MECLIZINE HYDROCHLORIDE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

State of Florida DOH Central Pharmacy

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness. Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

Termék összefoglaló:

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. Meclizine Hydrochloride Tablets, USP 25 mg - yellow, oval tablets debossed with “035” on one side and “par” on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Dispense in tight, light-resistant containers as defined in the USP. Store at controlled room temperature 15°-30°C (59°-86°F). Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC. Spring Valley, NY 10977 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

MECLIZINE HYDROCHLORIDE - MECLIZINE HYDROCHLORIDE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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,
stearic acid and other ingredients.
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.
INDICATIONS AND USAGE
For the prevention and treatment of nausea, vomiting, or dizziness
associated with motion sickness.
CONTRAINDICATIONS
Meclizine hydrochloride is contraindicated in individuals who have
shown a previous hypersensitivity
to it.
25
27
2
2
WARNINGS
Since drowsiness may, on occasion, occur with use of this drug,
patients should be warned of this
possibility and cautioned against driving a car or operating dangerous
machinery.
Patients should avoid alcoholic beverages while taking the drug. Due
to its potential anticholinergic
action, this drug should be used with caution in patients with asthma,
glaucoma, or enlargement of the
prostate gland. Do no