Levocetirizine

(lee'' voe se tir' i zeen)

Brand Name(s): Xyzal^®; also available generically

IMPORTANT WARNING:

On May 16, 2025, the Food and Drug Administration (FDA) issued a drug safety communication warning about a rare risk of severe itching that can occur after stopping long-term use of oral allergy medications, such as levocetirizine. Most patients who experienced itching after stopping the drug, had been taking the drug for 3 months or longer. Although some had taken for less than 1 month. Patients should contact their healthcare provider if they develop severe itching after stopping cetirizine. For additional information see: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines?utm_medium=email&utm_source=govdelivery

WHY is this medicine prescribed?

Levocetirizine is used to relieve runny nose; sneezing; and redness, itching, and tearing of the eyes caused by hay fever, seasonal allergies, and allergies to other substances such as dust mites, animal dander, and mold. It is also used to treat symptoms of hives, including itching and rash. Levocetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

HOW should this medicine be used?

Levocetirizine comes as a tablet to take by mouth. Take once a day in the evening with or without food. Take levocetirizine at the same time every day.

Take levocetirizine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking levocetirizine,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had. or any other medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking levocetirizine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or ever have had kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking levocetirizine, call your doctor. Do not breast-feed while you are taking levocetirizine.

• you should know that levocetirizine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking levocetirizine. Alcohol can add to the drowsiness caused by this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Levocetirizine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• sleepiness
• tiredness
• weakness
• sore throat
• dry mouth
• fever
• cough
• nosebleed

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• hives
• rash
• itching
• swelling of the arms, hands, feet, ankles, or lower legs

Levocetirizine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• drowsiness
• agitation
• restlessness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2025.