Pronunciation:

lee-voe-se-TI-ra-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 have not been performed on the relationship of age to the effects of levocetirizine in children under 6 years of age. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-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 an adjustment of dosage in patients receiving levocetirizine .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal 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:

• Kidney failure—Should not use in patients with this condition .

• Kidney disease—Use with caution. Effects of levocetirizine may be increased because of slower removal from the body .

Proper Use of This Medicine:

You may take this medicine with or without food.

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 form (tablet):
  • For hay fever or hives:
    • Adults and children 12 years of age and older—5 milligrams (mg) once a day in the evening .
    • Children 6 to 11 years of age—2.5 mg (half tablet) once a day in the evening.
    • Children under 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:

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 are 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 .

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 determined

Anxiety

attack, assault, force

blurred or loss of vision

cough

dark urine

difficult or labored breathing

difficulty 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 face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

light-colored stools

nausea and vomiting

nervousness

night blindness

overbright appearance of lights

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

redness of skin

restlessness

seizures

shaking

shortness of breath

skin rash

tightness in chest

trouble sleeping

tunnel vision

upper right abdominal pain

wheezing

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

dryness or soreness of throat

hoarseness

runny nose

tender, swollen glands in neck

trouble in swallowing

voice changes

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