Amiodarone Hydrochloride

Amiodarone Hydrochloride Manufacturers

• Remedyrepack Inc.
  

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  Amiodarone Hydrochloride | Remedyrepack Inc.

  

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  BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS 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 TABLET 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 hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: 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 mg/day to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone hydrochloride tablets 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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablets dose should be reduced to 600 mg/day to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets 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 CLINICAL PHARMACOLOGY).

  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 hydrochloride tablets and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:

  Loading Dose (Daily)

  Adjustment and Maintenance Dose (Daily)

  Ventricular Arrhythmias

  1 to 3 weeks

  ~1 month

  usual maintenance

  800 mg to 1,600 mg

  600 mg to 800 mg

  400 mg

   

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• Cardinal Health
  

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  Amiodarone Hydrochloride | Medline Industries, Inc

  

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  • Cleanse skin with Remedy Cleansing Body Lotion or Foaming Body Cleanser • Apply Clear-Aid liberally to affected area as needed

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• State Of Florida Doh Central Pharmacy
  

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  Amiodarone Hydrochloride | State Of Florida Doh Central Pharmacy

  

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  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 CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia:

  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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on Drug Interactions). 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 CLINICAL PHARMACOLOGY Monitoring Effectiveness). 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 CLINICAL PHARMACOLOGY).

  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:

  
  Loading Dose (Daily)
  Adjustment and Maintenance Dose (Daily)
  
  Ventricular Arrhythmias 
  1 to 3 weeks 
  ~1 month 
  usual maintenance
  
  800 to 1,600 mg 
  600 to 800 mg 
  400 mg
  

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• Apotex Inc.
  

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  Amiodarone Hydrochloride | Apotex Inc.

  

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  Amiodarone shows considerable interindividual variation in response. Thus, although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose as needed is essential. The recommended starting dose of intravenous amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  After the first 24 hours, the maintenance infusion rate of 0.5 mg/min (720 mg/24 hours) should be continued utilizing a concentration of 1 to 6 mg/mL (amiodarone HCl injection concentrations greater than 2 mg/mL should be administered via a central venous catheter). In the event of breakthrough episodes of VF or hemodynamically unstable VT, 150 mg supplemental infusions of amiodarone HCl injection mixed in 100 mL of D5W may be administered. Such infusions should be administered over 10 minutes to minimize the potential for hypotension. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. The initial infusion rate should not exceed 30 mg/min.

  Based on the experience from clinical studies of amiodarone injection, a maintenance infusion of up to 0.5 mg/min can be cautiously continued for 2 to 3 weeks regardless of the patient’s age, renal function, or left ventricular function. There has been limited experience in patients receiving amiodarone injection for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone injection must be delivered by a volumetric infusion pump.

  Amiodarone injection should, whenever possible, be administered through a central venous catheter dedicated to that purpose. An in-line filter should be used during administration.

  Amiodarone injection loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death (see PRECAUTIONS, Liver Enzymes Elevations).

  Amiodarone HCl injection concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, amiodarone HCl injection concentrations should not exceed 2 mg/mL unless a central venous catheter is used (See ADVERSE REACTIONS Postmarketing Reports).

  Amiodarone HCl injection infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Use of evacuated glass containers for admixing amiodarone HCl injection is not recommended as incompatibility with a buffer in the container may cause precipitation.

  It is well known that amiodarone adsorbs to polyvinyl chloride (PVC) tubing and the clinical trial dose administration schedule was designed to account for this adsorption. All of the clinical trials were conducted using PVC tubing and its use is therefore recommended. The concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect doses identified in these studies. Intravenous amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl) phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing intravenous amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. In addition, polysorbate 80, a component of intravenous amiodarone, is also known to leach DEHP from PVC (see DESCRIPTION). Therefore, it is important that the recommendations in DOSAGE AND ADMINISTRATION be followed closely.

  Intravenous amiodarone does not need to be protected from light during administration.

  Admixture Incompatibility
  Amiodarone HCI injection in D5W is incompatible with the drugs shown below.

  
  
  Intravenous to Oral Transition
  Patients whose arrhythmias have been suppressed by intravenous amiodarone may be switched to oral amiodarone. The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of intravenous amiodarone already administered, as well as the bioavailability of oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients.

  Since there are some differences between the safety and efficacy profiles of the intravenous and oral formulations, the prescriber is advised to review the package insert for oral amiodarone when switching from intravenous to oral amiodarone therapy.

  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 PRECAUTIONS, Drug Interactions).

  The following table provides suggested doses of oral amiodarone to be initiated after varying durations of intravenous amiodarone administration. These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

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• Wockhardt Usa Llc.
  

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  Amiodarone Hydrochloride | Wockhardt Usa Llc.

  

  ---

  Amiodarone shows considerable interindividual variation in response. Thus, although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose as needed is essential. The recommended starting dose of amiodarone injection is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  AMIODARONE INJECTION DOSE RECOMMENDATIONS-FIRST 24 HOURS-

  Loading infusions

                            First Rapid:

  150 mg over the FIRST 10 minutes (15 mg/min).

  Add 3 mL of amiodarone I.V. (150 mg) to 100 mL D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.

             Followed by Slow:

  360 mg over the NEXT 6 hours (1 mg/min).

  Add 18 mL of amiodarone I.V. (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL).

  Maintenance infusion

  540 mg over the REMAINING 18 hours (0.5 mg/min).

  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  After the first 24 hours, the maintenance infusion rate of 0.5 mg/min (720 mg/24 hours) should be continued utilizing a concentration of 1 to 6 mg/mL (amiodarone injection concentrations greater than 2 mg/mL should be administered via a central venous catheter). In the event of breakthrough episodes of VF or hemodynamically unstable VT, 150 mg supplemental infusions of amiodarone injection mixed in 100 mL of D5W may be administered. Such infusions should be administered over 10 minutes to minimize the potential for hypotension. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. The initial infusion rate should not exceed 30 mg/min.

  Based on the experience from clinical studies of amiodarone injection, a maintenance infusion of up to 0.5 mg/min can be cautiously continued for 2 to 3 weeks regardless of the patient’s age, renal function, or left ventricular function. There has been limited experience in patients receiving amiodarone injection for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone injection must be delivered by a volumetric infusion pump.

  Amiodarone injection should, whenever possible, be administered through a central venous catheter dedicated to that purpose. An in-line filter should be used during administration.

  Amiodarone injection loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death (see PRECAUTIONS, Liver Enzyme Elevations).

  Amiodarone injection concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, amiodarone injection concentrations should not exceed 2 mg/mL unless a central venous catheter is used (see ADVERSE REACTIONS, Postmarketing Reports).

  Amiodarone injection infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Use of evacuated glass containers for admixing amiodarone injection is not recommended as incompatibility with a buffer in the container may cause precipitation.

  It is well known that amiodarone adsorbs to polyvinyl chloride (PVC) tubing and the clinical trial dose administration schedule was designed to account for this adsorption. All of the clinical trials were conducted using PVC tubing and its use is therefore recommended. The concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect doses identified in these studies. Amiodarone injection has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone injection at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. In addition, polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC (see DESCRIPTION). Therefore, it is important that the recommendations in DOSAGE AND ADMINISTRATION be followed closely.

  Amiodarone injection does not need to be protected from light during administration.

