Is Xyzal safe to take while pregnant. What are the potential risks and side effects of using Xyzal during pregnancy. How does Xyzal affect breastfeeding and milk supply. What precautions should pregnant women take when considering Xyzal for allergy relief.

Understanding Xyzal: An Overview of the Antihistamine

Xyzal, also known by its generic name levocetirizine, is a popular antihistamine medication used to treat various allergy symptoms. It belongs to the second-generation antihistamine class, which means it’s less likely to cause drowsiness compared to older antihistamines.

Xyzal is primarily prescribed for:

• Perennial (year-round) allergies
• Seasonal allergies
• Skin-related allergy symptoms, including hives and itching

The medication can be prescribed to patients as young as six months old for year-round allergies. It’s available in both prescription and over-the-counter forms, making it easily accessible for those seeking allergy relief.

How does Xyzal work?

Xyzal works by blocking histamine receptors in the body. Histamine is a chemical released during allergic reactions that causes symptoms like sneezing, itching, and runny nose. By preventing histamine from binding to its receptors, Xyzal helps alleviate these uncomfortable allergy symptoms.

Xyzal and Pregnancy: Safety Considerations

One of the most common concerns for expectant mothers is the safety of medications during pregnancy. When it comes to Xyzal, the FDA has classified it as a Category B drug for pregnancy. This classification indicates that animal studies have not shown any risk to the fetus, but there are limited human studies available.

Here are some key points to consider regarding Xyzal use during pregnancy:

• Animal studies using doses 320 times higher than those prescribed to humans showed no negative effects on pregnancy or fetal development.
• There are no reports of adverse effects in pregnant women or fetuses from Xyzal use.
• Human studies on Xyzal’s effects during pregnancy are limited, so caution is still advised.

Despite its Category B classification, it’s crucial to consult with your healthcare provider before taking Xyzal or any medication during pregnancy. They can assess your individual situation and weigh the potential benefits against any risks.

Are there any alternatives to Xyzal for pregnant women?

While Xyzal is considered relatively safe during pregnancy, some healthcare providers may recommend alternative treatments for allergy symptoms. These can include:

• Nasal saline sprays
• Lifestyle modifications to reduce allergen exposure
• Other antihistamines with longer safety records in pregnancy

Discuss these options with your doctor to determine the best course of action for managing your allergies during pregnancy.

Potential Side Effects of Xyzal During Pregnancy

While Xyzal is generally considered safe for use during pregnancy, it’s essential to be aware of potential side effects that may occur. These side effects are not specific to pregnant women but can affect anyone taking the medication.

Common side effects of Xyzal include:

• Fatigue
• Weakness
• Dry mouth
• Weight gain

Less common but more serious side effects that have been reported include:

• Hearing problems
• Nosebleeds
• Difficulty urinating
• Agitation

If you experience any severe side effects while taking Xyzal during pregnancy, it’s crucial to contact your healthcare provider immediately. They can assess whether the benefits of continuing the medication outweigh any potential risks.

Can Xyzal cause birth defects?

Based on available data, there is no evidence to suggest that Xyzal causes birth defects. Animal studies using doses significantly higher than those prescribed to humans have not shown any negative effects on fetal development. However, as with all medications during pregnancy, it’s essential to use Xyzal only when necessary and under the guidance of a healthcare professional.

Xyzal and Breastfeeding: What Nursing Mothers Should Know

For new mothers who are breastfeeding, the safety of medications is an ongoing concern. When it comes to Xyzal, there are a few important considerations to keep in mind:

• Small amounts of Xyzal can pass into breast milk.
• There are no reports of significant negative side effects in infants exposed to small doses of Xyzal through breast milk.
• Larger doses may be associated with infant drowsiness or lethargy.
• Some women have reported reduced milk supply when taking higher doses of Xyzal.

A study involving breastfeeding mothers taking Xyzal found that:

• Approximately 10% of mothers reported infant irritability after breastfeeding.
• About 1.6% reported infant lethargy.

How does Xyzal affect milk production?

Antihistamines like Xyzal may reduce serum prolactin levels, which could potentially affect milk production. Some breastfeeding mothers have reported diminished milk supplies when taking Xyzal or similar medications. If you notice a decrease in milk production while taking Xyzal, consult with your healthcare provider to discuss alternative options for allergy relief.

Precautions and Contraindications for Xyzal Use

While Xyzal is generally considered safe for many people, including pregnant women, there are certain precautions and contraindications to be aware of:

• Patients with a known allergy to Zyrtec (cetirizine), levocetirizine, or cetirizine should not take Xyzal.
• Xyzal is contraindicated in patients with end-stage kidney disease or those on dialysis.
• Individuals with any stage of kidney disease or liver disease should consult a physician before taking Xyzal.
• Children absorb twice the amount of Xyzal as adults, so proper dosing is crucial for child safety.

It’s important to note that these precautions apply to all individuals, not just pregnant women. Always inform your healthcare provider of any existing medical conditions or medications you’re taking before starting Xyzal.

Can Xyzal interact with other medications?

Like many medications, Xyzal can potentially interact with other drugs. Some interactions to be aware of include:

• Central nervous system depressants: Xyzal may enhance the sedative effects of these medications.
• Ritonavir: This HIV medication may increase the blood levels of Xyzal.
• Theophylline: Xyzal may decrease the clearance of this asthma medication.

Always provide your healthcare provider with a complete list of medications, including over-the-counter drugs and supplements, to avoid potential interactions.

