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:

Blenheim Pharmacal, Inc.

INN (International Name):

MECLIZINE HYDROCHLORIDE

Composition:

MECLIZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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 15 (NDC 10544-108-15), 20 (NDC 10544-108-20) and 30 (NDC 10544-108-15). 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. Spring Valley, NY 10977 Manufactured by: BLENHEIM PHARMACAL, INC. North Blenheim, NY 12131, (USA) Revised: 11/2012 OS034-01-1-12

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
BLENHEIM PHARMACAL, INC.
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MECLIZINE HYDROCHLORIDE TABLET
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_
25
27
2
2
max
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
metabolism of mecliz