  AMIODARONE HCl SOLUTION STABILITY Solution Concentration Container Comments

  (mg/mL) 5% Dextrose in Water  1.0 – 6.0 PVC Physically compatible, (D5W)

  with amiodarone loss < 10% at 2 hours. 5% Dextrose in Water  1.0 – 6.0 Polyolefin, Physically compatible, (D5W)

  Glass with no amiodarone loss at 24 hours

  Admixture Incompatibility

  Amiodarone injection in D5W is incompatible with the drugs shown below.

  Y-SITE INJECTION INCOMPATIBILITY Drug  Vehicle Amiodarone  Comments

  Concentration Aminophylline D5W 4 mg/mL Precipitate Cefamandole Nafate D5W 4 mg/mL Precipitate Cefazolin Sodium D5W 4 mg/mL Precipitate Mezlocillin Sodium D5W 4 mg/mL Precipitate Heparin Sodium D5W

  ---------

  Precipitate Sodium Bicarbonate D5W 3 mg/mL Precipitate

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone injection may be switched to oral Amiodarone hydrochloride. The optimal dose for changing from intravenous to oral administration of Amiodarone hydrochloride will depend on the dose of amiodarone injection already administered, as well as the bioavailability of oral Amiodarone hydrochloride. When changing to oral Amiodarone hydrochloride therapy, clinical monitoring is recommended, particularly for elderly patients.

  Since there are some differences between the safety and efficacy profiles of the intravenous and oral formulations, the prescriber is advised to review the package insert for oral amiodarone when switching from intravenous to oral amiodarone therapy.

  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 PRECAUTIONS, Drug Interactions).

  The following table provides suggested doses of oral Amiodarone hydrochloride to be initiated after varying durations of amiodarone injection administration. These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  RECOMMENDATIONS FOR ORAL DOSAGE AFTER I.V. INFUSION Duration of  Initial Daily Dose of Amiodarone injection Infusion# Oral Amiodarone hydrochloride

  # Assuming a 720 mg/day infusion (0.5 mg/min).

  * Amiodarone injection is not intended for maintenance treatment.

  <1 week 800-1600 mg 1-3 weeks 600-800 mg >3 weeks* 400 mg

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• Wockhardt Usa Llc.
  

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  Amiodarone Hydrochloride | Wockhardt Usa Llc.

  

  ---

  Amiodarone shows considerable interindividual variation in response. Thus, although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose as needed is essential. The recommended starting dose of amiodarone I.V. is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  AMIODARONE HCl DOSE RECOMMENDATIONS– FIRST 24 HOURS –

  Loading infusions

                            First Rapid:

  150 mg over the FIRST 10 minutes (15 mg/min).

  Add 3 mL of amiodarone I.V. (150 mg) to 100 mL D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.

             Followed by Slow:

  360 mg over the NEXT 6 hours (1 mg/min).

  Add 18 mL of amiodarone I.V. (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL).

  Maintenance infusion

  540 mg over the REMAINING 18 hours (0.5 mg/min).

  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  After the first 24 hours, the maintenance infusion rate of 0.5 mg/min (720 mg/24 hours) should be continued utilizing a concentration of 1 to 6 mg/mL (amiodarone I.V. concentrations greater than 2 mg/mL should be administered via a central venous catheter). In the event of breakthrough episodes of VF or hemodynamically unstable VT, 150 mg supplemental infusions of amiodarone I.V. mixed in 100 mL of D5W may be administered. Such infusions should be administered over 10 minutes to minimize the potential for hypotension. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. The initial infusion rate should not exceed 30 mg/min.

  Based on the experience from clinical studies of amiodarone I.V., a maintenance infusion of up to 0.5 mg/min can be cautiously continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving amiodarone I.V. for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone I.V. must be delivered by a volumetric infusion pump.

  Amiodarone I.V. should, whenever possible, be administered through a central venous catheter dedicated to that purpose. An in-line filter should be used during administration.

  Amiodarone I.V. loading infusions at much higher concentrations and rates of infusion much faster than recommended have been resulted in hepatocellular necrosis and acute renal failure, leading to death (see PRECAUTIONS, Liver Enzyme Elevations).

  Amiodarone I.V. concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, amiodarone I.V. concentrations should not exceed 2 mg/mL unless a central venous catheter is used (see ADVERSE REACTIONS, Postmarketing Reports).

  Amiodarone I.V. infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Use of evacuated glass containers for admixing amiodarone I.V. is not recommended as incompatibility with a buffer in the container may cause precipitation.

  It is well known that amiodarone adsorbs to polyvinyl chloride (PVC) tubing and the clinical trial dose administration schedule was designed to account for this adsorption. All of the clinical trials were conducted using PVC tubing and its use is therefore recommended. The concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect doses identified in these studies. Amiodarone I.V. has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing Amiodarone I.V. at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. In addition, polysorbate 80, a component of amiodarone I.V., is also known to leach DEHP from PVC (see DESCRIPTION). Therefore, it is important that the recommendations in DOSAGE AND ADMINISTRATION be followed closely.

  Amiodarone I.V. does not need to be protected from light during administration.

  AMIODARONE HCl SOLUTION STABILITY Solution Concentration Container Comments

  (mg/mL) 5% Dextrose in Water (D5W) 1 – 6 PVC Physically compatible, with amiodarone loss <10% at 2 hours at room temperature. 5% Dextrose in Water (D5W) 1 – 6 Polyolefin, Glass Physically compatible, with no amiodarone loss at 24 hours at room temperature

  Admixture Incompatibility

  Amiodarone I.V. in D5W is incompatible with the drugs shown below.

  Y-SITE INJECTION INCOMPATIBILITY Drug Vehicle Amiodarone Concentration Comments Aminophylline D5W 4 mg/mL Precipitate Cefamandole Nafate D5W 4 mg/mL Precipitate Cefazolin Sodium D5W 4 mg/mL Precipitate Mezlocillin Sodium D5W 4 mg/mL Precipitate Heparin Sodium D5W

  ---------

  Precipitate Sodium Bicarbonate D5W 3 mg/mL Precipitate

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone I.V. may be switched to oral amiodarone. The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of amiodarone I.V. already administered, as well as the bioavailability of oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients.

  Since there are some differences between the safety and efficacy profiles of the intravenous and oral formulations, the prescriber is advised to review the package insert for oral amiodarone when switching from intravenous to oral amiodarone therapy.

  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 PRECAUTIONS, Drug interactions).

  The following table provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone I.V. administration. These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  RECOMMENDATIONS FOR ORAL DOSAGE AFTER I.V. INFUSION Duration of Amiodarone I.V. Infusion# Initial Daily Dose of Oral amiodarone

  #Assuming a 720 mg/day infusion (0.5 mg/min).

  *Amiodarone I.V.is not intended for maintenance treatment.

  <1 week 800-1600 mg 1-3 weeks 600-800 mg >3 weeks* 400 mg

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• Physicians Total Care, Inc.
  

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  Amiodarone Hydrochloride | Physicians Total Care, Inc.

  

  ---

  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 CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia:

  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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on Drug Interactions). 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 CLINICAL PHARMACOLOGY Monitoring Effectiveness). 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 CLINICAL PHARMACOLOGY).

  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:

  
  Loading Dose (Daily)
  Adjustment and Maintenance Dose (Daily)
  Ventricular Arrhythmias 
  1 to 3 weeks 
  ~1 month 
  usual maintenance
  
  800 to 1,600 mg 
  600 to 800 mg 
  400 mg
  

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• Rebel Distributors Corp
  

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  Amiodarone Hydrochloride | Rebel Distributors Corp

  

  ---

  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 CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia:

  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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on Drug Interactions). 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 CLINICAL PHARMACOLOGY Monitoring Effectiveness). 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 CLINICAL PHARMACOLOGY).

