What is in xyzal?

Contents

Xyzal vs. Zyrtec: Differences, similarities and which is better for you

Drug overview & main differences | Conditions treated | Efficacy | Insurance coverage and cost comparison | Side effects | Drug interactions | Warnings | FAQ

The misery of allergies: runny nose, itchy or watery eyes, sneezing, and congestion. You are not alone—allergies affect more than 50 million Americans every year. Fortunately, there are many allergy medications, both prescription and over-the-counter (OTC) to help relieve those bothersome symptoms.

Two popular FDA-approved medications are Xyzal (levocetirizine dihydrochloride) and Zyrtec (cetirizine hydrochloride). Both medications are antihistamines, also called H1 blockers. They block the action of histamine, thereby relieving allergy symptoms. Xyzal and Zyrtec are less sedating than the first generation H1 blockers (such as Benadryl, or diphenhydramine).

Xyzal and Zyrtec are classified as non-sedating antihistamines along with other popular medications such as Claritin (loratadine) and Allegra (fexofenadine) but they still do have the potential to cause some drowsiness. However, Xyzal may cause less drowsiness than Zyrtec.

Xyzal and Zyrtec both may significantly relieve allergy symptoms, but there are some notable differences between the two drugs.

What are the main differences between Xyzal vs. Zyrtec?

Main differences between Xyzal vs. Zyrtec
Xyzal Zyrtec
Drug class Antihistamine Antihistamine
Brand/generic status Brand and generic Brand and generic
What is the generic name? Levocetirizine dihydrochloride Cetirizine hydrochloride
What form(s) does the drug come in? Tablet, liquid Tablet (oral, chewable), capsule, liquid
What is the standard dosage? Adults: 2.5 to 5 mg every evening
Children: varies by age – 1.25 to 5 mg every evening
Adults: 5 to 10 mg daily
Children: varies by age – 2.5 to 10 mg daily
How long is the typical treatment? Varies – months to years Varies – months to years
Who typically uses the medication? Adults; children 6 years and older Adults; children 6 months and older

Conditions treated by Xyzal and Zyrtec

Xyzal is indicated for the relief of symptoms associated with perennial allergic rhinitis (having nasal allergy symptoms most days of the year) in patients ages six years and older. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria, or chronic hives (ages six years and older).

Zyrtec is indicated for relief of symptoms from seasonal allergic rhinitis (due to allergens such as ragweed, grass, and pollen) in patients ages two years and older. It is also indicated for relief of symptoms of perennial allergic rhinitis for ages six months and older, and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria, or chronic hives for ages six months and older.

Condition Xyzal Zyrtec
Perennial Allergic Rhinitis Yes (ages 6 years & older) Yes (ages 6 months & older)
Chronic Idiopathic Urticaria Yes (ages 6 years & older) Yes (ages 6 months & older)
Seasonal Allergic Rhinitis No Yes (ages 2 years and older)

Is Xyzal or Zyrtec more effective?

Clinical studies of Xyzal showed that the drug was significantly more effective than placebo in treating symptoms of perennial allergic rhinitis as well as chronic idiopathic urticaria.

Zyrtec clinical studies showed that the drug was significantly more effective than placebo in treating symptoms of perennial allergic rhinitis, seasonal allergic rhinitis, and chronic idiopathic urticaria.

Studies comparing Xyzal and Zyrtec have varying results, with some studies preferring Xyzal and some preferring Zyrtec. In practice, both drugs seem to be quite effective. The question of which drug is better seems to be a matter of trial and error, and personal preference.

Although both Xyzal and Zyrtec can be very effective in treating allergy symptoms, the most effective medication should only be determined by your doctor, taking into account your medical condition(s) and medical history.

Coverage and cost comparison of Xyzal vs. Zyrtec

Xyzal is available in both prescription and OTC form, and in both brand and generic. The average retail price of generic Xyazl, levocetirizine, is about $73 for 5 mg, 30 tablets but it can be purchased for about $50 with a levocetirizine coupon. Insurances and Medicare Part D typically cover the generic prescription form of levocetirizine.

Zyrtec is available over the counter in both brand and generic. The average retail price of Zyrtec for 30 – 10mg tablets ranges from $18-33. You can get the generic version of Zyrtec for as low as $4. using a SingleCare Zyrtec coupon. Zyrtec is only is typically not covered by insurance or Medicare Part D; however, some state Medicaid plans do cover generic cetirizine.

Xyzal Zyrtec
Typically covered by insurance? Yes; generic No (because it is only OTC); some states may cover generic under Medicaid
Typically covered by Medicare Part D? Yes; generic No
Standard dosage #30, 5 mg tablets #30, 10 mg tablets
Typical Medicare Part D copay $0-44 N/a
SingleCare cost $ 42-67 $4-12

Common side effects of Xyzal vs. Zyrtec

Xyzal and Zyrtec have similar adverse side effects. The most common side effects are somnolence (sleepiness), dry mouth, and fatigue.

Other side effects may occur. Consult your healthcare professional for a complete list of side effects.

Xyzal Zyrtec
Side Effect Applicable? Frequency Applicable? Frequency
Somnolence Yes 6% Yes 14%
Nasopharyngitis (throat inflammation) Yes 4% No
Pharyngitis Yes 1% Yes 2%
Fatigue Yes 4% Yes 5.9%
Dry mouth Yes 2% Yes 5%

Source: DailyMed (Xyzal), Product Information (Zyrtec)

Drug interactions of Xyzal vs. Zyrtec

High doses of theophylline (a breathing medication) may result in slightly increased levels of Zyrtec. The same interaction is possible with Xyzal.

