EMVERM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EMVERM (EMVERM).
Mebendazole binds to tubulin, inhibiting microtubule polymerization, which disrupts glucose uptake and causes energy depletion leading to parasite death.
| Metabolism | Primarily hepatic; metabolized by microsomal enzymes (CYP450) to major metabolite 2-aminomebendazole, which is less active; also undergoes further metabolism. |
| Excretion | Primarily fecal (approx. 90%) as unchanged drug and metabolites; <10% excreted renally. |
| Half-life | 2-8 hours; clinical context: the short half-life supports once-daily dosing; metabolites may persist longer. |
| Protein binding | ~90-95% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | ~1-2 L/kg; indicates extensive tissue distribution. |
| Bioavailability | Oral: ~22-40% due to first-pass metabolism; improved with food. |
| Onset of Action | Oral: onset of clinical effect (parasite elimination) within 24-48 hours; tablets may produce effect within hours due to local action. |
| Duration of Action | Single dose provides clinical cure in most cases, but a second dose after 2 weeks is often recommended due to possible reinfection; duration of drug action is about 24-48 hours. |
Mebendazole 100 mg orally twice daily for 3 days for adults and children over 2 years.
| Dosage form | TABLET, CHEWABLE |
| Renal impairment | No adjustment required for mild to moderate renal impairment. Not studied in severe renal impairment (CrCl <30 mL/min); use with caution. |
| Liver impairment | No adjustment for mild (Child-Pugh A) or moderate (Child-Pugh B) impairment. Avoid use in severe hepatic impairment (Child-Pugh C) due to increased risk of toxicity. |
| Pediatric use | Children ≥2 years: 100 mg orally twice daily for 3 days. Children <2 years: safety not established; use only if potential benefit outweighs risk. |
| Geriatric use | No specific adjustment required; use standard adult dosing. Monitor for adverse effects due to potential age-related renal or hepatic decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EMVERM (EMVERM).
| Breastfeeding | Excretion in human milk unknown. Caution should be exercised when administered to a nursing woman. M/P ratio not available. |
| Teratogenic Risk | FDA Pregnancy Category C. Animal studies have shown embryotoxicity and teratogenicity at high doses. Human data are limited; therefore, use during pregnancy only if clearly needed. Risk cannot be ruled out, especially in the first trimester. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to mebendazole or any component of the formulation","Absolute contraindication: Known hypersensitivity"]
| Precautions | ["Risk of neutropenia and agranulocytosis, especially with high doses or prolonged use","May cause bone marrow suppression; monitor blood counts in prolonged therapy","Hepatotoxicity reported; use caution in hepatic impairment","Seizures have occurred, particularly in patients with history of seizures","Not recommended in pregnancy (pregnancy category C); embryotoxic and teratogenic in animals"] |
Loading safety data…
| No specific maternal or fetal monitoring required; however, assess for hypersensitivity reactions or GI adverse effects. In pregnant women, consider ultrasound if exposure occurs in first trimester. |
| Fertility Effects | Animal studies have reported no adverse effects on fertility at therapeutic doses. Human data are insufficient to determine effects on fertility. |