  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:

  
  Loading Dose (Daily)
  Adjustment and Maintenance Dose (Daily)
  Ventricular Arrhythmias 
  1 to 3 weeks 
  ~1 month 
  usual maintenance
  
  800 to 1,600 mg 
  600 to 800 mg 
  400 mg
  

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• Cadila Healthcare Limited
  

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  Amiodarone Hydrochloride | Cadila Healthcare Limited

  

  ---

  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 CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia:

  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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on Drug Interactions). 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 CLINICAL PHARMACOLOGY Monitoring Effectiveness). 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 CLINICAL PHARMACOLOGY).

  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:

  
  Loading Dose (Daily)
  Adjustment and Maintenance Dose (Daily)
  Ventricular Arrhythmias 
  1 to 3 weeks 
  ~1 month 
  usual maintenance
  
  800 to 1,600 mg 
  600 to 800 mg 
  400 mg
  

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• Remedyrepack Inc.
  

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  Amiodarone Hydrochloride | Remedyrepack Inc.

  

  ---

  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 CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:
  
  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia:
  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 PRECAUTIONS, Drug Interactions).
  Upon starting amiodarone therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on Drug Interactions). 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 CLINICAL PHARMACOLOGY Monitoring Effectiveness). 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 CLINICAL PHARMACOLOGY).
  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:
  
  Loading Dose (Daily)Adjustment and Maintenance Dose (Daily)Ventricular Arrhythmias1 to 3 weeks~1 monthusual maintenance800 to 1,600 mg600 to 800 mg400 mg
  
  

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• Golden State Medical Supply, Inc.
  

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  Amiodarone Hydrochloride | Golden State Medical Supply, Inc.

  

  ---

  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 "CLINICAL PHARMACOLOGY"). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia

  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 "PRECAUTIONS, Drug Interactions").

  Upon starting amiodarone therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on "Drug Interactions"). 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 "CLINICAL PHARMACOLOGY, Monitoring Effectiveness"). 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 "CLINICAL PHARMACOLOGY").

  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:

  Loading Dose
  (Daily) Adjustment and Maintenance Dose
  (Daily) Ventricular Arrhythmias 1 to 3 weeks ~1 month usual maintenance 800 to 1,600 mg 600 to 800 mg 400 mg

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• App Pharmaceuticals, Llc
  

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  Amiodarone Hydrochloride | App Pharmaceuticals, Llc

  

  ---

  Amiodarone shows considerable interindividual variation in response.  Thus, although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose as needed is essential.  The recommended starting dose of amiodarone HCl injection is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

   

  AMIODARONE HCL INJECTION DOSE RECOMMENDATIONS– FIRST 24 HOURS –

  Loading infusions

  First Rapid:

  150 mg over the FIRST 10 minutes (15 mg/min).  Add 3 mL of Amiodarone HCl Injection (150 mg) to 100 mL D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.

                    Followed by Slow:

  360 mg over the NEXT 6 hours (1 mg/min).  Add 18 mL of Amiodarone HCl Injection (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL).

  Maintenance infusion

   

  540 mg over the REMAINING 18 hours (0.5 mg/min).  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  
  

  After the first 24 hours, the maintenance infusion rate of 0.5 mg/min (720 mg/24 hours) should be continued utilizing a concentration of 1 to 6 mg/mL (Amiodarone HCl Injection concentrations greater than 2 mg/mL should be administered via a central venous catheter).  In the event of breakthrough episodes of VF or hemodynamically unstable VT, 150 mg supplemental infusions of amiodarone HCl injection mixed in 100 mL of D5W may be administered.  Such infusions should be administered over 10 minutes to minimize the potential for hypotension.  The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension.  The initial infusion rate should not exceed 30 mg/min.

  Based on the experience from clinical studies of amiodarone HCl injection, a maintenance infusion of up to 0.5 mg/min can be cautiously continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function.  There has been limited experience in patients receiving amiodarone HCl injection for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced.  This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used.  Amiodarone HCl injection must be delivered by a volumetric infusion pump.

  Amiodarone HCl injection should, whenever possible, be administered through a central venous catheter dedicated to that purpose.  An in-line filter should be used during administration.
   
  Amiodarone HCl injection loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death (see PRECAUTIONS, Liver Enzyme Elevations).

  Amiodarone HCl injection concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating.  Therefore, for infusions longer than 1 hour, amiodarone HCl injection concentrations should not exceed 2 mg/mL unless a central venous catheter is used (see ADVERSE REACTIONS, Postmarketing Reports).

  Amiodarone HCl injection infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W.  Use of evacuated glass containers for admixing amiodarone HCl injection is not recommended as incompatibility with a buffer in the container may cause precipitation.

  It is well known that amiodarone adsorbs to polyvinyl chloride (PVC) tubing and the clinical trial dose administration schedule was designed to account for this adsorption.  All of the clinical trials were conducted using PVC tubing and its use is therefore recommended.  The concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect doses identified in these studies.  Amiodarone HCl injection has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing).  The degree of leaching increases when infusing amiodarone HCl injection at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION.  In addition, polysorbate 80, a component of amiodarone HCl injection, is also known to leach DEHP from PVC (see DESCRIPTION).  Therefore, it is important that the recommendations in DOSAGE AND ADMINISTRATION be followed closely.

  Amiodarone HCl injection does not need to be protected from light during administration.

  Note: Parenteral drug products should be inspected visually for particulate matter, whenever solution and container permit.

  AMIODARONE HCL INJECTION SOLUTION STABILITY

  Solution

  Concentration (mg/mL)

  Container

  Comments

  5% Dextrose in Water (D5W)

  1 to 6

  PVC

  Physically compatible, with amiodarone loss <10% at 2 hours at room temperature.

  5% Dextrose in Water (D5W)

  1 to 6

  Polyolefin, Glass

  Physically compatible, with no amiodarone loss at 24 hours at room temperature.

  
  Admixture Incompatibility
  

  Amiodarone HCl injection in D5W is incompatible with the drugs shown below.

   

  Y-SITE INJECTION INCOMPATIBILITY

  Drug

  Vehicle

  Amiodarone Concentration

  Comments

  Aminophylline

  D5W

  4 mg/mL

  Precipitate

  Cefamandole Nafate

  D5W

  4 mg/mL

  Precipitate

  Cefazolin Sodium

  D5W

  4 mg/mL

  Precipitate

  Mezlocillin Sodium

  D5W

  4 mg/mL

  Precipitate

  Heparin Sodium

  D5W

  ----

  Precipitate

  Sodium Bicarbonate

  D5W

  3 mg/mL

  Precipitate

  
  Intravenous to Oral Transition
  

  Patients whose arrhythmias have been suppressed by amiodarone HCl injection may be switched to oral amiodarone.  The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of amiodarone HCl injection already administered, as well as the bioavailability of oral amiodarone.  When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients.

  Since there are some differences between the safety and efficacy profiles of the intravenous and oral formulations, the prescriber is advised to review the package insert for oral amiodarone when switching from intravenous to oral amiodarone therapy.

  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 PRECAUTIONS, Drug Interactions).