Alcohol should not be used in combination with Xyzal or Zyrtec. The combination can cause impairment and affect alertness.

Additionally, CNS depressants should not be taken in combination with either drug due to additive effects. CNS depressants include drugs such as anxiety medications, insomnia medications, and barbiturates. CNS depressants are sometimes called sedatives or tranquilizers.

Drug Xyzal Zyrtec
Alcohol Yes Yes
CNS (central nervous system) depressants, anxiety medications such as Xanax (alprazolam), sleeping medications such as Ambien (zolpidem), and barbiturates such as phenobarbital Yes Yes
Theophylline Yes Yes

Warnings of Xyzal and Zyrtec

Xyzal and Zyrtec warnings include somnolence, or sleepiness, and fatigue. You should avoid driving until you know how you react to Xyzal or Zyrtec. You should not drink alcohol while taking Xyzal or Zyrtec, because the combination can affect alertness and cause impairment.

Xyzal or Zyrtec may also cause urinary retention and should be used with caution in patients with a prostate condition. Consult your healthcare provider for medical advice if you have prostate problems.

Xyzal or Zyrtec can usually be used safely while pregnant, and short-term while breastfeeding, but only if approved by your doctor. You should always consult your healthcare provider for personalized advice. If you are already taking Xyzal or Zyrtec and become pregnant, consult your healthcare provider.

Frequently asked questions about Xyzal vs. Zyrtec

What is Xyzal?

Xyzal helps treat symptoms associated with perennial allergic rhinitis. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria, or chronic hives.

What is Zyrtec?

Zyrtec is an antihistamine used to treat seasonal allergic rhinitis due to allergens such as ragweed, grass, and pollen. It is also used for relief from perennial allergic rhinitis and skin manifestations of chronic idiopathic urticaria or chronic hives.

Are Xyzal vs. Zyrtec the same?

Xyzal is a chemical mirror image of Zyrtec. They are very similar and have similar drug interactions and side effects. Some patients prefer one to the other. Consult your allergist or other healthcare provider for information.

Is Xyzal vs. Zyrtec better?

Everyone is different; some prefer Xyzal, while others prefer Zyrtec. It may take some trial and error to find the right medication for you. Consult your healthcare provider for advice.

Can I use Xyzal vs. Zyrtec while pregnant?

Xyzal or Zyrtec can usually be used safely in pregnancy, and short-term (with caution) while breastfeeding—only if approved by your doctor. Be sure to check with your doctor before using either drug during pregnancy or while breastfeeding. If you are already taking Xyzal or Zyrtec and become pregnant, consult your healthcare provider.

Can I use Xyzal vs. Zyrtec with alcohol?

You should not drink alcohol while taking Xyzal or Zyrtec, because the combination can affect alertness and cause impairment. You should also not take CNS depressants, such as sleeping medications or anxiety medications, with Xyzal or Zyrtec.

Is it OK to take 2 Xyzal a day?

It is not necessary to take extra doses of Xyzal. Follow the directions for your age or the directions given by your doctor. Do not exceed this dose. Doing so will increase side effects, and will not make the medicine work better.

The manufacturer of Xyzal, Sanofi, explains that in addition to affecting your daily life, allergies can cause sleepless nights, causing you to feel tired and unable to function. Therefore, Xyzal was designed to be taken in the evening so you sleep better and wake up rested.

What is the difference between levocetirizine and cetirizine?

Chemically, they are mirror images of each other. Levocetirizine is newer than cetirizine. However, because everyone is different, one may be better than the other for your symptoms. Although both medications are classified as non-sedating antihistamines, they still can potentially cause drowsiness. Some people find levocetirizine to be less sedating, and others find cetirizine to be less sedating. It may take some trial and error to figure out which one is better for you.

With 2018 being an especially bad year for allergies, you may be reconsidering your current allergy medication. The sheer number of allergy relief commercials that crop up during high-pollen months can make it pretty tempting. Among the brands frequently advertised are household names like Claritin (loratadine), Allegra (fexofenadine), and Zyrtec (cetirizine), but there’s a new contender—Xyzal (levocetirizine).

First approved by the FDA 11 years ago, Xyzal was only available with a prescription until February 2017, when drugstores started stocking it over the counter as well, under the name Xyzal Allergy 24HR. Let’s see how Xyzal stacks up against other popular antihistamines.

Identical: Prescription Xyzal vs. OTC Xyzal

Over-the-counter (OTC) Xyzal Allergy 24HR is the same strength as the prescription product; both come as tablets with 5 mg of levocetirizine each. The “24 hour relief” part of Xyzal Allergy 24 HR applies to the prescription product as well, and recommended dosing for adults and children over the age of 12 is one tablet per day.

Generic levocetirizine is also available over the counter (typically sold as store-brand). Sometimes, though, the pharmacy may carry a generic version behind the counter that may be cheaper if you use a GoodRx coupon. All you need to do is get a prescription from your doctor and bring that along with a GoodRx coupon straight to the pharmacist.

*Cost of medication with GoodRx coupon

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Practically the same: Xyzal vs. Zyrtec

Xyzal and Zyrtec are remarkably similar to each other. Just take a look at their generic names, levocetirizine and cetirizine. Imagine two bananas joined together at the stem. The left banana is Xyzal (levocetirizine) and the right banana is dextrocetirizine. Together, the two bananas represent Zyrtec (cetirizine).

Since levocetirizine is the active component and cetirizine contains levocetirizine (along with the inactive dextrocetirizine), Xyzal (left banana) and Zyrtec (both bananas) are effectively the same drug and should work the same. In one of Xyzal Allergy 24HR’s commercials, they say that the 5 mg Xyzal is “just as effective as Zyrtec at only half the size”—because it’s only one banana versus Zyrtec’s two bananas.

