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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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 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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  • Amiodarone hydrochloride is a member of a class of antiarrhythmic drugs with predominantly Class III (Vaughan Williamsu2019 classification) effects, available for oral administration as white to off-white, scored tablets containing 200 mg of amiodarone hydrochloride USP. The inactive ingredients present are colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate. Amiodarone hydrochloride is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5u00ad-diiodophenyl ketone hydrochloride.n The structural formula is as follows:
  • Amiodarone hydrochloride USP is a white or almost white, fine crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight.
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  • Because of its life-threatening side effects and the substantial management difficulties associated with its use (see 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.u00a0
  • 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.n Amiodarone hydrochloride tabletsu00a0should 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 hydrochloride tablets should be carried out in the hospital.
  • Amiodarone hydrochloride tablets are 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).n Amiodarone hydrochloride tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of its components, including iodine.
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  • Adverse reactions have been very common in virtually all series of patients treated with amiodarone hydrochloride 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 hydrochloride 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.n 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.n 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.n 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.n 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 hydrochloride occasionally results in a blue-gray pigmentation. This is slowly and occasionally incompletely reversible on discontinuation of drug but is of cosmetic importance only.n 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.n 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).n n Gastrointestinal: Nausea and vomiting.n n Dermatologic: Solar dermatitis/photosensitivity.n Neurologic: Malaise and fatigue, tremor/abnormal involuntary movements, lack of coordination, abnormal gait/ataxia, dizziness, paresthesias.n Gastrointestinal: Constipation, anorexia.n Ophthalmologic: Visual disturbances.n Hepatic: Abnormal liver-function tests.n Respiratory: Pulmonary inflammation or fibrosis.n n Thyroid: Hypothyroidism, hyperthyroidism.n Neurologic: Decreased libido, insomnia, headache, sleep disturbances.n Cardiovascular: Congestive heart failure, cardiac arrhythmias, SA node dysfunction.n Gastrointestinal: Abdominal pain.n Hepatic: Nonspecific hepatic disorders.n Other: Flushing, abnormal taste and smell, edema, abnormal salivation, coagulation abnormalities.n n n Blue skin discoloration, rash, spontaneous ecchymosis, alopecia, hypotension, and cardiac conduction abnormalities.n In surveys of almost 5,000 patients treated in open U.S. studies and in published reports of treatment with amiodarone hydrochloride, the adverse reactions most frequently requiring discontinuation of amiodarone hydrochloride included pulmonary infiltrates or fibrosis, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes. Other symptoms causing discontinuations less often included visual disturbances, solar dermatitis, blue skin discoloration, hyperthyroidism, and hypothyroidism.
  • In postmarketing surveillance, serious symptomatic bradycardia has been reported in patients taking amiodarone who initiate treatment with ledipasvir/sofosbuvir or with sofosbuvir with simeprevir, hypotension (sometimes fatal), sinus arrest, anaphylactic/anaphylactoid reaction (including shock), angioedema, urticaria, eosinophilic pneumonia, hepatitis, cholestatic hepatitis, cirrhosis, pancreatitis, acute pancreatitis, renal impairment, renal insufficiency, acute renal failure, acute respiratory distress syndrome in the post-operative setting, u00a0bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest, and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), fever, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates and/or mass, pulmonary alveolar hemorrhage, pleural effusion, pleuritis, pseudotumor cerebri, parkinsonian symptoms such as akinesia and bradykinesia (sometimes reversible with discontinuation of therapy), syndrome of inappropriate antidiuretic hormone secretion (SIADH), thyroid nodules/thyroid cancer, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, bullous dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS), eczema, skin cancer, vasculitis, pruritus, hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma, myopathy, muscle weakness, rhabdomyolysis, demyelinating polyneuropathy, hallucination, confusional state, disorientation, delirium, epididymitis, impotence, dry mouth,u00a0 and lupus-like syndrome, also have been reported with amiodarone therapy.
  • There have been cases, some fatal, of amiodarone hydrochloride overdose.n 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 hydrochloride nor its metabolite is dialyzable.n 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 HYDROCHLORIDE 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 HYDROCHLORIDE u00a0THERAPY, AND WHO HAVE ACCESS TO LABORATORY FACILITIES CAPABLE OF ADEQUATELY MONITORING THE EFFECTIVENESS AND SIDE EFFECTS OF TREATMENT.n 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 hydrochloride has not been determined. Because of the food effect on absorption, amiodarone hydrochloride 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 hydrochloride 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. n 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 ).n Upon starting amiodarone hydrochloride 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 hydrochloride 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 hydrochloride 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 ).n n n 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 hydrochloride and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:u00a0u00a0
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  • Amiodarone Hydrochloride Tabletsn n- Arrayn- Arrayn- Array
  • 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.n n- u201cWhat are the possible side effects of amiodarone hydrochloride tablets?u201dn- Arrayn- Arrayn- Arrayn- Array
  • What should I tell my doctor before taking amiodarone hydrochloride tabletsn n- Array
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.n n
  • 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.n These are not all the possible side effects of amiodarone hydrochloride tablets. For more information, ask your doctor or pharmacist.n Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n n
  • Keep amiodarone hydrochloride tablets and all medicines out of the reach of children.n n- Arrayn- Arrayn- Arrayn- Arrayn- Dispense with Medication Guide available at: n- Arrayn- Aurobindo Pharma USA, Inc.n n- Aurobindo Pharma Limitedn
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