Levocetirizine

Levocetirizine is an over-the-counter antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction.

Levocetirizine is available under the following different brand names: Xyzal Allergy 24HR Tablets, Xyzal Allergy 24HR Oral Solution, and Xyzal.

Dosages of Levocetirizine:

Adult and Pediatric Dosages:

Tablet

• 5 mg

Oral Solution

• 2.5 mg/5 ml

Dosage Considerations – Should be Given as Follows:

Allergic Rhinitis

Adult

• Indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis
• 5 mg orally daily in the evening
• Some patients may respond to 2.5 mg/day

Pediatric

• Indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis
• Infants under 6 months: Safety and efficacy not established
• Infants over 6 months to Children 5 years: 1.25 mg orally each day in the evening
• Children 6-12 years: 2.5 mg orally each day in the evening
• Children over 12 years: 5 mg orally each day in the evening; some patients may respond to 2.5 mg/day

Chronic Hives (Urticaria)

Adult

• Indicated for uncomplicated skin manifestations of chronic idiopathic hives
• 5 mg orally daily in the evening

Pediatric

• Indicated for uncomplicated skin manifestations of chronic idiopathic hives
• Infants under 6 months: Safety and efficacy not established
• Infants over 6 months to Children 5 years: 1.25 mg orally each day in the evening
• Children 6-12 years: 2.5 mg orally each day in the evening
• Children over 12 years: 5 mg orally each day in the evening

Dosage Modifications

Renal impairment

Adults

• Creatinine Clearance 50-80 mL/min: 2.5 mg orally each day
• Creatinine Clearance 30-50 mL/min: 2.5 mg orally every other day
• Creatinine Clearance 10-30 mL/min: 2.5 mg orally 2 times/week (every 3-4 days)
• Creatinine Clearance less than 10 mL/min and or hemodialysis: Contraindicated

Pediatric

Children 12 years or older:

• Creatinine Clearance 50-80 mL/min: 2.5 mg orally each day
• Creatinine Clearance l 30-50 mL/min: 2.5 mg orally every other day
• Creatinine Clearance 10-30 mL/min: 2.5 mg orally 2 times/week (every 3-4 days)
• Creatinine Clearance less than 10 mL/min and or hemodialysis: Contraindicated

Infants 6 months to children 11 years:

• Any degree of renal impairment: contraindicated

Hepatic impairment

• Adult and Pediatric: No dose adjustment required

Side effects of levocetirizine include:

• dry mouth
• fatigue
• runny or stuffy nose
• sore throat
• central nervous system depression
• drowsiness
• sedation
• dizziness
• mental or physical weariness
• disturbed coordination
• restlessness
• inability to sleep (insomnia)
• shakiness (tremors)
• intense excitement
• nervousness
• disturbed state of mind
• irregular heartbeat
• seizures
• upper abdominal distress
• loss of appetite
• nausea
• vomiting
• diarrhea
• constipation
• impaired bile flow (cholestasis)
• inflammation of the liver (hepatitis)
• liver failure
• liver function abnormality
• fast heart rate
• ECG changes
• abnormal heart rhythm (extra heartbeat, heart block)
• low blood pressure
• high blood pressure (hypertension)
• difficult or painful urination
• urinary retention
• impotence
• spinning sensation (vertigo)
• visual disturbances
• blurred vision
• double vision
• ringing in the ears (tinnitus)
• acute inflammation of the inner ear
• irritability
• involuntary movement of facial muscles
• tightness of the chest
• thickening of bronchial secretions
• wheezing
• sweating
• chills
• early menses
• toxic psychosis
• headache
• faintness
• numbness and tingling
• lowered white blood cell count
• low red blood cell count
• deficiency of platelets

Rare side effects of levocetirizine reported include:

• yellowing skin and eyes (jaundice)

Postmarketing side effects of Levocetirizine reported include:

• Skin/Allergy: hypersensitivity and acute allergic reaction (anaphylaxis), swelling of the skin, fixed drug eruption, itching, rash, skin eruptions with superficial pustules (acute generalized exanthematous pustulosis [AGEP]), and hives
• Neurologic: convulsion, numbness and tingling, dizziness, aggression and agitation, hallucinations, depression, movement disorders (including dystonia and oculogyric crisis), tic, sudden muscle contractions, extrapyramidal symptoms
• Ocular: visual disturbances, blurred vision
• Cardiovascular: irregular heartbeat, fast heart rate
• Pulmonary: shortness of breath
• Gastrointestinal: nausea, vomiting, hepatitis
• Genitourinary: difficult or painful urination
• Musculoskeletal: muscle pain, joint pain

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Levocetirizine has no known severe interactions with other drugs.

Serious interactions of levocetirizine include:

• isocarboxazid
• tranylcypromine

Moderate interactions of levocetirizine include:

• clobazam
• hyaluronidase
• lurasidone
• phenelzine
• ritonavir

Mild interactions of levocetirizine include:

• dyphylline
• theophylline

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

This medication contains levocetirizine. Do not take Xyzal Allergy 24HR Tablets, Xyzal Allergy 24HR Oral Solution, or Xyzal if you are allergic to levocetirizine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Documented hypersensitivity
• Lower respiratory disease, such as asthma (controversial)
• Preemies and neonates
• Nursing women
• Hypersensitivity to levocetirizine or cetirizine
• End stage renal disease (Creatinine Clearance less than 10 mL/min) or patients undergoing hemodialysis
• Children aged 6 month to 11 years with renal impairment

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Levocetirizine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Levocetirizine?"

Cautions

• Caution in narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction
• May impair mental alertness
• Avoid alcohol or other central nervous system depressants

Pregnancy and Lactation

• Use of levocetirizine during pregnancy may be acceptable
• Either animal studies show no risk but human studies are not available or animal studies show minor risks and human studies were done and showed no risk
• Levocetirizine is expected to be excreted in breast milk; avoid if breastfeeding