A potential side effect of Xyzal and Zyrtec is drowsiness, though both are considered non-sedating antihistamines. If you feel drowsiness or fatigue on one of them, you can consider switching to the other to see if the side effect goes away.

Just like with Xyzal, you can use a GoodRx coupon to save on Zyrtec if you get a prescription for the generic version.

Very similar: Xyzal vs. newer antihistamines

Second-generation antihistamines (like Zyrtec and Claritin) and third-generation antihistamines (like Xyzal, Allegra and Clarinex) are thought to be interchangeable. You may experience each medication’s effectiveness and side effects differently, so if one isn’t working for you, you can try another one.

These antihistamines do not interact with the brain, so they are less likely to cause drowsiness than older, first-generation antihistamines, which is seen as a major upside. This means second- and third-generation antihistamines are relatively safe for children over the age of 2 when taken as indicated. All the brands mentioned above have children’s versions in liquid or syrup form with a slightly lower dose. Another advantage is that they’re relatively long-acting, so they only have to be taken once or twice a day.

Again, remember to shop around with GoodRx discounts and compare the costs of OTC and behind-the-counter versions.

Not so similar: Xyzal vs. first-generation antihistamines

First-generation antihistamines have been around for over 70 years. Medications like Benadryl (diphenhydramine) and Unisom (doxylamine) do reach the brain and commonly cause drowsiness and fatigue. Because of this, these drugs are often used as sleeping aids. The effects of these medications wear off in 4-6 hours. Elderly people, breastfeeding women and children under the age of 6 should not use first-generation antihistamines. While there is a Children’s Benadryl Allergy Liquid formulation, children under 6 years old are not recommended to take it unless directed by a doctor.

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  • levocetirizine (Xyzal)

    Brand Names: Xyzal

    Generic Name: levocetirizine

    • 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 (Xyzal)?

    What is levocetirizine (Xyzal)?

    Levocetirizine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms such as a runny nose or hives.

    Levocetirizine is used to treat symptoms of year-round (perennial) allergies in children who are at least 6 months 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 purposes not listed in this medication guide.

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

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

    Stop using levocetirizine and call your doctor at once if you have:

    • worsening allergy or urticaria symptoms;
    • painful or difficult urination;
    • little or no urination;
    • a light-headed feeling, like you might pass out;
    • fever; or
    • signs of an ear infection–ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child.

    Common side effects may include:

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

    Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

    Xyzal Allergy 24HR FAQ

    FAQ about Xyzal Allergy 24HR, and generic Xyzal, levocetirizine 5 mg. All FAQ items are reviewed by a board-certified allergist.

    How long does Xyzal Allergy last?

    Xyzal Allergy tablets are designed to offer consistent allergy relief for 24 hours. It takes effect within an hour of use, and offers the same level of continuous relief at hour 24. For daily symptoms – like during the allergy season or for people who have chronic allergies – it is best to take Xyzal everyday.

    Does Xyzal Allergy 24HR help with congestion?

    No. Xyzal Allergy 24HR is indicated for only certain symptoms of hay fever. These include runny nose, sneezing, watery eyes, and itching of the eyes, nose, and throat. For congestion relief, instead seek out an oral decongestant or a nasal spray.

    Why is Xyzal taken at night?

    Xyzal is considered a minimally drowsy antihistamine – there is a small chance that Xyzal could make you feel sleepy. By contrast, extreme drowsiness occurs as a side-effect of older antihistamines like Benadryl. But Xyzal is not nearly as sedating.

    In fact, in clinical studies only 6% of people who used Xyzal experienced drowsiness. Still it is suggested that you take Xyzal in the evening, preferably just before bed.

    What allergies does Xyzal Allergy 24HR treat?

    Xyzal Allergy 24HR treats both indoor and outdoor allergies. That’s why it is effective and indicated for both seasonal allergies and perennial (year-round) allergies. Year round symptoms result from indoor allergens like pet dander, mold, and dust. Seasonal symptoms result from outdoor pollen like ragweed, and airborne molds in your local environment.

    Does Xyzal treat dog allergies?

    Yes. Xyzal is an effective “all-around” antihistamine, which means it combats your body’s immune response to a wide range of allergens. This certainly includes indoor allergens like dog dander. When dogs cause your body to react negatively to their shedding skin particles (dander), Xyzal will temporarily neutralize that reaction process.

    Does Xyzal treat cat allergies?

    Yes. Cat allergies result from your body’s reaction to a cat’s dander (dead skin particles), saliva or even urine. Cats release a huge amount of these allergens, which are known to stubbornly linger in indoor environments. Xyzal disarms your body’s overly-defensive response to these otherwise harmless dander particles.

    Does Xyzal treat hives or itchy rashes?

    When taken under the care of a physician, Xyzal can be used to treat chronic idopathic urticara, ie. hives. Consult your doctor to learn whether Xyzal is the right treatment for your exact skin symptoms.

    How many mg of Xyzal Allergy 24HR can I take in a single dosage?

    Your Xyzal dosage will depend on your age and symptom severity.

    People between the ages of 12 and 64 years old should take a 5 mg tablet once daily in the evening. No one should exceed 5 mg per day without physician supervision. For less severe symptoms, Xyzal gives the option to take only 2.5 mg, or half of one tablet.

    Children between the ages of 6 and 11 should take only 2.5 mg (a half-tablet), once daily, while symptoms last.

    Xyzal is not approved for children under 6 years of age, nor anyone with kidney diseases. And adults over 65 years old should consult their doctors before use.

