Is Xyzal safe to use during pregnancy. What are the potential risks and side effects of taking Xyzal while pregnant. Are there safer alternatives for allergy relief during pregnancy. How does Xyzal compare to other antihistamines for use in pregnancy.

Understanding Xyzal: An Overview of the Antihistamine Medication

Xyzal, also known by its generic name levocetirizine, is a popular antihistamine medication used to treat various allergy symptoms. As an FDA-approved drug, it’s commonly prescribed for both seasonal and perennial allergies, offering relief from symptoms like sneezing, itchy eyes, runny nose, and itching of the nose or throat.

But what exactly is Xyzal, and how does it work? Xyzal belongs to a class of drugs called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. By doing so, it helps alleviate the uncomfortable effects of allergies, providing 24-hour relief for many users.

Key Features of Xyzal

• Active ingredient: Levocetirizine
• FDA Drug Category: B
• Available as prescription and over-the-counter medication
• Suitable for patients as young as six months old (for perennial allergies)
• Provides 24-hour relief of allergy symptoms

Xyzal and Pregnancy: Evaluating the Safety and Risks

One of the most pressing questions for expectant mothers dealing with allergies is: Can I take Xyzal while pregnant? The short answer is that Xyzal is generally considered safe during pregnancy, but as with any medication, it should be used under the guidance of a healthcare provider.

Xyzal falls under the FDA’s Pregnancy Category B, which indicates that animal studies have not shown a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. This classification suggests a relatively low risk, but it’s essential to weigh the potential benefits against any possible risks.

Research Findings on Xyzal During Pregnancy

While human studies on the effects of Xyzal during pregnancy are limited, animal studies have shown promising results. In these studies, doses up to 320 times higher than those prescribed to humans showed no negative effects, pregnancy complications, or fetal issues. However, it’s crucial to remember that animal studies don’t always translate directly to human outcomes.

Potential Risks and Considerations

Although Xyzal is considered relatively safe, there are always potential risks to consider when taking any medication during pregnancy. Some potential concerns include:

• Possible impact on fetal development
• Risk of allergic reactions in sensitive individuals
• Potential for drowsiness, which may affect daily activities
• Interactions with other medications or prenatal supplements

Xyzal vs. Other Antihistamines During Pregnancy

When considering allergy relief during pregnancy, it’s natural to wonder how Xyzal compares to other antihistamines. While many antihistamines are considered safe for use during pregnancy, some may be preferred over others based on available research and clinical experience.

Comparing Xyzal to Other Common Antihistamines

• Zyrtec (cetirizine): Also Category B, similar safety profile to Xyzal
• Claritin (loratadine): Category B, widely used and considered safe during pregnancy
• Benadryl (diphenhydramine): Category B, but may cause more drowsiness
• Allegra (fexofenadine): Category C, less data available on safety during pregnancy

While Xyzal and several other antihistamines are considered relatively safe, the choice of medication should always be made in consultation with a healthcare provider who can consider individual factors and medical history.

Side Effects and Precautions When Taking Xyzal During Pregnancy

As with any medication, Xyzal can cause side effects, some of which may be more concerning during pregnancy. Understanding these potential side effects and taking necessary precautions is crucial for expectant mothers considering Xyzal for allergy relief.

Common Side Effects of Xyzal

• Drowsiness
• Fatigue
• Dry mouth
• Nausea
• Headache

While these side effects are generally mild, they may be more pronounced or concerning during pregnancy. For instance, increased drowsiness could potentially lead to accidents or falls, which could be dangerous for both mother and baby.

Precautions and Contraindications

Certain conditions or factors may make it inadvisable to take Xyzal during pregnancy. These include:

• Known allergy to levocetirizine or cetirizine
• Severe kidney disease
• Liver disease
• History of adverse reactions to antihistamines

It’s crucial to inform your healthcare provider about any pre-existing conditions, allergies, or medications you’re taking to ensure the safe use of Xyzal during pregnancy.

