Mintezol

Name: Mintezol

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:

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.

Patient information

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

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 entire FDA prescribing information for Mintezol (Thiabendazole)

Read More »

Mintezol Overview

Mintezol is a brand name medication included in the following groups of medications: Benzimidazole derivatives, Imidazole and triazole derivatives. For more information about Mintezol see its generic Tiabendazole

Contraindications

Hypersensitivity to this product.

Thiabendazole is contraindicated as prophylactic treatment for pinworm infestation.

Precautions

General

Mintezol 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 should be used only in patients in whom susceptible worm infestation has been diagnosedand should not be used prophylactically.

Information for Patients

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

Laboratory Tests

Rarely, a transient rise in liver function tests has occurred in patients receiving Mintezol.

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.

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 2½ 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 2½ 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 suspendedin olive oil and given at the same dose. There are no adequate and well controlled studies in pregnant women. Mintezol 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, 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 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.

How is Mintezol Supplied

No. 3331  Mintezol 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 Chewable Tablets, 500 mg, are white to off-white, orange-flavored, round, scored, compressed tablets, coded MSD 907 on one side and Mintezol 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

Printed in USA

7930815

Mintezol 
thiabendazole tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-0907
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
thiabendazole (thiabendazole) thiabendazole 500 mg
Inactive Ingredients
Ingredient Name Strength
acacia  
calcium phosphate  
flavors  
lactose  
magnesium stearate  
mannitol  
methylcellulose  
sodium saccharin  
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND (round) Size 19mm
Flavor Imprint Code MSD;907;Mintezol
Contains     
Coating false Symbol false
Packaging
# Item Code Package Description
1 NDC:0006-0907-36 9 BLISTER PACK (9 BLISTER PACK) in 1 CARTON
1 NDC:0006-0907-01 4 TABLET, CHEWABLE (4 TABLET) in 1 BLISTER PACK
Mintezol 
thiabendazole suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-3331
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
thiabendazole (thiabendazole) thiabendazole 500 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
antifoam agent  
flavors  
polysorbate  
water  
sorbitol solution  
tragacanth  
sorbic acid  
Packaging
# Item Code Package Description
1 NDC:0006-3331-60 1 BOTTLE (1 BOTTLE) in 1 CARTON
1 120 mL (120 MILLILITER) in 1 BOTTLE
Labeler - Merck & Co., Inc.
Revised: 11/2007   Merck & Co., Inc.
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