DENTIPATCH
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DENTIPATCH (DENTIPATCH).
Local anesthetic agent that inhibits sodium ion influx into nerve cells, blocking nerve conduction and pain sensation.
| Metabolism | Hepatic metabolism via amidases; excreted renally. |
| Excretion | Approximately 60% of the dose is excreted renally as unchanged drug and metabolites; the remainder is eliminated via biliary/fecal routes. |
| Half-life | Terminal elimination half-life is approximately 7–9 hours; clinically, steady-state is achieved after 2–3 days of daily application. |
| Protein binding | Approximately 90% bound to serum proteins, primarily albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Volume of distribution is approximately 3.5–4.0 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Transdermal patch: Approximately 55–70% bioavailability relative to intravenous administration. |
| Onset of Action | Transdermal: Therapeutic effect observed within 2–4 hours after patch application. |
| Duration of Action | Duration of action is approximately 24 hours after patch application; sustained drug release provides consistent effect over the wearing period. |
Apply one 10 mg/10 cm² transdermal patch to intact skin once daily, typically in the morning; remove after 24 hours and replace with a new patch.
| Dosage form | FILM, EXTENDED RELEASE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (GFR ≥30 mL/min). For severe renal impairment (GFR <30 mL/min) or end-stage renal disease, consider reducing dose or increasing interval; exact modification not established. |
| Liver impairment | In Child-Pugh class A or B: no adjustment needed. Child-Pugh class C: use with caution, starting at lowest effective dose and titrating slowly; reduce dose by 50% if indicated. |
| Pediatric use | Safety and efficacy in pediatric patients (<18 years) not established; not recommended. |
| Geriatric use | Initiate at lowest effective dose (10 mg/10 cm² patch) and titrate slowly to response; monitor for orthostatic hypotension and falls due to increased sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DENTIPATCH (DENTIPATCH).
| Breastfeeding | Lidocaine is excreted into breast milk in small amounts (M/P ratio approximately 0.4-0.6). Infant exposure via topical patch is negligible due to low systemic absorption (4.5% bioavailability). Considered compatible with breastfeeding; however, caution with excessive or prolonged use. Observe infant for sedation or skin irritation. |
| Teratogenic Risk | DENTIPATCH contains lidocaine, a local anesthetic. Lidocaine crosses the placenta. No adequate and well-controlled studies in pregnant women; animal studies show no evidence of teratogenicity. Use during first trimester only if clearly needed. Second and third trimester: potential for fetal bradycardia with systemic absorption. Avoid high doses or prolonged use near term due to possible neonatal CNS depression. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to lidocaine or any component of the formulation; application to large areas of broken or inflamed skin; use in children under 2 years of age without medical advice.
| Precautions | Avoid contact with eyes; do not use for prolonged periods; discontinue if irritation or allergic reaction occurs; caution in patients with methemoglobinemia or G6PD deficiency. |
Loading safety data…
| Fetal Monitoring | Monitor maternal vital signs (BP, HR) and fetal heart rate if systemic toxicity suspected. Assess maternal neurological status for signs of lidocaine toxicity (perioral numbness, tinnitus, seizures). No routine fetal monitoring required with patch use. |
| Fertility Effects | No human data. Animal studies: lidocaine did not impair fertility in rats at doses up to 60 mg/kg/day (equivalent to 1.8× MRHD based on BSA). No known effect on human fertility. |