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:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions (6) and Description (11)]. 7.1 CNS Depressants There may be increased CNS depression when meclizine hydrochloride is administered concurrently with other CNS depressants, including alcohol [see Warnings and Precautions (5.1)]. 7.2 CYP2D6 Inhibitors Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore, there is a possibility for a drug interaction between meclizine hydrochloride and CYP2D6 inhibitors. Therefore, monitor for adverse reactions and clinical effect accordingly.

Product summary:

16.1 How Supplied Meclizine Hydrochloride Tablets USP, 12.5 mg are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. They are available as follows: Bottles of 30: Bottles of 100: Bottles of 500: Bottles of 1000: Blister packs: (Packages of 100 unit doses, 10 cards of 10 tablets each) Meclizine Hydrochloride Tablets USP, 25 mg are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. They are available as follows: Bottles of 30: Bottles of 100: Bottles of 500: Bottles of 1000: Blister packs: (Packages of 100 unit doses, 10 cards of 10 tablets each) Meclizine Hydrochloride Tablets USP, 50 mg are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. They are available as follows: Bottles of 30: Bottles of 100: Bottles of 500: Bottles of 1000: Blister packs: (Packages of 100 unit doses, 10 cards of 10 tablets each) 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep this and all medication out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
DIRECT_RX
----------
MECLIZINE HYDROCHLORIDE
Meclizine hydrochloride tablets are indicated for the treatment of
vertigo associated with diseases
affecting the vestibular system in adults.
2.1 Recommended Dosage
The recommended dosage is 25 mg to 100 mg daily administered orally,
in divided doses, depending
upon clinical response.
2.2 Administration Instructions
Tablets
Meclizine hydrochloride tablets must be swallowed whole.
12.5 mg: light blue colored, oval shaped tablets with “AN 441”
debossed on one side and plain on the
other side.
25 mg: light yellow colored, oval shaped tablets with “AN 442”
debossed on one side and plain on the
other side.
50 mg: white, oval shaped, partially bisected tablets with “AN
444” debossed on one side and plain on
the other side.
Meclizine hydrochloride tablets are contraindicated in patients with a
hypersensitivity to meclizine or
any of the inactive ingredients [see Adverse Reactions (6) and
Description (11)].
5.1 Drowsiness
Since drowsiness may occur with use of meclizine hydrochloride,
patients should be warned of this
possibility and cautioned against driving a car or operating dangerous
machinery.
Patients should avoid alcoholic beverages while taking meclizine
hydrochloride [see Drug Interactions
(7.1)].
5.2 Concurrent Medical Conditions
Because of its potential anticholinergic action, meclizine
hydrochloride should be used with caution in
patients with asthma, glaucoma, or enlargement of the prostate gland.
The following adverse reactions associated with the use of meclizine
hydrochloride were identified in
clinical studies or postmarketing reports. Because some of these
reactions were reported voluntarily
from a population of uncertain size, it is not always possible to
reliably estimate their frequency or
establish a causal relationship to drug exposure.
Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and
vomiting. On rare occasions
blurred vision has been reported.
7.1 CNS Depressants
T