MECLIZINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

MECLIZINE HYDROCHLORIDE

Composition:

MECLIZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Meclizine Hydrochloride Tablets USP are available as: 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 63187-258-10 in bottles of 10 NDC 63187-258-20 in bottles of 20 NDC 63187-258-30 in bottles of 30 NDC 63187-258-60 in bottles of 60 NDC 63187-258-90 in bottles of 90 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 Made in USA Revised April 2014 MF012REV04/14 OE1035 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
PROFICIENT RX LP
----------
MECLIZINE HYDROCHLORIDE TABLETS USP, 12.5 MG AND 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.
ABS ORPTION
Meclizine is absorbed after oral administration with maximum plasma
concentrations reaching at a
median Tmax value of 3 hours post-dose (range: 1.5 to 6 hours) for the
tablet dosage form.
DIS TRIBUTION
Drug distribution characteristics for meclizine in humans are unknown.
METABOLIS M
The metabolic fate of meclizine in humans is unknown. In an in vitro
metabolic study using human
hepatic microsome and recombinant CYP enzyme, CYP 2D6 was found to be
the dominant enzyme for
25
27
2
2
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 b