Pronunciation:

lee-voe-se-TIR-a-zeen

Brand Names:

• Xyzal

Dosage Forms:

• Solution
• Tablet

Classifications:

Therapeutic—

Respiratory Agent

Pharmacologic—

Antihistamine, Less-Sedating

Chemical—

Piperazine (class)

Uses of This Medicine:

Levocetirizine is used to relieve the symptoms of hay fever and hives of the skin. It is an antihistamine that works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. It can also close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some persons to have hives, with severe itching of the skin.

This medicine is available only with your doctor's prescription.

Children's Xyzal® Allergy 24HR and Xyzal® Allergy 24HR are available without a prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levocetirizine in children. Safety and efficacy have not been established in infants younger than 6 months of age for levocetirizine oral solution, children younger than 2 years of age for Children's Xyzal® Allergy 24HR oral solution, and children younger than 6 years of age for the tablet.

Use is not recommended in children 6 months to 11 years of age with kidney disease.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levocetirizine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving levocetirizine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acepromazine
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aripiprazole
• Aripiprazole Lauroxil
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Droperidol
• Enflurane
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Levorphanol
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Olanzapine
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Pitolisant
• Potassium Oxybate
• Prazepam
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Ropeginterferon Alfa-2b-njft
• Secobarbital
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Enlarged prostate or
• Lesions in the spinal cord—Use with caution. May increase risk for urinary retention.

• Kidney disease, severe (eg, end-stage kidney disease) or
• Patients undergoing hemodialysis—Should not be used in patients with these conditions.

• Urinary retention (problem passing urine)—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Follow the instructions on the medicine label if you are using this medicine without a prescription.

You may take this medicine with or without food.

Measure the oral solution with a marked measuring spoon, oral syringe, or medicine cup.

Swallow the tablet whole. If you need a lower dose, your doctor may tell you to break the tablet in half.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For hay fever:
  • For oral dosage form (Children's Xyzal® Allergy 24HR solution):
    • Adults and children 12 years of age and older—5 or 10 milliliters (mL) once a day taken in the evening. Do not take more than 10 mL in 24 hours.
    • Children 6 to 11 years of age—5 mL once a day taken in the evening. Do not take more than 5 mL in 24 hours.
    • Children 2 to 5 years of age—2.5 mL once a day taken in the evening. Do not take more than 2.5 mL in 24 hours.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (levocetirizine dihydrochloride solution):
    • Adults and children older than 2 years of age—5 milligrams (mg) or 10 milliliters (mL) (1 teaspoon) once a day taken in the evening.
    • Children 6 months to 2 years of age—At first, 1.25 mg or 2.5 mL (1/2 teaspoon) once a day taken in the evening. Your doctor may adjust your dose as needed.
    • Children younger than 6 months of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and children 12 years of age and older—5 milligrams (mg) (1 tablet) once a day taken in the evening. Some patients may be given 2.5 mg (1/2 tablet) once a day taken in the evening. Do not take more than 5 mg per day.
    • Children 6 to 11 years of age—2.5 mg (1/2 tablet) once a day taken in the evening. Do not take more than 2.5 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
• For hives:
  • For oral dosage form (levocetirizine dihydrochloride solution):
    • Adults and children 12 years of age and older—5 milligrams (mg) or 10 milliliters (mL) (2 teaspoons) once a day taken in the evening. Some patients may be given 2.5 mg or 5 mL (1 teaspoon) once a day taken in the evening.
    • Children 6 to 11 years of age—2.5 mg or 5 mL (1 teaspoon) once a day taken in the evening. Do not take more than 2.5 mg per day.
    • Children 6 months to 5 years of age—At first, 1.25 mg or 2.5 mL (1/2 teaspoon) once a day taken in the evening. Do not take more than 1.25 mg per day.
    • Children younger than 6 months of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and children 12 years of age and older—5 milligrams (mg) (1 tablet) once a day taken in the evening. Some patients may be given 2.5 mg (1/2 tablet) once a day taken in the evening. Do not take more than 5 mg per day.
    • Children 6 to 11 years of age—2.5 mg (1/2 tablet) once a day taken in the evening. Do not take more than 2.5 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress to make sure this medicine is working properly. Urine tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

This medicine may cause incomplete emptying of the bladder (urinary retention). Check with your doctor right away if you have a decrease in the frequency of urination or urine volume, difficulty in passing urine (dribbling), or painful urination.

This medicine may make you tired or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with levocetirizine may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Fever

nosebleed

Incidence not known

Anxiety

attack, assault, or force

bloody, cloudy, or dark urine

blurred or loss of vision

burning feeling while urinating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chills

clay-colored stools

confusion

cough

decrease in the frequency of urination

decrease in urine volume

deep or fast breathing with dizziness

diarrhea

difficult or labored breathing

difficulty in passing urine (dribbling)

difficulty with swallowing or speaking

discouragement

disturbed color perception

dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position

double vision

drooling

dry mouth

fast, irregular, pounding, or racing heartbeat or pulse

feeling of constant movement of self or surroundings

feeling sad or empty

fixed position of the eye

general tiredness and weakness

halos around lights

headache

hives or welts, itching, skin rash

inability to move the eyes

increased blinking or spasms of the eyelid

irritability

joint or muscle pain

lack of appetite

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

loss of balance control

loss of interest or pleasure

muscle trembling, twitching, jerking, or stiffness

nausea

nervousness

night blindness

numbness of the feet, hands, and around the mouth

overbright appearance of lights

painful urination

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

restlessness

rhythmic movement of the muscles

seeing, hearing, or feeling things that are not there

seizures

sensation of spinning

shaking

shuffling walk

sticking out of the tongue

stomach pain

swelling of the face, feet, or lower legs

thoughts of killing oneself

tightness in the chest

tremor

trouble concentrating

trouble with sleeping

tunnel vision

twisting movements of the body

uncontrolled movements, especially of the face, mouth, tongue, neck, and back

uncontrolled twisting movements of the neck, trunk, arms, or legs

unpleasant breath odor

unusual facial expressions

unusual tiredness or weakness

upper right stomach pain

vomiting with or without blood

weight gain

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Muscle aches

sleepiness or unusual drowsiness

sore throat

stuffy or runny nose

Less common

Body aches or pain

dryness of the throat

earache

hoarseness

redness or swelling in the ear

tender, swollen glands in the neck

voice changes

Less common

Change in or loss of taste

difficulty in moving

increased appetite

joint pain or swelling

muscle pain, cramp, or stiffness

nightmares

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.