Alternative Allergy Relief Options for Pregnant Women

While Xyzal may be a suitable option for some pregnant women, others may prefer to explore alternative methods of allergy relief. Fortunately, there are several non-pharmacological approaches that can help manage allergy symptoms during pregnancy.

Natural and Lifestyle-Based Allergy Relief Methods

• Nasal irrigation with saline solution
• Using air purifiers to reduce indoor allergens
• Keeping windows closed during high pollen days
• Wearing a mask when outdoors during allergy season
• Regularly washing bedding in hot water to reduce dust mites
• Avoiding known allergens when possible

These methods can be effective in reducing allergy symptoms without the need for medication. However, for severe allergies, a combination of these approaches with medication under medical supervision may be necessary.

Xyzal and Breastfeeding: What Nursing Mothers Should Know

For mothers who have recently given birth and are breastfeeding, the question of whether Xyzal is safe to use while nursing is equally important. While Xyzal is generally considered compatible with breastfeeding, there are some considerations to keep in mind.

Effects of Xyzal on Breastfeeding

Research on the effects of Xyzal during breastfeeding is limited, but available data suggests:

• Small amounts of Xyzal may pass into breast milk
• No significant adverse effects have been reported in breastfed infants
• Some mothers report a possible reduction in milk supply with higher doses
• Approximately 10% of mothers reported infant irritability after breastfeeding
• A small percentage (1.6%) reported infant lethargy

While these findings suggest that Xyzal is generally safe during breastfeeding, it’s important to monitor both yourself and your baby for any unusual symptoms or changes in feeding patterns.

Consulting with Healthcare Providers: Making Informed Decisions About Xyzal Use

Given the complexities surrounding medication use during pregnancy and breastfeeding, it’s crucial to consult with healthcare providers before starting or continuing Xyzal. These professionals can offer personalized advice based on individual health factors, severity of allergies, and potential risks and benefits.

Questions to Ask Your Healthcare Provider

• Is Xyzal the best choice for my allergy symptoms during pregnancy?
• Are there any specific risks I should be aware of given my medical history?
• What signs or symptoms should I watch for that might indicate a problem?
• Are there any alternative treatments we should consider?
• How might Xyzal interact with my prenatal vitamins or other medications?
• What’s the recommended dosage and duration of use during pregnancy?

Remember, your healthcare provider is your best resource for navigating the use of medications like Xyzal during pregnancy and breastfeeding. They can help you weigh the potential benefits against any risks and make an informed decision that’s best for you and your baby.

Long-term Considerations: Xyzal Use Throughout Pregnancy and Beyond

When considering the use of Xyzal during pregnancy, it’s important to think about long-term considerations and how the medication might be used throughout the different stages of pregnancy and postpartum period.

Xyzal Use Across Trimesters

The safety profile of Xyzal may vary across different stages of pregnancy. While it’s generally considered safe throughout pregnancy, some healthcare providers may recommend adjusting usage based on the trimester:

• First Trimester: Some providers may be more cautious during this critical period of fetal development
• Second Trimester: Often considered the safest period for medication use
• Third Trimester: Providers may monitor more closely for any effects on labor or delivery

Transitioning from Pregnancy to Postpartum

As you transition from pregnancy to the postpartum period, your allergy management strategy may need to be reevaluated. Factors to consider include:

• Changes in allergy symptoms post-pregnancy
• Breastfeeding considerations
• Potential for postpartum depression and how antihistamines might interact

Continuous communication with your healthcare provider throughout this transition is crucial to ensure the safest and most effective allergy management strategy.

Understanding Xyzal’s Mechanism of Action and Its Implications for Pregnancy

To fully grasp the potential effects of Xyzal during pregnancy, it’s helpful to understand how the medication works in the body. Xyzal, as an antihistamine, primarily targets the histamine system, which plays a role in allergic reactions but also has other functions in the body.

