MECLIZINE HYDROCHLORIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Unit Dose Services

INN (Rahvusvaheline Nimetus):

MECLIZINE HYDROCHLORIDE

Koostis:

MECLIZINE HYDROCHLORIDE 25 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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. Possibly Effective: Management of vertigo associated with diseases affecting the vestibular system. Final classification of the less than effective indications required further investigation. Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

Toote kokkuvõte:

Product: 50436-3988 NDC: 50436-3988-1 30 TABLET in a BOTTLE NDC: 50436-3988-3 90 TABLET in a BOTTLE

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
UNIT DOSE SERVICES
----------
RX ONLY
DESCRIPTION
Meclizine hydrochloride, an oral antiemetic, is a white, slightly
yellowish, crystalline powder which
has a slight odor and is tasteless. It has the following structural
formula:
C
H CIN •2HCI•H O
M.W. 481.89
The chemical name is
1-(_p_-chloro-alpha-phenylbenzyl)-4-(_m_-methyl-benzyl) - piperazine
dihydrochloride monohydrate.
Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg
strengths for oral administration.
*Contains FD&C Yellow #5 (see PRECAUTIONS).
Each tablet contains the following inactive ingredients: colloidal
silicon dioxide, lactose, magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, starch,
and stearic acid. In addition, the
12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains
D&C Yellow #10 and FD&C
Yellow #5.
CLINICAL PHARMACOLOGY
Meclizine hydrochloride is an antihistamine which 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 in unknown.
_METABOLISM_
The metabolic fate of meclizine in humans in unknown. In an i_n vitro
_metabolic study using human hepatic
microsome and recombinant CYP enzyme, CYP2D6 was found to be the
dominant enzyme for
25
27
2
2
max
metabolism of meclizine.
The genetic polymorphism