DYCLONE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DYCLONE (DYCLONE).
Local anesthetic that stabilizes the neuronal membrane by inhibiting sodium ion influx, thereby blocking impulse initiation and conduction.
| Metabolism | Primarily hydrolyzed by plasma pseudocholinesterase; hepatic metabolism minor. |
| Excretion | Renal: <5% unchanged; Biliary/fecal: negligible; primarily metabolized in liver, metabolites excreted renally. |
| Half-life | Approximately 2-4 hours; clinical context: rapid clearance limits systemic accumulation with topical use. |
| Protein binding | ~85% bound to plasma proteins (albumin and α1-acid glycoprotein). |
| Volume of Distribution | ~1.7 L/kg; indicates extensive tissue distribution. |
| Bioavailability | Topical: minimal systemic absorption (<10% depending on site); oral: not available; intravenous: 100%. |
| Onset of Action | Topical: within 2-5 minutes; local infiltration: immediate. |
| Duration of Action | Topical: 20-30 minutes for anesthesia; clinical note: rapid onset but short duration, suitable for minor procedures. |
0.5% to 1% solution: 2 mL (10 mg) applied topically to the affected area q4h prn; may be used as a rinse or spray.
| Dosage form | SOLUTION |
| Renal impairment | No dosage adjustment required for renal impairment; systemic absorption is negligible. |
| Liver impairment | No dosage adjustment required for hepatic impairment; local use only. |
| Pediatric use | Safety and efficacy in pediatric patients (<12 years) not established; use with caution at lowest effective dose. |
| Geriatric use | No specific geriatric dose adjustments recommended; use cautiously due to potential increased sensitivity and dry mouth. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DYCLONE (DYCLONE).
| Breastfeeding | Excretion into breast milk unknown. Risk likely low with topical application, but avoid nursing on treated areas. M/P ratio not available. |
| Teratogenic Risk | Category C: No adequate studies in pregnant women. Animal studies have not been reported. First trimester risk unknown; second and third trimester risk minimal if used topically as directed, but systemic absorption may cause fetal bradycardia. Avoid use near term due to potential for neonatal respiratory depression. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to dyclonine or other local anesthetics of the ester type","History of allergic reactions to parabens (cross-sensitivity)"]
| Precautions | ["Rapid absorption can lead to systemic toxicity including CNS and cardiovascular effects","Use with caution in patients with impaired liver function or pseudocholinesterase deficiency","Avoid application to broken or irritated skin"] |
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| Monitor maternal heart rate and blood pressure during prolonged use. Fetal heart rate monitoring if maternal systemic effects (e.g., arrhythmias) occur. No routine fetal monitoring required for topical use. |
| Fertility Effects | No known effects on fertility in humans. Animal studies not reported. |