SCANDONEST PLAIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SCANDONEST PLAIN (SCANDONEST PLAIN).
Scandonest Plain (mepivacaine) is an amide-type local anesthetic that stabilizes neuronal membranes by binding to voltage-gated sodium channels, inhibiting sodium influx and blocking nerve impulse conduction.
| Metabolism | Hepatic metabolism primarily via CYP1A2 and to a lesser extent CYP3A4; undergoes N-demethylation to inactive metabolites. |
| Excretion | Renal excretion of unchanged drug and metabolites accounts for >95% of elimination; approximately 80% as unchanged mepivacaine and 15% as N-demethylated metabolites; biliary/fecal excretion minimal (<5%). |
| Half-life | Terminal elimination half-life: 1.9–3.2 hours in healthy adults; prolonged to 6–8 hours in hepatic impairment or severe renal disease; clinically meaningful for redosing intervals. |
| Protein binding | Approximately 75–80% bound to plasma proteins, primarily alpha-1-acid glycoprotein and albumin. |
| Volume of Distribution | Volume of distribution: 1–2 L/kg at steady state (Vdss); high Vd indicates extensive tissue distribution, binding to skeletal muscle and adipose tissue. |
| Bioavailability | Bioavailability: 100% following intravenous administration; oral bioavailability not applicable due to extensive first-pass hepatic metabolism (and not used orally). |
| Onset of Action | Onset of clinical effect: infiltration 1–2 minutes; peripheral nerve block 5–15 minutes; epidural 10–20 minutes. |
| Duration of Action | Duration of clinical effect: infiltration 1.5–3 hours; peripheral nerve block 2–4 hours; epidural 1.5–3 hours (dose-dependent and without epinephrine). |
Dental infiltration: 1-2 mL (20-40 mg mepivacaine). Nerve block: 2-4 mL (40-80 mg). Max dose: 400 mg (approx 7 mg/kg). Do not repeat within 2 hours.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment recommended; use with caution in severe renal impairment (CrCl <30 mL/min) due to potential accumulation of metabolites. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose by 50%. Child-Pugh C: Avoid use or use with extreme caution, monitoring for toxicity. |
| Pediatric use | Infiltration or block: Up to 4.4-5.0 mg/kg (max 300 mg). Adjust based on age/weight; reduce doses in younger children. |
| Geriatric use | Reduce initial dose by 20-30% due to decreased clearance and increased sensitivity; monitor for prolonged effect or toxicity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SCANDONEST PLAIN (SCANDONEST PLAIN).
| Breastfeeding | Excreted in breast milk in small amounts. M/P ratio not determined. Consider benefits of breastfeeding and importance of drug to mother. Monitor infant for signs of local anesthetic toxicity (e.g., irritability, drowsiness). |
| Teratogenic Risk | FDA Pregnancy Category C. No adequate and well-controlled studies in pregnant women. Animal studies have shown fetal harm. Risk cannot be ruled out. First trimester: Limited data, but potential for teratogenicity based on animal studies. Second and third trimesters: May cause fetal bradycardia and acidosis. Use only if benefit outweighs risk. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to mepivacaine or other amide-type local anesthetics","Severe hypotension or cardiogenic shock","Paracervical block in obstetric procedures (due to risk of fetal bradycardia)","Severe hepatic disease"]
| Precautions | ["Risk of methemoglobinemia, especially in patients with glucose-6-phosphate dehydrogenase deficiency or concurrent use of oxidizing agents","Systemic toxicity can occur if high doses are inadvertently administered intravascularly","Use with caution in patients with hepatic impairment, as metabolism may be reduced","May cause allergic reactions in patients with amide-type local anesthetic hypersensitivity","Avoid use in patients with severe shock or heart block"] |
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| Fetal Monitoring | Monitor maternal vital signs (heart rate, blood pressure), fetal heart rate (continuous electronic monitoring for signs of bradycardia), and maternal ECG for arrhythmias. Assess for signs of systemic toxicity (e.g., neurological symptoms, seizures). |
| Fertility Effects | No specific data on human fertility. Animal studies did not show impaired fertility at clinically relevant doses. Theoretical risk based on anesthetic effects on sperm or oocyte function is low. |