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Levocetirizine (Oral route)

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 an antihistamine used to relieve the symptoms of hay fever and hives of the skin. It 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 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.

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.

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

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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—Use with caution. The effects of levocetirizine may be increased because of slower removal from the body.
  • Kidney disease, severe or
  • Kidney failure—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.

You may take this medicine with or without food.

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

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 oral dosage forms (solution or tablets):
    • For hay fever or hives:
      • Adults and children 12 years of age and older—5 milligrams (mg) or 10 milliliters (mL) once a day in the evening. Your doctor may adjust your dose as needed.
      • Children 6 to 11 years of age—2.5 mg (half tablet) or 5 mL once a day in the evening.
      • Children 6 months to 5 years of age—1.25 mg or 2.5 mL once a day in the evening.
      • Infants up to 6 months 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:

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

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor or dentist before taking any of the above while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (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
Bloody nose
fever
Incidence not known
Anxiety
attack, assault, or force
blurred or loss of vision
cough
dark urine
decrease in the frequency of urination
decrease in urine volume
difficult or labored breathing
difficulty in passing urine (dribbling)
difficulty with swallowing
disturbed color perception
dizziness
double vision
dry mouth
fast, irregular, pounding, or racing heartbeat or pulse
general tiredness and weakness
halos around lights
hives or welts
hyperventilation
irritability
itching skin
joint or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
nausea and vomiting
nervousness
night blindness
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
seizures
shaking
skin rash
tightness in the chest
trouble with sleeping
tunnel vision
upper right abdominal or stomach pain
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
Headache
muscle aches
sleepiness or unusual drowsiness
sore throat
stuffy or runny nose
Less common
Body aches or pain
congestion
diarrhea
dryness or soreness of the throat
earache
hoarseness
redness or swelling in the ear
tender, swollen glands in the neck
voice changes

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.


Last Updated: 11/4/2014

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