MEBENDAZOLE tablet, chewable

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

MEBENDAZOLE (UNII: 81G6I5V05I) (MEBENDAZOLE - UNII:81G6I5V05I)

זמין מ:

Physicians Total Care, Inc.

INN (שם בינלאומי):

MEBENDAZOLE

הרכב:

MEBENDAZOLE 100 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Mebendazole tablets are indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections. Efficacy varies as a function of such factors as preexisting diarrhea and gastrointestinal transit time, degree of infection, and helminth strains. Efficacy rates derived from various studies are shown in the table below: Mebendazole is contraindicated in persons who have shown hypersensitivity to the drug.

leaflet_short:

Mebendazole 100 mg, chewable, round, light peach-colored, unscored tablets, debossed “93” and “107” on one side and plain on the other side, supplied in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

MEBENDAZOLE - MEBENDAZOLE TABLET, CHEWABLE
PHYSICIANS TOTAL CARE, INC.
----------
MEBENDAZOLE TABLETS, USP 100 MG
9107
DESCRIPTION
Mebendazole is a (synthetic) broad-spectrum anthelmintic available as
chewable tablets, each containing
100 mg of mebendazole. Inactive ingredients are: anhydrous lactose NF,
corn starch, magnesium
stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium
saccharin, sodium starch glycolate,
stearic acid, and FD&C Yellow #6.
Mebendazole is methyl 5-benzoylbenzimidazole-2-carbamate and has the
following structural formula:
Molecular Formula: C
H N O
Mebendazole is a white to slightly yellow powder with a molecular
weight of 295.29. It is less than
0.05% soluble in water, dilute mineral acid solutions, alcohol, ether
and chloroform, but is soluble in
formic acid.
CLINICAL PHARMACOLOGY
Following administration of 100 mg twice daily for three consecutive
days, plasma levels of
mebendazole and its primary metabolite, the 2-amine, do not exceed
0.03 mcg/mL and 0.09 mcg/mL,
respectively. All metabolites are devoid of anthelmintic activity. In
man, approximately 2% of
administered mebendazole is excreted in urine and the remainder in the
feces as unchanged drug or a
primary metabolite.
MODE OF ACTION
Mebendazole inhibits the formation of the worms’ microtubules and
causes the worms’ glucose
depletion.
INDICATIONS AND USAGE
Mebendazole tablets are indicated for the treatment of _Enterobius
vermicularis_ (pinworm), _Trichuris_
_trichiura_ (whipworm), _Ascaris lumbricoides_ (common roundworm),
_Ancylostoma duodenale_ (common
hookworm), _Necator americanus_ (American hookworm) in single or mixed
infections.
Efficacy varies as a function of such factors as preexisting diarrhea
and gastrointestinal transit time,
degree of infection, and helminth strains. Efficacy rates derived from
various studies are shown in the
table below:
Pinworm
Whipworm
Common
16
13
3
3
Pinworm
(enterobiasis)
Whipworm
(trichuriasis)
Roundworm
(ascariasis)
Hookworm
CURE
RATES mean
95%
68%
98%
96%
EGG
REDUCTION
me