    Please consult your physician for additional dosing questions.

    Can kids take Xyzal Allergy 24HR?

    Yes! Xyzal is FDA indicated for children 6 years and up. Kids between the ages of 6 and 11 should take only 2.5 mg (a half-tablet). Kids 12 years and up can take the full 5 mg tablet.

    Is Xyzal good for treating colds?

    No, Xyzal is not FDA indicated to treat colds. Xyzal is specifically designed to treat allergies. Even though some allergy symptoms like runny nose also occur when you have a cold, they are caused by viruses, not allergens.

    Xyzal relieves your allergy symptoms by temporarily disarming your body’s negative response to allergens. For colds, people find decongestants or pain relievers helpful, depending on symptoms.

    Can I take Xyzal everyday?

    Yes. Xyzal is designed for daily use. You may find this especially helpful throughout allergy season, and/or if you have year-round allergy symptoms.

    You can also rest assured that, in clinical studies, Xyzal didn’t get in the way of patients’ work. If anything, allergy sufferers reported less work impairment due to their symptoms and fewer missed days, while using Xyzal.

    Is there a generic for Xyzal Allergy 24HR?

    Yes. For example, Curist levocetirizine is a generic for Xyzal.

    Curist levocetirizine has the same active ingredient and strength as Xyzal (levocetirizine dihydrochloride 5 mg). The FDA explains that “generic medicine works in the same way and provides the same clinical benefit as its brand-name version.”

    The reason why access to generics is so important is that brand name drugs are very expensive. Curist levocetirizine offers the same relief, but at half the cost.

    What is the generic name of Xyzal Allergy 24HR?

    The generic name for Xyzal is Levocetirizine Dihydrochloride.

    Xyzal, a brand name medication, has levocetirizine dihydrochloride as it’s active ingredient. Generic versions of Xyzal contain the same medication (levocetirizine dihydrochloride) in the same 5 mg strength as the brand name Xyzal.

    The FDA explains that “a generic medicine works in the same way and provides the same clinical benefit as its brand-name version.” In other words, Xyzal and the generic of Xyzal have the identical active ingredient, dosage, strength, and quality.

    Do you need a prescription to take Xyzal Allergy 24HR?

    No. Xyzal is available over-the-counter (OTC) in a once-daily 5mg tablet. Same goes for its generic version, like Curist levocetirizine.

    For many years, Xyzal was available only with a prescription. But now that same prescription strength is available OTC and in generic form.

    Is Xyzal available OTC without a prescription?

    Yes. Both Xyzal and its generic levocetirizine are available over-the-counter from pharmacies and online medicine retailers. You can purchase the once-daily 5mg tablets without a prescription, for instance on curistrelief.com.

    Xyzal vs Zyrtec (levocetirizine vs cetirizine)

    Xyzal (levocetirizine) and Zyrtec (cetirizine) are both oral antihistamines that are available over-the-counter.

    Out of all the antihistamines on the market, Xyzal is structurally the most similar to Zyrtec. You might notice that the name of the medication in Xyzal — levocetrizine — is very similar to Zyrtec’s (cetirizine) because the medicines share a common core chemical structure

    The similarities between Zyrtec and Xyzal include a common core chemical structure and an overlap in the allergy symptoms they’re indicated to treat. But Zyrtec has a higher incidence of sedation.

    That said, everyone’s body is unique, and if Zyrtec hasn’t helped you, or has become ineffective, it’s entirely possible that Xyzal can offer you relief. The same goes for side effects, if Zyrtec makes you drowsy, there’s a chance you’ll have better luck with Xyzal.

    Xyzal vs Claritin (levocetirizine vs loratadine)

    Xyzal (levocetirizine) and Claritin (loratadine) are both second generation antihistamines. As antihistamines, they operate similarly in the body. They also treat the exact same symptoms of hay fever, and are both available over-the-counter.

    However, because each person’s body is unique, you may find that one offers you better relief or fewer side-effects than the other.

    Claritin and Xyzal have different chemical structures. As such, Claritin is specifically designed to prevent drowsiness. It may be more effective taken during daytime rather than before bed.

    Taking Claritin over the long term, some people may find it has become less effective than it once was. When that’s the case, it may be a good option to try Xyzal as a replacement antihistamine.

    Xyzal vs Allegra (levocetirizine vs fexofenadine)

    Xyzal (levocetirizine) and Allegra (fexofenadine) are both over-the-counter oral antihistamines. They treat the exact same symptoms of hay fever. But despite sharing the same overall approach to relieving your allergy symptoms, they have several key differences.

    First, Xyzal and Allegra have different chemical structures.

    Second, while Xyzal is considered a minimally-sedating antihistamine, it may cause drowsiness in a small number of individuals. Allegra is meanwhiles categorized as a specifically non-drowsy antihistamine.

    Third, whereas Allegra users must avoid certain fruit juices (e.g. grapefruit) while using Allegra, Xyzal users do not.

    Fourth, Allegra is not approved for children under 12 years old. However, children between 6 and 12 years old can safely take Xyzal at half-strength (a half-tablet).

    In general, everyone’s body is unique. Finding the right antihistamine that works best for you means knowing you have options. If Allegra has not worked for you in the past, it may be a good option to try Xyzal as a replacement antihistamine.

    Xyzal vs Benadryl (levocetirzine vs diphenhydramine)

    Xyzal (levocetirizine) and Benadryl (diphenhydramine) are both oral antihistamines that you can buy over-the-counter. They both treat the same symptoms of indoor and outdoor allergies. But Benadryl differs from the more recent Xyzal in several ways.

