Inocor

Generic Name: Inamrinone Lactate
Class: Cardiotonic Agents
VA Class: CV900
Chemical Name: 5-Amino(3,4′-bipyridin)-6(1H)-one compd. with 3-hydroxypropanoic acid
Molecular Formula: C₁₀H₉N₃O•C₃H₆O₃
CAS Number: 75898-90-7

Introduction

Positive inotropic agent that has vasodilating effects; phosphodiesterase (PDE) inhibitor.^{1 2 4 60}

Uses for Inocor

CHF

Short-term management of CHF.^{1 2 8 27 28 29 59 60} In most clinical studies, used in patients with NYHA class III or IV CHF who continued to receive therapy with cardiac glycosides (e.g., digoxin) and/or diuretics.^{2 8}

Not found to be safe and effective in the long-term (>48 hours) treatment of CHF.^{59 60} (See Mortality Associated with Long-term Use under Cautions.)

Some clinicians recommend reserving inamrinone therapy for patients with heart failure whose condition is refractory to or who are intolerant to therapy with cardiac glycosides, diuretics, and/or vasodilators.^{1 2 27}

ACC and AHA strongly discourage use of intermittent infusions of positive inotropic agents at home, in outpatient medical facilities (e.g., clinics), or in short-stay medical units for the long-term management of heart failure, even for advanced stages of the disease.⁶³ However, ACC and AHA state that short-term continuous positive inotropic therapy can be considered for palliative therapy in patients with refractory end-stage heart failure.⁶³

Has been used for treatment of heart failure associated with cardiac surgery†.⁶⁵

CPR

An alternative therapy in conjunction with catecholamines in ACLS† for improving cardiac output when catecholamine therapy alone is ineffective in patients with severe heart failure, cardiogenic shock, or other forms of shock.^{55 66}

Used in conjunction with sympathomimetic agents (e.g., dobutamine) and volume titration for treatment of drug-induced cardiogenic shock.⁶⁶

AMI†

Not recommended for use during the acute phase following MI;^{1 30 60} not included in the ACC and AHA recommendations for management of AMI.⁶²

Has been used in children with myocardial dysfunction and increased systemic or pulmonary vascular resistance†⁶⁶

Inocor Dosage and Administration

Administration

Administer IV.^{1 60}

For ACLS during CPR†, may be administered by intraosseous injection† in pediatric patients without reliable/immediate IV access.⁶⁶

Has been administered orally†,^{2 16 18 33 36 37 38} but the high frequency of adverse GI effects has precluded use of this route of administration.³⁵

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by slow direct IV injection and/or by continuous IV infusion.^{1 60}

May be administered undiluted for direct IV injection.^{1 60} Use direct IV injection for initial loading dose and supplemental bolus doses.^{1 60}

Dilution

Continuous IV infusion: Dilute to a final concentration of 1–3 mg/mL in 0.45 or 0.9% sodium chloride.^{1 60}

Rate of Administration

Administer the appropriate initial and/or supplemental bolus doses slowly (see Dosage) directly into a vein or the tubing of a freely flowing compatible IV solution.^{1 60}

Usually, infuse maintenance dosage continuously IV at a rate of 5–10 mcg/kg per minute.^{1 60}

Adjust rate of IV infusion according to clinical response of the patient and tolerance to adverse effects.^{1 60}

Dosage

Available as inamrinone lactate; dosage expressed in terms of inamrinone.^{1 60}

Individualize dosage based on clinical response (cardiac output, pulmonary wedge pressure, central venous pressure, urine output, body weight, orthopnea, dyspnea, fatigue) and tolerance to adverse effects.^{1 60}

Pediatric Patients

CPR†

ACLS†

IV or Intraosseous†

Initially, approximately 0.75–1 mg/kg over 5 minutes which may be repeated up to 2 times, followed by an infusion of 2–20 mcg/kg per minute.⁶⁶

