Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1373
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MINTEZOL (Tablet, Chewable)
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The recommended maximum daily
dose of MINTEZOL is 3 grams. MINTEZOL
should be given after meals if possible. Tablets MINTEZOL 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: The regimen for each indication follows:
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| dailymed-instance:descripti... |
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-thiazolyl)-1H
-benzimidazole. The empirical formula is CHNS
and the structural formula is:
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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.<br/>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.
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Hypersensitivity to this product. Thiabendazole
is contraindicated as prophylactic treatment for pinworm infestation.
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| dailymed-instance:supply |
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).<br/>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).<br/>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
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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.<br/>Information for Patients: Because CNS side effects may occur quite frequently, activities
requiring mental alertness should be avoided.<br/>Laboratory Tests: Rarely, a transient rise in liver function tests has occurred
in patients receiving MINTEZOL.<br/>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.<br/>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.<br/>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 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.<br/>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.<br/>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.<br/>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 endof 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.
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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 LDof MINTEZOL is 3.6 g/kg,
3.1 g/kg and 3.8 g/kg in the mouse, rat, and rabbit, respectively.
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thiabendazole
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MINTEZOL (Tablet, Chewable)
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| dailymed-instance:adverseRe... |
Gastrointestinal:
anorexia, nausea, vomiting, diarrhea, epigastric distress, abdominal
pain, jaundice, cholestasis, parenchymal liver damage and hepatic failure. 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. 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.
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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. In rare
cases, liver damage has been severe and has led to irreversible hepatic failure. Abnormal
sensation in eyes, xanthopsia, blurred vision, drying of mucous membranes,
and Sicca syndrome have been reported in patients treated with MINTEZOL. 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.
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MINTEZOL is indicated for the treatment of: Trichinosis: Relief of symptoms and fever and a reduction
of eosinophilia have followed the use of MINTEZOL 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 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).
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MINTEZOL
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