  The following table provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone HCl injection administration.  These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

   

  RECOMMENDATIONS FOR ORAL DOSAGE AFTER IV INFUSION

  Duration of Amiodarone HCl Injection Infusion#

  Initial Daily Dose of Oral Amiodarone

  <1 week

  800 to 1600 mg

  1 to 3 weeks

  600 to 800 mg

  > 3 weeks*

  400 mg

  #Assuming a 720 mg/day infusion (0.5 mg/min).

  *Amiodarone HCl Injection is not intended for maintenance treatment.

  Admixture Incompatibility
  

  Amiodarone HCl injection in D5W is incompatible with the drugs shown below.

   

  Y-SITE INJECTION INCOMPATIBILITY

  Drug

  Vehicle

  Amiodarone Concentration

  Comments

  Aminophylline

  D5W

  4 mg/mL

  Precipitate

  Cefamandole Nafate

  D5W

  4 mg/mL

  Precipitate

  Cefazolin Sodium

  D5W

  4 mg/mL

  Precipitate

  Mezlocillin Sodium

  D5W

  4 mg/mL

  Precipitate

  Heparin Sodium

  D5W

  ----

  Precipitate

  Sodium Bicarbonate

  D5W

  3 mg/mL

  Precipitate

  
  Intravenous to Oral Transition
  

  Patients whose arrhythmias have been suppressed by amiodarone HCl injection may be switched to oral amiodarone.  The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of amiodarone HCl injection already administered, as well as the bioavailability of oral amiodarone.  When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients.

  Since there are some differences between the safety and efficacy profiles of the intravenous and oral formulations, the prescriber is advised to review the package insert for oral amiodarone when switching from intravenous to oral amiodarone therapy.

  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 PRECAUTIONS, Drug Interactions).

  The following table provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone HCl injection administration.  These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

   

  RECOMMENDATIONS FOR ORAL DOSAGE AFTER IV INFUSION

  Duration of Amiodarone HCl Injection Infusion#

  Initial Daily Dose of Oral Amiodarone

  <1 week

  800 to 1600 mg

  1 to 3 weeks

  600 to 800 mg

  > 3 weeks*

  400 mg

  #Assuming a 720 mg/day infusion (0.5 mg/min).

  *Amiodarone HCl Injection is not intended for maintenance treatment.

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• Physicians Total Care, Inc.
  

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  Amiodarone Hydrochloride | Physicians Total Care, Inc.

  

  ---

  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS Loading infusions First Rapid: 150 mg over the FIRST 10 minutes (15 mg/min).
  Add 3 mL of amiodarone (150 mg) to 100 mL
  D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes. Followed by Slow: 360 mg over the NEXT 6 hours (1 mg/min).
  Add 18 mL of amiodarone (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL) Maintenance infusion 540 mg over the REMAINING 18 hours (0.5 mg/min).
  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension).

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.

  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation.

  Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Table 2: AMIODARONE HCl SOLUTION STABILITY Solution Concentration
  (mg/mL) Container Comments 5% Dextrose in Water (D5W) 1 to 6 PVC Physically compatible, with amiodarone loss <10% at 2 hours at room temperature. 5% Dextrose in Water (D5W) 1 to 6 Polyolefin, Glass Physically compatible, with no amiodarone loss at 24 hours at room temperature.

  Admixture Incompatibility

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Table 3: Y-SITE INJECTION INCOMPATIBILITY Drug Vehicle Amiodarone Concentration Comments Aminophylline D5W 4 mg/mL Precipitate Cefamandole Nafate D5W 4 mg/mL Precipitate Cefazolin Sodium D5W 4 mg/mL Precipitate Mezlocillin Sodium D5W 4 mg/mL Precipitate Heparin Sodium D5W -- Precipitate Sodium Bicarbonate D5W 3 mg/mL Precipitate

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  Table 4: RECOMMENDATIONS FOR ORAL DOSAGE AFTER INTRAVENOUS INFUSION Duration of Amiodarone Infusion* Initial Daily Dose of Oral Amiodarone * Assuming a 720 mg/day infusion (0.5 mg/min). † Intravenous amiodarone is not intended for maintenance treatment. < 1 week 800 to 1600 mg 1-3 weeks 600 to 800 mg > 3 weeks† 400 mg

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• Mckesson Contract Packaging
  

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  Amiodarone Hydrochloride | Mckesson Contract Packaging

  

  ---

  BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS 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 TABLET 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 hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: 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 mg/day to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone hydrochloride tablets 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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablets dose should be reduced to 600 mg/day to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets 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 CLINICAL PHARMACOLOGY).

  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 hydrochloride tablets and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:

  Loading Dose (Daily) Adjustment and Maintenance Dose (Daily) Ventricular Arrhythmias 1 to 3 weeks ~1 month usual maintenance 800 mg to 1,600 mg 600 mg to 800 mg 400 mg

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  Amiodarone Hydrochloride | Wockhardt Limited

  

  ---

  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS
  
  
  Loading infusions
  First Rapid:
  150 mg over the FIRST 10 minutes (15 mg/min).
  Add 3 mL of amiodarone (150 mg) to 100 mL 
  D5W (concentration = 1.5 mg/mL). 
  Infuse 100 mL over 10 minutes.
  
  
  Followed by 
  Slow:
  
  360 mg over the NEXT 6 hours (1 mg/min).
  Add 18 mL of amiodarone (900 mg) to 500 mL 
  D5W (concentration = 1.8 mg/mL)
  
  Maintenance infusion
  
  540 mg over the REMAINING 18 hours (0.5 mg/min).
  Decrease the rate of the slow loading infusion to 
  0.5 mg/min.  
  

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension).  

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.

  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation.

  Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience as been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Table 2: AMIODARONE HCl SOLUTION STABILITY
  Concentration
  
  
  Solution
  (mg/mL)
  Container
  Comments
  5% Dextrose in Water (D5W) 
  1 - 6
  PVC
  Physically compatible, with amiodarone loss <10% at 2 hours at room temperature.
  
  
  
  
  5% Dextrose in Water (D5W) 
  1 - 6
  Polyolefin, Glass
  Physically compatible, with no amiodarone loss at 24 hours at room temperature.
  

  Admixture Incompatibility

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Table 3: Y-SITE INJECTION INCOMPATIBILITY
  Drug
  
  Vehicle
  Amiodarone
  Concentration
  
  Comments
  Aminophylline
  D5W
  4 mg/mL
  Precipitate
  Cefamandole Nafate
  D5W
  4 mg/mL
  Precipitate
  Cefazolin Sodium
  D5W
  4 mg/mL
  Precipitate
  Mezlocillin Sodium
  D5W
  4 mg/mL
  Precipitate
  Heparin Sodium
  D5W
  --
  Precipitate
  Sodium Bicarbonate
  D5W
  3 mg/mL
  Precipitate
  

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  Table 4: RECOMMENDATIONS FOR ORAL DOSAGE AFTER INTRAVENOUS INFUSION

  # Assuming a 720 mg/day infusion (0.5 mg/min).
  

  * Intravenous amiodarone is not intended for maintenance treatment.
  

  Duration of Amiodarone Infusion#
  Initial Daily Dose of
  Oral Amiodarone
  < 1 week
  800-1600 mg
  1-3 weeks
  600-800 mg
  > 3 weeks*
  400 mg
  

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• West-ward Pharmaceutical Corp
  

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  Amiodarone Hydrochloride | West-ward Pharmaceutical Corp

  

  ---

  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS  Loading infusions  First Rapid:  150 mg over the FIRST 10 minutes (15 mg/min).
  Add 3 mL of amiodarone (150 mg) to 100 mL
  D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.    Followed by Slow:  360 mg over the NEXT 6 hours (1 mg/min).
  Add 18 mL of amiodarone (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL)  Maintenance infusion    540 mg over the REMAINING 18 hours (0.5 mg/min).
  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension).