How Xyzal Works

Xyzal (levocetirizine) works by blocking histamine receptors, specifically the H1 receptors. This action prevents histamine from binding to these receptors, thereby reducing allergy symptoms. However, histamine also plays roles in:

• Regulating sleep-wake cycles
• Controlling stomach acid production
• Influencing cognitive functions

While the primary effects of Xyzal are beneficial for allergy relief, these other roles of histamine in the body explain some of the potential side effects and considerations during pregnancy.

Implications for Pregnancy

Understanding Xyzal’s mechanism of action raises several points to consider during pregnancy:

• Potential effects on fetal histamine systems
• Influence on maternal sleep patterns and fatigue levels
• Possible impacts on digestive processes

While research has not shown significant negative impacts, these considerations underscore the importance of using Xyzal judiciously and under medical supervision during pregnancy.

Monitoring and Managing Xyzal Use During Pregnancy

If you and your healthcare provider decide that using Xyzal during pregnancy is appropriate, it’s important to establish a plan for monitoring and managing its use. This approach ensures that you’re getting the maximum benefit from the medication while minimizing any potential risks.

Strategies for Safe Xyzal Use During Pregnancy

• Start with the lowest effective dose
• Monitor for side effects and allergy symptom improvement
• Keep a symptom and medication diary
• Schedule regular check-ins with your healthcare provider
• Be prepared to adjust usage based on changing pregnancy needs

By closely monitoring your Xyzal use and maintaining open communication with your healthcare provider, you can ensure the safest possible approach to managing your allergies during pregnancy.

Combining Xyzal with Other Allergy Management Techniques During Pregnancy

While Xyzal can be an effective tool for managing allergies during pregnancy, it’s often most beneficial when used as part of a comprehensive allergy management plan. Combining medication with other techniques can help minimize reliance on drugs and provide more complete symptom relief.

Complementary Allergy Management Strategies

• Allergen avoidance: Identify and minimize exposure to known allergens
• Environmental controls: Use air purifiers, dust-mite proof bedding, and regular cleaning
• Dietary adjustments: Some pregnant women find relief by avoiding certain foods
• Stress management: Stress can exacerbate allergy symptoms, so relaxation techniques may help
• Nasal rinses: Saline nasal rinses can help clear allergens and provide symptom relief

By incorporating these strategies alongside Xyzal use, you may be able to achieve better allergy control with potentially lower medication doses.

Future Research and Developments in Allergy Management During Pregnancy

As medical research continues to advance, our understanding of safe and effective allergy management during pregnancy is likely to evolve. Staying informed about new developments can help you make the best decisions for your health and your baby’s well-being.

Areas of Ongoing Research

• Long-term studies on the effects of antihistamines during pregnancy
• Development of new, pregnancy-safe allergy medications
• Improved understanding of the impact of maternal allergies on fetal development
• Advancements in non-pharmacological allergy management techniques

While current research supports the relative safety of Xyzal during pregnancy, future studies may provide even more detailed guidance on its use. Staying in touch with your healthcare provider and being open to adjusting your allergy management strategy as new information becomes available is key to ensuring the best outcomes for you and your baby.

Xyzal During Pregnancy and Breastfeeding

By: 

Amos Grünebaum

Updated on March 25, 2019

Generic Name: Levocetirizine
Indications: Antihistamine prescribed for perennial (year-round) allergies, seasonal allergies and skin-related symptoms of allergies, including hives and itching. May be prescribed off-label for other conditions.
FDA Drug Category: B

Summary Recommendations: Xyzal is prescribed to patients with year-round or seasonal allergies. This allergy medication can be prescribed to patients as young as six months old, in the case of year-round allergies. There are no reports of negative side effects in pregnant women or fetuses, thus the pregnancy drug category B.

General Precautions: Patients with a known allergy to Zyrtec (cetirizine), drugs containing levocetirizine or cetirizine should not take Xyzal. Xyzal is contraindicated in patients with end-stage kidney disease and/or patients on dialysis. Patients with any stage of kidney disease or liver disease should consult a physician about possible side effects before taking Xyzal.

