EMVERM mebendazole tablet chewable

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Amedra Pharmaceuticals LLC

DCI (Dénomination commune internationale):

MEBENDAZOLE

Composition:

MEBENDAZOLE 100 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

EMVERM- MEBENDAZOLE TABLET, CHEWABLE
AMEDRA PHARMACEUTICALS LLC
----------
PRESCRIBING INFORMATION
EMVERM
(MEBENDAZOLE)
CHEWABLE TABLET, USP
Rx only
DESCRIPTION
Mebendazole, USP is a (synthetic) broad-spectrum anthelmintic
available as chewable tablets, each
containing 100 mg of mebendazole, USP. Inactive ingredients are:
microcrystalline cellulose, corn
starch, anhydrous lactose NF, sodium starch glycolate, magnesium
stearate, stearic acid, sodium lauryl
sulfate, sodium saccharin, and FD&C Yellow #6.
Mebendazole, USP is methyl 5-benzoylbenzimidazole-2-carbamate and has
the following structural
formula:
Molecular Formula: C
H N O
Mebendazole, USP 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
Emverm (mebendazole) chewable tablet, USP is 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
™
16
13
3
3
™
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
(ENTEROBIAS IS )
WHIPWORM
(TRICHURIAS IS )
COMMON ROUNDWORM
(AS