NANAZOXID 500mg f.c. tabs.

국가: 이집트

언어: 영어

출처: EDA (Egyptian Drug Authority)

Download 환자 정보 전단 (PIL)
19-06-2024

제공처:

UTOPIA PHARMACEUTICALS COMPANY-EGYPT

복용량:

500 mg

약제 형태:

coated tablet

패키지 단위:

6 tabs

Manufactured by:

MEDIZEN PHARMACEUTICAL INDUSTRIES-EGYPT

승인 날짜:

2009-12-17

환자 정보 전단

                                NANAZOXID 500 MG TABLET
Nitazoxanide 500mg
Film-coated Tablets
COMPOSITION:
Each tablet contains:
ACTIVE INGREDIENTS:
Nitazoxanide 500mg.
INACTIVE INGREDIENTS: Starch, sucrose, sodium starch glycolate, talc, magnesium stearate,
poly vinyl alcohol, HPMC
titanium dioxide.
DESCRIPTION:
NANAZOXID 500MG tablets contains the active ingredient nitazoxanide; a
synthetic antiprotozoal agent for oral
administration. Chemically, nitazoxanide is
2-acetyloxy-_N_-(5-nitro-2-thiazolyl) benzamide.
CLINICAL PHARMACOLOGY:
ABSORPTION: Following oral administration of NANAZOXID 500MG tablets,
maximum plasma concentrations of the
active metabolites tizoxanide and tizoxanide glucuronide are observed
within 1-4 hours. The parent nitazoxanide is
not detected in plasma. When NANAZOXID 500MG tablet was administered
with food, the AUC
t
of tizoxanide and
tizoxanide glucuronide increased almost two-folds and the C
max
increased by almost 50%.
DISTRIBUTION:
In plasma, more than 99% of tizoxanide is bound to proteins.
METABOLISM:
Nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide
(desacetyl-nitazoxanide). Tizoxanide then
undergoes conjugation, primarily by glucuronidation. ELIMINATION:
Tizoxanide is excreted in the urine, bile and feces, and tizoxanide
glucuronide is excreted in urine and bile.
Approximately two-thirds of the oral dose of nitazoxanide is excreted
in the feces and one-third in the urine.
MECHANISM OF ACTION:
The antiprotozoal activity of nitazoxanide is believed to be due to
interference with the pyruvate: ferredoxin
oxidoreductase (PFOR) enzyme-dependent electron transfer reaction
which is essential to anaerobic energy
metabolism
.
INDICATIONS AND USAGE:
NANAZOXID 500MG tablets is indicated for the treatment of diarrhea
caused by _giardia lamblia or cryptosporidium _
_parvum._
DOSAGE AND ADMINISTRATION:
One tablet every 12 hours with food for three days.
OVERDOSAGE:
Information on nitazoxanide overdosage is not available
.
CONTRAINDICATIONS: NANAZOXID 500GM tablets is contraindicated in patients with a pri
                                
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