Thiabendazole (Mintezol)
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Thiabendazole (Mintezol)

Mintezol®
(thiabendazole) Chewable Tablets And Suspension

DRUG DESCRIPTION

MINTEZOL (Thiabendazole) is an anthelmintic provided as 500 mg chewable tablets, and as a suspension, containing 500 mg thiabendazole per 5 mL. The suspension also contains sorbic acid 0.1% added as a preservative. Inactive ingredients in the tablets are acacia, calcium phosphate, flavors, lactose, magnesium stearate, mannitol, methylcellulose, and sodium saccharin. Inactive ingredients in the suspension are an antifoam agent, flavors, polysorbate, purified water, sorbitol solution, and tragacanth.

Thiabendazole is a white to off-white odorless powder with a molecular weight of 201.26, which is practically insoluble in water but readily soluble in dilute acid and alkali. Its chemical name is 2-(4-thiazolyr)-1/-/-benzimidazole. The empirical formula is C10H7N3S and the structural formula is:

MINTEZOL (Thiabendazole) structural formula illustration

What are the possible side effects of thiabendazole (Mintezol)?

Stop taking thiabendazole and seek emergency medical attention if you experience an allergic reaction (swelling of the lips, tongue, or face; shortness of breath; closing of the throat; or hives).

Rarely, other serious side effects can occur. Stop taking thiabendazole and contact your doctor if you experience

  • seizures;
  • behavior or personality changes;
  • skin rash;
  • vision changes; or
  • yellowing of the skin or eyes.

Other, less serious side effects may be more likely to occur. Continue to take thiabendazole and talk to your doctor if...

Read All Potential Side Effects and See Pictures of Mintezol »

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

MINTEZOL (thiabendazole) is indicated for the treatment of: Strongyloidiasis (threadworm) Cutaneous larva migrans (creeping eruption) Visceral larva migrans

Trichinosis: Relief of symptoms and fever and a reduction of eosinophilia have followed the use of MINTEZOL (thiabendazole) during the invasion stage of the disease.

Thiabendazole is usually inappropriate as first line therapy for enterobiasis (pinworm). However, when enterobiasis occurs with any of the conditions listed above, additional therapy is not required for most patients.

MINTEZOL (thiabendazole) should be used only in the following infestations when more specific therapy is not available or cannot be used or when further therapy with a second agent is desirable: Uncinariasis (hookworm: Necator americanus and Ancylostoma duodenale); Trichuriasis (whipworm); Ascariasis (large roundworm).

DOSAGE AND ADMINISTRATION

The recommended maximum daily dose of MINTEZOL (thiabendazole) is 3 grams.

MINTEZOL (thiabendazole) should be given after meals if possible. Tablets MINTEZOL (thiabendazole) should be chewed before swallowing. Dietary restriction, complementary medications and cleansing enemas are not needed.

The usual dosage schedule for all conditions is two doses per day. The dosage is determined by the patient's weight.

A weight-dose chart follows:

Weight Each Dose
g mL
30 lb 0.25 (½ tablet) 2.5 (½ teaspoon)
50 lb 0.5 (1 tablet) 5.0 (1 teaspoon)
75 lb 0.75 (1½ tablets) 7.5 (1½ teaspoons)
100 lb 1.0 (2 tablets) 10.0 (2 teaspoons)
125 lb 1.25 (2½ tablets) 12.5 (2½ teaspoons)
150 lb & over 1.5 (3 tablets) 15.0 (3 teaspoons)

The regimen for each indication follows:

