MECLIZINE HYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

RedPharm Drug, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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)] . 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% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data

Produkt oversigt:

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:              NDC 65162-441-03 Bottles of 100:            NDC 65162-441-10 Bottles of 500:            NDC 65162-441-50 Bottles of 1000:          NDC 65162-441-11 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:              NDC 65162-442-03 Bottles of 100:            NDC 65162-442-10 Bottles of 500:            NDC 65162-442-50 Bottles of 1000:          NDC 65162-442-11 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:              NDC 65162-444-03 Bottles of 100:            NDC 65162-444-10 Bottles of 500:            NDC 65162-444-50 Bottles of 1000:          NDC 65162-444-11 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
----------
MECLIZINE 25MG TAB
1 INDICATIONS AND USAGE
Meclizine hydrochloride tablets are 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.
3 DOSAGE FORMS AND STRENGTHS
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.
4 CONTRAINDICATIONS
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 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 of the
prostate gland.
6 ADVERSE REACTIONS
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 dru