    The differences arise from the fact that Benadryl and Xyzal have different chemical structures. Benadryl is a 1st generation antihistamine and Xyzal is a 2nd generation antihistamine.

    The main distinctions between the two involve drowsiness and duration of relief. Benadryl is known to cause drowsiness, to the extent that some use it as a sleep aid. For this reason it is not typically recommended for everyday use. Xyzal, meanwhile, caused only 6% of study participants to feel drowsy, and did not interfere with work.

    Benadryl lasts for only 4-6 hours, while Xyzal lasts for 24 hours.

    Although Benadryl is thought to be a more potent antihsitamine, neither is categorically better than the other. It is worth considering both Benadryl and Xyzal in order to find which one best meets your needs.

    Xyzal vs Flonase (levocetirzine vs fluticasone)

    Both Xyzal (levocetrizine) and Flonase (fluticasone) are indicated for the treatment of indoor and outdoor allergies. They both last 24 hours. They are both available over-the-counter. And they overlap in several of the symptoms they relieve. Those symptoms include runny nose, itchy and watery eyes, and sneezing.

    But a few major differences set these two apart. For starters, Xyzal is an oral antihistamine and Flonase is a nasal steroid spray. Not only do you use them differently, but they also relieve your symptoms in entirely different ways.

    Xyzal, the antihistamine, temporarily disarms the chemicals that your body releases in response to allergens. Those chemicals (or histamines) are then blocked from causing more symptoms in your body.

    Flonase, the nasal steroid spray, reduces the swelling and symptoms that have already occurred as a result of histamines and can prevent new symptoms from starting. These symptoms include congestion, which Xyzal does not treat.

    The good news is that Xyzal and Flonase can in some cases work together to offer compounded relief. Treating your allergic response and your ensuing symptoms at the same time might be worth a shot.

    Reviewed by Dr. Marc Goldstein, MD

    This content is for informational use only and does not replace professional medical advice, diagnosis or treatment. It is not a substitute for and should not be relied upon for specific medical recommendations. Please talk with your doctor about any questions or concerns.

    CLINICAL PHARMACOLOGY

    Mechanism Of Action

    Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. In vitro binding studies revealed that levocetirizine has an affinity for the human H1-receptor 2-fold higher than that of cetirizine (Ki = 3 nmol/L vs. 6 nmol/L, respectively). The clinical relevance of this finding is unknown.

    Pharmacodynamics

    Studies in adult healthy subjects showed that levocetirizine at doses of 2.5 mg and 5 mg inhibited the skin wheal and flare caused by the intradermal injection of histamine. In contrast, dextrocetirizine exhibited no clear change in the inhibition of the wheal and flare reaction. Levocetirizine at a dose of 5 mg inhibited the wheal and flare caused by intradermal injection of histamine in 14 pediatric subjects (aged 6 to 11 years) and the activity persisted for at least 24 hours. The clinical relevance of histamine wheal skin testing is unknown.

    A QT/QTc study using a single dose of 30 mg of levocetirizine did not demonstrate an effect on the QTc interval. While a single dose of levocetirizine had no effect, the effects of levocetirizine may not be at steady state following single dose. The effect of levocetirizine on the QTc interval following multiple dose administration is unknown. Levocetirizine is not expected to have QT/QTc effects because of the results of QTc studies with cetirizine and the long postmarketing history of cetirizine without reports of QT prolongation.

    Pharmacokinetics

    Levocetirizine exhibited linear pharmacokinetics over the therapeutic dose range in adult healthy subjects.

    Absorption

    Levocetirizine is rapidly and extensively absorbed following oral administration. In adults, peak plasma concentrations are achieved 0.9 hour after administration of the oral tablet. The accumulation ratio following daily oral administration is 1.12 with steady state achieved after 2 days. Peak concentrations are typically 270 ng/mL and 308 ng/mL following a single and a repeated 5 mg once daily dose, respectively. Food had no effect on the extent of exposure (AUC) of the levocetirizine tablet, but Tmax was delayed by about 1.25 hours and Cmax was decreased by about 36% after administration with a high fat meal; therefore, levocetirizine can be administered with or without food.

    A dose of 5 mg (10 mL) of XYZAL oral solution is bioequivalent to a 5 mg dose of XYZAL tablets. Following oral administration of a 5 mg dose of XYZAL oral solution to healthy adult subjects, the mean peak plasma concentrations were achieved approximately 0.5 hour post dose.

    Distribution

    The mean plasma protein binding of levocetirizine in vitro ranged from 91 to 92%, independent of concentration in the range of 90-5000 ng/mL, which includes the therapeutic plasma levels observed. Following oral dosing, the average apparent volume of distribution is approximately 0.4 L/kg, representative of distribution in total body water.

    Metabolism

    The extent of metabolism of levocetirizine in humans is less than 14% of the dose and therefore differences resulting from genetic polymorphism or concomitant intake of hepatic drug metabolizing enzyme inhibitors are expected to be negligible. Metabolic pathways include aromatic oxidation, N-and O-dealkylation, and taurine conjugation. Dealkylation pathways are primarily mediated by CYP3A4 while aromatic oxidation involves multiple and/or unidentified CYP isoforms.

    Elimination

    The plasma half-life in adult healthy subjects was about 8 to 9 hours after administration of oral tablets and oral solution, and the mean oral total body clearance for levocetirizine was approximately 0.63 mL/kg/min. The major route of excretion of levocetirizine and its metabolites is via urine, accounting for a mean of 85.4% of the dose. Excretion via feces accounts for only 12.9% of the dose. Levocetirizine is excreted both by glomerular filtration and active tubular secretion. Renal clearance of levocetirizine correlates with that of creatinine clearance. In patients with renal impairment the clearance of levocetirizine is reduced .

