LEVOCETIRIZINE DIHYDROCHLORIDE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

NuCare Pharmaceuticals,Inc.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

. Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 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. The use of levocetirizine dihydrochloride 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 (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 reproductio

Termék összefoglaló:

Levocetirizine dihydrochloride tablets, USP are white to off white, film-coated, biconvex, oval-shaped, scored, debossed with M 17 on one side and contain 5 mg levocetirizine dihydrochloride USP. This tablet is having functional scoring. They are supplied in unit of use HDPE bottles. NDC 68071-4629-9 BOTTLES OF 90 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
NUCARE 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
LEVOCETIRIZINE DIHYDROCHLORIDE
TABLETS.
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are 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
idiopathic urticaria (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 tablets. ( 5.1)
• Avoid concurrent use of alcohol or other central nervous system
depressants with levocetirizine dihydrochloride tablets.
( 5.1)
• Use with caution in patients with predisposing factors of urinary
retention (e.g. spinal cord lesion, prostatic hyperplasia).
Discontinue levocetirizine dihydrochloride tablets if urinary
r