NIFURAL
GENERIK
Nifuroksazida.
INDIKASI
Diare akut, kolopati spesifik & tidak spesifik, diare yang disebabkan
oleh E. coli pada anak-anak & orang dewasa.
KONTRA INDIKASI
Gangguan fungsi hati atau ginjal.
Hipertiroidisme, intoleransi Iodin.
PERHATIAN
Gangguan persarafan.
EFEK SAMPING
Neurotoksisitas berat, nyeri perut, diare, pigmen hijau pada lidah,
tinja & urin (air seni), gangguan otak.
KEMASAN
Sirup 250 mg/5 ml x 60 ml.
DOSIS
a.. Dewasa : 3 kali sehari 1-2 sendok teh.
a.. Anak-anak & bayi berusia lebih dari 6 bulan : 3 kali sehari 1
sendok teh.
a.. Bayi berusia kurang dari 6 bulan : 2 kali sehari 1 sendok teh.
PABRIK
Darya-Varia/Pharos Chemie.
Nifural (Nifuraxozide) derivat nitrofurantoin
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
Nitrofurantoin presented evidence of carcinogenic activity in female B6C3F1
mice as shown by increased incidences of tubular adenomas, benign mixed
tumors, and granulosa cell tumors of the ovary. In male F344/N rats, there
were increased incidences of uncommon kidney tubular cell neoplasms,
osteosarcomas of the bone, and neoplasms of the subcutaneous tissue. In one
study involving subcutaneous administration of 75 mg/kg nitrofurantoin to
pregnant female mice, lung papillary adenomas of unknown significance were
observed in the F1 generation.
Nitrofurantoin has been shown to induce point mutations in certain strains
of Salmonella typhimurium and forward mutations in L5178Y mouse lymphoma
cells. Nitrofurantoin induced increased numbers of sister chromatid
exchanges and chromosomal aberrations in Chinese hamster ovary cells but not
in human cells in culture. Results of the sex-linked recessive lethal assay
in Drosophila were negative after administration of nitrofurantoin by
feeding or by injection. Nitrofurantoin did not induce heritable mutation in
the rodent models examined.
The significance of the carcinogenicity and mutagenicity findings relative
to the therapeutic use of nitrofurantoin in humans is unknown.
The administration of high doses of nitrofurantoin to rats causes temporary
spermatogenic arrest; this is reversible on discontinuing the drug. Doses of
10 mg/kg/day or greater in healthy human males may, in certain unpredictable
instances, produce a slight to moderate spermatogenic arrest with a decrease
in sperm count.
Pregnancy, Teratogenic Effects: Pregnancy Category B. Several reproduction
studies have been performed in rabbits and rats at doses up to six times the
human dose and have revealed no evidence of impaired fertility or harm to
the fetus due to nitrofurantoin. In a single published study conducted in
mice at 68 times the human dose (based on mg/kg administered to the dam),
growth retardation and a low incidence of minor and common malformations
were observed. However, at 25 times the human dose, fetal malformations were
not observed; the relevance of these findings to humans is uncertain. There
are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human
response, this drug should be used during pregnancy only if clearly needed.
Non-teratogenic effects: Nitrofurantoin has been shown in one published
transplacental carcinogenicity study to induce lung papillary adenomas in
the F1 generation mice at doses 19 times the human dose on a mg/kg basis.
The relationship of this finding to potential human carcinogenesis is
presently unknown. Because of the uncertainty regarding the human
implications of these animal data, this drug should be used during pregnancy
only if clearly needed.
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