MECLIZINE HYDROCHLORIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Apotheca Inc.

INN (Mezinárodní Name):

MECLIZINE HYDROCHLORIDE

Složení:

MECLIZINE HYDROCHLORIDE 25 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows: Effective: Management of nausea and vomiting, and dizziness associated with motion sickness. Final classification of the less than effective indications requires further investigation. Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

Přehled produktů:

25 mg, white, modified oval-shaped tablets, de-bossed “ Є14 ” on one side and plain on the other side. They are supplied as follows: NDC 12634-424-00 Bottles of 10 NDC 12634-424-01 Bottles of 100 NDC 12634-424-09 Bottles of 35 NDC 12634-424-12 Bottles of 120 NDC 12634-424-18 Bottles of 180 NDC 12634-424-40 Bottles of 40 NDC 12634-424-42 Bottles of 42 NDC 12634-424-45 Bottles of 45 NDC 12634-424-50 Bottles of 50 NDC 12634-424-52 Blister Pack of 12 NDC 12634-424-54 Blister Pack of 14 NDC 12634-424-57 Blister Pack of 20 NDC 12634-424-59 Blister Pack of 30 NDC 12634-424-60 Bottles of 60 NDC 12634-424-61 Blister Pack of 10 NDC 12634-424-63 Blister Pack of 3 NDC 12634-424-66 Blister Pack of 6 NDC 12634-424-67 Blister Pack of 7 NDC 12634-424-69 Blister Pack of 9 NDC 12634-424-71 Bottles of 30 NDC 12634-424-74 Bottles of 24 NDC 12634-424-78 Bottles of 28 NDC 12634-424-79 Bottles of 25 NDC 12634-424-80 Bottles of 20 NDC 12634-424-81 Bottles of 21 NDC 12634-424-82 Bottles of 12 NDC 12634-424-84 Bottles of 14 NDC 12634-424-85 Bottles of 15 NDC 12634-424-90 Bottles of 90 NDC 12634-424-91 Blister Pack of 1 NDC 12634-424-92 Bottles of 2 NDC 12634-424-93 Bottles of 3 NDC 12634-424-94 Bottles of 4 NDC 12634-424-95 Bottles of 5 NDC 12634-424-96 Bottles of 6 NDC 12634-424-97 Bottles of 7 NDC 12634-424-98 Bottles of 8 NDC 12634-424-99 Bottles of 9 Store at 20º to 25ºC (68 to 77ºF) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Revised January 2016 MF012REV01/16 OE1035 Repackaged & Distributed by: Apotheca Inc. Phoenix, AZ 85006

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
APOTHECA INC.
----------
MECLIZINE HYDROCHLORIDE TABLETS USP, 25 MG
RX ONLY
DESCRIPTION
Chemically, meclizine hydrochloride is 1-(
_p_-chloro-α-phenylbenzyl)-4-( _m_-methylbenzyl) piperazine
dihydrochloride monohydrate.
C
H
CIN
·2HCl·H
0 M.W. 481.89
Meclizine hydrochloride tablets, USP are available in two different
strengths, 12.5 mg and 25 mg.
Inactive ingredients: microcrystalline cellulose, lactose monohydrate,
croscarmellose sodium and
magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1
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_
The metabolic fate of meclizine in humans is unknown. In an in vitro
metabolic study using human
25
27
2
2
max
hepatic microsome and recombinant CYP enzyme, CYP 2D6 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 5-6 hours in
humans.
INDICATIONS
Based on a review of this drug by the