Xyzal

DRUG DESCRIPTION

Levocetirizine dihydrochloride, the active component of XYZAL (levocetirizine dihydrochloride) tablets and oral solution, is an orally active H]-receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-l-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O3•2HCl. The molecular weight is 461.82 and the chemical structure is shown below:

XYZAL
  (levocetirizine dihydrochloride) Structural Formula Illustration

Levocetirizine dihydrochloride is a white, crystalline powder and is water soluble.

XYZAL (levocetirizine dihydrochloride) 5 mg tablets are formulated as immediate release, white, film-coated, oval-shaped scored tablets for oral administration. The tablets are imprinted on both halves of the scored line with the letter Y in red (Opacode® Red). Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and macrogol 400.

XYZAL (levocetirizine dihydrochloride) 0.5 mg/mL oral solution is formulated as an immediate release, clear, colorless liquid. Inactive ingredients are: sodium acetate trihydrate, glacial acetic acid, maltitol solution, glycerin, methylparaben, propylparaben, saccharin, flavoring (consisting of triacetin, natural & artificial flavors, dl-alpha-tocopherol), purified water.

What are the possible side effects of levocetirizine (Xyzal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • nosebleed (especially in a child);
  • confusion, hallucinations, unusual thoughts;
  • numbness or tingling around your lips or mouth;
  • jaundice (yellowing of your skin or eyes);
  • ...

Read All Potential Side Effects and See Pictures of Xyzal »

What are the precautions when taking levocetirizine dihydrochloride (Xyzal)?

Before taking levocetirizine, tell your doctor or pharmacist if you are allergic to it; or to cetirizine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: very severe kidney disease (e.g., dialysis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

This drug may make you drowsy or tired. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit...

Read All Potential Precautions of Xyzal »


Xyzal Consumer (continued)

SIDE EFFECTS: Drowsiness, tiredness, and dry mouth may occur. Fever or cough may also occur, especially in children. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking levocetirizine, tell your doctor or pharmacist if you are allergic to it; or to cetirizine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: very severe kidney disease (e.g., dialysis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

This drug may make you drowsy or tired. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be at greater risk for side effects while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Xyzal Patient Information Including Side Effects

Brand Names: Xyzal

Generic Name: levocetirizine (Pronunciation: LEE voe se TIR a zeen)

  • What is levocetirizine (Xyzal)?
  • What are the possible side effects of levocetirizine (Xyzal)?
  • What is the most important information I should know about levocetirizine (Xyzal)?
  • What should I discuss with my healthcare provider before taking levocetirizine (Xyzal)?
  • How should I take levocetirizine (Xyzal)?
  • What happens if I miss a dose (Xyzal)?
  • What happens if I overdose (Xyzal)?
  • What should I avoid while taking levocetirizine (Xyzal)?
  • What other drugs will affect levocetirizine (Xyzal)?
  • Where can I get more information?

What is levocetirizine (Xyzal)?

Levocetirizine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Levocetirizine is used to treat symptoms of year-round (perennial) allergies in adults and children who are at least 6 months old. It is also used to treat symptoms of seasonal allergies in adults and children who are at least 2 years old.

Levocetirizine is also used to treat itching and swelling caused by chronic urticaria (hives) in adults and children who are at least 6 months old.

Levocetirizine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of levocetirizine (Xyzal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • nosebleed (especially in a child);
  • confusion, hallucinations, unusual thoughts;
  • numbness or tingling around your lips or mouth;
  • jaundice (yellowing of your skin or eyes);
  • dark-colored urine, foul-smelling stools; or
  • fever, stomach pain, loss of appetite.

Less serious side effects may include:

  • drowsiness, weakness;
  • stuffy nose, sinus pain, sore throat, cough;
  • tired feeling;
  • dry mouth; or
  • weight gain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about levocetirizine (Xyzal)?

You should not use this medication if you are allergic to levocetirizine or cetirizine (Zyrtec).

Do not take levocetirizine if you have end-stage kidney disease or if you are on dialysis. Any child under 12 with kidney disease should not take levocetirizine.

Before taking levocetirizine, tell your doctor if you are allergic to any drugs, or if you have kidney or liver disease, or gallbladder problems.

It is very important not to give a child more than the prescribed dose of this medication. A child's body absorbs twice as much of the same dose size of levocetirizine as an adult's body.

Levocetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of levocetirizine.

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by levocetirizine.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

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