Children absorb twice the amount of Xyzal as adults so proper dosing is imperative for child-safety. Never give a child more than the prescribed dose of Xyzal. If allergy symptoms do not improve or if a fever develops, contact your physician immediately.

Symptoms reported in patients taking Xyzal include fatigue, weakness, dry mouth and weight gain. More serious, but less frequently reported, symptoms include hearing problems, nosebleeds, difficulty urinating and agitation. If you feel you are experiencing serious side effects contact your physician.

Effects While Trying to Conceive: Animal studies delivered doses 25 times higher than therapeutic doses in humans with no negative effect on male or female fertility.

Effects on Pregnancy: Xyzal is in the drug category B, according to the FDA. Doses in excess of 320 times that prescribed to humans showed no negative effects, pregnancy complications or fetal complications. Human studies on the effect of Xyzal during pregnancy have not been completed. As is the case with all prescription and over-the-counter medication, Xyzal should only be used during pregnancy when absolutely necessary. Discuss any concerns about taking the drug during pregnancy with your doctor.

Safe During Breastfeeding: There are no reports of negative side effects in infants at small doses of Xyzal. Larger doses may be associated with infant drowsiness or lethargy. There are also reports of reduced milk supply in women taking larger doses of Xyzal. About 10% of mothers interviewed reported infant irritability after breastfeeding. Another 1.6% reported infant lethargy.

Antihistamines may reduce serum prolactin levels. This could affect milk production, leaving the breastfeeding mother with diminished milk supplies when taking drugs like Xyzal.

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Frequently Asked Questions | Xyzal® Allergy Relief Medicine

About the brand

Production information

Ingredient information

Dosing and usage

Warnings and safety information

Purchase

About the brand

• To pronounce Xyzal®, break the word into two syllables (zi · zol) with an emphasis on the first syllable.

• Xyzal® is an oral antihistamine approved to relieve common allergy symptoms associated with hay fever or other respiratory allergies.

• Xyzal® relieves allergy related symptoms such as sneezing, itchy eyes, watery eyes, runny nose, and itching of the nose or throat.

• Xyzal® is made in Switzerland and distributed by Chattem, Inc., a Sanofi company and leader in global healthcare.

• An allergist, pharmacist, or other healthcare provider can help answer additional questions.

• Xyzal® is available at its original, full prescription strength in stores nationwide — no prescription necessary.

• Nigel prefers the term, “spokes-owl.” And the answer is quite simple — why not?

Production information

• Xyzal® starts working one hour after taking the medication.

• Xyzal® tablets are available in 10-count, 35-count, 55-count, 80-count and 110-count — (110-count is only available at club stores). Also, Children’s Xyzal is available in a liquid 5 fl. oz. solution.

• Yes, Xyzal® Allergy 24HR is the same original, full prescription strength medicine as Xyzal®.

• Xyzal® provides 24-hour relief of sneezing, runny nose, itchy eyes, watery eyes, and itchy nose or throat.

• Yes, drowsiness may occur. In clinical studies where Xyzal® was administered at night, 6% of users experienced drowsiness. Xyzal® should be taken at night, and users should be careful if driving a motor vehicle or operating machinery.

• Yes. Xyzal® temporarily relieves allergy symptoms, which can be caused by an allergic response to indoor or outdoor allergens. Symptoms include sneezing, runny nose, itchy eyes, watery eyes, and itchy nose or throat.

• When used as directed, Xyzal® provides 24-hour relief of allergy symptoms for all-night, all-day allergy relief.

• Yes. Xyzal® relieves both indoor and outdoor allergy symptoms, including pet allergies.

• Yes. Xyzal® relieves both indoor and outdoor allergy symptoms, including mold allergies.

Ingredient information

Dosing and usage

Warnings and safety information

• Pregnant or nursing women should consult with a physician before taking any medication, including Xyzal®.

