MECLIZINE HYDROCHLORIDE- meclizine tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Mylan Pharmaceuticals Inc.

INN (Tên quốc tế):

MECLIZINE HYDROCHLORIDE

Thành phần:

MECLIZINE HYDROCHLORIDE 12.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg or 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 0378-5485-77 bottles of 90 tablets NDC 0378-5485-10 bottles of 1000 tablets 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 0378-5486-77 bottles of 90 tablets NDC 0378-5486-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 4/2018 MECL:R4

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MECLIZINE HYDROCHLORIDE- MECLIZINE TABLET
MYLAN PHARMACEUTICALS INC.
----------
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.
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_
Meclizine has a plasma elimination half-life of about 5-6 hours in
humans.
max
INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of
vertigo associated with diseases
affectin