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 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 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 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
|
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 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
|
|
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.
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