Adults

CHF

IV

Initially, 0.75 mg/kg as a slow (over 2–3 minutes) direct injection; if warranted, may administer a supplemental direct IV dose of 0.75 mg/kg 30 minutes after the initial dose.^{1 60} Direct IV injection is followed by an IV infusion of 5–10 mcg/kg per minute.¹ Duration of therapy determined by clinical response and tolerance to adverse effects.^{1 60}

CPR†

ACLS†

IV

Initially, approximately 0.75 mg/kg over 10–15 minutes (may administer over 2–3 minutes in absence of ventricular dysfunction), followed by an IV infusion of 5–15 mcg/kg per minute adjusted to desired clinical effect.⁶⁶ May administer an additional bolus in 30 minutes.⁶⁶

Prescribing Limits

Adults

CHF

IV

Maximum total dosage (including initial and supplemental doses and cumulative infused dose) usually 10 mg/kg daily.¹ Higher dosages (up to 18 mg/kg daily) have been administered for short periods in a limited number of patients.^{1 29 60}

Special Populations

Renal Impairment

Consider dosage reduction.⁶⁵

Cautions for Inocor

Contraindications

• 
  

  Known hypersensitivity to inamrinone or any ingredient in the formulation.¹

  
  


• 
  

  Known hypersensitivity to sulfiting agents (i.e., sulfur dioxide, potassium or sodium bisulfite, potassium or sodium metabisulfite, sodium sulfite).^{1 65}

  
  


• 
  

  Some experts state that inamrinone is contraindicated in patients with heart valve stenosis that limits cardiac output.⁶⁶

  
  

Warnings/Precautions

Warnings

Mortality Associated with Long-term Use

Not found to be safe and effective for long-term (>48 hours) treatment of CHF;^{59 60} chronic oral therapy did not consistently alleviate CHF symptoms and was consistently associated with increased risk of hospitalization and sudden death, particularly in patients with NYHA class IV disease.^{59 60}

Sensitivity Reactions

Apparent hypersensitivity reactions associated with prolonged oral† therapy.¹

Marked alterations in liver function test results^{1 11 51 52} and symptoms suggestive of an idiopathic hypersensitivity reaction (e.g., eosinophilia) reported.^{1 51} Promptly discontinue therapy if liver function test results and clinical symptoms suggestive of an idiosyncratic hypersensitivity reaction occur.¹ Evaluate nonspecific hepatic changes (e.g., moderate alterations in liver function test results without clinical symptoms of hepatotoxicity) on an individual basis and consider the potential risk versus benefit of continued inamrinone therapy.¹

Sulfite Sensitivity

Some formulations contain sulfites, which may cause allergic-type reaction (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.^{41 42 43 44 45 46 56 60}

General Precautions

Hematologic Effects

Dose-dependent thrombocytopenia (platelet counts less than 100,000–150,000/mm³)^{1 11 15 17 18 20 27} reported with short-term IV administration of usual dosages of inamrinone.^{1 30}

Monitor platelet counts prior to and frequently during therapy.¹ If thrombocytopenia occurs, decrease dosage, although platelet counts may return to pretreatment levels without dosage adjustment.¹ Discontinue if possible risk of thrombocytopenia outweighs potential benefit of therapy.¹

Cardiovascular Effects

Possible hypotension.^{1 2 10 32}

Close monitoring of BP and heart rate recommended, especially in patients with CHF and compromised renal and hepatic perfusion.¹ Decrease or stop the IV infusion if excessive decreases in BP occur.¹

Should not replace surgical removal of the obstruction in patients with severe aortic or pulmonic valvular disease.¹ Use with caution in patients with hypertrophic subaortic stenosis since the drug may aggravate outflow tract obstruction.¹

Effects on Cardiac Conduction

Possible slight increase in conduction velocity through AV node; may result in increased ventricular response in undigitalized patients with atrial flutter or fibrillation.^{1 40} Prior administration of cardiac glycosides recommended in patients with atrial flutter or fibrillation.^{1 60}

Arrhythmogenic Effects

Potential for increased risk for ventricular and supraventricular arrhythmias in some high-risk patients with severe CHF.^{1 40}

