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Pronunciation:

(thye a BEN da zole)

U.S. Brand Names:

Mintezol®

Synonyms:

Tiabendazole

Generic Available:

Use:

Treatment of strongyloidiasis, cutaneous larva migrans, visceral larva migrans, dracunculiasis, trichinosis, and mixed helminthic infections

Use - Unlabeled/Investigational:

Cutaneous larva migrans (topical application)

Pregnancy Risk Factor:

Pregnancy Implications:

Cleft palate and skeletal defects were observed in some animal studies. There are no adequate and well-controlled studies in pregnant women.

Lactation:

Excretion in breast milk unknown/not recommended

Contraindications:

Hypersensitivity to thiabendazole or any component of the formulation; not for use as prophylactic treatment of enterobiasis (pinworm) infestation

Warnings/Precautions:

Use with caution in patients with renal or hepatic impairment, malnutrition or anemia, or dehydration. Causes sedation; caution must be used in performing tasks which require alertness. Not suitable treatment for mixed infections with Ascaris. Ophthalmic changes may occur and persist >1 year. Safety and efficacy are limited in children <14 kg (30 lb).

Adverse Reactions:

Frequency not defined.

Central nervous system: Seizures, hallucinations, delirium, dizziness, drowsiness, headache, chills

Dermatologic: Rash, Stevens-Johnson syndrome, pruritus, angioedema

Endocrine & metabolic: Hyperglycemia

Gastrointestinal: Anorexia, diarrhea, nausea, vomiting, drying of mucous membranes, abdominal pain

Genitourinary: Malodor of urine, hematuria, crystalluria, enuresis

Hematologic: Leukopenia

Hepatic: Jaundice, cholestasis, hepatic failure, hepatotoxicity

Neuromuscular & skeletal: Numbness, incoordination

Ocular: Abnormal sensation in eyes, blurred vision, dry eyes, Sicca syndrome, vision decreased, xanthopsia

Otic: Tinnitus

Renal: Nephrotoxicity

Miscellaneous: Anaphylaxis, hypersensitivity reactions, lymphadenopathy

Overdosage/Toxicology:

Symptoms of overdose include altered mental status and visual problems. Treatment is supportive.

Drug Interactions:

Substrate of CYP1A2 (minor); Inhibits CYP1A2 (strong)

CYP1A2 substrates: Thiabendazole may increase the levels/effects of CYP1A2 substrates. Example substrates include aminophylline, fluvoxamine, mexiletine, mirtazapine, ropinirole, theophylline, and trifluoperazine.

Theophylline: Thiabendazole may decrease theophylline metabolism. Dosage adjustment of theophylline should be considered.

Mechanism of Action:

Inhibits helminth-specific mitochondrial fumarate reductase

Pharmacodynamics/Kinetics:

Absorption: Rapid and well absorbed

Metabolism: Rapidly hepatic; metabolized to 5-hydroxy form

Half-life elimination: 1.2 hours

Time to peak, plasma: Oral suspension: Within 1-2 hours

Excretion: Urine (90%) and feces (5%) primarily as conjugated metabolites

Dosage:

Purgation is not required prior to use; drinking of fruit juice aids in expulsion of worms by removing the mucous to which the intestinal tapeworms attach themselves.

Children and Adults:

Oral: 50 mg/kg/day divided every 12 hours (if >68 kg: 1.5 g/dose); maximum dose: 3 g/day

Treatment duration:

Strongyloidiasis, ascariasis, uncinariasis: For 2 consecutive days

Cutaneous larva migrans: For 2 consecutive days; if active lesions are still present 2 days after completion, a second course of treatment is recommended.

Visceral larva migrans: For 7 consecutive days

Trichinosis: For 2-4 consecutive days; optimal dosage not established

Dracunculosis: 50-75 mg/kg/day divided every 12 hours for 3 days

Topical (unlabeled): Cutaneous larva migrans: Apply directly to larval tracks 2-3 times/day for up to 2 weeks; application frequencies may range from 2-6 times/day. Note: Not available as a topical formulation; oral suspension (10% to 15%) has been used topically, as well as a number of extemporaneous formulations.

Dosing comments in renal/hepatic impairment: Use with caution

Monitoring Parameters:

Periodic renal and hepatic function tests

Patient Education:

Take exactly as directed for full course of medication. Tablets may be chewed, swallowed whole, or crushed and mixed with food. Increase dietary intake of fruit juices. All family members and close friends should also be treated. To reduce possibility of reinfection, wash hands and scrub nails carefully with soap and hot water before handling food, before eating, and before and after toileting. Keep hands out of mouth. Disinfect toilet daily and launder bed lines, undergarments, and nightclothes daily with hot water and soap. Do not go barefoot and do not sit directly on grass or ground. May cause dizziness, fainting, or lightheadedness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or abdominal pain, nausea, dry mouth, or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help). Report skin rash or itching, unresolved diarrhea or vomiting, CNS changes (hallucinations, delirium, acute headache), change in color of urine or stool, or easy bruising or unusual bleeding. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause drowsiness, dizziness, hallucinations, or delirium

Mental Health: Effects on Psychiatric Treatment:

May rarely cause leukopenia; use caution with clozapine and carbamazepine

Dosage Forms:

Suspension, oral: 500 mg/5 mL (120 mL)

Tablet, chewable: 500 mg [orange flavor]

Extemporaneously Prepared:

Topical application of thiabendazole has been recommended for the treatment of cutaneous larva migrans (Redbook, 2003; Med Letter, 2002). In some cases, the commercially-available 10% oral suspension has been used for topical application. Alternatively, a number of extemporaneous preparations have used crushed tablets to prepare distinct formulations. These include a 10% ointment (in white petrolatum), a 15% topical lotion (suspended with compound tragacanth powder 250 mg/40 mL), a 15% cream (in either hydrophilic or fat-based creams), and topical solutions (2% to 4% in DMSO). The stability of these formulations has not been established, and there are no comparative studies evaluating different formulations. All preparations have been applied between 2-6 times daily for up to 2 weeks.

International Brand Names:

Foldan® (AR, BR); Mintezol® (AU, EG, HK, RO, ZA); Soldrin® (CL); Tiabendazole® (CY); Tiafarma® (DO); Triasox® (ES); Tutiverm® (BR)

References

Committee on Infectious Diseases, American Academy of Pediatrics, "Cutaneous Larva Migrans,"Red Book®: 2003 Report of the Committee on Infectious Diseases, 26th ed, Pickering L, ed, Elk Grove Village, IL: American Academy of Pediatrics, 2003, 257.

"Drugs for Parasitic Infections,"Med Lett Drugs Ther, 2002. Available at: http://www.medicalletter.com/freedocs/parasitic.pdf. Accessed September 4, 2003.

Walden J, "Parasitic Diseases. Other Roundworms. Trichuris, Hookworm, and Strongyloides,"Prim Care, 1991, 18(1):53-74.

Zygmunt DJ, "Strongyloides stercoralis,"Infect Control Hosp Epidemiol, 1990, 11(9):495-7.

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