MECLIZINE HYDROCHLORIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)

Διαθέσιμο από:

AvKARE

INN (Διεθνής Όνομα):

MECLIZINE HYDROCHLORIDE

Σύνθεση:

MECLIZINE HYDROCHLORIDE 12.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system. Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

Περίληψη προϊόντος:

Meclizine Hydrochloride Tablets, USP 12.5 mg, are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. Meclizine Hydrochloride Tablets, USP 25 mg, are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. They are available as follows: Bottles of 1000: NDC 42291-609-10 Meclizine Hydrochloride Tablets, USP 50 mg, are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured for: AvKARE Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of New York, LLC Brookhaven, NY 11719 Mfg. Rev. 10-2019-05 AV 03/23

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
AVKARE
----------
MECLIZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Chemically, meclizine hydrochloride, USP is 1-(
_p_-chloro-α-phenylbenzyl)-4-( _m_-
methylbenzyl) piperazine dihydrochloride monohydrate.
Inactive ingredients for the tablets are: colloidal silicon dioxide,
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, sodium starch
glycolate and talc. The
12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg
tablets also
contain D&C Yellow #10 Aluminum Lake.
CLINICAL PHARMACOLOGY
Meclizine hydrochloride is an antihistamine that shows marked
protective activity against
nebulized histamine and lethal doses of intravenously injected
histamine in guinea pigs. It
has a marked effect in blocking the vasodepressor response to
histamine, but only a
slight blocking action against acetylcholine. Its activity is
relatively weak in inhibiting the
spasmogenic action of histamine on isolated guinea pig ileum.
PHARMACOKINETICS
The available pharmacokinetic information for meclizine following oral
administration has
been summarized from published literature.
ABSORPTION
Meclizine is absorbed after oral administration with maximum plasma
concentrations
reaching at a median T
value of 3 hours post-dose (range: 1.5 to 6 hours) for the
tablet dosage form.
DISTRIBUTION
Drug distribution characteristics for meclizine in humans are unknown.
METABOLISM
max
The metabolic fate of meclizine in humans is unknown. In an _in vitro_
metabolic study
using human hepatic microsome and recombinant CYP enzyme, CYP2D6 was
found to
be the dominant enzyme for metabolism of meclizine.
The genetic polymorphism of CYP2D6 that results in extensive-, poor-,
intermediate- and
ultrarapid metabolizer phenotypes could contribute to large
inter-individual variability in
meclizine exposure.
ELIMINATION
Meclizine has a plasma elimination half-life of about 5 to 6 hours in
humans.
INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment