Amiodarone Hydrochloride (Amiodarone Hydrochloride)

Trade Name : Amiodarone hydrochloride

NCS HealthCare of KY, Inc dba Vangard Labs

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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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 NCS HealthCare of KY, Inc dba Vangard Labs. 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 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.
  • No data
  • Because of its life-threatening side effects and the substantial management difficulties associated with its use (see 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 arrhythmias treated, potential interactions with prior therapy, and potential exacerbation of the arrhythmia, initiation of therapy with amiodarone should be carried out in the hospital.
  • Amiodarone is contraindicated in patients with cardiogenic shock; severe sinus-node dysfunction, causing marked sinus bradycardia; second- or third-degree atrioventricular block; and when episodes of bradycardia have caused syncope (except when used in conjunction with a pacemaker).
  • Amiodarone is contraindicated in patients with a known hypersensitivity to the drug or to any of its components, including iodine.
  • No data
  • No data
  • Adverse reactions have been very common in virtually all series of patients treated with amiodarone for ventricular arrhythmias with relatively large doses of drug (400 mg/day and above), occurring in about three-fourths of all patients and causing discontinuation in 7 to 18%. The most serious reactions are pulmonary toxicity, exacerbation of arrhythmia, and rare serious liver injury (see but other adverse effects constitute important problems. They are often reversible with dose reduction or cessation of amiodarone treatment. Most of the adverse effects appear to become more frequent with continued treatment beyond six months, although rates appear to remain relatively constant beyond one year. The time and dose relationships of adverse effects are under continued study.
  • Neurologic problems are extremely common, occurring in 20 to 40% of patients and including malaise and fatigue, tremor and involuntary movements, poor coordination and gait, and peripheral neuropathy; they are rarely a reason to stop therapy and may respond to dose reductions or discontinuation (see There have been spontaneous reports of demyelinating polyneuropathy.
  • Gastrointestinal complaints, most commonly nausea, vomiting, constipation, and anorexia, occur in about 25% of patients but rarely require discontinuation of drug. These commonly occur during high-dose administration (i.e., loading dose) and usually respond to dose reduction or divided doses.
  • Ophthalmic abnormalities including optic neuropathy and/or optic neuritis, in some cases progressing to permanent blindness, papilledema, corneal degeneration, photosensitivity, eye discomfort, scotoma, lens opacities, and macular degeneration have been reported (see n
  • Asymptomatic corneal microdeposits are present in virtually all adult patients who have been on drug for more than 6 months. Some patients develop eye symptoms of halos, photophobia, and dry eyes. Vision is rarely affected and drug discontinuation is rarely needed.
  • Dermatological adverse reactions occur in about 15% of patients, with photosensitivity being most common (about 10%). Sunscreen and protection from sun exposure may be helpful, and drug discontinuation is not usually necessary. Prolonged exposure to amiodarone occasionally results in a blue-gray pigmentation. This is slowly and occasionally incompletely reversible on discontinuation of drug but is of cosmetic importance only.
  • Cardiovascular adverse reactions, other than exacerbation of the arrhythmias, include the uncommon occurrence of congestive heart failure (3%) and bradycardia. Bradycardia usually responds to dosage reduction but may require a pacemaker for control. CHF rarely requires drug discontinuation. Cardiac conduction abnormalities occur infrequently and are reversible on discontinuation of drug.
  • The following side-effect rates are based on a retrospective study of 241 patients treated for 2 to 1,515 days (mean 441.3 days).
  • There have been cases, some fatal, of amiodarone overdose.
  • In addition to general supportive measures, the patientu2019s cardiac rhythm and blood pressure should be monitored, and if bradycardia ensues, a u03b2-adrenergic agonist or a pacemaker may be used. Hypotension with inadequate tissue perfusion should be treated with positive inotropic and/or vasopressor agents. Neither amiodarone nor its metabolite is dialyzable.
  • The acute oral LD of amiodarone hydrochloride in mice and rats is greater than 3,000 mg/kg.
  • BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE SHOULD BE ADMINISTERED ONLY BY PHYSICIANS WHO ARE EXPERIENCED IN THE TREATMENT OF LIFE-THREATENING ARRHYTHMIAS WHO ARE THOROUGHLY FAMILIAR WITH THE RISKS AND BENEFITS OF AMIODARONE THERAPY, AND WHO HAVE ACCESS TO LABORATORY FACILITIES CAPABLE OF ADEQUATELY MONITORING THE EFFECTIVENESS AND SIDE EFFECTS OF TREATMENT.
  • In order to insure that an antiarrhythmic effect will be observed without waiting several months, loading doses are required. A uniform, optimal dosage schedule for administration of amiodarone has not been determined. Because of the food effect on absorption, amiodarone should be administered consistently with regard to meals (see Individual patient titration is suggested according to the following guidelines:
  • Close monitoring of the patients is indicated during the loading phase, particularly until risk of recurrent ventricular tachycardia or fibrillation has abated. Because of the serious nature of the arrhythmia and the lack of predictable time course of effect, loading should be performed in a hospital setting. Loading doses of 800 to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs.) If side effects become excessive, the dose should be reduced. Elimination of recurrence of ventricular fibrillation and tachycardia usually occurs within 1 to 3 weeks, along with reduction in complex and total ventricular ectopic beats.
  • Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone (see ).
  • Upon starting amiodarone therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on ). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see ). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone may be administered as a single daily dose, or in patients with severe gastrointestinal intolerance, as a b.i.d. dose. In each patient, the chronic maintenance dose should be determined according to antiarrhythmic effect as assessed by symptoms, Holter recordings, and/or programmed electrical stimulation and by patient tolerance. Plasma concentrations may be helpful in evaluating nonresponsiveness or unexpectedly severe toxicity (see ).
  • The lowest effective dose should be used to prevent the occurrence of side effects. In all instances, the physician must be guided by the severity of the individual patient's arrhythmia and response to therapy.
  • When dosage adjustments are necessary, the patient should be closely monitored for an extended period of time because of the long and variable half-life of amiodarone and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:
  • 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 0615-8213-39u00a0in blistercards of 30 tablets
  • NDCu00a00615-8213-05 in blistercards ofu00a015 tablets
  • Storage:
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from lightn
  • Dispense in a tight, light-resistant container.
  • Manufactured by:
  • Cadila Healthcare Ltd.
  • India
  • Distributed by:
  • Zydus Pharmaceuticals (USA) Inc.
  • Pennington, NJ 08534
  • Rev.: 06/17
  • Medication Guide
  • Amiodarone Hydrochloride
  • (n- 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:
  • Call your doctor or get medical help right away if you have any of the following symptoms during treatment with amiodarone hydrochloride tablets:
  • 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 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 n- ablets 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 Tablets?
  • Amiodarone is a prescription medicine used to treat life-threatening heartbeat problems called ventricular arrhythmias, for which other treatment did not work or was not tolerated. Amiodarone hydrochloride tablets have not been shown to help people with lifethreatening heartbeat problems live longer. Amiodarone hydrochloride tablets should be started in a hospital to monitor your condition. You should have regular check-ups, blood tests, chest x-rays, and eye exams before and during treatment with amiodarone hydrochloride tablets to check for serious side effects.
  • It is not known if amiodarone hydrochloride tablets are safe and effective in children.
  • Who should not take Amiodarone Hydrochloride Tablets?
  • Do not take amiodarone hydrochloride n- ablets if you:
  • What should I tell my doctor before taking Amiodarone Hydrochloride Tablets Before you take Amiodarone Hydrochloride Tablets tell your doctor about all of your medical conditions including if you:
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I take Amiodarone Hydrochloride Tablets?
  • What should I avoid while taking Amiodarone Hydrochloride Tablets?
  • Avoid sunlight.
  • What are the possible side effects of Amiodarone Hydrochloride Tablets?
  • See n
  • The most common side effects of amiodarone hydrochloride tablets include:
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of Amiodarone hydrochloride tablets. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Amiodarone Hydrochloride Tablets?
  • General information about Amiodarone Hydrochloride Tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use amiodarone hydrochloride tablets for a condition for which it was not prescribed. Do not give amiodarone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them.
  • If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about amiodarone hydrochloride tablets that was written for healthcare professionals.
  • Please address medical inquiries to, ([email protected]) Tel.: 1-877-993-8779.
  • What are the ingredients in Amiodarone Hydrochloride Tablets?
  • Active Ingredient:
  • Inactive Ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • This product's package insert may have been updated. For current package insert, please visit www.zydususa.com.
  • Manufactured by:
  • Cadila Healthcare Ltd.
  • India
  • Distributed by:
  • Zydus Pharmaceuticals (USA) Inc.
  • Pennington, NJ 08534
  • Rev.: 06/17
  • No data

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