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.

  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation.

  Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Table 2: AMIODARONE HCl SOLUTION STABILITY Solution Concentration
  (mg/mL) Container Comments  5% Dextrose in Water (D5W)  1 to 6  PVC  Physically compatible, with amiodarone loss <10% at 2 hours at room temperature.  5% Dextrose in Water (D5W)  1 to 6  Polyolefin, Glass  Physically compatible, with no amiodarone loss at 24 hours at room temperature. Admixture Incompatibility

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Table 3: Y-SITE INJECTION INCOMPATIBILITY Drug Vehicle Amiodarone Concentration Comments  Aminophylline  D5W  4 mg/mL  Precipitate  Cefamandole Nafate  D5W  4 mg/mL  Precipitate  Cefazolin Sodium  D5W  4 mg/mL  Precipitate  Mezlocillin Sodium  D5W  4 mg/mL  Precipitate  Heparin Sodium  D5W  --  Precipitate  Sodium Bicarbonate  D5W  3 mg/mL  Precipitate Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  Table 4: RECOMMENDATIONS FOR ORAL DOSAGE AFTER INTRAVENOUS INFUSION Duration of Amiodarone Infusion* Initial Daily Dose of Oral Amiodarone * Assuming a 720 mg/day infusion (0.5 mg/min). † Intravenous amiodarone is not intended for maintenance treatment.  < 1 week  800 to 1600 mg  1-3 weeks  600 to 800 mg  > 3 weeks†  400 mg

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• General Injectables & Vaccines, Inc
  

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  Amiodarone Hydrochloride | General Injectables & Vaccines, Inc

  

  ---

  
  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:
  
  Table 1:  AMIODARONE DOSE RECOMMENDATIONS:  FIRST 24 HOURS
  
  Loading infusions
  First Rapid:
  150 mg over the FIRST 10 minutes (15 mg/min).
  
  
  Add 3 mL of amiodarone (150 mg) to 100 mL D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.
  
  Followed by Slow:
  360 mg over the NEXT 6 hours (1 mg/min).
  
  
  Add 18 mL of amiodarone (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL)
  Maintenance infusion
  
  540 mg over the REMAINING 18 hours (0.5 mg/min).
  
  
  Decrease the rate of the slow loading infusion to 0.5 mg/min.
  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.
  
  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension).
  
  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.
  
  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.
  
  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.
  
  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.
  
  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death[see Warnings and Precautions (5.3)].
  
  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used[see Adverse Reactions (6.2)].
  
  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation.
  
  Amiodarone absorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.
  
  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC[see Description (11)].
  
  Amiodarone does not need to be protected from light during administration.
  
  NOTE:  Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.
  
  Table 2:  AMIODARONE HCL SOLUTION STABILITY
  
  Solution
  Concentration
  (mg/mL)
  Container
  Comments
  5% Dextrose in Water (D5W)
  1 to 6
  PVC
  Physically compatible, with amiodarone loss less than 10% at 2 hours at room temperature.
  5% Dextrose in Water (D5W)
  1 to 6
  Polyolefin, Glass
  Physically compatible, with no amiodarone loss at 24 hours at room temperature.
  Admixture Incompatibility
  Amiodarone in D5W is incompatible with the drugs shown in Table 3.
  
  Table 3:  Y-SITE INJECTION INCOMPATIBILITY
  
  Drug
  Vehicle
  Amiodarone Concentration
  Comments
  Aminophylline
  D5W
  4 mg/mL
  Precipitate
  Cefamandole Nafate
  D5W
  4 mg/mL
  Precipitate
  Cefazolin Sodium
  D5W
  4 mg/mL
  Precipitate
  Mezlocillin Sodium
  D5W
  4 mg/mL
  Precipitate
  Heparin Sodium
  D5W
  --
  Precipitate
  Sodium Bicarbonate
  D5W
  3 mg/mL
  Precipitate
  Intravenous to Oral Transition
  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.
  
  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone[see Drug Interactions (7)].
  
  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These reommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.
  
  Table 4:  RECOMMENDATIONS FOR ORAL DOSAGE AFTER INTRAVENOUS INFUSION
  
  Duration of Amiodarone Infusion † Initial Daily Dose of Oral Amiodarone
  Less than 1 week
  800 to 1600 mg
  1-3 weeks
  600 to 800 mg
  Greater than 3 weeks *
  400 mg
  † Assuming a 720 mg/day infusion (0.5 mg/min).
  * Intravenous amiodarone is not intended for maintenance treatment.
  

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  ---

  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS

  Loading infusions

  First Rapid:

  150 mg over the FIRST 10 minutes (15 mg/min).
  Add 3 mL of amiodarone (150 mg) to 100 mL
  D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.

  Followed by Slow:

  360 mg over the NEXT 6 hours (1 mg/min).
  Add 18 mL of amiodarone (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL)

  Maintenance infusion

  540 mg over the REMAINING 18 hours (0.5 mg/min).
  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension).

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.

  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation.

  Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Table 2: AMIODARONE HCl SOLUTION STABILITY Solution Concentration
  (mg/mL) Container Comments

  5% Dextrose in Water (D5W)

  1 to 6

  PVC

  Physically compatible, with amiodarone loss < 10% at 2 hours at room temperature.

  5% Dextrose in Water (D5W)

  1 to 6

  Polyolefin, Glass

  Physically compatible, with no amiodarone loss at 24 hours at room temperature.

  Admixture Incompatibility

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Table 3: Y-SITE INJECTION INCOMPATIBILITY Drug Vehicle Amiodarone Concentration Comments

  Aminophylline

  D5W

  4 mg/mL

  Precipitate

  Cefamandole Nafate

  D5W

  4 mg/mL

  Precipitate

  Cefazolin Sodium

  D5W

  4 mg/mL

  Precipitate

  Mezlocillin Sodium

  D5W

  4 mg/mL

  Precipitate

  Heparin Sodium

  D5W

  --

  Precipitate

  Sodium Bicarbonate

  D5W

  3 mg/mL

  Precipitate

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  Table 4: RECOMMENDATIONS FOR ORAL DOSAGE AFTER INTRAVENOUS INFUSION Duration of Amiodarone Infusion* Initial Daily Dose of Oral Amiodarone * Assuming a 720 mg/day infusion (0.5 mg/min). † Intravenous amiodarone is not intended for maintenance treatment.

  < 1 week

  800 to 1600 mg

  1 - 3 weeks

  600 to 800 mg

  > 3 weeks†

  400 mg

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  Amiodarone Hydrochloride | Hospira, Inc.

  

  ---

  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  Table 1: Amiodarone Dose Recommendations: First 24 Hours

  Loading
  infusions

  First Rapid:

  150 mg over the FIRST 10 minutes (15 mg/min).
  Add 3 mL of amiodarone (150 mg) to 100 mL D5W or normal saline (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.

  Followed by Slow:

  360 mg over the NEXT 6 hours (1 mg/min).
  Add 18 mL of amiodarone (900 mg) to 500 mL D5W or normal saline (concentration = 1.8 mg/mL)

   

  Maintenance infusion

   

  540 mg over the REMAINING 18 hours (0.5 mg/min).
  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W or normal saline and infused over 10 minutes to minimize the potential for hypotension).