Fluid and Electrolyte Imbalance

Observe patients closely for changes in fluid and electrolyte balance and renal function.¹

Inamrinone-induced increases in cardiac output with resultant diuresis may require dosage reduction of diuretics to prevent excessive potassium loss.¹ Hypokalemia may predispose digitalized patients to cardiac arrhythmias.¹ Correct hypokalemia by potassium supplementation prior to and/or during inamrinone therapy.¹

Correct or adjust fluid and electrolyte balance to optimize response to inamrinone therapy.¹ May increase fluid and electrolyte intake cautiously in patients who have received vigorous diuretic therapy prior to inamrinone administration, since cardiac filling pressure may be insufficient for adequate response to the drug.¹

AMI

Use not recommended during the acute phase following MI.^{1 30 60} (See AMI under Uses.)

Specific Populations

Pregnancy

Category C.⁶⁰

Lactation

Not known whether inamrinone is distributed into milk.¹ Caution advised if used in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 40} The drug has been used in children with myocardial dysfunction and increased systemic or pulmonary vascular resistance† (e.g., postoperative cardiac surgical patients with CHF, patients with dilated cardiomyopathy, selected children with septic shock and myocardial dysfunction with a high systemic vascular resistance).⁶¹

Hepatic Impairment

Carefully monitor hemodynamic response in patients with CHF who have hepatic impairment, since plasma concentrations of inamrinone may increase during IV infusion of the drug.^{1 60}

Renal Impairment

Carefully monitor hemodynamic response in patients with CHF who have renal impairment, since plasma concentrations of inamrinone may increase during IV infusion of the drug.^{1 60}

Common Adverse Effects

Thrombocytopenia,^{1 60} arrhythmias,^{1 60} hypotension,^{1 60} nausea,^{1 60} vomiting, ⁶⁰ fever.⁶⁰

Interactions for Inocor

Specific Drugs

Drug	Interaction	Comments
Captopril	No evidence of unusual adverse effects1
Chlorthalidone	No evidence of unusual adverse effects1	Decreased diuretic dosage requirements27 30
Diazepam	No evidence of unusual adverse effects1
Digoxin	Additive inotropic effects1
Disopyramide	Excessive hypotension 1 40	Use with caution1 40
Ethacrynic acid	No evidence of unusual adverse effects1	Decreased diuretic dosage requirements27 30
Furosemide	No evidence of unusual adverse effects1	Decreased diuretic dosage requirements27 30
Heparin	No evidence of unusual adverse effects1
Hydralazine	No evidence of unusual adverse effects1
Hydrochlorothiazide	No evidence of unusual adverse effects1	Decreased diuretic dosage requirements27 30
Insulin	No evidence of unusual adverse effects1
Isosorbide dinitrate	No evidence of unusual adverse effects1
Lidocaine	No evidence of unusual adverse effects1
Metoprolol	No evidence of unusual adverse effects1
Nitroglycerin	No evidence of unusual adverse effects1
Potassium supplements	No evidence of unusual adverse effects1
Prazosin	No evidence of unusual adverse effects1
Propranolol	No evidence of unusual adverse effects1
Quinidine	No evidence of unusual adverse effects1
Spironolactone	No evidence of unusual adverse effects1	Decreased diuretic dosage requirements27 30
Warfarin	No evidence of unusual adverse effects1

Inocor Pharmacokinetics

Absorption

Onset

Following IV administration, cardiovascular effects usually apparent within 2–5 minutes;^{4 7} peak effects generally occur within 10 minutes at all dosages.^{1 7}

Duration

Approximately 0.5 or 2 hours at IV dosages of 0.75 or 3 mg/kg, respectively.¹

Plasma Concentrations

Plasma inamrinone concentrations appear to correlate with cardiovascular effects.^{2 21 39} Therapeutic plasma inamrinone concentrations range from 0.5–7 mcg/mL.^{1 3 21 40}

Dosing generally aimed at maintaining a steady-state plasma concentration of about 3 mcg/mL.^{1 40}

