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Pronunciation
(thye a BEN da zole)
U.S. Brand Names
Index Terms
Generic Available
No
Pharmacologic Category
Use: Labeled Indications
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
C
Pregnancy Considerations
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
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Hypersensitivity reactions: Erythema multiforme and Stevens-Johnson syndrome have been reported (including fatalities); discontinue at first sign of reaction.
• Ocular effects: Ophthalmic changes may occur and persist >1 year.
Disease-related concerns:
• Anemia: Use with caution in patients with anemia.
• Ascaris infections: Not suitable treatment for mixed infections with Ascaris.
• Dehydration: Use with caution in patients with dehydration.
• Hepatic impairment: Use with caution in patients with hepatic impairment; jaundice, cholestasis and parenchymal liver damage have occurred.
• Malnutrition: Use with caution in patients with malnutrition.
• Renal impairment: Use with caution in patients with renal impairment.
Special populations:
• Pediatrics: Safety and efficacy are limited in children <14 kg (30 lb).
Adverse Reactions
Frequency not defined.
Central nervous system: Chills, delirium, dizziness, drowsiness, hallucinations, headache, seizure
Dermatologic: Angioedema, pruritus, rash, Stevens-Johnson syndrome
Endocrine & metabolic: Hyperglycemia
Gastrointestinal: Abdominal pain, anorexia, diarrhea, drying of mucous membranes, nausea, vomiting
Genitourinary: Crystalluria, enuresis, hematuria, malodor of urine
Hematologic: Leukopenia
Hepatic: Cholestasis, hepatic failure, hepatotoxicity, jaundice
Neuromuscular & skeletal: Incoordination, numbness
Ocular: Abnormal sensation in eyes, blurred vision, dry eyes, Sicca syndrome, vision decreased, xanthopsia
Otic: Tinnitus
Renal: Nephrotoxicity
Miscellaneous: Anaphylaxis, hypersensitivity reactions, lymphadenopathy
Metabolism/Transport Effects
Substrate of CYP1A2 (minor); Inhibits CYP1A2 (strong)
Drug Interactions
Aminoquinolines (Antimalarial): May decrease the serum concentration of Anthelmintics. Risk C: Monitor therapy
Bendamustine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Bendamustine. Concentrations of the active metabolites of bendamustine may be decreased. Risk C: Monitor therapy
CYP1A2 Substrates: CYP1A2 Inhibitors (Strong) may decrease the metabolism of CYP1A2 Substrates. Risk D: Consider therapy modification
Theophylline Derivatives: Thiabendazole may decrease the metabolism of Theophylline Derivatives. Exceptions: Dyphylline. Risk D: Consider therapy modification
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 linens, 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
Key adverse event(s) related to dental treatment: Drying of mucous membranes.
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
Nursing: Physical Assessment/Monitoring
Worm infestations are easily transmitted, all close family members should be treated. Instruct patient/caregiver on appropriate use, transmission prevention, possible side effects/appropriate interventions, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension, oral: 500 mg/5 mL (120 mL) [DSC]
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.
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.
International Brand Names
Lexi-Comp.com
Last full review/revision January 2009
Content last modified January 2009
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