LEVOCETIRIZINE DIHYDROCHLORIDE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)

Saadav alates:

Marlex Pharmaceuticals Inc

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 years of age and older. Levocetirizine dihydrochloride tablet are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. The use of levocetirizine dihydrochloride tablets are contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions ( 6.2 ) ]. Patients with end-stage renal disease (CL CR < 10 mL/min) and patients undergoing hemodialysis Children 6 months to 11 years of age with impaired renal function Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine dihydrochloride s

Toote kokkuvõte:

Levocetirizine dihydrochloride tablets, USP are white to off white, oval shaped biconvex, film-coated tablet debossed with 'I' and '12' on one side and score line on the other side and contain 5 mg levocetirizine dihydrochloride. They are supplied in NDC 10135-0639-30 NDC 10135-0639-90 Storage: Store at 20 to 25ºC (68 to 77ºF); excursions permitted to 15 to 30ºC (59 to 86°F) [see USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
MARLEX PHARMACEUTICALS INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOCETIRIZINE
DIHYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LEVOCET IRIZINE
DIHYDROCHLORIDE TABLETS.
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Indications and Usage (1.1)
Dosage and Administration (2.2)
01/2018
01/2018
INDICATIONS AND USAGE
Levocetirizine dihydrochloride is a histamine H
-receptor antagonist indicated for:
The relief of symptoms associated with perennial allergic rhinitis
(1.1)
The treatment of the uncomplicated skin manifestations of chronic
idiopathicurticaria (1.2)
DOSAGE AND ADMINISTRATION
CHRONIC IDIOPATHIC URTICARIA (2.2)
Adults and children 12 years of age and older: 5 mg once daily in the
evening Children 6 to 11 years of age: 2.5 mg
once daily in the evening
Renal Impairment
Adjust the dose in patients 12 years of age and older with decreased
renal function (12.3)
DOSAGE FORMS AND STRENGTHS
Immediate release breakable (scored) tablets, 5 mg (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to levocetirizine or any of the
ingredients of levocetirizine dihydrochloride
tablets or to cetirizine (4.1)
Patients with end-stage renal disease at less than 10 mL/min
creatinine clearance or patients undergoing hemodialysis
(4.2)
Children 6 months to 11 years of age with renal impairment (4.3)
WARNINGS AND PRECAUTIONS
Avoid engaging in hazardous occupations requiring complete mental
alertness such as driving or operating machinery
when taking levocetirizine dihydrochloride (5.1).
Avoid concurrent use of alcohol or other central nervous system
depressants with levocetirizine dihydrochloride (5.1).
Use with caution in patients with predisposing factors of urinary
retention (e.g. spinal cord lesion, prostatic hyperplasia).
Discontinue levocetirizine dihydrochloride if urin