    Drug Interaction Studies

    In vitro data on metabolite interaction indicate that levocetirizine is unlikely to produce, or be subject to metabolic interactions. Levocetirizine at concentrations well above Cmax level achieved within the therapeutic dose ranges is not an inhibitor of CYP isoenzymes 1A2, 2C9, 2C19, 2A1, 2D6, 2E1, and 3A4, and is not an inducer of UGT1A or CYP isoenzymes 1A2, 2C9 and 3A4.

    No formal in vivo drug interaction studies have been performed with levocetirizine. Studies have been performed with the racemic cetirizine .

    Pediatric Patients

    Data from a pediatric pharmacokinetic study with oral administration of a single dose of 5 mg levocetirizine in 14 children age 6 to 11 years with body weight ranging between 20 and 40 kg show that Cmax and AUC values are about 2-fold greater than that reported in healthy adult subjects in a cross-study comparison. The mean Cmax was 450 ng/mL, occurring at a mean time of 1.2 hours, weight-normalized, total body clearance was 30% greater, and the elimination half-life 24% shorter in this pediatric population than in adults.

    Dedicated pharmacokinetic studies have not been conducted in pediatric patients younger than 6 years of age. A retrospective population pharmacokinetic analysis was conducted in 323 subjects (181 children 1 to 5 years of age, 18 children 6 to 11 years of age, and 124 adults 18 to 55 years of age) who received single or multiple doses of levocetirizine ranging from 1.25 mg to 30 mg. Data generated from this analysis indicated that administration of 1.25 mg once daily to children 6 months to 5 years of age results in plasma concentrations similar to those of adults receiving 5 mg once daily.

    Geriatric Patients

    Limited pharmacokinetic data are available in elderly subjects. Following once daily repeat oral administration of 30 mg levocetirizine for 6 days in 9 elderly subjects (65-74 years of age), the total body clearance was approximately 33% lower compared to that in younger adults. The disposition of racemic cetirizine has been shown to be dependent on renal function rather than on age. This finding would also be applicable for levocetirizine, as levocetirizine and cetirizine are both predominantly excreted in urine. Therefore, the XYZAL dose should be adjusted in accordance with renal function in elderly patients .

    Gender

    Pharmacokinetic results for 77 patients (40 men, 37 women) were evaluated for potential effect of gender. The half-life was slightly shorter in women (7.08 ± 1.72 hr) than in men (8.62 ± 1.84 hr); however, the body weight-adjusted oral clearance in women (0.67 ± 0.16 mL/min/kg) appears to be comparable to that in men (0.59 ± 0.12 mL/min/kg). The same daily doses and dosing intervals are applicable for men and women with normal renal function.

    Race

    The effect of race on levocetirizine has not been studied. As levocetirizine is primarily renally excreted, and there are no important racial differences in creatinine clearance, pharmacokinetic characteristics of levocetirizine are not expected to be different across races. No race-related differences in the kinetics of racemic cetirizine have been observed.

    Renal Impairment

    The total body clearance of levocetirizine after oral dosing was correlated to the creatinine clearance and was progressively reduced based on severity of renal impairment. Therefore, it is recommended to adjust the dose and dosing intervals of levocetirizine based on creatinine clearance in patients with mild, moderate, or severe renal impairment. In end-stage renal disease patients (CLCR < 10 mL/min) levocetirizine is contraindicated. The amount of levocetirizine removed during a standard 4-hour hemodialysis procedure was <10%.

    The dosage of XYZAL should be reduced in patients with mild renal impairment. Both the dosage and frequency of administration should be reduced in patients with moderate or severe renal impairment .

    Hepatic Impairment

    XYZAL has not been studied in patients with hepatic impairment. The non-renal clearance (indicative of hepatic contribution) was found to constitute about 28% of the total body clearance in healthy adult subjects after oral administration.

    As levocetirizine is mainly excreted unchanged by the kidney, it is unlikely that the clearance of levocetirizine is significantly decreased in patients with solely hepatic impairment .

    Clinical Studies

    Perennial Allergic Rhinitis

    The efficacy of XYZAL was evaluated in four randomized, placebo-controlled, double-blind clinical trials in adult and adolescent patients 12 years and older with symptoms of perennial allergic rhinitis. The four clinical trials include two dose-ranging trials of 4 weeks duration and two efficacy trials (one 6-week and one 6-month) in patients with perennial allergic rhinitis.

    These trials included a total of 1729 patients (752 males and 977 females) of whom 227 were adolescents 12 to 17 years of age. Efficacy was assessed using a total symptom score from patient recording of 4 symptoms (sneezing, rhinorrhea, nasal pruritus, and ocular pruritus) in three studies and 5 symptoms (sneezing, rhinorrhea, nasal pruritus, ocular pruritus, and nasal congestion) in one study. Patients recorded symptoms using a 0-3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) once daily in the evening reflective of the 24 hour treatment period. The primary endpoint was the mean total symptom score averaged over the first week and over 4 weeks for perennial allergic rhinitis trials.

    The two dose-ranging trials were conducted to evaluate the efficacy of XYZAL 2.5, 5, and 10 mg once daily in the evening. These trials were 4 weeks in duration and included patients with perennial allergic rhinitis. In these trials, each of the three doses of XYZAL demonstrated greater decrease in the reflective total symptom score than placebo and the difference was statistically significant for all three doses in the two studies. Results for one of these trials are shown in Table 4.

