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. |
| Molecular Weight | 367.46 |
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 | Avoid due to lack of safety data; potential for fetal harm based on animal studies. |
| 2nd trimester | Avoid unless clearly needed; no adequate human studies. |
| 3rd trimester | Avoid due to risk of premature closure of ductus arteriosus and oligohydramnios. |
Clinical note
Comprehensive clinical and safety monograph for DENTIPATCH (DENTIPATCH).
| Placental transfer | Expected to cross placenta due to low molecular weight; documented in animal studies. |
| Breastfeeding | Not recommended; excreted in animal milk, unknown in humans. Potential for serious adverse reactions in nursing infants. |
| Lactation Rating |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to DENTIPATCH or any componentCurrent or recent myocardial infarctionHistory of coronary artery disease
| 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. |
| Food/Dietary | No known food interactions. However, due to anesthetic effect, avoid hot, hard, or sharp-edged foods until sensation returns to prevent oral injury. Avoid alcohol near application site. |
| Clinical Pearls |
Loading safety data…
| L5 - Contraindicated |
| 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. |
| 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. |
| DENTIPATCH is a lidocaine-containing mucoadhesive patch for oral mucosal anesthesia. Onset is within 2-5 minutes; duration up to 45 minutes. Not for use on broken mucosa. Avoid in patients with severe hepatic disease or methemoglobinemia risk. One patch per application, discard after use. |
| Patient Advice | Apply the patch directly to the gum or oral mucosa at the procedure site. · Press firmly for 5 seconds; keep in place for at least 15 minutes before procedure. · Do not chew or swallow the patch. Remove and discard after use. · Numbness may persist for up to 45 minutes after removal; avoid hot foods/liquids. · Do not use if allergic to lidocaine or other amide anesthetics. · Contact clinician if swelling, rash, or difficulty breathing occurs. |