• No. Mixing alcohol with Xyzal® can increase the nervous system effects of the drug. These side effects include dizziness, drowsiness, and increased difficulty concentrating. And remember alcohol, sedatives, and tranquilizers may increase drowsiness too.

• Yes. Xyzal® is safe to use every day in the evening. Use only as directed and please read the product label for complete dosing instructions and warnings.

• As with any medicine, you should ask your doctor or healthcare provider about using other allergy medications with Xyzal®.

• For children, Children’s Xyzal® has been FDA approved for over-the-counter use for children 2 years of age and older. Parents who have additional questions should talk to a pediatrician, allergist, pharmacist, or other healthcare provider.

Purchase

• Pricing for Xyzal® will be at the discretion of each retailer.

• No. Xyzal® is available for purchase without having to visit a healthcare provider first. However, people with additional questions should consult their healthcare provider as needed.

• Xyzal® is available in drug stores, grocery stores, mass merchandisers, and savings club stores nationwide.

• Over-the-counter medications are not typically covered by insurance plans. However, insurance plans differ for each individual so be sure to check with your insurance company.

• You may be able to use your HSA or FSA tax-preferred savings account to purchase certain OTC products, like Xyzal® Allergy 24HR or Children’s Xyzal® Allergy 24HR. The passage of the CARES Act by Congress includes provisions to restore OTC eligibility under tax-preferred HSA and FSA accounts. Plan details vary, so save your receipt and check with your benefits or health provider for eligibility.

Ksizal instructions, price in pharmacies of Ukraine

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Creation date: 04/27/2021
Date updated: 20.07.2023

Warehouse and release form

1 tablet, coated with shell, Xyzal revenge:

• Levocetirizine dihydrochloride – 5 mg
• Additive ingredients including lactozymonogidrate

1 ml drops for oral administration 002

additive ingredients .

Tablets, coated with a shell, Xyzal, 7 or 10 pieces packed in a blister pack, 1 or 2 pods in a cardboard box.

Oral drops Xyzal 10 ml in dark-coloured bottles with a small dropper, in a carton pack of 1 bottle.

Pharmacological action:

Xizal is a medicinal preparation that exhibits antihistamine and antiallergic action. The active ingredient in Xizal is levocetirizine, the R-enantiomer of cetirizine. Levocetirizine competitively blocks H1-histamine receptors, and the pharmacological activity of levocetirizine is almost 2 times greater than that of cetirizine.
Xyzal is added to the histamine-dependent phase of the allergic reaction. In addition, levocetirizine leads to a change in the migration of eosinophils and a decrease in the penetration of the vessel wall. Ksizal also improves the viability of cytokines and mediators of inflammation.

The drug may have anti-verb and anti-exudative effects, ease the overshoot and delay the development of allergic reactions. Levocetirizine practically does not affect cholinergic and serotonin receptors, does not have a significant sedative effect.
After oral administration, levocetirizine is well absorbed in the intestinal tract. Taking the drug at the same time as taking the drug should not lead to a change in the bioavailability and speed of absorption of levocetirizine.

Peak plasma concentration of active speech is reached within 1 year after intake. Equal plasma concentrations are available for other dobu therapy Levocetirizine.

The degree of binding of levocetirizine with plasma proteins reaches 90%, oral bioavailability 100%. An insignificant world is metabolized in organisms. It is excreted most importantly by channels of tubular secretion and glomerular filtration.

Approximately 13% of levocetirizine is excreted by the intestine. The period of drinking varies from 6 to 10 years, depending on the individual characteristics of the patient. In children, the period of administration of levocetirizine shortened.
Patients with impaired function of nirok show an increase in the period of drinking. It is practical not to administer levocetirizine during hemodialysis (during 4-year hemodialysis, no more than 10% levocetirizine should be administered).
The active ingredient of Xyzal passes into breast milk.

