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:

DirectRx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride is contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see ADVERSE REACTIONS (6) and DESCRIPTION (11)]. 8.1 Pregnancy Risk Summary Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data Epidemi

Product summary:

16.1 How Supplied Tablets Meclizine hydrochloride 12.5 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “34” and one white to off white layer debossed with “L”. Bottles of 100 Bottles of 500 Meclizine hydrochloride 25 mg tablets are oval shaped, biconvex, two-layered tablet, one yellow to pale yellow layer debossed with “49” and one white to off white layer debossed with “L”. Bottles of 100 Bottles of 1000 Meclizine hydrochloride 50 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “50” and one yellow to pale yellow layer and debossed with “L”. Bottles of 100 Chewable Tablets Meclizine hydrochloride 25 mg chewable tablets are pink colored round tablets debossed with “M 25” on one side and break line on other side. Bottles of 100 16.2 Storage and Handling Store at 20oC to 25oC (68oF to 77oF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
DIRECTRX
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MECLIZINE HYDROCHLORIDE
Meclizine hydrochloride is 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.
Chewable Tablets
Meclizine hydrochloride chewable tablets must be chewed or crushed
completely before
swallowing. Do not swallow chewable tablets whole.
Tablets
12.5 mg: oval-shaped, biconvex, two-layered tablet, one blue to pale
blue layer debossed
with “34” and one white to off white layer debossed with “L”.
25 mg: oval-shaped, biconvex, two-layered tablet, one yellow to pale
yellow layer
debossed with “49” and one white to off white layer debossed with
“L”.
50 mg: oval-shaped, biconvex, two-layered tablet, one blue to pale
blue layer debossed
with “50” and one yellow to pale yellow layer and debossed with
“L”.
Chewable Tablets
25 mg: pink colored round tablets debossed with “M 25” on one side
and break line on
other side.
Meclizine hydrochloride is 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 o