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.

  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone may be diluted in D5W or saline and administered in polyvinyl chloride (PVC), polyolefin, or glass containers. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation. Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION (2) reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION (2). Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Table 2: Amiodarone HCl Solution Stability

  Solution

  Concentration
  (mg/mL)

  Container

  Comments

  5% Dextrose in Water (D5W)

  1 – 6

  PVC

  Physically compatible, with amiodarone loss <10% at 2 hours at room temperature.

  5% Dextrose in Water (D5W)

  1 – 6

  Polyolefin, Glass

  Physically compatible, with no amiodarone loss at 24 hours at room temperature.

  Admixture Incompatibility

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Table 3: Y-Site Injection Incompatibility

  Drug

  Vehicle

  Amiodarone Concentration

  Comments

  Aminophylline

  D5W

  4 mg/mL

  Precipitate

  Cefamandole Nafate

  D5W

  4 mg/mL

  Precipitate

  Cefazolin Sodium

  D5W

  4 mg/mL

  Precipitate

  Mezlocillin Sodium

  D5W

  4 mg/mL

  Precipitate

  Heparin Sodium

  D5W

  --

  Precipitate

  Sodium Bicarbonate

  D5W

  3 mg/mL

  Precipitate

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of amiodarone already administered, as well as the bioavailability of oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  Table 4: Recommendations For Oral Dosage After Intravenous Infusion

   

  Duration of Amiodarone Infusion#

  Initial Daily Dose of Oral Amiodarone

  <1 week

  800 - 1600 mg

  1-3 weeks

  600 - 800 mg

  >3 weeks*

  400 mg

  # Assuming a 720 mg/day infusion (0.5 mg/min).

  * Intravenous amiodarone is not intended for maintenance treatment.

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  Amiodarone Hydrochloride | Sagent Pharmaceuticals

  

  ---

  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS Loading infusions First Rapid:    150 mg over the FIRST 10 minutes
  (15 mg/min).
  Add 3 mL of amiodarone (150 mg) to 100 mL D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.
  Followed by Slow:   
  360 mg over the NEXT 6 hours (1 mg/min). Add 18 mL of amiodarone (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL)
  Maintenance infusion 540 mg over the REMAINING 18 hours
  (0.5 mg/min).
  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension).

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.

  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation.

  Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Table 2: AMIODARONE HCl SOLUTION STABILITY Concentration Solution (mg/mL) Container Comments   5% Dextrose in Water (D5W) 1 to 6 PVC Physically compatible,
  with amiodarone loss
  <10% at 2 hours at room temperature. 5% Dextrose in Water (D5W) 1 to 6 Polyolefin, Physically compatible,
  with no amiodarone
  loss at 24 hours at room Glass temperature.  

  Admixture Incompatibility

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Table 3: Y-SITE INJECTION INCOMPATIBILITY Drug Vehicle Amiodarone
  Concentration Comments Aminophylline D5W 4 mg/mL Precipitate Cefamandole Nafate D5W 4 mg/mL Precipitate Cefazolin Sodium D5W 4 mg/mL Precipitate Mezlocillin Sodium D5W 4 mg/mL Precipitate Heparin Sodium D5W -- Precipitate Sodium Bicarbonate D5W 3 mg/mL Precipitate

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  Table 4: RECOMMENDATIONS FOR ORAL DOSAGE AFTER INTRAVENOUS INFUSION

  # Assuming a 720 mg/day infusion (0.5 mg/min).

  * Intravenous amiodarone is not intended for maintenance treatment.

  Duration of Amiodarone Infusion# Initial Daily Dose of
  Oral Amiodarone < 1 week 800 to 1600 mg 1-3 weeks 600 to 800 mg > 3 weeks* 400 mg

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  Amiodarone Hydrochloride | Mylan Institutional Inc.

  

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  2.1 General Dosing Information

  The patient should be placed on a standard cholesterol-lowering diet before receiving pravastatin sodium tablets and should continue on this diet during treatment with pravastatin sodium tablets [see NCEP Treatment Guidelines for details on dietary therapy].

  2.2 Adult Patients

  The recommended starting dose is 40 mg once daily. If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. In patients with significant renal impairment, a starting dose of 10 mg daily is recommended. Pravastatin sodium tablets can be administered orally as a single dose at any time of the day, with or without food. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.

  2.3 Pediatric Patients

  Children (Ages 8 to 13 Years, Inclusive)

  The recommended dose is 20 mg once daily in children 8 to 13 years of age. Doses greater than 20 mg have not been studied in this patient population.

  Adolescents (Ages 14 to 18 Years)

  The recommended starting dose is 40 mg once daily in adolescents 14 to 18 years of age. Doses greater than 40 mg have not been studied in this patient population.

  Children and adolescents treated with pravastatin should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C [see Indications and Usage (1.2)].

  2.4 Concomitant Lipid-Altering Therapy

  Pravastatin sodium tablets may be used with bile acid resins. When administering a bile-acid-binding resin (e.g., cholestyramine, colestipol) and pravastatin, pravastatin sodium tablets should be given either 1 hour or more before or at least 4 hours following the resin [see Clinical Pharmacology (12.3)].

  2.5 Dosage in Patients Taking Cyclosporine

  In patients taking immunosuppressive drugs such as cyclosporine concomitantly with pravastatin, therapy should begin with 10 mg of pravastatin sodium once-a-day at bedtime and titration to higher doses should be done with caution. Most patients treated with this combination received a maximum pravastatin sodium dose of 20 mg/day. In patients taking cyclosporine, therapy should be limited to 20 mg of pravastatin sodium once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].

  2.6 Dosage in Patients Taking Clarithromycin

  In patients taking clarithromycin, therapy should be limited to 40 mg of pravastatin sodium once daily [see Drug Interactions (7.2)].

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  Amiodarone Hydrochloride | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

  ---

  BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS 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 TABLET 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 hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: 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 mg/day to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone hydrochloride tablets 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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablets dose should be reduced to 600 mg/day to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets 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 CLINICAL PHARMACOLOGY).

  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 hydrochloride tablets and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:

     Loading Dose (Daily)  Adjustment and Maintenance Dose (Daily)  Ventricular Arrhythmias  1 to 3 weeks  ~1 month  usual maintenance    800 mg to 1,600 mg  600 mg to 800 mg  400 mg

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  Amiodarone Hydrochloride | General Injectables & Vaccines, Inc.

  

  ---

  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VT or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension).

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.

  Intravenous amiodarone loading infusions at which higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation. Amiodarone absorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE:  Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Admixture Incompatibility

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone. 

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  Amiodarone Hydrochloride | Hospira, Inc.

  

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  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS

  Loading

  infusions

  First Rapid:

  150 mg over the FIRST 10 minutes (15 mg/min).

  Add 3 mL of amiodarone (150 mg) to 100 mL D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.

   

  Followed by Slow:

  360 mg over the NEXT 6 hours (1 mg/min).

  Add 18 mL of amiodarone (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL).

  Maintenance infusion

   

  540 mg over the REMAINING 18 hours (0.5 mg/min).

  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension). 

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.

  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation.

  Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Table 2: AMIODARONE HCl SOLUTION STABILITY

  Solution

  Concentration

  (mg/mL)

  Container

  Comments

  5% Dextrose in Water (D5W)

  1 – 6

   

  PVC

  Physically compatible, with amiodarone loss <10% at 2 hours at room temperature.