Indications before congestion:

Existing indications for symptomatic therapy of patients who suffer from the color and seasonal form of allergic conjunctivitis and rhinitis, I are accompanied by wheezing, swelling of the nasal mucosa, lacrimation, rhinorrhea and hyperemia of the nasal mucosa and con’ junctiv.
Xizal is also prescribed to patients who suffer from polynosis, a chronic form of idiopathic croup, flare-ups and allergic dermatoses, as they are accompanied by visip and severbitis.

Method of administration:

Tablets, coated with shell, Xizal:

Prescription drug for oral administration. It is not recommended to take a pill or to open the pill. Ksizal should be taken directly in the form of a drink, a tablet should be washed down with a small amount of drinking water.

Trivality of the course of treatment and dose of levocetirizine indicates a favorable drug.
Adults and children over 6 years of age are usually given 1 tablet Xyzal per day.
Children younger than 6 years of age are advised to administer the drug in the form of oral droplets.

Patients with reduced function nirok should adjust the dose of levocetirizine:
With creatinine clearance of 30 to 50 ml / min, as a rule, prescribe 1 tablet of the drug Xizal 1 time in 48 years.
When creatinine clearance is 10 to 30 ml/min, as a rule, 1 tablet of Xizal is prescribed once every 72 years.
When creatinine clearance becomes less than 10 ml/min (patients on hemodialysis), levocetirizine does not stop.
With normal function of the liver in patients with a frail age and patients with impaired liver function, the dose of levocetirizine should not be corrected.
Trivality of lust to become from 1 tyzhnya to 6 months in fallow land due to the nature of the disease. In the last few days, the course is continued for up to 12 months under the control of the doctor.

Drops for oral infusion Xizal:

The drug is taken directly in the middle of the intake. If necessary, I will need to dilute a small amount of drops in a small amount of drinking water (no more than 10 ml). The validity of the intake and dose of Xizal depends on the drug.
Adults and children older than 6 years old, as a rule, are prescribed 20 drops of Xizal per dose. The additional dose is recommended to be taken in 1 dose.
Children aged 2 to 6 years, as a rule, are prescribed 5 drops of the drug Ksizal dvіchi per doba.
The maximum recommended additional dose of levocetirizine for adults and children over 6 years of age is 5 mg.
The maximum recommended additional dose of levocetirizine for children aged 2 to 6 years is 2. 5 mg.

Patients with impaired creatinine clearance, doses of levocetirizine should be carried out to improve indications of creatinine clearance:
As a rule, prescribe 20 drops of Xizal once every 48 years.
Patients with a creatinine clearance of 10 to 30 ml/min are usually given 20 drops of Xizal once every 72 years.
Do not prescribe levocetirizine to patients who are on hemodialysis.
Patients with a frail age and patients with impaired liver function with normal function need no dose adjustment of levocetirizine.
The duration of therapy, as a rule, becomes from 1 day to 6 months. In other cases, under the close supervision of the doctor, the course of healing can be increased up to 18 months.

Side effects:

Xizal is generally not well tolerated by patients. During the period of Levocetirizine therapy in some patients, the development of the following unimportant effects was noted:
On the side of the organs of sensitivity and the central nervous system: decreased vision, drowsiness, increased stupor, headache, aggression, asthenia, depressive states. In lonely moods, the development of hallucinations and judgment is possible.

On the side of the intestinal tract and liver: discomfort and pain in the epigastric cavity, dryness of the mucous membrane of the mouth, nausea, diarrhea, hepatitis, increased liver enzymes. In lonely cases, a change in the mass of the body was indicated.
Allergic reactions: kropivyanka, sverbizh shkir and visip, anaphylactic shock, angioedema.
Інші: quickened heartbeat, butt, butt, bіl in m’yazah.

Contraindications:

Xizal should not be prescribed to patients with individual hypersensitivity to levocetirizine and similar piperazine.
Coated tablets, Xyzal are not recommended for patients with glucose-galactose malabsorption syndrome, galactosemia and lactase deficiency.
Levocetirizine has not been indicated in patients with severe deficiency in blood function (creatinine clearance less than 10 ml/min).
Xyzal is not recommended for use during pregnancy and lactation.
Tablets, coated with a shell, not vicarious for the delight of children under 6 years of age.
Oral drops are not vicorous for the delight of children up to 2 years of age.

