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Levocetirizine

    Brands

    DEA Class; OTC

    Common Brand Names; Xyzal Allergy 24HR Tablets, Xyzal Allergy 24HR Oral Solution, Xyzal

    • Antihistamines, 2nd Generation

    Selective low-sedating antihistamine; the drug is the R-enantiomer of cetirizine
    Prescription products are used for seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria in adults and pediatric patients 6 months and older
    Some non-prescription products are available for use in adults and children as young as 2 years of age

    Indicated for the management of symptoms of seasonal allergies or perennial allergies, including allergic rhinitis.

    Hypersensitivity to levocetirizine or cetirizine

    ESRD (CrCl <10 mL/min) or patients undergoing hemodialysis

    Children aged 6 month to <12 years with renal impairment

    • Dry mouth
    • Fatigue
    • Nasopharyngitis
    • Pharyngitis
    • CNS depression
    • Drowsiness
    • Sedation ranging from mild drowsiness to deep sleep (most frequent)
    • Dizziness
    • Lassitude
    • Disturbed coordination
    • Restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures is less common
    • Epigastric distress
    • Anorexia
    • Nausea
    • Vomiting
    • Diarrhea
    • Constipation
    • Cholestasis, hepatitis, hepatic failure, hepatic function abnormality, jaundice is rare
    • Tachycardia, palpitation ECG changes (eg, widened QRS)
    • Arrhythmias (eg, extrasystole, heart block)
    • Hypotension
    • Hypertension

    Caution in narrow angle glaucoma, stenosing peptic ulcer, or pyloroduodenal obstruction

    Pruritus may rebound within several days of stopping therapy, following long term use

    May cause CNS depression and impair physical or mental abilities; avoid performin tasks that require mental alertness, including operating heavy machinery or driving

    Urinary retention may occur; use caution in patients at risk of urinary retention, including prostatic hyperplasia and spinal cord injuries

    Use caution in patients with mild to severe renal impairment

    Avoid alcohol or other CNS depressants

    Available data from published literature and postmarketing experience in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes

    There are no data on presence of levocetirizine in human milk, effects on breastfed infant, or on milk production

    Adults

    5 mg/day PO.

    Geriatric

    5 mg/day PO.

    Adolescents

    5 mg/day PO.

    Children

    12 years: 5 mg/day PO.
    6 to 11 years: 2.5 mg/day PO.
    3 to 5 years: 1.25 mg/day PO.
    1 to 2 years: 1.25 mg/day PO; up to 0.125 mg/kg/dose PO twice daily has been used off-label for atopic dermatitis.

    Infants

    6 to 11 months: 1.25 mg/day PO.
    Less than 6 months: Safety and efficacy have not been established.

    Levocetirizine dihydrochloride

    tablet

    • 5mg

    oral solution

    • 2.5mg/5mL