MECLIZINE HYDROCHLORIDE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

RedPharm Drug, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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)] . 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 Da

Descriptif du produit:

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                   NDC 16571-660-01 Bottles of 500                   NDC 16571-660-50 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                   NDC 16571-661-01 Bottles of 1000                 NDC 16571-661-10 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                   NDC 16571-662-01 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                   NDC 16571-663-01 Store at 20 o C to 25 o C (68 o F to 77 o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
----------
MECLIZINE 25MG TABS
1 INDICATIONS AND USAGE
Meclizine hydrochloride is indicated for the treatment of vertigo
associated with diseases
affecting the vestibular system in adults.
2 DOSAGE AND ADMINISTRATION
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.
3 DOSAGE FORMS AND STRENGTHS
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.
4 CONTRAINDICATIONS
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 WARNINGS AND PRECAUTIONS
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