ILOTYCIN GLUCEPTATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ILOTYCIN GLUCEPTATE (ILOTYCIN GLUCEPTATE).
Erythromycin gluceptate is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, blocking peptide chain elongation.
| Metabolism | Primarily hepatic via CYP3A4; erythromycin is a substrate and inhibitor of CYP3A4. Excretion mainly in bile, with some renal elimination. |
| Excretion | Primarily hepatic metabolism and biliary excretion; about 10-15% excreted unchanged in urine; some fecal elimination due to biliary excretion. |
| Half-life | Terminal elimination half-life is approximately 1.5-2 hours in adults with normal renal function; may be prolonged in hepatic impairment (up to 5-6 hours). |
| Protein binding | Erythromycin is approximately 70-80% bound to plasma proteins, primarily alpha-1-acid glycoprotein. |
| Volume of Distribution | Approximately 0.5-0.7 L/kg, indicating distribution into total body water and moderate tissue penetration. |
| Bioavailability | Intravenous: 100%; intramuscular: approximately 30-40% due to poor absorption; oral (erythromycin base/stearate/estolate): variable 30-65% due to acid instability and first-pass metabolism. |
| Onset of Action | Intravenous: rapid, within 30 minutes after infusion; intramuscular: variable, but clinical effect observed within 1-2 hours. |
| Duration of Action | Intravenous: approximately 6 hours following a single dose; intramuscular: up to 8-12 hours for susceptible organisms. |
Erythromycin gluceptate (Ilotycin Gluceptate) is administered intravenously at a dose of 250-500 mg every 6 hours for adults. Maximum daily dose: 4 g.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment is recommended for renal impairment. However, caution is advised in severe renal dysfunction (CrCl <10 mL/min) due to potential accumulation, and monitoring for adverse effects is recommended. |
| Liver impairment | Contraindicated in patients with pre-existing liver disease or hepatic impairment. Avoid use. If necessary, dose reduction may be considered, but no specific guidelines exist. |
| Pediatric use | Intravenous dose: 15-50 mg/kg/day divided every 6 hours. Maximum daily dose: 50 mg/kg, not to exceed 4 g/day. |
| Geriatric use | No specific dose adjustment is required. However, elderly patients may have reduced renal function and increased risk of QT prolongation; use with caution and monitor ECG. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ILOTYCIN GLUCEPTATE (ILOTYCIN GLUCEPTATE).
| Breastfeeding | Erythromycin is excreted into breast milk in small amounts (M/P ratio approximately 0.5). Generally considered compatible with breastfeeding; however, monitor infant for gastrointestinal disturbances and potential pyloric stenosis. Use with caution if infant has pre-existing GI issues. |
| Teratogenic Risk | Category B: Animal studies have not demonstrated fetal risk, and there are no adequate controlled studies in pregnant women. Erythromycin, including Ilotycin Gluceptate, is generally considered safe in all trimesters when used as indicated. No known teratogenic effects in first trimester; risk of infantile hypertrophic pyloric stenosis (IHPS) if used after second trimester, especially in neonates exposed late in pregnancy or during lactation. |
■ FDA Black Box Warning
Not available
| Serious Effects |
Hypersensitivity to erythromycin or any macrolide antibiotic; concomitant use with terfenadine, astemizole, cisapride, or ergotamine derivatives due to risk of QT prolongation and arrhythmias.
| Precautions | QT prolongation and risk of cardiac arrhythmias (especially torsades de pointes) due to K+ channel blockade; increased risk in elderly, patients with electrolyte disturbances, bradycardia, or concurrent use of other QT-prolonging drugs. Hepatotoxicity; hypersensitivity reactions including anaphylaxis; pseudomembranous colitis; exacerbation of myasthenia gravis; use caution in renal and hepatic impairment. |
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| Fetal Monitoring | No specific maternal-fetal monitoring required beyond routine obstetric care. Monitor for maternal GI intolerance (nausea, vomiting, abdominal cramps) and signs of hepatitis. In neonate, observe for symptoms of IHPS (projectile vomiting) if exposed late in pregnancy. |
| Fertility Effects | No evidence of adverse effects on human fertility. Animal studies have not shown impaired fertility. |