MECLIZINE HYDROCHLORIDE- meclizine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

MECLIZINE HYDROCHLORIDE

Composition:

MECLIZINE HYDROCHLORIDE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the management of nausea and vomiting, and dizziness associated with motion sickness. Meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

Product summary:

Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg and 25 mg of meclizine hydrochloride, USP. The 12.5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 12 on the other side. They are available as follows: NDC 51079-423-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 25 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 25 on the other side. They are available as follows: NDC 51079-511-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12121 R2 9/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MECLIZINE HYDROCHLORIDE- MECLIZINE TABLET
MYLAN INSTITUTIONAL INC.
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DESCRIPTION
Chemically, meclizine hydrochloride, USP is 1-(
_p_-Chloro-α-phenylbenzyl)-4-( _m_-methylbenzyl)
piperazine dihydrochloride monohydrate. The molecular weight is 481.88
g/mole. It has the following
structural formula:
Meclizine hydrochloride tablets, USP are available in two different
strengths, 12.5 mg and 25 mg.
Inert ingredients for the tablets are: anhydrous lactose, colloidal
silicon dioxide, crospovidone,
magnesium stearate and microcrystalline cellulose.
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 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_
max
Meclizine has a plasma elimination half-life of about 5 to 6 hours in
humans.
INDICATIONS AND USAGE
For the management of nausea and vomiting, and dizziness associa