Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Xyzal

Descriptions


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.

  • Pitolisant

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 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

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

  1. Fever
  2. nosebleed

Incidence not known

  1. Anxiety
  2. attack, assault, or force
  3. bloody, cloudy, or dark urine
  4. blurred or loss of vision
  5. burning feeling while urinating
  6. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  7. chills
  8. clay-colored stools
  9. confusion
  10. cough
  11. decrease in the frequency of urination
  12. decrease in urine volume
  13. deep or fast breathing with dizziness
  14. diarrhea
  15. difficult or labored breathing
  16. difficulty in passing urine (dribbling)
  17. difficulty with swallowing or speaking
  18. discouragement
  19. disturbed color perception
  20. dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
  21. double vision
  22. drooling
  23. dry mouth
  24. fast, irregular, pounding, or racing heartbeat or pulse
  25. feeling of constant movement of self or surroundings
  26. feeling sad or empty
  27. fixed position of the eye
  28. general tiredness and weakness
  29. halos around lights
  30. headache
  31. hives or welts, itching, skin rash
  32. inability to move the eyes
  33. increased blinking or spasms of the eyelid
  34. irritability
  35. joint or muscle pain
  36. lack of appetite
  37. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  38. light-colored stools
  39. loss of balance control
  40. loss of interest or pleasure
  41. muscle trembling, twitching, jerking, or stiffness
  42. nausea
  43. nervousness
  44. night blindness
  45. numbness of the feet, hands, and around the mouth
  46. overbright appearance of lights
  47. painful urination
  48. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  49. redness of the skin
  50. restlessness
  51. rhythmic movement of the muscles
  52. seeing, hearing, or feeling things that are not there
  53. seizures
  54. sensation of spinning
  55. shaking
  56. shuffling walk
  57. sticking out of the tongue
  58. stomach pain
  59. swelling of the face, feet, or lower legs
  60. thoughts of killing oneself
  61. tightness in the chest
  62. tremor
  63. trouble concentrating
  64. trouble with sleeping
  65. tunnel vision
  66. twisting movements of the body
  67. uncontrolled movements, especially of the face, mouth, tongue, neck, and back
  68. uncontrolled twisting movements of the neck, trunk, arms, or legs
  69. unpleasant breath odor
  70. unusual facial expressions
  71. unusual tiredness or weakness
  72. upper right stomach pain
  73. vomiting with or without blood
  74. weight gain
  75. 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

  1. Muscle aches
  2. sleepiness or unusual drowsiness
  3. sore throat
  4. stuffy or runny nose

Less common

  1. Body aches or pain
  2. dryness of the throat
  3. earache
  4. hoarseness
  5. redness or swelling in the ear
  6. tender, swollen glands in the neck
  7. voice changes

Less common

  1. Change in or loss of taste
  2. difficulty in moving
  3. increased appetite
  4. joint pain or swelling
  5. muscle pain, cramp, or stiffness
  6. 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.