It is recommended to take precautions by prescribing levocetirizine to patients with impaired function, chronic alcoholism, and patients of a frail age.
Patients who drive a car or control potentially unsafe mechanisms should be especially careful during the hour of Levocetirizine therapy.

Vagination:

Levocetirizine should not be used for therapy in women during pregnancy, in connection with the number of reliable data on the infusion of levocetirizine during the period of pregnancy vagity.
In the period of lactation, the drug Xyzal may be used only after the development of nutrition for breastfeeding, but levocetirizine passes into breast milk.

Interaction with other medical problems:

May be able to increase the period of administration of levocetirizine in case of one-hour ingestion with theophylline.
It is not recommended to administer levocetirizine with ethyl alcohol and drugs overnight, as they depress the central nervous system.

Overdose:

Taking high doses of levocetirizine may cause unreasonable restlessness, arousal or drowsiness. Moreover, it is possible to strengthen the manifestation of negligible effects.
There is no specific antidote. When taking high doses of the drug, it is necessary to skip the tube and sign the intake of enterosorbents. If necessary, carry out therapy directed at the symptoms of intoxication.
Hemodialysis with levocetirizine overdose is not effective.

Wash up the savings:

Drops oral Xyzal after saving no more than 2 years after preparation.

Tablets, coated with shell, Xyzal should save no more than 3 years after preparation.

Directly dispensed, the drug is taken in places where the temperature does not exceed 25 degrees Celsius.

Oral droplets should be taken no more than 3 months after the first vial opening.

Ksizal: instructions

XYZAL®
(UA/9127/01/01)

Release form:

tablets, covered with a plaited shell, 5 mg, 7 or 10 tablets in a blister; 1 or 2 blisters in a cardboard box

Stock:

1 tablet levocetirizine dihydrochloride 5 mg

Manufacturer:

Switzerland

Instruction sheet Xyzal film-coated tablets 5 mg №10

Pending

INSTRUCTION

for medical use of the drug

XYZAL ®

(XYZAL®)

Composition of the medicinal product:

active ingredient: levocetirizine;

1 tablet contains levocetirizine dihydrochloride 5 mg;

other ingredients: microcrystalline cellulose, anhydrous colloidal silicon dioxide, lactose monohydrate, magnesium stearate, Opadry® Y-1-7000 (hypromelose (E 464), titanium dioxide (E 171), macrogol 400).

Dosage form.

Film-coated tablets.

Film-coated tablets, white to off-white, oval-shaped, with a Y logo on one side.

Manufacturer’s name and location.

1) Acica Pharmaceuticals S.R.L (primary and secondary packaging, manufacturer responsible for batch release and quality control).

Via Praglia, 15 – 10044 Pianezza (TO), Italy.

2) YUSB Farshim S.A. (manufacturer in bulk).

Z.I. de Planchu, Chemin de Croix Blanche 10, 1630 Bulle, Switzerland.

Pharmacotherapeutic group.

Antihistamines for systemic use. Piperazine derivatives. ATC code R06A E09.

Levocetirizine is an active stable R-enantiomer of cetirizine, belonging to the group of competitive histamine antagonists. Pharmacological action is due to the blocking of H1-histamine receptors. The affinity for H1-histamine receptors in levocetirizine is 2 times higher than that of cetirizine. It affects the histamine-dependent stage of the development of an allergic reaction, reduces the migration of eosinophils, vascular permeability, and limits the release of inflammatory mediators. It prevents the development and suppresses the course of allergic reactions, has anti-exudative, antipruritic, anti-inflammatory effects, almost no anticholinergic and antiserotonin effects.

Pharmacokinetic parameters of levocetirizine are linear and almost do not differ from those of cetirizine.

