LEVOCETIRIZINE DIHYDROCHLORIDE tablet film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Lake Erie Medical DBA Quality Care Products LLC

INN (Jina la Kimataifa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Tungo:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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, nasoph