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Amiodarone HCl
Overview
What is Amiodarone HCl?
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.
What does Amiodarone HCl look like?
What are the available doses of Amiodarone HCl?
Sorry No records found.
What should I talk to my health care provider before I take Amiodarone HCl?
Sorry No records found
How should I use Amiodarone HCl?
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 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.
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:
For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia:
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:
What interacts with Amiodarone HCl?
Sorry No Records found
What are the warnings of Amiodarone HCl?
Sorry No Records found
What are the precautions of Amiodarone HCl?
Sorry No Records found
What are the side effects of Amiodarone HCl?
Sorry No records found
What should I look out for while using Amiodarone HCl?
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.
What might happen if I take too much Amiodarone HCl?
There have been cases, some fatal, of amiodarone overdose.
In addition to general supportive measures, the patient's cardiac rhythm and blood pressure should be monitored, and if bradycardia ensues, a β-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 HCl in mice and rats is greater than 3,000 mg/kg.
How should I store and handle Amiodarone HCl?
Protect from light and moisture. [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Store the hospital unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Store the hospital unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Store the hospital unit-dose blister packages in the carton until contents have been used.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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00Amiodarone 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 42494-307-03Amiodarone 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 42494-308-06Amiodarone 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 42494-309-03 Keep tightly closed.Store at Controlled Room Temperature, 20to 25C (68to 77F) (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.cameronpharma.com.Distributed by: LOUISVILLE, KY 40245 USAManufactured by: LEXINGTON, KY 40509 USAIssued: October 2017P192-00
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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:
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 in a decreased sinus rate of 15 to 20%, increased PR and QT intervals of about 10%, the development of U-waves, and changes in T-wave contour. These changes should not require discontinuation of amiodarone as they are evidence of its pharmacological action, although amiodarone can cause marked sinus bradycardia or sinus arrest and heart block. On rare occasions, QT prolongation has been associated with worsening of arrhythmia (see
).
Non-Clinical Toxicology
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.
In view of the long and variable half-life of amiodarone, potential for drug interactions exists, not only with concomitant medication, but also with drugs administered after discontinuation of amiodarone.
Pharmacodynamic interactions
Drugs inducing TdP or prolonging QT
Co-administration of amiodarone with drugs known to prolong the QT interval (such as class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, IV pentamidine, and azole antifungals) increases the risk of Torsades de Points. Avoid concomitant use of drugs that prolong the QT interval.
Drugs lowering heart rate or causing automaticity or conduction disorders
Concomitant use of drugs with depressant effects on the sinus and AV node (e.g., digoxin, beta blockers, verapamil, diltiazem, ivabradine, clonidine) can potentiate the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate in patients on amiodarone and concomitant drugs that slow heart rate.
Effects of other medicinal products on amiodarone
Since amiodarone is a substrate for CYP3A and CYP2C8, drugs/substances that inhibit CYP3A (e.g., certain protease inhibitors, loratadine, cimetidine, trazodone) may decrease the metabolism and increase serum concentrations of amiodarone. Concomitant use of CYP3A inducers (rifampin, St. John’s Wort), may lead to decreased serum concentrations and loss of efficacy. Consider serial measurement of amiodarone serum concentration during concomitant use of drugs affecting CYP3A activity.
Grapefruit juice given to healthy volunteers increased amiodarone AUC by 50% and Cby 84%, and decreased DEA to unquantifiable concentrations. Grapefruit juice inhibits CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone; therefore, grapefruit juice should not be taken during treatment with oral amiodarone. This information should be considered when transitioning from intravenous to oral amiodarone Cholestyramine reduces enterohepatic circulation of amiodarone thereby increasing its elimination. This results in reduced amiodarone serum levels and half-life.
Effects of amiodarone on other medicinal products
Amiodarone inhibits P-glycoprotein and certain CYP450 enzymes, including CYP1A2, CYP2C9, CYP2D6, and CYP3A. This inhibition can result in unexpectedly high plasma levels of other drugs which are metabolized by those CYP450 enzymes or are substrates of P-glycoprotein. Reported examples of this interaction include the following:
Cyclosporine
Combination of amiodarone with other antiarrhythmic therapy should be reserved for patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent or incompletely responsive to amiodarone. During transition to amiodarone the dose levels of previously administered agents should be reduced by 30 to 50% several days after the addition of amiodarone, when arrhythmia suppression should be beginning. The continued need for the other antiarrhythmic agent should be reviewed after the effects of amiodarone have been established, and discontinuation ordinarily should be attempted. If the treatment is continued, these patients should be particularly carefully monitored for adverse effects, especially conduction disturbances and exacerbation of tachyarrhythmias, as amiodarone is continued. In amiodarone-treated patients who require additional antiarrhythmic therapy, the initial dose of such agents should be approximately half of the usual recommended dose.
Metabolism of lidocaine (CYP3A substrate) can be inhibited by amiodarone resulting in increased lidocaine concentrations. Sinus bradycardia and seizure has been reported in patients receiving concomitant lidocaine and amiodarone.
A potential interaction between and amiodarone resulting in ineffective inhibition of platelet aggregation has been reported.
Dabigatran etexilate when taken concomitantly with amiodarone may result in elevated serum concentration of dabigatran.
Fentanyl
Increased steady-state levels of phenytoin during concomitant therapy with amiodarone have been reported. Monitor phenytoin levels in patients taking both drugs.
Dextromethorphan is a substrate for both CYP2D6 and CYP3A. Amiodarone inhibits CYP2D6 and CYP3A. Chronic (>2 weeks) amiodarone treatment impairs metabolism of dextromethorphan leading to increased serum concentration.
Optic Neuropathy and/or NeuritisCases of optic neuropathy and optic neuritis have been reported (see ).
Corneal Microdeposits
Corneal microdeposits appear in the majority of adults treated with amiodarone. They are usually discernible only by slit-lamp examination, but give rise to symptoms such as visual halos or blurred vision in as many as 10% of patients. Corneal microdeposits are reversible upon reduction of dose or termination of treatment. Asymptomatic microdeposits alone are not a reason to reduce dose or discontinue treatment (see ).
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 ).
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).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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