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Inocor I V Side Effects

Generic Name: inamrinone

Note: This page contains information about the side effects of inamrinone. Some of the dosage forms included on this document may not apply to the brand name Inocor I V.

For the Consumer

Applies to inamrinone: parenteral injection for iv use

Side effects include:

Thrombocytopenia, arrhythmias, hypotension, nausea, vomiting, fever.

For Healthcare Professionals

Applies to inamrinone: intravenous solution

Hematologic

A potentially serious hematologic abnormality is thrombocytopenia. Reduced platelet counts have been seen in 20% to 46% of patients, but were rarely symptomatic. Thrombocytopenia appears to be related to the total daily dose and duration of infusion and generally has resolved within 2 to 4 days following amrinone withdrawal.

Rare cases of hemorrhagic pericardial effusions and splenomegaly have been associated with inamrinone-induced thrombocytopenia.[Ref]

Thrombocytopenia may not necessitate drug discontinuation. It is recommended that patients whose platelet count is less than 150,000/mm3 be carefully monitored.

There is limited evidence to support either a direct drug-associated platelet effect or platelet destruction due to an IgG antiplatelet antibody. The exact mechanism is not known.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension, arrhythmias, and heart failure. Infusion-related hypotension occurred in 1% to 3% of patients. New cases of sustained atrial and ventricular arrhythmias or worsened congestive heart failure have been reported in 9% of patients. Some data are from uncontrolled studies and a casual relationship may be difficult to determine due to the serious underlying cardiac disease of the study population. Chest pain is reported in 0.2% of patients.[Ref]

Gastrointestinal

Gastrointestinal symptoms of general abdominal pain, anorexia, diarrhea, nausea, or vomiting have occurred in up to 27% of patients. Rare complaints of smell or taste loss have been reported.[Ref]

Nervous system

Nervous system side effects have included dizziness, headache, lightheadedness, or paresthesias in approximately 20% of patients. Somnolence and fatigue are reported in 3% and 15% of patients, respectively.[Ref]

Dermatologic

Dermatologic side effects have included skin dryness and yellow nail discoloration.[Ref]

Hepatic

Hepatic toxicity has been reported after long-term oral use of inamrinone (the active ingredient contained in Inocor I V) In a study of 173 patients, approximately 20% developed elevated serum SGOT or LDH levels. Hepatotoxicity associated with short-term intravenous use has occurred rarely. Elevations in bilirubin and jaundice have been reported.[Ref]

Cases of reproducible and reversible hepatitis have been associated with inamrinone use. In some cases, elevated serum transaminases and LDH were accompanied by bilateral pulmonary infiltrates and eosinophilia suggestive of an allergic drug reaction.[Ref]

Hypersensitivity

Hypersensitivity to amrinone may present as a generalized viral-like syndrome characterized by myalgias, arthralgias, and fever. This syndrome may be accompanied by myositis, diffuse pulmonary infiltrates, pruritus, and confusion.[Ref]

Respiratory

Respiratory infections have been reported in up to 22% of patients.[Ref]

Local

Local intravenous site injection pain has been reported in 0.2% of patients. This may be minimized by diluting the inamrinone (the active ingredient contained in Inocor I V) infusate in normal or half-normal saline to a final concentration of 1 to 3 mg/mL.[Ref]

References

1. DiBianco R, Shabetai R, Silverman BD, Leier CV, Benotti JR "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 4 (1984): 855-66

2. Dunkman WB, Wilen MM, Franciosa JA "Adverse effects of long-term amrinone administration in congestive heart failure." Am Heart J 105 (1983): 861-3

3. Bottorff MB, Rutledge DR, Pieper JA "Evaluation of intravenous amrinone: the first of a new class of positive inotropic agents with vasodilator properties." Pharmacotherapy 5 (1985): 227-37

4. Robinson PJ, Lvoff R, Chong B, Barrett PA "Amrinone--a new inotropic agent in chronic resistant congestive cardiac failure." Aust N Z J Med 11 (1981): 666-8

5. "Product Information. Inocor (inamrinone)." Sanofi Winthrop Pharmaceuticals, New York, NY.

6. Ward A, Brogden RN, Heel RC, Speight TM, Avery GS "Amrinone: a preliminary review of its pharmacological properties and therapeutic use." Drugs 26 (1983): 468-502

7. Treadway G "Clinical safety of intravenous amrinone--a review." Am J Cardiol 56 (1985): b39-40

8. Brandt JT, Miller L, Hermiller J, Unverferth DV, Leier CV "Effect of oral amrinone on platelet function and survival." Clin Pharmacol Ther 36 (1984): 260-4

9. Rubin SA, Lee S, O'Connor L, Hubenette A, Tober J, Swan HJ "Thrombocytopenia and fever in a patient taking amrinone." N Engl J Med 301 (1979): 1185

10. Wilmshurst PT, Thompson DS, Juul SM, Jenkins BS, Coltart DJ, Webb-Peploe MM "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 dilatedcardiomyopathy." Br Heart J 52 (1984): 38-48

11. Packer M, Medina N, Yushak M "Hemodynamic and clinical limitations of long-term inotropic therapy with amrinone in patients with severe chronic heart failure." Circulation 70 (1984): 1038-47

12. Wilmshurst PT, Al-Hasani SF, Semple MJ, Hamblin AS, Kioy PG, Lucas GF, Savidge GF, Webb-Peploe MM "The effects of amrinone on platelet count, survival and function in patients with congestive cardiac failure." Br J Clin Pharmacol 17 (1984): 317-24

13. Silverman B, Merrill A, Gerber L "Clinical effects and side effects of amrinone. A study of 24 patients with chronic congestive heart failure." Arch Intern Med 145 (1985): 825-9

14. Ansell J, Tiarks C, McCue J, Parrilla N, Benotti J "Amrinone-induced thrombocytopenia." Arch Intern Med 144 (1984): 949-52

15. Gilman ME, Margolis SC "Amrinone-induced hepatotoxicity." Clin Pharm 3 (1984): 422-4

16. Hermiller JB, Leithe ME, Magorien RD, Unverferth DV, Leier CV "Amrinone in severe congestive heart failure: another look at an intriguing new cardioactive drug." J Pharmacol Exp Ther 228 (1984): 319-26

17. Benotti JR, Grossman W, Braunwald E, Davolos DD, Alousi AA "Hemodynamic assessment of amrinone. A new inotropic agent." N Engl J Med 299 (1978): 1373-7

Not all side effects for Inocor I V may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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