Description
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.
This product is available in the following dosage forms:
- Solution
- Tablet
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
- Butalbital
- 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
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
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 oral dosage form (Children's Xyzal® Allergy 24HR solution):
- 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.
- For oral dosage form (levocetirizine dihydrochloride solution):
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
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
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.
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