  5% Dextrose in Water (D5W)

  1 – 6

  Polyolefin, Glass

  Physically compatible, with no amiodarone loss at 24 hours at room temperature.

  Admixture Incompatibility

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Table 3: Y-SITE INJECTION INCOMPATIBILITY

  Drug

  Vehicle

  Amiodarone Concentration

  Comments

  Aminophylline

  D5W

  4 mg/mL

  Precipitate

  Cefamandole Nafate

  D5W

  4 mg/mL

  Precipitate

  Cefazolin Sodium

  D5W

  4 mg/mL

  Precipitate

  Mezlocillin Sodium

  D5W

  4 mg/mL

  Precipitate

  Heparin Sodium

  D5W

  --

  Precipitate

  Sodium Bicarbonate

  D5W

  3 mg/mL

  Precipitate

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  Table 4: RECOMMENDATIONS FOR ORAL DOSAGE AFTER INTRAVENOUS INFUSION

  Duration of Amiodarone Infusion#

  Initial Daily Dose of
  Oral Amiodarone

  <1 week

  800-1600 mg

  1-3 weeks

  600-800 mg

  >3 weeks*

  400 mg

  # Assuming a 720 mg/day infusion (0.5 mg/min).

  *Intravenous amiodarone is not intended for maintenance treatment.

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  Amiodarone Hydrochloride | American Health Packaging

  

  ---

  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 CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia:

  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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on Drug Interactions).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 CLINICAL PHARMACOLOGY-Monitoring Effectiveness). 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 CLINICAL PHARMACOLOGY).

  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:

  Loading Dose (Daily)
  

  Adjustment and Maintenance Dose (Daily)
  

  Ventricular Arrhythmias 
  

  1 to 3 weeks 
  

  ~1 month 
  

  usual maintenance
  

  800 to 1,600 mg 
  

  600 to 800 mg 
  

  400 mg
  

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• Zydus Pharmaceuticals (Usa) Inc.
  

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  Amiodarone Hydrochloride | Baxter Healthcare Corporation

  

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  All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

  As directed by a physician. Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient’s age, weight, clinical condition, concomitant treatment, and on the patient’s clinical and laboratory response to treatment.

  When other electrolytes or medicines are added to this solution, the dosage and the infusion rate will also be dictated by the dose regimen of the additions.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

  Do not administer unless the solution is clear and seal is intact.

  Additives may be incompatible with Sodium Chloride Injection, USP. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sodium Chloride Injection, USP is appropriate. After addition, check for unexpected color changes and/or the appearance of precipitates, insoluble complexes or crystals.

  The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible must not be used. When introducing additives to Sodium Chloride Injection, USP, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

  After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Discard any unused portion.

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• Taro Pharmaceuticals U.s.a., Inc.
  

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  Amiodarone Hydrochloride | Baxter Healthcare Corporation

  

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  IFEX should be administered intravenously at a dose of 1.2 grams per m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity.

  In order to prevent bladder toxicity, IFEX should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. Mesna should be used to reduce the incidence of hemorrhagic cystitis. IFEX should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Studies of IFEX in patients with hepatic or renal impairment have not been conducted [see Use in Specific Populations (8.6, 8.7)].

  Injections are prepared for parenteral use by adding Sterile Water for Injection, USP or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve. Before parenteral administration, the substance must be completely dissolved. Use the quantity of diluents shown below to constitute the product:

  Dosage Strength

  Quantity of Diluent

  Final Concentration

  1 gram

  20 mL

  50 mg per mL

  3 grams

  60 mL

  50 mg per mL

  Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

  5% Dextrose Injection, USP

  0.9% Sodium Chloride Injection, USP

  Lactated Ringer’s Injections, USP

  Sterile Water for Injection, USP

  Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, VIAFLEX bags or PAB bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.

  Constituted or constituted and further diluted solutions of IFEX should be refrigerated and used within 24 hours. Benzyl-alcohol-containing solutions can reduce the stability of ifosfamide.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Teva Pharmaceuticals Usa Inc
  

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  Amiodarone Hydrochloride | Sandoz Inc

  

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  2.1 General Instructions for Use

  Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of guanfacine release. Do not administer with high fat meals, due to increased exposure.

  2.2 Dose Selection

  Take guanfacine extended-release tablets orally once daily, either in the morning or evening, at approximately the same time each day. Begin at a dose of 1 mg/day, and adjust in increments of no more than 1 mg/week.

  In monotherapy clinical trials, there was dose- and exposure-related clinical improvement as well as risks for several clinically significant adverse reactions (hypotension, bradycardia, sedative events). To balance the exposure-related potential benefits and risks, the recommended target dose range depending on clinical response and tolerability for guanfacine extended-release tablets is 0.05 to 0.12 mg/kg/day (total daily dose between 1 to 7 mg. (See Table 1).

  Table 1: Recommended Target Dose Range for Therapy with Guanfacine Extended-Release Tablets

  Weight

  Target dose range (0.05 - 0.12 mg/kg/day)

  25 to 33.9 kg

  2 to 3 mg/day

  34 to 41.4 kg

  2 to 4 mg/day

  41.5 to 49.4 kg

  3 to 5 mg/day

  49.5 to 58.4 kg

  3 to 6 mg/day

  58.5 to 91 kg

  4 to 7 mg/day

  >91 kg

  5 to 7 mg/day

  Doses above 4 mg/day have not been evaluated in children (ages 6 to 12 years) and doses above 7 mg/day have not been evaluated in adolescents (ages 13 to 17 years)

  In the adjunctive trial which evaluated guanfacine extended-release tablets treatment with psychostimulants, the majority of patients reached optimal doses in the 0.05 to 0.12 mg/kg/day range. Doses above 4 mg/day have not been studied in adjunctive trials.

  2.3 Switching from Immediate-Release Guanfacine to Guanfacine Extended-Release Tablets

  If switching from immediate-release guanfacine, discontinue that treatment, and titrate with guanfacine extended-release tablets following above recommended schedule.

  Do not substitute for immediate-release guanfacine tablets on a milligram-per-milligram basis, because of differing pharmacokinetic profiles. Guanfacine extended-release tablets has significantly reduced Cmax (60% lower), bioavailability (43% lower), and a delayed Tmax (3 hours later) compared to those of the same dose of immediate-release guanfacine[see Clinical Pharmacology (12.3)].

  2.4 Maintenance Treatment

  Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of guanfacine extended-release tablets and adjust weight-based dosage as needed. The majority of children and adolescents reach optimal doses in the 0.05-0.12 mg/kg/day range. Doses above 4 mg/day have not been evaluated in children (ages 6-12 years) and above 7 mg/day have not been evaluated in adolescents (ages 13-17 years) [see Clinical Studies (14)].

  2.5 Discontinuation of Treatment

  Following discontinuation of guanfacine extended-release tablets, patients may experience increases in blood pressure and heart rate [see Adverse Reactions (6.1)]. Patients/caregivers should be instructed not to discontinue guanfacine extended-release tablets without consulting their health care provider. Monitor blood pressure and pulse when reducing the dose or discontinuing the drug. Taper the daily dose in decrements of no more than 1 mg every 3 to 7 days to avoid rebound hypertension.

  2.6 Missed Doses

  When reinitiating patients to the previous maintenance dose after two or more missed consecutive doses, consider titration based on patient tolerability.

