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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
Brands: Inocor

Warning(s)

Special Alerts:

Bedford discontinued inamrinone in May, 2011 to concentrate on the manufacturing of other products. There are no alternative manufacturers of inamrinone injection.

Introduction

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

Uses for Inamrinone Lactate

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.)

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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 resistance66

Inamrinone Lactate 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 Inamrinone Lactate

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 results1 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 Inamrinone Lactate

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

Inamrinone Lactate 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 CompatibilityHID

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

Actions

  • 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 output1 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 arterial1 4 10 11 and diastolic pressures.1 2 11

  • Does not increase myocardial oxygen consumption (MVO2).8

  • Heart rate generally remains unchanged1 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

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 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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2. Ward A, Brogden RN, Heel RC et al. Amrinone: a preliminary review of its pharmacological properties and therapeutic use. Drugs. 1983; 26:468-502. [IDIS 178951] [PubMed 6360634]

3. Winthrop-Breon Laboratories. Inocor I.V. (amrinone) product information form. New York; 1984 Aug.

4. Benotti JR, Grossman W, Braunwald E et al. Hemodynamic assessment of amrinone. N Engl J Med. 1978; 299:1373-7. [IDIS 91443] [PubMed 714115]

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]

8. Winthrop-Breon Laboratories. Inocor I.V. (amrinone): summary clinical experience. New York; 1984 Aug.

9. Meisheri KD, Palmer RF, Van Breeman C. The effects of amrinone on contractility, Ca2+ uptake and cAMP in smooth muscle. Eur J Pharmacol. 1980; 61:159-65. [PubMed 6243565]

10. Wilmshurst PT, Thompson DS, Jenkins BS et al. Haemodynamic effects of intravenous amrinone in patients with impaired left ventricular function. Br Heart J. 1983; 49:77-82. [IDIS 165942] [PubMed 6821613]

11. Hermiller JB, Leithe ME, Magorien RD et al. Amrinone in severe congestive heart failure: another look at an intriguing new cardioactive drug. J Pharmacol Exp Ther. 1984; 228:319-26. [IDIS 181940] [PubMed 6694112]

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14. Jentzer JH, LeJemtel TH, Sonnenblick EH et al. Beneficial effect of amrinone on myocardial oxygen consumption during acute left ventricular failure in dogs. Am J Cardiol. 1981; 48:75-83. [PubMed 7246447]

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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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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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49. Reviewers’ comments (personal observations).

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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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60. Bedford Laboratories. Inamrinone injection prescribing information. Bedford, OH; 2000 July.

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62. Antman EM, Anbe DT, Armstrong PW et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of patients with acute myocardial infarction). J Am Coll Cardiol. 2004; 4:E1-211.

63. Hunt SA, Baker DW, Chin MH et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol. 2001; 38:2101-13. From website. [IDIS 474368] [PubMed 11738322]

64. White CM, Chow MSS. The role of positive inotropic agents in severe congestive heart failure. Formulary. 1997; 32:255-66.

65. Fogg KJ, Royston D. Improved performance with single dose phosphodiesterase inhibitor? Br J Anaesth. 1998; 81:663-6.

66. The American Heart Association. Guidelines 2005 for cardiopulmonary resuscitation and emergency cardiovascular care. 2005; 112 (Suppl): IV1-211.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:936-9.

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