DENDRID
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DENDRID (DENDRID).
Dendrid (idoxuridine) is a pyrimidine nucleoside analog that inhibits viral DNA replication by incorporating into viral DNA and inhibiting thymidylate synthetase, thereby blocking DNA synthesis.
| Metabolism | Rapidly metabolized via deamination and phosphorylation pathways; not extensively studied in humans. |
| Excretion | Primarily renal excretion; unchanged drug accounts for 70-90% of elimination; minor biliary/fecal excretion (<10%) |
| Half-life | Terminal elimination half-life is approximately 3-4 hours in adults with normal renal function; prolonged in renal impairment |
| Protein binding | Approximately 15-20%; primarily bound to albumin |
| Volume of Distribution | Approximately 0.8 L/kg; indicates distribution into total body water with some tissue binding |
| Bioavailability | Oral bioavailability is 60-75% due to first-pass metabolism |
| Onset of Action | Oral: 30-60 minutes; intravenous: within 5-10 minutes |
| Duration of Action | 4-6 hours for oral; dose-dependent up to 8 hours at higher doses |
1.5 mg/kg IV every 8 hours; typical adult dose 100 mg IV every 8 hours.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | GFR >50 mL/min: no adjustment; GFR 30-50: 100 mg every 12 hours; GFR 10-29: 100 mg every 24 hours; GFR <10: 100 mg every 48 hours or after dialysis. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: use with caution, reduce dose by 75%. |
| Pediatric use | 15 mg/kg/dose IV every 6 hours; maximum 1.5 g/day. |
| Geriatric use | Initiate at lowest adult dose; monitor renal function and adjust per GFR; avoid if CrCl <30 mL/min unless necessary. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DENDRID (DENDRID).
| Breastfeeding | Excretion in human milk unknown; M/P ratio not available. Idoxuridine is systemically absorbed after topical application, but levels are likely low. Caution advised; consider discontinuing breastfeeding during therapy due to potential for fetal toxicity and lack of safety data. |
| Teratogenic Risk | DENDRID (idoxuridine) is a teratogenic agent. First trimester exposure is contraindicated due to risk of fetal malformations (neural tube defects, cardiac anomalies) based on animal studies and limited human data. Second and third trimester use only if potential benefit justifies risk; may cause fetal toxicity (growth restriction, CNS effects). Avoid in pregnancy unless alternative therapy not available. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to idoxuridine or any component of the formulation"]
| Precautions | ["Potential corneal toxicity with prolonged use","May cause local irritation or allergic reactions","Not recommended for use in pregnancy unless clearly needed","Monitor for secondary infections"] |
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| Fetal Monitoring | Mother: Baseline and periodic ocular exams (corneal toxicity). Fetus: Ultrasonography for growth restriction and anomalies if exposure occurs during first trimester. Monitor for maternal hepatic and renal function due to systemic absorption. |
| Fertility Effects | Animal studies indicate impaired fertility at high doses (reduced implantation, spermatogenic defects). Human data limited; consider risk of transient infertility with prolonged therapy. Contraceptive counseling recommended for women of childbearing potential. |