INDICATIONS AND CLINICAL USE:
Erythrocin® I.V. (erythromycin lactobionate injection) should be used in the treatment of patients when oral administration is not possible or when it is desirable to obtain higher serum levels of erythromycin than achievable with orally administered preparations. Intravenous erythromycin should be replaced by an oral form of erythromycin as soon as possible.
Erythromycin is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Lower respiratory tract infections of mild to moderate severity caused by S. pyogenes (Group A beta-hemolytic streptococci), S. pneumoniae and M. pneumoniae.
|2.||Skin and soft tissue infections of mild to moderate severity caused by S. pyogenes and S. aureus.|
|N.B.||Resistance of staphylococci may emerge during treatment.|
Legionnaires' disease caused by L. pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited clinical data suggest that erythromycin can be effective in treating Legionnaires' disease. Clinical evidence suggests that erythromycin is the preferred antibiotic for treating Legionnaires' Diseases.
|4.||Erythromycin should not be used for the treatment of syphilis in pregnancy because it cannot be relied upon to cure an infected fetus (see PRECAUTIONS, Pregnancy).|
Erythromycin is contraindicated in patients with known hypersensitivity to erythromycin, clarithromycin or other macrolide antibacterial agents. Erythromycin is also contraindicated as concurrent therapy with astemizole*, terfenadine*, cisapride*, pimozide, and ergotamine or dihydroergotamine Please see complete precautions ( Drug interactions) and full prescribing information in the Product Monograph for further information.
Erythromycin lactobionate I.V. must be administered by continuous or intermittent intravenous infusion only. I.V. bolus/push is an unacceptable route of administration.
* Astemizole, terfenadine and cisapride are no longer marketed in Canada.
Erythromycin should be administered with caution to any patient who has demonstrated some form of allergy to drugs. If an allergic reaction to erythromycin occurs, administration of the drug should be discontinued. Serious hypersensitivity reactions may require epinephrine, antihistamines, or corticosteroids.
Hepatic dysfunction, including increased liver enzymes and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin. If findings suggestive of significant hepatic dysfunction occur, therapy with erythromycin products should be discontinued.
There have been reports suggesting erythromycin does not reach the fetus in adequate concentrations to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.
Prolonged QTc interval and ventricular arrhythmias have rarely been reported in patients receiving erythromycin IV.
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin.
Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including Erythrocin® I.V. Please see complete warnings and full prescribing information for further information.
Adverse reactions reported have included Gastrointestinal (Abdominal cramping, discomfort), Hepatotoxicity (Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur) Pancreatitis (rare), Allergic reactions ( Urticaria, mild skin eruptions and anaphylaxis) Cardiovascular (Occasional case reports of cardiac arrhythmias such as ventricular tachycardia have been documented in patients receiving erythromycin therapy) Neurological (Central nervous system side effects including seizures, hallucinations, confusion, vertigo and tinnitus have been reported occasionally in patients; however, a cause and effect relationship has not been established and others of a miscellaneous nature.
The above is not a complete list of adverse reactions reported with the use of Erythrocin® I.V. For a complete list of adverse reactions reported with the use of Erythrocin® I.V. please consult the Product Monograph.
Erythrocin® I.V. (erythromycin lactobionate injection) is available in Fliptop vials that contain a soluble salt of erythromycin without preservative suitable for intravenous administration. Each Fliptop vial contains 500 mg or 1 g erythromycin base in the form of erythromycin lactobionate for injection as sterile lyophilized powder. They are available in packages of 10 vials.
Erythrocin® I.V. 500 mg - DIN: 00682268
Erythrocin® I.V. 1 g - DIN: 00682276
For full prescribing information please refer to the Product Monograph.