    Table 4: Mean Reflective Total Symptom Score* in Allergic Rhinitis Dose-Ranging Trials

    One clinical trial evaluated the efficacy of XYZAL 5 mg once daily in the evening compared to placebo in patients with perennial allergic rhinitis over a 6-week treatment period. Another trial conducted over a 6-month treatment period assessed efficacy at 4 weeks. XYZAL 5 mg demonstrated a greater decrease from baseline in the reflective total symptom score than placebo and the difference from placebo was statistically significant. Results of the former are shown in Table 5.

    Table 5: Mean Reflective Total Symptom Score* in Allergic Rhinitis Trials

    Treatment N Baseline On Treatment Adjusted Mean Difference from Placebo
    Estimate 95% CI p-value
    Perennial Allergic Rhinitis Trial – Reflective total symptom score
    XYZAL 5 mg 150 7.69 3.93 1.17 (0.70, 1.64) <0.001
    Placebo 142 7.44 5.10
    * Total symptom score is the sum of individual symptoms of sneezing, rhinorrhea, nasal pruritus, and ocular pruritus as assessed by patients on a 0-3 categorical severity scale.

    Onset of action was evaluated in two environmental exposure unit studies in allergic rhinitis patients with a single dose of XYZAL 2.5 or 5 mg. XYZAL 5 mg was found to have an onset of action 1 hour after oral intake. Onset of action was also assessed from the daily recording of symptoms in the evening before dosing in the allergic rhinitis trials. In these trials, onset of effect was seen after 1 day of dosing.

    Pediatric Patients Less Than 12 Years Of Age

    There are no clinical efficacy trials with XYZAL 2.5 mg once daily in pediatric patients under 12 years of age, and no clinical efficacy trials with XYZAL 1.25 mg once daily in pediatric patients 6 months to 5 years of age. The clinical efficacy of XYZAL in pediatric patients under 12 years of age has been extrapolated from adult clinical efficacy trials based on pharmacokinetic comparisons .

    Chronic Idiopathic Urticaria

    Adult Patients 18 Years Of Age And Older

    The efficacy of XYZAL for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria was evaluated in two multi-center, randomized, placebo-controlled, double-blind clinical trials of 4 weeks duration in adult patients 18 to 85 years of age with chronic idiopathic urticaria. The two trials included one 4-week dose-ranging trial and one 4-week single-dose level efficacy trial. These trials included 423 patients (139 males and 284 females). Most patients (>90%) were Caucasian and the mean age was 41. Of these patients, 146 received XYZAL 5 mg once daily in the evening. Efficacy was assessed based on patient recording of pruritus severity on a severity score of 0-3 (0 = none to 3 = severe). The primary efficacy endpoint was the mean reflective pruritus severity score over the first week and over the entire treatment period. Additional efficacy variables were the instantaneous pruritus severity score, the number and size of wheals, and duration of pruritus.

    The dose-ranging trial was conducted to evaluate the efficacy of XYZAL 2.5, 5, and 10 mg once daily in the evening. In this trial, each of the three doses of XYZAL demonstrated greater decrease in the reflective pruritus severity score than placebo and the difference was statistically significant for all three doses (see Table 6).

    The single dose level trial evaluated the efficacy of XYZAL 5 mg once daily in the evening compared to placebo in patients with chronic idiopathic urticaria over a 4-week treatment period.

    XYZAL 5 mg demonstrated a greater decrease from baseline in the reflective pruritus severity score than placebo and the difference from placebo was statistically significant.

    Duration of pruritus, number and size of wheals, and instantaneous pruritus severity score also showed significant improvement over placebo. The significant improvement in the instantaneous pruritus severity score over placebo confirmed end of dosing interval efficacy (see Table 6).

    Table 6: Mean Reflective Pruritus Severity Score in Chronic Idiopathic Urticaria Trials

    There are no clinical efficacy trials in pediatric patients with chronic idiopathic urticaria .

    Levocetirizine

    Generic Name: levocetirizine (LEE voe se TIR a zeen)
    Brand Name: Xyzal, LEVRIX, XYZALL

    Medically reviewed by Drugs.com on Apr 25, 2018 – Written by Cerner Multum

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    What is levocetirizine?

    Levocetirizine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms such as a runny nose or hives.

    Levocetirizine is used to treat symptoms of year-round (perennial) allergies in children who are at least 6 months 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 purposes not listed in this medication guide.

    Important Information

    Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

    Before taking this medicine

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

    You should not take levocetirizine if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take levocetirizine.

    Tell your doctor if you have ever had:

    • kidney disease;

    • liver disease;

    • urination problems (caused by conditions such as enlarged prostate or spinal cord lesion); or

    • gallbladder problems.

    Levocetirizine is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

    You should not breast-feed while using this medicine.

    Levocetirizine is not approved for use by anyone younger than 6 months old.

    How should I take levocetirizine?

    Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

    A child’s dose of levocetirizine is based on the age of the child. Follow your doctor’s dosing instructions very carefully.

    Do not give a child more than the prescribed dose of this medicine. A child’s body absorbs twice as much of the same dose size of levocetirizine as an adult’s body.

    Taking more of this medication will not make it more effective, and may cause severe drowsiness.

    Levocetirizine is usually taken in the evening, with or without food.

    Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

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

    Store at room temperature away from moisture and heat.

    What happens if I miss a dose?

    Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

    What happens if I overdose?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

    What should I avoid while taking levocetirizine?

    Avoid driving or hazardous activity until you know how levocetirizine will affect you. Your reactions could be impaired.

    Drinking alcohol with this medicine can cause side effects.

    Levocetirizine side effects

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

    Stop using levocetirizine and call your doctor at once if you have:

    • worsening allergy or urticaria symptoms;

    • painful or difficult urination;

    • little or no urination;

    • a light-headed feeling, like you might pass out;

    • fever; or

    • signs of an ear infection–ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child.

