Ilosone 200/Ilosone DS Warnings

Ilosone DS: Hepatic dysfunction with or without jaundice has occurred chiefly in adults, in association with erythromycin estolate administration. It may be accompanied by malaise, nausea, vomiting, abdominal colic and fever. In some instances, severe abdominal pain may simulate an abdominal surgical emergency. If the previously mentioned findings occur, discontinue erythromycin estolate promptly.
Erythromycin estolate is contraindicated for patients with known history of sensitivity to this drug and for those with pre-existing liver disease.
The administration of erythromycin estolate has been associated with the infrequent occurrence of cholestatic hepatitis. Laboratory findings have been characterized by abnormal hepatic function test values, peripheral eosinophilia, and leukocytosis. Symptoms may include malaise, nausea, vomiting, abdominal cramps, and fever. Jaundice may or may not be present. In some instances severe abdominal pain may simulate the pain of biliary colic, pancreatitis, perforated ulcer, or an acute abdominal surgical problem. In other instances clinical symptoms and results of liver function tests have resembled findings in extrahepatic obstructive jaundice.
Initial symptoms have developed in some cases after a few days of treatment but generally have followed 1 or 2 weeks of continuous therapy. Symptoms reappear promptly, usually within 48 hours after the drug is readministered to sensitive patients. The symptoms seem to result from a form of sensitization, occurs chiefly in adults, and has been reversible when medication is discontinued.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin estolate, and may range in severity from mild to life-threatening. Therefore, it is important to consider the diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, appropriate measures should be taken.
Rhabdomyolysis with or without renal impairment has been reported in patients receiving erythromycin concomitantly with HMG-CoA reductase inhibitors such as lovastatin and simvastatin. Therefore, patients receiving concomitant HMG-CoA reductase inhibitors and erythromycin should be very carefully monitored for creatine kinase (CK) and serum transaminase levels.
Ilosone 200: Concomitant use of CYP3A inhibitors like nitroimidazole antifungals can cause increased serum levels of erythromycin and probably increase the risk of cardiac arrhythmia. However, concurrent use of diltiazem or verapamil with erythromycin should be avoided by persons at risk for heart irregularities or those with long QT manifestations.