Therapeutic Regimens

Indication Regimen Comments
**STRONGYLOIDIASIS 2 doses per day for 2 successive days. A single dose of 20 mg/lb or 50 mg/kg may be employed as an alternative schedule, but a higher incidence of side effects should be expected.
CUTANEOUS LARVA MIGRANS (Creeping Eruption) 2 doses per day for 2 successive days. If active lesions are still present 2 days after completion of therapy, a second course is recommended.
VISCERAL LARVA MIGRANS 2 doses per day for 7 successive days. Safety and efficacy data on the seven-day treatment course are limited.
**TRICHINOSIS 2 doses per day for 2-4 successive days according to the response of the patient. The optimal dosage for the treatment of trichinosis has not been established.
Other IndicationsIntestinal roundworms (including Ascariasis, Uncinariasis and Trichuriasis) 2 doses per day for 2 successive days. A single dose of 20 mg/lb or 50 mg/kg may be employed as an alternative schedule, but a higher incidence of side effects should be expected.
**Clinical experience with thiabendazole for treatment of each of these conditions in pediatric patients weighing less than 30 lbs has been limited.

HOW SUPPLIED

No. 3331 — MINTEZOL (thiabendazole) Suspension, 500 mg per 5 mL, is white to off-white and is supplied as follows:

NDC 0006-3331-60 in bottles of 120 mL
(6505-00-935-5835, 0.5 g/5 mL, 120 mL).

Storage

Store in a well-closed container at controlled room temperature [15-30°C (59-86°F)]. Protect from freezing.

No. 3332 — MINTEZOL (thiabendazole) Chewable Tablets, 500 mg, are white to off-white, orange-flavored, round, scored, compressed tablets, coded MSD 907 on one side and MINTEZOL (thiabendazole) on the other.

They are supplied as follows:

NDC 0006-0907-36 unit dose packages of 36
(6505-01-226-9909, 500 mg chewable, individually sealed 36's).

Storage

Store in a well-closed container at controlled room temperature [15-30°C (59-86°F)].

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Issued June 2003. FDA rev date: 6/11/2003

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Gastrointestinal: anorexia, nausea, vomiting, diarrhea, epigastric distress, abdominal pain, jaundice, cholestasis, parenchymal liver damage and hepatic failure. (See WARNINGS.)

Central Nervous System: dizziness, weariness, drowsiness, giddiness, headache, numbness, hyperirritability, convulsions, collapse, confusion, depression, floating sensation, weakness and lack of coordination.

Special Senses: tinnitus, abnormal sensation in eyes, xanthopsia, blurred vision, reduced vision, drying of mucous membranes (mouth, eyes, etc.), Sicca syndrome. (See WARNINGS.)

Cardiovascular: hypotension.

Metabolic: hyperglycemia.

Hematologic: transient leukopenia.

Genitourinary: hematuria, enuresis, malodor of the urine, crystalluria.

Hypersensitivity: pruritus, fever, facial flush, chills, conjunctival injection, angioedema, anaphylaxis, skin rashes (including perianal), erythema multiforme (including Stevens-Johnson syndrome), and lymphadenopathy.

Miscellaneous: appearance of live Ascaris in the mouth and nose.

Read the Mintezol (thiabendazole) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Thiabendazole may compete with other drugs, such as theophylline, for sites of metabolism in the liver, thus elevating the serum levels of such compounds to potentially toxic levels. Therefore, when concomitant use of thiabendazole and xanthine derivatives is anticipated, it may be necessary to monitor blood levels and/or reduce the dosage of such compounds. Such concomitant use should be administered under careful medical supervision.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

If hypersensitivity reactions occur, the drug should be discontinued immediately and not be resumed. Erythema multiforme has been associated with thiabendazole therapy; in severe cases (Stevens-Johnson syndrome), fatalities have occurred.

Because CNS side effects may occur quite frequently, activities requiring mental alertness should be avoided.

Jaundice, cholestasis, and parenchymal liver damage have been reported in patients treated with MINTEZOL (thiabendazole) . In rare cases, liver damage has been severe and has led to irreversible hepatic failure. (See ADVERSE REACTIONS.)

Abnormal sensation in eyes, xanthopsia, blurred vision, drying of mucous membranes, and Sicca syndrome have been reported in patients treated with MINTEZOL (thiabendazole) . These adverse effects of the eye were in some cases persistent for prolonged intervals which have exceeded one year. (See ADVERSE REACTIONS.)