    Common side effects may include:

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Levocetirizine dosing information

    Usual Adult Dose for Urticaria:

    5 mg orally once a day in the evening
    Comments: Some patients may be adequately controlled on 2.5 mg orally once a day in the evening.
    Use: For the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria

    Usual Adult Dose for Allergic Rhinitis:

    Seasonal Allergic Rhinitis (OTC): 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

    Usual Pediatric Dose for Allergic Rhinitis:

    Perennial Allergic Rhinitis:
    6 months to 2 years: 1.25 mg orally once a day in the evening
    Comments: The recommended dose in pediatric patients 6 months to 2 years should not be exceeded.
    Use: For the relief of symptoms associated with perennial allergic rhinitis
    Seasonal Allergic Rhinitis (OTC):
    6 to 11 years: 2.5 mg orally once a day in the evening
    12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day
    Comments: Avoid use in patients less than 6 years.

    Usual Pediatric Dose for Urticaria:

    6 months to 5 years: 1.25 mg orally once a day in the evening
    6 to 11 years: 2.5 mg orally once a day in the evening
    12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day
    Comments: The recommended doses in pediatric patients 6 months to 12 years should not be exceeded.
    Use: For the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria

    What other drugs will affect levocetirizine?

    Using levocetirizine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

    Tell your doctor about all your other medicines, especially:

    • ritonavir; or

    • theophylline.

    This list is not complete. Other drugs may affect levocetirizine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

    Further information

    Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

    Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

    Copyright 1996-2018 Cerner Multum, Inc. Version: 5.01.

    Medical Disclaimer

    More about levocetirizine

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    • Drug class: antihistamines

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    • Levocetirizine Tablets
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    Other brands: Xyzal

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    Related treatment guides

    • Allergic Rhinitis
    • Allergies
    • Urticaria

    What Is Xyzal (Levocetirizine) for Allergies?

    You’ve probably heard the names Claritin, Allegra, Zyrtec, and Benadryl, but have you heard of Xyzal (Levocetirizine)?

    Xyzal: The New Allergy Antihistamine on the Block

    For over a decade, an allergy medicine called Xyzal (Levocetirizine) has been available by prescription only. Today, it’s available over-the-counter, and not a minute too soon. With allergies on the rise — 2018 was called “pollengeddon” by some concerned albeit playfully clever experts — it’s important to have as many options readily available when allergy symptoms kick in.

    What is Xyzal? How does Xyzal work?

    Xyzal is an oral antihistamine that works for 24 hrs to relieve symptoms of indoor and outdoor allergies. The way an antihistamine works is by counteracting your body’s response to allergens. When allergic individuals encounter allergens, their bodies release “histamines.”

    Histamines are released in the nose, eyes, ears, skin, chest, and GI tract during allergic reactions. In the eyes, they can cause itching. In the nose, histamines can cause sneezing, itching, and watery mucus in the nose. In the lips, roof of the mouth, and back of the throat, histamines produce itching and/or swelling. In the skin, they can produce hives. An antihistamine effectively disarms these particles, and temporarily quells your irritating symptoms.

    Antihistamines that you can purchase over-the-counter include Claritin (loratadine), Allegra (fexofenadine), Zyrtec (cetirizine), and the older standby Benadryl (diphenhydramine). And now you can add Xyzal (levocetirizine) to the list.

    What is Levocetirizine?

    Very simply, levocetirizine is the active ingredient in Xyzal. It’s the medicine that works to improve symptoms.

    Xyzal vs Levocetirizine: What’s the Difference?

    What differentiates one antihistamine from another is the active ingredient: the ingredient that is biologically active, i.e. the medicine. It’s that intimidating word on the label that no one knows how to pronounce, in this case ‘levocetirizine’. The name most people are familiar with is the marketing brand used by a drug company to sell the medicine, in this case ‘Xyzal’. So to summarize, Xyzal is the name of a brand which has levocetirizine as its active ingredient.

    Xyzal Generic: Allergy Medicine Minus the Marketing Cost

    According to the FDA:

    A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. Generic medicines work the same as brand-name medicines A generic medicine works in the same way and provides the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used. In more cynical words:

    Xyzal = Levocetirizine + Marketing Budget = $ Higher Prices

    For instance, check out Curist levocetirizine for significant savings relative to the brand Xyzal for the same strength medicine.

    Ok, So What Does Xyzal Do?

    Levocetirizine (Xyzal) temporarily relieves symptoms due to hay fever or other respiratory allergies:

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • and other commonly associated symptoms

    The great thing is that in clinical studies, it provided noticeable allergy symptom relief in under 1 hour — twice as fast as Claritin (loratadine). It was also found to be just as effective after 24 hours (which beats Benadryl by 6 times). And it is safe for adults and children over 2 years old.

    Does Xyzal Make You Drowsy?

    The answer is maybe, the active ingredient in Xyzal, levocetirizine, may make you drowsy. As a newer generation antihistamine, levocetirizine was designed to reduce drowsiness especially when compared to first generation antihistamines like Benadryl. In studies, only 6% of users experienced drowsiness when taking Xyzal. If you drowsiness is an issue for you when taking levocetirizine, consider taking in the evening before bed.

    Is Xyzal Right For My Allergies?

    Finding the right antihistamine for you may take a little bit of trial. Everyone’s body is unique and responds differently to various allergy medicines. So if other antihistamines have not worked for you (or have stopped working for you), levocetirizine may be a good alternative to try. Levocetirizine is available at Curist at a fraction of the cost of brand name Xyzal.

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