레보세티리진염산염

Levocetirizine dihydrochloride tablets are a histamine H 1 -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 ) 1.1 Perennial Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

The use of levocetirizine dihydrochloride tablets are contraindicated in: • 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 ) 4.1 Patients with Known Hypersensitivity 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 ) ]. 4.2 Patients with End-Stage Renal Disease Patients with end-stage renal disease (CL CR < 10 mL/min) and patients undergoing hemodialysis 4.3 Pediatric Patients with Impaired Renal Function Children 6 months to 11 years of age with impaired renal function

• 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 urinary retention occurs ( 5.2 ). • Risk of New Onset Pruritus After Discontinuation of levocetirizine dihydrochloride : New onset pruritus within a few days after discontinuation of levocetirizine dihydrochloride has been reported, usually after long-term use (e.g., few months to years) of levocetirizine dihydrochloride Symptoms may improve with restarting or tapering levocetirizine dihydrochloride ( 5.3 ). 5.1 Somnolence In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with levocetirizine dihydrochloride. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride. Concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous …

8.1 Pregnancy Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral route to pregnant rats and rabbits, during the period of organogenesis, at doses up to 390 times and 470 times, respectively, the maximum recommended human dose (MRHD) in adults. In rats treated during late gestation and the lactation period, cetirizine had no effects on pup development at oral doses up to …