Proper Dosage and Administration of Xyzal

The correct dosage of Xyzal can vary depending on factors such as age, kidney function, and the severity of allergy symptoms. For adults and children 12 years and older, the typical recommended dose is 5 mg once daily in the evening. However, dosages may be adjusted based on individual needs and responses to the medication.

Here are some general guidelines for Xyzal dosage:

• Adults and children 12 years and older: 5 mg once daily
• Children 6-11 years: 2.5 mg once daily
• Children 6 months to 5 years (for perennial allergic rhinitis): 1.25 mg once daily

It’s crucial to follow your healthcare provider’s instructions or the package directions carefully. Never exceed the recommended dose, especially during pregnancy or while breastfeeding.

When is the best time to take Xyzal?

Xyzal is typically recommended to be taken in the evening. This timing can help minimize any potential drowsiness during the day. However, if you find that the medication doesn’t cause drowsiness for you, it can be taken at any time of day. Consistency in timing can help maintain steady levels of the medication in your system for optimal symptom relief.

Alternatives to Xyzal for Allergy Relief During Pregnancy

While Xyzal is considered relatively safe during pregnancy, some women may prefer to explore alternative options for managing their allergy symptoms. Here are some potential alternatives that can be discussed with your healthcare provider:

• Nasal saline sprays: These can help flush out allergens and provide symptom relief without medication.
• Nasal corticosteroid sprays: Some are considered safe during pregnancy and can effectively manage allergy symptoms.
• Other antihistamines: Certain older antihistamines, like chlorpheniramine, have a longer history of use during pregnancy.
• Natural remedies: Options like steam inhalation or using a neti pot may provide relief for some individuals.
• Lifestyle modifications: Reducing exposure to allergens through measures like using air purifiers or keeping windows closed during high pollen days can help manage symptoms.

It’s important to note that the safety and efficacy of these alternatives can vary, and what works best may depend on individual circumstances. Always consult with your healthcare provider before starting any new treatment regimen during pregnancy.

Are there any non-medicinal ways to manage allergy symptoms during pregnancy?

Yes, there are several non-medicinal approaches that can help manage allergy symptoms during pregnancy:

• Use air purifiers with HEPA filters in your home
• Keep windows closed during high pollen days
• Shower and change clothes after spending time outdoors
• Use dust-mite proof covers on pillows and mattresses
• Vacuum regularly with a HEPA filter vacuum
• Avoid known allergens as much as possible

These methods can help reduce exposure to allergens and potentially decrease the need for medication. However, for severe allergy symptoms, a combination of these approaches and appropriate medication under medical supervision may be necessary.

Long-term Considerations for Xyzal Use During Pregnancy

When considering the use of any medication during pregnancy, it’s important to think about potential long-term effects. While current research suggests that Xyzal is generally safe during pregnancy, long-term studies on its effects are limited.

Here are some factors to consider regarding long-term Xyzal use during pregnancy:

• Continuous use throughout pregnancy: The safety of using Xyzal for extended periods during pregnancy has not been extensively studied.
• Potential impact on fetal development: While no significant risks have been identified, the long-term effects on child development are not fully known.
• Allergies in offspring: Some studies suggest that antihistamine use during pregnancy may influence allergy development in children, but more research is needed.

It’s crucial to weigh the benefits of symptom relief against any potential risks. Regular check-ins with your healthcare provider can help monitor your condition and adjust treatment as necessary throughout your pregnancy.

Can long-term use of Xyzal during pregnancy affect the baby’s immune system?

The impact of long-term Xyzal use during pregnancy on a baby’s immune system is not fully understood. Some research suggests that exposure to antihistamines in utero may influence immune system development, but the specific effects of Xyzal have not been extensively studied. More research is needed to determine any potential long-term impacts on the baby’s immune system. If you have concerns about long-term use, discuss them with your healthcare provider to explore the best approach for managing your allergies during pregnancy.

Monitoring and Follow-up Care When Using Xyzal During Pregnancy

If you and your healthcare provider decide that using Xyzal during pregnancy is appropriate for your situation, it’s important to establish a plan for monitoring and follow-up care. This can help ensure both your health and your baby’s well-being throughout the pregnancy.

Consider the following aspects of monitoring and follow-up care:

• Regular prenatal check-ups: These visits allow your healthcare provider to monitor your overall health and the baby’s development.
• Symptom tracking: Keep a record of your allergy symptoms and how well Xyzal is managing them.
• Side effect monitoring: Be aware of any potential side effects and report them to your healthcare provider promptly.
• Dosage adjustments: Your healthcare provider may need to adjust your Xyzal dosage as your pregnancy progresses.
• Alternative treatments: Discuss potential alternatives if Xyzal becomes less effective or causes concerns.

Remember that open communication with your healthcare provider is key to ensuring the best possible care for you and your baby.

How often should pregnant women taking Xyzal have follow-up appointments?

The frequency of follow-up appointments for pregnant women taking Xyzal may vary depending on individual circumstances. Generally, you should follow your regular prenatal care schedule, which typically involves monthly visits in the first and second trimesters, increasing to bi-weekly or weekly visits in the third trimester. However, if you’re taking Xyzal, your healthcare provider may recommend additional check-ins to monitor your allergy symptoms and medication effectiveness. Always follow your healthcare provider’s recommendations for appointment frequency and don’t hesitate to schedule additional visits if you have concerns about your medication or symptoms.

In conclusion, while Xyzal is generally considered safe for use during pregnancy, it’s crucial to approach its use with caution and under medical supervision. By understanding the potential benefits, risks, and alternatives, expectant mothers can make informed decisions about managing their allergy symptoms throughout pregnancy. Always consult with your healthcare provider to determine the best course of action for your individual situation.

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.