Thiabendazole should not usually be used as first line therapy for the treatment of enterobiasis. It should be reserved for use in patients who have experienced allergic reactions, or resistance to other treatments.

PRECAUTIONS

General

MINTEZOL (thiabendazole) is not suitable for the treatment of mixed infections with ascaris because it may cause these worms to migrate.

Ideally, supportive therapy is indicated for anemic, dehydrated or malnourished patients prior to initiation of the anthelmintic therapy.

In the presence of hepatic or renal dysfunction, patients should be carefully monitored.

MINTEZOL (thiabendazole) should be used only in patients in whom susceptible worm infestation has been diagnosed and should not be used prophylactically.

Laboratory Tests

Rarely, a transient rise in liver function tests has occurred in patients receiving MINTEZOL (thiabendazole) .

Carcinogenesis, Mutagenesis, Impairment of Fertility

Thiabendazole has been used in numerous short- and long-term studies in animals at doses up to 15 times the usual human dose and was without carcinogenic effects. It did not adversely affect fertility in the mouse at 2% times the usual human dose or in the rat at a dose equivalent to the usual human dose. Thiabendazole had no mutagenic activity in in vitro microbial mutagen test, the micronucleus test and the host mediated assay in vivo.

Pregnancy

Pregnancy Category C: Reproduction and teratogenic studies done in the rabbit at a dose up to 15 times the usual human dose, in the rat at a dose equivalent to the human dose, and in the mouse at a dose up to 2% times the usual human dose, revealed no evidence of harm to the fetus. In an additional study in the mouse, no defects were observed when thiabendazole was given in aqueous suspension, at a dose 10 times the usual human dose; however, cleft palate and axial skeletal defects were observed when thiabendazole was suspended in olive oil and given at the same dose. There are no adequate and well controlled studies in pregnant women. MINTEZOL (thiabendazole) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from MINTEZOL (thiabendazole) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of thiabendazole for the treatment of Strongyloidiasis, Ascariasis, Uncinariasis, Trichuriasis and Trichinosis in pediatric patients weighing less than 30 lbs has been limited.

Geriatric Use

Clinical studies of MINTEZOL (thiabendazole) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is metabolized almost completely by the liver, and the metabolites are known to be substantially excreted by the kidney, therefore the risk of toxicity may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Overdosage may be associated with transient disturbances of vision and psychic alterations.

There is no specific antidote in the event of overdosage. Therefore, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed carefully.

The oral LD50 of MINTEZOL (thiabendazole) is 3.6 g/kg, 3.1 g/kg and 3.8 g/kg in the mouse, rat, and rabbit, respectively.

CONTRAINDICATIONS

Hypersensitivity to this product.

Thiabendazole is contraindicated as prophylactic treatment for pinworm infestation.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

In man, thiabendazole is rapidly absorbed and peak plasma concentration is reached within 1 to 2 hours after the oral administration of a suspension. It is metabolized almost completely to the 5-hydroxy form which appears in the urine as glucuronide or sulfate conjugates. In 48 hours, about 5% of the administered dose is recovered from the feces and about 90% from the urine. Most is excreted in the first 24 hours.

Mechanism of Action

The precise mode of action of thiabendazole on the parasite is unknown, but it may inhibit the helminth-specific enzyme fumarate reductase.

Thiabendazole is vermicidal and/or vermifugal against Ascaris lumbricoides ("common roundworm"), Strongyloides stercoralis (threadworm), Necator americanus, and Ancylostoma duodenale (hookworm), Trichuris trichiura (whipworm), Ancylostoma braziliense (dog and cat hookworm), Toxocara canis and Toxocara cati (ascarids), and Enterobius vermicularis (pinworm).

Its effect on larvae of Trichinella spiralis that have migrated to muscle is questionable.

