LEVOCETIRIZINE DIHYDROCHLORIDE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Dispensing Solutions, Inc.

INN (International ime):

LEVOCETIRIZINE DIHYDROCHLORIDE

Sastav:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.'s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. The use of levocetirizine dihydrochloride tablets is 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 (CLCR < 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 preg

Proizvod sažetak:

Levocetirizine dihydrochloride tablets are available as follows: 5 mg - white to off-white, film-coated, oval-shaped, scored tablets. One side of the tablet is scored in half and debossed with the number "9" on one side of the score and "3" on the other. The other side of the tablet debossed with the number "7701". They are available in bottles of 90. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
DISPENSING SOLUTIONS, 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 LEVOCETIRIZINE
DIHYDROCHLORIDE TABLETS.
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Urinary Retention (5.2) [09/2012]
INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H -receptor
antagonist indicated for:
The treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria (1.3)
DOSAGE AND ADMINISTRATION
Adults and children 12 years of age and older: 5 mg once daily in the
evening (2.1)
Children 6 to 11 years of age: 2.5 mg once daily in the evening (2.2)
Renal Impairment
Adjust the dose in patients 12 years of age and older with decreased
renal function (2.4, 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)
Patients with end-stage renal disease at less than 10 mL/min
creatinine clearance or patients undergoing hemodialysis
(4)
Children 6 months to 11 years of age with renal impairment (4)
WARNINGS AND PRECAUTIONS
Avoid engaging in hazardous occupations requiring complete mental
alertness such as driving or operating machinery
when taking levocetirizine (5.1).
Avoid concurrent use of alcohol or other central nervous system
depressants with levocetirizine (5.1).
Use with caution in patients with predisposing factors of urinary
retention (e.g., spinal cord lesion, prostatic hyperplasia).
Discontinue levocetirizine if urinary retention occurs (5.2).
ADVERSE REACTIONS
The most common adverse reactions (rate ≥ 2% and > placebo) were
somnolence, nasopharyngitis, fatigue, d