Fugacar

Fugacar

mebendazole

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Full Prescribing Info
Contents
Mebendazole.
Action
Fugacar inhibits the formation of the worm microtubules and causes the worms' glucose depletion.
Pharmacology: Pharmacokinetics: Following administration of 100 mg twice daily for 3 consecutive days, plasma levels of Fugacar and its primary metabolite, the 2-amine, do not exceed 0.03 mcg/mL, respectively. All metabolites are devoid of anthelmintic activity. In man, approximately 2% of administered Fugacar is excreted in urine and remainder in the faeces as unchanged drug or a primary metabolite.
Microbiology: With a potent anthelmintic activity against nematodes. Fugacar is effective against Enterobius vermicularis (pinworm), threadworm, Ascaris lumbricoides (large roundworm), Ancylostoma duodenale (hookworm) and Trichuris trichiura (whipworm).
Indications/Uses
Treatment of enterobiasis, ascariasis, trichuriasis, ancylostomiasis in single or mixed infections.
Dosage/Direction for Use
The same dosage schedule applies to children and adults. The tablet may be chewed, swallowed or crushed, and mixed with food.
Ascariasis, Enterobiasis, Ancylostomiasis, Trichuriasis: 500-mg single dose.
Overdosage
In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.
Contraindications
Fugacar should not be administered in pregnant women during the first 3 months of pregnancy and patients suffering from liver disease.
Special Precautions
Carcinogenicity & Mutagenicity: In carcinogenicity tests of Fugacar in mice and rats, no carcinogenic effects were seen at doses as high as 40 mg/kg given daily for >2 years. Dominant lethal mutation tests in mice showed no mutagenicity at single doses as high as 640 mg/kg. Neither the spermatocyte test, the F1 translocation test, nor the Ames test indicated mutagenic properties.
Use in children: Mebendazole has not been extensively studied in children <2 years; therefore, in the treatment of children <2 years the relative benefit/risk should be considered.
Use In Pregnancy & Lactation
Since the safety of Fugacar during pregnancy has not been established, the drug should not be administered to pregnant women during the first 3 months of pregnancy.
Adverse Reactions
Transient symptoms of abdominal pain and diarrhea have occurred in case of massive infection and expulsion of worms.
MIMS Class
ATC Classification
P02CA01 - mebendazole ; Belongs to the class of benzimidazole derivative agents. Used as antinematodal.
Presentation/Packing
Chewable tab 500 mg x 10 x 1's.
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