Thiabendazole also suppresses egg and/or larval production and may inhibit the subsequent development of those eggs or larvae which are passed in the feces.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Because CNS side effects may occur quite frequently, activities requiring mental alertness should be avoided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Because CNS side effects may occur quite frequently, activities requiring mental alertness should be avoided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Mintezol®
(thiabendazole) Chewable Tablets And Suspension

DRUG DESCRIPTION

MINTEZOL (Thiabendazole) is an anthelmintic provided as 500 mg chewable tablets, and as a suspension, containing 500 mg thiabendazole per 5 mL. The suspension also contains sorbic acid 0.1% added as a preservative. Inactive ingredients in the tablets are acacia, calcium phosphate, flavors, lactose, magnesium stearate, mannitol, methylcellulose, and sodium saccharin. Inactive ingredients in the suspension are an antifoam agent, flavors, polysorbate, purified water, sorbitol solution, and tragacanth.

Thiabendazole is a white to off-white odorless powder with a molecular weight of 201.26, which is practically insoluble in water but readily soluble in dilute acid and alkali. Its chemical name is 2-(4-thiazolyr)-1/-/-benzimidazole. The empirical formula is C10H7N3S and the structural formula is:

MINTEZOL (Thiabendazole) structural formula illustration

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

Mintezol®
(thiabendazole) Chewable Tablets And Suspension

DRUG DESCRIPTION

MINTEZOL (Thiabendazole) is an anthelmintic provided as 500 mg chewable tablets, and as a suspension, containing 500 mg thiabendazole per 5 mL. The suspension also contains sorbic acid 0.1% added as a preservative. Inactive ingredients in the tablets are acacia, calcium phosphate, flavors, lactose, magnesium stearate, mannitol, methylcellulose, and sodium saccharin. Inactive ingredients in the suspension are an antifoam agent, flavors, polysorbate, purified water, sorbitol solution, and tragacanth.

Thiabendazole is a white to off-white odorless powder with a molecular weight of 201.26, which is practically insoluble in water but readily soluble in dilute acid and alkali. Its chemical name is 2-(4-thiazolyr)-1/-/-benzimidazole. The empirical formula is C10H7N3S and the structural formula is:

MINTEZOL (Thiabendazole) structural formula illustration

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

Mintezol®
(thiabendazole) Chewable Tablets And Suspension

DRUG DESCRIPTION

MINTEZOL (Thiabendazole) is an anthelmintic provided as 500 mg chewable tablets, and as a suspension, containing 500 mg thiabendazole per 5 mL. The suspension also contains sorbic acid 0.1% added as a preservative. Inactive ingredients in the tablets are acacia, calcium phosphate, flavors, lactose, magnesium stearate, mannitol, methylcellulose, and sodium saccharin. Inactive ingredients in the suspension are an antifoam agent, flavors, polysorbate, purified water, sorbitol solution, and tragacanth.

Thiabendazole is a white to off-white odorless powder with a molecular weight of 201.26, which is practically insoluble in water but readily soluble in dilute acid and alkali. Its chemical name is 2-(4-thiazolyr)-1/-/-benzimidazole. The empirical formula is C10H7N3S and the structural formula is:

MINTEZOL (Thiabendazole) structural formula illustration

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

Mintezol Patient Information Including Side Effects

Brand Names: Mintezol

Generic Name: thiabendazole (Pronunciation: thye a BEN da zole)

What is thiabendazole (Mintezol)?

Thiabendazole is an "antihelmintic," or anti-worm, medication. It prevents worms from growing or multiplying in the body.

Thiabendazole is used to treat infections caused by worms such as threadworm. Thiabendazole may also be used to treat pinworm (when it occurs with threadworm), hookworm, whipworm, roundworm, and trichinosis.

Thiabendazole may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of thiabendazole (Mintezol)?

Stop taking thiabendazole and seek emergency medical attention if you experience an allergic reaction (swelling of the lips, tongue, or face; shortness of breath; closing of the throat; or hives).