Absorption. After oral administration, the drug is rapidly and extensively absorbed. The degree of absorption of the drug does not depend on the dose and does not change with food intake, but the maximum concentration (Cmax) of the drug decreases and reaches its maximum value later. Bioavailability reaches 100%.

In 50% of patients, the effect of the drug develops 12 minutes after a single dose, and in 95% – after 0.5-1 hour. Smakh in blood serum is reached in 50 minutes after single intake of a therapeutic dose. The equilibrium concentration in the blood is reached after 2 days of taking the drug. Cmax is 270 ng/ml after a single dose and 308 ng/ml after repeated use at a dose of 5 mg, respectively.

Division. There is no information on the distribution of the drug in human tissues, as well as on the penetration of levocetirizine through the blood-brain barrier. In animal studies, the highest concentration is recorded in the liver and kidneys, and the lowest – in the tissues of the central nervous system. The volume of distribution is 0.4 l / kg. Plasma protein binding – 90%.

Biotransformation. About 14% of levocetirizine is metabolized in the human body. The metabolic process includes oxidation, N- and O-dealkylation and coupling with taurine. Dealkylation primarily occurs with the participation of cytochrome CYP 3A4, while numerous and (or) indefinite isoforms of CYP are involved in the process of oxidation. Levocetirizine does not affect the activity of cytochrome isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, 3A4 at concentrations significantly higher than the maximum after a dose.

5 mg orally. Given the low degree of metabolism and the lack of ability to inhibit metabolism, the interaction of levocetirizine with other substances (and vice versa) is unlikely.

Output. Excretion of the drug occurs mainly due to glomerular filtration and active tubular secretion. The plasma half-life in adults (T1 / 2) is 7.9 + 1.9 hours. The half-life of the drug is shorter in young children. The total clearance in adults is 0.63 ml / min / kg. Basically, the excretion of levocetirizine and its metabolites from the body occurs with urine (an average of 85.4% of the drug dose is excreted). Only 12.9 is excreted with faeces% of the drug dose.

Apparent body clearance of levocetirizine correlates with creatinine clearance. Therefore, in patients with moderate to severe renal impairment, it is recommended to select the intervals between doses of levocetirizine, taking into account creatinine clearance. With anuria in end-stage kidney disease, the total body clearance of patients, compared with the total body clearance of individuals without such disorders, is reduced by about 80%. The amount of levocetirizine excreted during a standard 4-hour hemodialysis procedure was < 10%.

Indications for use.

Symptomatic treatment of allergic rhinitis (including perennial allergic rhinitis) and urticaria.

Contraindications.

Hypersensitivity to levocetirizine or to any other component of this dosage form, or to any piperazine derivatives.

Severe CKD (creatinine clearance < 10 ml/min).

Rare hereditary disorders of galactose intolerance, lactase deficiency or impaired absorption of glucose and galactose.

Appropriate safety precautions for use. Use with caution in patients with chronic renal failure (dosage adjustment is needed) and in elderly patients with renal insufficiency (glomerular filtration may be reduced). During the use of the drug should refrain from alcohol.

In patients with certain factors that provoke urinary retention (eg, spinal cord injury, prostatic hyperplasia), attention should be paid to prescribing the drug, since levocetirizine may increase the risk of urinary retention.

Special reservations.

Use during pregnancy or lactation.

Levocetirizine is contraindicated for use during pregnancy. Cetirizine passes into breast milk, therefore, if necessary, the use of the drug, breast-feeding should be discontinued.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms. You should refrain from driving vehicles or working with other mechanisms for the period of treatment with the drug.

Children. The drug in the form of tablets should not be used in children under 6 years of age, since this dosage form does not allow for the necessary correction of the dosing regimen. This category of patients is recommended to use levocetirizine in a dosage form suitable for use in pediatrics.

Dosage and administration.

The drug is prescribed for adults and children from 6 years old orally in a daily dose of 5 mg.

1 time per day. Take the tablet with or without food. The tablet must be swallowed whole with a small amount of water.