MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Golden State Medical Supply, Inc.

INN (International Name):

MECLIZINE HYDROCHLORIDE

Sammensætning:

MECLIZINE HYDROCHLORIDE 12.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

Meclizine Hydrochloride Tablets, USP 12.5 mg - blue, oval tablets debossed with “034” on one side and “par” on the other side. Tablets may contain characteristic dye spots. They are supplied in bottles of 100 (NDC 60429-204-01) and 1000 (NDC 60429-204-10). Meclizine Hydrochloride Tablets, USP 25 mg - yellow, oval tablets debossed with “035” on one side and “par” on the other side. They are supplied in bottles of 100 (NDC 60429-205-01) and 1000 (NDC 60429-205-10). Dispense in tight, light-resistant containers as defined in the USP. Store at controlled room temperature 15° to 30°C (59° to 86°F). Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC. Chestnut Ridge, NY 10977 Marketed/Packaged by: GSMS, Incorporated Camarillo, CA 93012 Revised: 07/15                                                                                                                                                                              OS034-01-1-15

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
MECLIZINE HYDROCHLORIDE
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.
25
27
2
2
max
_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
metabol