodarone hydrochloride can exacerbate arrhythmias. Initiate amiodarone hydrochloride in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available n
  • WARNING: PULMONARY, HEPATIC, and CARDIAC TOXICITY
  • See full prescribing information for complete boxed warning.
  • Reserve amiodarone hydrochloride for patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity, some also life-threatening. Utilize alternative agents first. ()
  • Amiodarone hydrochlorideu2019s life-threatening toxicities include pulmonary (), hepatic (), and proarrhythmic ().
  • Initiate under hospital or specialist supervision. ()
  • Amiodarone hydrochloride is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.
  • Amiodarone hydrochloride is an antiarrhythmic indicated for:
  • Dosage must be individualized based on severity of arrhythmia and response. Use the lowest effective dose. Obtain baseline chest x-ray, pulmonary function tests, thyroid function tests, and liver aminotransferases. Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating treatment
  • Recommended Dosage
  • Initiate treatment with a loading doses of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce amiodarone hydrochloride dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day.
  • Administration
  • Administer amiodarone hydrochloride consistently with regard to meals . Administration of amiodarone hydrochloride in divided doses with meals is suggested for total daily doses of 1000 mg or higher, or when gastrointestinal intolerance occurs.
  • Initiate treatment with a loading doses of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce amiodarone hydrochloride dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. ()
  • 200 mg tablets: round, flat-faced, beveled edge, yellow tablets debossed over bisect, u201c below bisect, plain on the reverse side
  • Tablets, 200 mg. ()
  • Amiodarone hydrochloride is contraindicated in patients with ():
  • No data
  • The following serious adverse reactions are described in more detail in other sections of the prescribing information:
  • To report SUSPECTED ADVERSE REACTIONS, contact
  • Sandoz, Inc. at 1-800-525-8747
  • or FDA at 1-800-FDA-1088 or n
  • u2022
  • 6
  • Because of amiodaroneu2019s long half-life, expect drug interactions to persist for weeks to months after discontinuation of amiodarone.
  • Drug interactions with amiodarone are described in below.
  • No data
  • There have been cases, some fatal, of amiodarone hydrochloride overdose.
  • Monitor the patientu2019s cardiac rhythm and blood pressure, and, if bradycardia ensues, a u03b2-adrenergic agonist or a pacemaker may be used. Treat hypotension with inadequate tissue perfusion with positive inotropic and vasopressor agents. Neither amiodarone hydrochloride nor its metabolite is dialyzable.
  • Amiodarone hydrochloride tablets are an antiarrhythmic drug, available for oral administration as yellow, scored tablets containing 200 mg of amiodarone hydrochloride. The inactive ingredients present are 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:
  • CHINO u2022 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.
  • No data
  • Amiodarone hydrochloride was associated with a statistically significant, dose-related increase in the incidence of thyroid tumors (follicular adenoma and/or carcinoma) in rats. The incidence of thyroid tumors was greater than control even at the lowest dose level tested, i.e., 5 mg/kg/day (approximately 0.08 times the maximum recommended human maintenance dose*).
  • Mutagenicity studies (Ames, micronucleus, and lysogenic tests) with amiodarone hydrochloride were negative.
  • In a study in which amiodarone hydrochloride was administered to male and female rats, beginning 9 weeks prior to mating, reduced fertility was observed at a dose level of 90 mg/kg/day (approximately 1.4 times the maximum recommended human maintenance dose*).
  • *600 mg in a 60 kg patient (dose compared on a body surface area basis)
  • Amiodarone hydrochloride tablets, for oral administration, are available as
  • Arrayn- 200 mg
  • Round, flat-faced, beveled edge, yellow tablets debossed over bisect, u201c below bisect, plain on the reverse side and supplied as:
  • NDC 0185-0144-60 bottles of 60
  • NDC 0185-0144-09 bottles of 90
  • NDC 0185-0144-01 bottles of 100
  • NDC 0185-0144-05 bottles of 500
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required.
  • Protect from light.
  • KEEP TIGHTLY CLOSED.
  • KEEP OUT OF THE REACH OF CHILDREN.
  • This productu2019s 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.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy n
  • Advise women that breastfeeding is not recommended during treatment with amiodarone hydrochloride n
  • Advise patients to avoid grapefruit juice and St. John's Wort.
  • Advise patients to seek medical attention if they experience the signs and symptoms of pulmonary toxicity, worsening arrhythmia, bradycardia, visual impairment, or hypo- and hyperthyroidism.
  • Distributed by
  • Sandoz Inc.
  • Princeton, NJ 08540
  • 46193212
  • Rev. November 2018
  • MF0144REV11/18
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • NDC
  • Amiodarone Hydrochloride Tablets
  • 200 mg
  • PHARMACIST:
  • Rx only
  • 60 Tablets
  • Sandoz

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