Distribution

Extent

May be distributed to some extent into tissues.^{1 22}

Not known whether inamrinone crosses the blood-brain barrier.³

Not known whether inamrinone crosses the placenta³ or is distributed into milk.^{1 3}

Plasma Protein Binding

Approximately 10–49%.^{1 60}

Elimination

Metabolism

Metabolized in the liver to several metabolites; mainly involves conjugate formation.^{2 25}

Elimination Route

Excreted principally in urine as unchanged drug and metabolites.^{1 3}

Half-life

Biphasic;^{1 22} mean terminal half-life is about 3.6 hours in healthy adults.^{1 22} Terminal half-life averaged 5.8 hours in patients with CHF.¹

Stability

Storage

Parenteral

Injection, for IV use

15–30° C; protect from light.^{1 3} Use diluted solutions within 24 hours.^{1 3 40}

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Sodium chloride 0.45%
Sodium chloride 0.9%1
Incompatible
Dextrose 5% in water1 3 30 40

Drug Compatibility

Admixture CompatibilityHID

Compatible
Propafenone HCl

Y-Site CompatibilityHID

Compatible
Aminophylline
Atropine sulfate
Bivalirudin
Bretylium tosylate
Calcium chloride
Cimetidine HCl
Dexmedetomidine HCI
Digoxin
Dobutamine HCl
Dopamine HCl
Epinephrine HCl
Famotidine
Fenoldopam mesylate
Hetastarch in lactated electrolyte injection (Hextend)
Hydrocortisone sodium succinate
Isoproterenol HCl
Lidocaine HCl
Metaraminol bitartrate
Methylprednisolone sodium succinate
Nitroglycerin
Norepinephrine bitartrate
Phenylephrine HCl
Potassium chloride
Propofol
Propranolol HCl
Remifentanil HCl
Sodium nitroprusside
Verapamil HCl
Incompatible
Furosemide1
Sodium bicarbonate
Variable
Procainamide HCl

ActionsActions

• 
  

  Inhibits cyclic adenosine monophosphate (cAMP) phosphodiesterase activity in cardiac and vascular muscles, resulting in increased cellular concentrations of cAMP;^{1 2 5 8} such increases in cAMP may be associated with increased intracellular ionized calcium and result in increased myocardial contractility.^{1 2 4 5 6 7 8 14 19 64}

  
  


• 
  

  In addition to its inotropic effect, the drug has vasodilatory activity.^{1 2 6 7 8 9 10 11 14 39 48 49 50}

  
  


• 
  

  Increases cardiac output^{1 4 7 8 13 27 30 49 50} and decreases left ventricular end-diastolic pressure,^{4 10 14} pulmonary wedge pressure,^{1 4 7 8 11 13} systemic vascular resistance,^{1 4 7 11} and systemic arterial^{1 4 10 11} and diastolic pressures.^{1 2 11}

  
  


• 
  

  Does not increase myocardial oxygen consumption (MVO₂).⁸

  
  


• 
  

  Heart rate generally remains unchanged^{1 2 4 7 8 11 14} or increases slightly.^{2 10}

  
  


• 
  

  May slightly increase conduction velocity through the AV node.^{1 40}

  
  

Advice to Patients

• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.⁶⁰

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.⁶⁰

  
  


• 
  

  Importance of informing patients of other important precautionary information.⁶⁰ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Inamrinone Lactate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV use only	5 mg (of inamrinone) per mL*	Inamrinone Injection

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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5. Endoh M, Yamashita S, Taira N. Positive inotropic effect of amrinone in relation to cyclic nucleotide metabolism in the canine ventricular muscle. J Pharmacol Exp Ther. 1982; 221:775-83. [PubMed 6283063]

6. Alousi AA, Farah AE, Lesher GY et al. Cardiotonic activity of amrinone—Win 40680 [5-amino-3,4′-bipyridin-6(1H)-one]. Circ Res. 1979; 45:666-77. [PubMed 39684]

