TAO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TAO (TAO).
Troleandomycin (TAO) is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide chain elongation.
| Metabolism | Primarily hepatic via cytochrome P450 3A4 (CYP3A4); inhibits CYP3A4, leading to drug interactions. |
| Excretion | Primarily hepatic metabolism with <10% excreted unchanged in urine; approximately 30% excreted in feces via bile. |
| Half-life | Terminal elimination half-life of 12-24 hours in adults; may be prolonged in hepatic impairment (up to 40-60 hours) and in neonates (2-5 days). |
| Protein binding | 92-94% primarily to albumin and α1-acid glycoprotein. |
| Volume of Distribution | 0.5-0.8 L/kg, indicating moderate tissue distribution. |
| Bioavailability | Oral: 30-40% (variable due to first-pass metabolism); intramuscular: 70-80%. |
| Onset of Action | Oral: 1-2 hours; intravenous: within 30 minutes; topical: several hours to days for effect. |
| Duration of Action | Oral: 6-12 hours; IV: 8-12 hours; duration may be extended in hepatic dysfunction. |
250-500 mg orally every 6 hours or 500 mg intravenously every 6 hours. For severe infections, up to 500 mg every 6 hours IV.
| Dosage form | SUSPENSION |
| Renal impairment | CrCl 10-50 mL/min: administer 250 mg every 6-8 hours or 500 mg every 12 hours. CrCl <10 mL/min: 250 mg every 12 hours or 500 mg every 24 hours. |
| Liver impairment | Child-Pugh Class A: no adjustment. Class B: reduce dose by 50% or extend interval to every 8-12 hours. Class C: avoid use or reduce dose by 75% with monitoring. |
| Pediatric use | Neonates: 20-30 mg/kg/day divided every 12 hours. Infants/children: 40-50 mg/kg/day orally divided every 6 hours or 30-40 mg/kg/day IV divided every 6 hours. |
| Geriatric use | Initiate at lower end of dosing range (250 mg every 6 hours) and adjust based on renal function; monitor for QT prolongation and electrolyte disturbances. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TAO (TAO).
| Breastfeeding | Excreted in human milk in low amounts; M/P ratio not reported. Short-term use considered compatible with breastfeeding. Monitor infant for diarrhea, rash, or feeding intolerance. |
| Teratogenic Risk | Troleandomycin (TAO) is a macrolide antibiotic. Limited human data; animal studies show no teratogenicity. FDA Category C. First trimester: theoretical risk, avoid unless essential. Second and third trimesters: generally considered safe, but use only if clearly needed due to potential maternal hepatotoxicity. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to troleandomycin or other macrolides","Pre-existing liver disease or hepatic impairment","Concurrent use with CYP3A4 substrates with narrow therapeutic index (e.g., ergotamine, pimozide, cisapride)"]
| Precautions | ["Hepatotoxicity: elevated liver enzymes, jaundice; discontinue if signs of liver injury","QT prolongation: risk of cardiac arrhythmias, especially with other QT-prolonging drugs","Drug interactions: potent CYP3A4 inhibitor; avoid with certain statins, ergot alkaloids, and other CYP3A4 substrates"] |
Loading safety data…
| Monitor liver function tests (ALT, AST, bilirubin) in pregnant women due to risk of cholestatic hepatitis. Fetal ultrasound may be considered for prolonged therapy. |
| Fertility Effects | No known adverse effects on fertility in humans or animal studies. |