  2.7 Dosage Adjustment with Concomitant Use of Strong CYP3A4 Inhibitors or Inducers

  Dosage adjustments for guanfacine extended-release tablets are recommended with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole), or CYP3A4 inducers (e.g., carbamazepine) (Table 2) [see Drug Interactions (7)].

  Table 2: Guanfacine Extended-Release Tablets Dosage Adjustments for Patients Taking Concomitant CYP3A4 Inhibitors or Inducers

  Clinical Scenarios Starting guanfacine extended-release tablets while currently on a CYP3A4 modulator Continuing guanfacine extended-release tablets while adding a CYP3A4 modulator Continuing guanfacine extended-release tablets while stopping a CYP3A4 modulator

  CYP3A4
  Strong Inhibitors

  Decrease guanfacine extended-release tablets dosage to half the recommended level. (see Table 1)

  Decrease guanfacine extended-release tablets dosage to half the recommended level. (see Table 1)

  Increase guanfacine extended-release tablets dosage to recommended level. (see Table 1)

  CYP3A4
  Strong Inducers

  Consider increasing guanfacine extended-release tablets dosage up to double the recommended level. (see Table 1)

  Consider increasing guanfacine extended-release tablets dosage up to double the recommended level over 1 to 2 weeks. (see Table 1)

  Decrease guanfacine extended-release tablets dosage to recommended level over 1 to 2 weeks. (see Table 1)

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• Eon Labs, Inc.
  

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  Amiodarone Hydrochloride | Eon Labs, Inc.

  

  ---

  BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS 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 TABLET 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 hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: 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 mg/day to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone hydrochloride tablets 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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablets dose should be reduced to 600 mg/day to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets 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 CLINICAL PHARMACOLOGY).

  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 hydrochloride tablets and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:

  Loading Dose (Daily)

  Adjustment and Maintenance Dose (Daily)

  Ventricular Arrhythmias

  1 to 3 weeks

  ~1 month

  usual maintenance

  800 mg to 1,600 mg

  600 mg to 800 mg

  400 mg

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• Mckesson Packaging A Business Unit Of Mckesson Corporation
  

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  Amiodarone Hydrochloride | Mckesson Packaging A Business Unit Of Mckesson Corporation

  

  ---

  BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS 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 TABLET 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 hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: 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 mg/day to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone hydrochloride tablets 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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablets dose should be reduced to 600 mg/day to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets 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 CLINICAL PHARMACOLOGY).

  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 hydrochloride tablets and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:

  Loading Dose (Daily)

  Adjustment and Maintenance Dose (Daily)

  Ventricular Arrhythmias

  1 to 3 weeks

  ~1 month

  usual maintenance

  800 mg to 1,600 mg

  600 mg to 800 mg

  400 mg

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• Remedyrepack Inc.
  

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  Amiodarone Hydrochloride | Remedyrepack Inc.

  

  ---

  BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS 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 hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). 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 tablets 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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablet dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets 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 CLINICAL PHARMACOLOGY).

  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:

  Loading Dose Adjustment and Maintenance Dose (Daily) (Daily) Ventricular Arrhythmias 1 to 3 weeks ~1 month usual maintenance 800 to 1,600 mg 600 to 800 mg 400 mg

   

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• Cardinal Health
  

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  Amiodarone Hydrochloride | Cardinal Health

  

  ---

  BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS 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 hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For Life-Threatening Ventricular Arrhythmias, Such as Ventricular Fibrillation or Hemodynamically Unstable Ventricular Tachycardia

  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 tablets 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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablet dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets 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 CLINICAL PHARMACOLOGY).

  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:

  Loading Dose

  Adjustment and Maintenance Dose

  (Daily)

  (Daily)

  Ventricular Arrhythmias

  1 to 3 weeks

  ~1 month

  usual maintenance

  800 to 1,600 mg

  600 to 800 mg

  400 mg

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• Apotex Corp
  

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  Amiodarone Hydrochloride | Ningbo Jiangbei Ocean Star Trading Co.,ltd

  

  ---

  Other Information

  Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.

  
  

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• General Injectables And Vaccines, Inc.
  

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  Amiodarone Hydrochloride | General Injectables And Vaccines, Inc.

  

  ---

  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL. (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension.

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenouse amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line flter during administration.

  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 ml/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation.

  Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [dii-(2-ethylhexyl)phthalate] from intravenous tubing (including PCV tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC. [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Admixture Incompatibility

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Intravenous to Oral Transition

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

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  Amiodarone Hydrochloride | Remedyrepack Inc.

  

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  Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

  Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS  Loading infusions  First Rapid:  150 mg over the FIRST 10 minutes (15 mg/min).
  Add 3 mL of amiodarone (150 mg) to 100 mL
  D5W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes.    Followed by Slow:  360 mg over the NEXT 6 hours (1 mg/min).
  Add 18 mL of amiodarone (900 mg) to 500 mL D5W (concentration = 1.8 mg/mL)  Maintenance infusion    540 mg over the REMAINING 18 hours (0.5 mg/min).
  Decrease the rate of the slow loading infusion to 0.5 mg/min.

  After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

  In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes to minimize the potential for hypotension).

  The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.

  Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.

  The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump.

  Administer amiodarone, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.

  Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].

  Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed amiodarone concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].

  Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation.

  Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies.

  Amiodarone has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Polysorbate 80, a component of amiodarone injection, is also known to leach DEHP from PVC [see Description (11)].

  Amiodarone does not need to be protected from light during administration.

  NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Table 2: AMIODARONE HCl SOLUTION STABILITY Solution Concentration
  (mg/mL) Container Comments  5% Dextrose in Water (D5W)  1 to 6  PVC  Physically compatible, with amiodarone loss <10% at 2 hours at room temperature.  5% Dextrose in Water (D5W)  1 to 6  Polyolefin, Glass  Physically compatible, with no amiodarone loss at 24 hours at room temperature.

   

  Amiodarone in D5W is incompatible with the drugs shown in Table 3.

  Table 3: Y-SITE INJECTION INCOMPATIBILITY Drug Vehicle Amiodarone Concentration Comments  Aminophylline  D5W  4 mg/mL  Precipitate  Cefamandole Nafate  D5W  4 mg/mL  Precipitate  Cefazolin Sodium  D5W  4 mg/mL  Precipitate  Mezlocillin Sodium  D5W  4 mg/mL  Precipitate  Heparin Sodium  D5W  --  Precipitate  Sodium Bicarbonate  D5W  3 mg/mL  Precipitate

   

  Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.

  Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].

  Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

  Table 4: RECOMMENDATIONS FOR ORAL DOSAGE AFTER INTRAVENOUS INFUSION Duration of Amiodarone Infusion* Initial Daily Dose of Oral Amiodarone  < 1 week  800 to 1600 mg  1-3 weeks  600 to 800 mg  > 3 weeks†  400 mg

  1

  2

   

  1 Assuming a 720 mg/day infusion (0.5 mg/min). 2 Intravenous amiodarone is not intended for maintenance treatment.

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  Amiodarone Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc

  

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  BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS 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 hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: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 tablets 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 PRECAUTIONS, Drug Interactions).

  Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablet dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets 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 CLINICAL PHARMACOLOGY).

  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:

  Loading Dose

  Adjustment and Maintenance Dose

  (Daily)

  (Daily)

  Ventricular Arrhythmias

  1 to 3 weeks

  ~1 month

  usual maintenance

  800 to 1,600 mg

  600 to 800 mg

  400 mg

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