VERMOX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VERMOX (VERMOX).
Binds to β-tubulin in parasitic cells, inhibiting microtubule polymerization, thereby impairing glucose uptake and causing energy depletion and parasite death.
| Metabolism | Hepatic metabolism via unidentified enzymes; undergoes extensive first-pass metabolism; metabolites are excreted primarily in bile. |
| Excretion | Fecal (90%) as unchanged drug and metabolites; renal (<10%) |
| Half-life | 2-8 hours (terminal half-life, may be prolonged in hepatic impairment or obstruction) |
| Protein binding | 90-95% (primarily to albumin) |
| Volume of Distribution | 0.5-1.0 L/kg (large Vd indicating extravascular distribution) |
| Bioavailability | Oral: 1-10% (poor and variable due to extensive first-pass metabolism) |
| Onset of Action | Oral: 2-4 hours (paralysis of helminths) |
| Duration of Action | 24-48 hours (continued expulsion of dead worms) |
| Action Class | Cell wall active agent -Extended spectrum Penicillin |
| Brand Substitutes | Cipmox 500 Capsule, Tidoxyl 500mg Capsule, Actimox 500mg Capsule, SB Mox 500mg Capsule, Mitmox 500mg Capsule, Ranoxyl 125mg Syrup, Nodimox 125mg Syrup, Biomoxil 125mg Syrup, Alkamox 125mg Syrup, Swimox 125mg Syrup, Amoxipen 250mg Capsule, Hipen A 250mg Capsule, Moxipal 250mg Capsule, Amoxil 250mg Capsule, Moxikem 250mg Capsule |
Mebendazole 100 mg orally twice daily for 3 days for pinworm, whipworm, hookworm, and roundworm infections. For pinworm, may repeat after 2 weeks. For hookworm and whipworm, may require longer courses.
| Dosage form | TABLET, CHEWABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. Insufficient data for severe renal impairment (GFR <30 mL/min). Caution advised. |
| Liver impairment | Contraindicated in patients with hepatic impairment (Child-Pugh class B or C) due to risk of toxicity. Use with caution in mild impairment (Child-Pugh class A) with monitoring. |
| Pediatric use | Children ≥1 year: 100 mg orally twice daily for 3 days. For children <1 year: not recommended (safety and efficacy not established). |
| Geriatric use | No specific dose adjustment required. Use standard adult dosing with caution for age-related renal/hepatic decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VERMOX (VERMOX).
| Breastfeeding | Mebendazole is excreted into human breast milk in small amounts. M/P ratio not available. Use with caution in nursing mothers; consider risk-benefit due to potential adverse effects in infants. |
| Teratogenic Risk | FDA Pregnancy Category C. Animal studies have shown embryotoxic and teratogenic effects at high doses; no adequate human studies. First trimester: Risk cannot be excluded; use only if clearly needed. Second/third trimester: Limited data suggest no increased risk of major malformations with short-term use. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to mebendazole or any component of the formulation","Pregnancy (especially first trimester)"]
| Precautions | ["Hematologic effects: neutropenia has occurred, especially at high doses; monitor complete blood counts during prolonged therapy.","Gastrointestinal effects: abdominal pain, diarrhea, and nausea may occur, particularly with heavy infections.","Hepatotoxicity: elevated liver enzymes reported; use caution in patients with hepatic impairment.","Hypersensitivity reactions: discontinue if skin rash, urticaria, or erythema multiforme occurs.","Pregnancy: avoid use, especially in first trimester; animal studies have shown embryotoxicity and teratogenicity."] |
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| Fetal Monitoring |
| No specific monitoring required; however, due to potential hepatotoxicity, monitor liver function tests if prolonged use. Fetal ultrasound not routinely indicated unless overdose or toxicity suspected. |
| Fertility Effects | No known adverse effects on fertility in humans. Animal studies at high doses have shown reduced fertility; clinical significance is unknown. |