Rarely, other serious side effects can occur. Stop taking thiabendazole and contact your doctor if you experience

  • seizures;
  • behavior or personality changes;
  • skin rash;
  • vision changes; or
  • yellowing of the skin or eyes.

Other, less serious side effects may be more likely to occur. Continue to take thiabendazole and talk to your doctor if you experience

  • dizziness, drowsiness, or headache;
  • numbness;
  • nausea, vomiting, diarrhea, upset stomach, or decreased appetite;
  • unusual urine odor;
  • fever or chills;
  • ringing in the ears;
  • blurred vision or dryness of the eyes; or
  • appearance of live worms in the mouth or nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Mintezol (thiabendazole) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about thiabendazole (Mintezol)?

Take thiabendazole with food to lessen stomach upset. Chew the chewable tablets thoroughly before swallowing.

Follow your doctor's instructions regarding treatment; washing of clothes, linens, and towels; and household disinfecting. Pinworm infections are easily spread from one person to another.

Use caution when driving, operating machinery, or performing other hazardous activities. Thiabendazole may cause dizziness. If you experience dizziness, avoid these activities.

Side Effects Centers

Mintezol Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking thiabendazole (Mintezol)?

Before taking thiabendazole, tell your doctor about any other medical conditions that you have, especially liver or kidney disease. You may not be able to take thiabendazole, or you may require a dosage adjustment or special monitoring during treatment if you have any other medical conditions.

Thiabendazole is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take thiabendazole without first talking to your doctor if you are pregnant.

It is also not known whether thiabendazole passes into breast milk. Do not take thiabendazole without first talking to your doctor if you are breast-feeding a baby.

Children who weigh less than 30 pounds should not use thiabendazole unless otherwise directed by a doctor.

How should I take thiabendazole (Mintezol)?

Take thiabendazole exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Chew the chewable tablets thoroughly before swallowing.

Shake the suspension well before measuring a dose. Measure each dose with a dose-measuring dropper, spoon or cup, not a regular table spoon, to ensure that you measure the correct amount of medicine. Ask your pharmacist where you can get a dose-measuring device if you do not have one.

Take each dose with food to lessen stomach upset.

Doses are usually taken twice a day. Follow your doctor's instructions.

It may take 2 days or more for the treatment to remove the worm from the stomach and intestines. Repeat treatment is usually necessary in 7 days to prevent reinfection.

Fasting, laxatives, or purging will not help to cure the infection.

Treatment of family members and other close contacts may be necessary. Pinworm is spread very easily to others in close contact with the infected person.

To prevent reinfection, toilets must be disinfected daily, and clothing, linens, towels, and pajamas must be changed and washed daily.

Store thiabendazole at room temperature away from moisture and heat.

Side Effects Centers

Mintezol Patient Information including If I Miss a Dose

What happens if I miss a dose (Mintezol)?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Mintezol)?

Seek emergency medical attention.

Symptoms of a thiabendazole overdose might include changes in vision and changes in behavior or personality.

What should I avoid while taking thiabendazole (Mintezol)?

Treatment of family members and other close contacts may be necessary. Pinworm is spread very easily to others in close contact with the infected person.

Toilets must be disinfected daily and clothing, linens, towels, and pajamas must be changed and washed daily to prevent reinfection.

Use caution when driving, operating machinery, or performing other hazardous activities. Thiabendazole may cause dizziness. If you experience dizziness, avoid these activities.

What other drugs will affect thiabendazole (Mintezol)?

Theophylline (Theo-Dur, Theolair, Theochron, Theo-Bid, Elixophyllin, others) may have dangerous side effects when taken with thiabendazole. Your doctor may want to monitor blood theophylline levels if you are taking theophylline during treatment with thiabendazole.

Drugs other than those listed here may also interact with thiabendazole. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist can provide more information about thiabendazole.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision date: 12/15/2010.

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