7. LeJemtel TH, Keung E, Sonnenblick EH et al. Amrinone: a new non-glycosidic, non-adrenergic cardiotonic agent effective in the treatment of intractable myocardial failure in man. Circulation. 1979; 59:1098-1104. [IDIS 97143] [PubMed 436202]

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28. Siskind SJ, Sonnenblick EH, Forman R et al. Acute substantial benefit of inotropic therapy with amrinone on exercise hemodynamics and metabolism in severe congestive heart failure. Circulation. 1981; 64:966-73. [IDIS 140043] [PubMed 7285310]

29. Klein NA, Siskind SJ, Frishman WH et al. Hemodynamic comparison of intravenous amrinone and dobutamine in patients with chronic congestive heart failure. Am J Cardiol. 1981; 48:170-5. [IDIS 135819] [PubMed 7246440]

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31. Kinney EL, Carlin B, Ballard JO et al. Clinical experience with amrinone in patients with advanced congestive heart failure. J Clin Pharmacol. 1982; 22:433-40. [IDIS 161218] [PubMed 7174853]

32. Wilsmhurst PT, Webb-Peploe MM. Side effects of amrinone therapy. Br Heart J. 1983; 49:447-51. [IDIS 170954] [PubMed 6838732]

33. Dunkman WB, Wilen MW, Franciosa JA. Adverse effects of long-term amrinone administration in congestive heart failure. Am Heart J. 1983; 105:861-3. [IDIS 169792] [PubMed 6846131]

34. Neal WA, Pierpont ME. Effect of amrinone on cardiac function in children with severe congestive heart failure (CHF). Pediatr Res. 1981; 15:469.

35. Sterling Drug Inc. Sterling accelerates milrinone studies and discontinues oral amrinone study in the U.S. New York; 1984 Jan 19. Press release.

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37. Maskin CS, Forman R, Klein NA et al. Long-term amrinone therapy in patients with severe heart failure: drug-dependent hemodynamic benefits despite progression of the disease. Am J Med. 1982; 72:113-8. [IDIS 143619] [PubMed 7058816]

38. Siegel LA, LeJemtel TH, Strom J et al. Improvement in exercise capacity despite cardiac deterioration: noninvasive assessment of long-term therapy with amrinone in severe heart failure. Am Heart J. 1983; 106:1042-7. [IDIS 177941] [PubMed 6416041]

39. Wilmshurst PT, Thompson DS, Juul SM et al. Comparison of the effects of amrinone and sodium nitroprusside on haemodynamics, contractility, and myocardial metabolism in patients with cardiac failure due to coronary artery disease and dilated cardiomyopathy. Br Heart J. 1984; 52:38-48. [IDIS 188232] [PubMed 6743422]

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48. Wilmshurst PT, Walker JM, Fry CH et al. Inotropic and vasodilator effects of amrinone on isolated human tissue. Cardiovasc Res. 1984; 18:302-9. [PubMed 6733734]

49. Reviewers’ comments (personal observations).

50. Konstam MA, Cohen SR, Salem DN et al. Amrinone reduction in left ventricular end-systolic volume: inotrope or vasodilator? Circulation. 1984; 70(Suppl. 2):II-168. Abstract.

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52. Dibianco R, Shabetai R, Silverman BD et al. Oral amrinone for the treatment of chronic congestive heart failure: results of a multicenter randomized double-blind and placebo-controlled withdrawal study. J Am Coll Cardiol. 1984; 4:855-66. [PubMed 6386932]

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54. Baim DS, McDowell AV, Cherniles J et al. Evaluation of a new bipyridine inotropic agent—milrinone—in patients with severe congestive heart failure. N Engl J Med. 1983; 309:748-56. [IDIS 175911] [PubMed 6888453]

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58. Packer M, Carver JR, Rodeheffer RJ et al. Effect of oral milrinone on mortality in severe chronic heart failure: the PROMISE Study Research Group. N Engl J Med. 1991; 325:1468-75. [IDIS 288125] [PubMed 1944425]

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