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 using Xyzal for allergies.

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 a class of drugs called second-generation antihistamines, which are known for their effectiveness in managing allergic reactions with fewer side effects 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, highlighting its wide range of applications. However, when it comes to pregnancy, many women have concerns about the safety of using Xyzal.

Xyzal and Pregnancy: FDA Classification and Safety Considerations

The U.S. Food and Drug Administration (FDA) has classified Xyzal 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.

Is Xyzal safe to take during pregnancy? While no definitive human studies have been conducted, animal research has provided some reassuring data. Studies involving doses up to 320 times higher than those prescribed to humans showed no negative effects, pregnancy complications, or fetal issues. This suggests a relatively low risk for pregnant women using Xyzal at normal therapeutic doses.

However, it’s important to note that, as with all medications during pregnancy, Xyzal should only be used when the potential benefits outweigh the risks. Pregnant women should always consult their healthcare provider before starting or continuing any medication regimen.

Potential Side Effects of Xyzal During Pregnancy

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

• Fatigue
• Weakness
• Dry mouth
• Weight gain

Less common but more serious side effects may include:

• Hearing problems
• Nosebleeds
• Difficulty urinating
• Agitation

If a pregnant woman experiences any of these side effects, especially the more serious ones, it’s crucial to contact a healthcare provider immediately. The risk of these side effects must be weighed against the benefits of managing allergy symptoms during pregnancy.

Xyzal and Breastfeeding: Considerations for New Mothers

For new mothers who are breastfeeding, the safety of Xyzal is another important consideration. Can Xyzal affect breastfeeding and milk supply? While small doses of Xyzal have not been associated with negative side effects in infants, there are some factors to consider:

1. Larger doses may cause drowsiness or lethargy in infants.
2. Some women report reduced milk supply when taking higher doses of Xyzal.
3. Approximately 10% of mothers interviewed reported infant irritability after breastfeeding while taking Xyzal.
4. About 1.6% reported infant lethargy.

It’s worth noting that antihistamines, in general, may reduce serum prolactin levels, which could potentially affect milk production. This might lead to diminished milk supplies in breastfeeding mothers taking drugs like Xyzal.

Precautions and Contraindications for Xyzal Use

While Xyzal is generally considered safe, there are certain precautions and contraindications to be aware of:

• Patients with a known allergy to Zyrtec (cetirizine) or 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 crucial for child safety.

How should pregnant women approach these precautions? It’s essential for expectant mothers to discuss their full medical history, including any kidney or liver conditions, with their healthcare provider before starting Xyzal. This ensures that the medication is safe for both the mother and the developing fetus.

Alternatives to Xyzal During Pregnancy

For pregnant women who are hesitant about using Xyzal or for whom it may be contraindicated, there are alternative methods for managing allergy symptoms:

• Saline nasal sprays to relieve congestion
• Nasal irrigation with a neti pot
• Using air purifiers to reduce allergens in the home
• Avoiding known allergens when possible
• Wearing a mask when outdoors during high pollen count days

In some cases, healthcare providers may recommend other antihistamines that have a longer history of use during pregnancy. However, each medication comes with its own set of risks and benefits, which should be discussed with a medical professional.

Xyzal’s Impact on Fertility and Conception

For couples trying to conceive, the potential effects of medications on fertility are a significant concern. Does Xyzal affect fertility or conception chances? Animal studies provide some reassuring data on this front. Research involving doses 25 times higher than therapeutic doses in humans showed no negative effect on male or female fertility.

This suggests that Xyzal is unlikely to interfere with conception efforts. However, as with all aspects of reproductive health, individuals or couples trying to conceive should consult with their healthcare provider about any medications they are taking, including Xyzal.

Monitoring Allergy Symptoms During Pregnancy

When using Xyzal or any allergy medication during pregnancy, it’s crucial to monitor symptoms closely. If allergy symptoms do not improve or if a fever develops, it’s important to contact a healthcare provider immediately. This vigilance ensures that any potential complications or ineffective treatment can be addressed promptly.

Additionally, pregnant women should be aware of any changes in their body’s response to allergens or medications. Pregnancy can sometimes alter the severity of allergies or the effectiveness of treatments, making regular check-ins with a healthcare provider essential.

Long-term Considerations of Xyzal Use in Pregnancy

While short-term use of Xyzal during pregnancy appears to be safe based on available data, what about long-term use throughout pregnancy? Currently, there is limited research on the long-term effects of Xyzal use throughout pregnancy. This lack of data underscores the importance of using the medication only when necessary and under the guidance of a healthcare provider.

Pregnant women who require long-term allergy management should work closely with their healthcare team to monitor both maternal and fetal health throughout the pregnancy. This may involve regular check-ups, ultrasounds, and discussions about any changes in symptoms or side effects.

Dosage Considerations for Pregnant Women

The appropriate dosage of Xyzal can vary depending on individual factors, including the severity of allergy symptoms and the stage of pregnancy. Typically, the recommended dose for adults is 5 mg once daily in the evening. However, pregnant women may require dosage adjustments.

It’s crucial never to exceed the prescribed dose of Xyzal, especially during pregnancy. If allergy symptoms are not adequately controlled with the prescribed dose, it’s important to consult with a healthcare provider rather than adjusting the dosage independently.

Interactions with Other Medications During Pregnancy

Pregnant women often need to take various medications to manage different aspects of their health. How does Xyzal interact with other common medications used during pregnancy? While Xyzal generally has few drug interactions, it’s important to be aware of potential interactions with:

• Sedatives or tranquilizers
• Other antihistamines
• Certain antidepressants
• Alcohol

These substances can potentially increase the sedative effects of Xyzal, leading to increased drowsiness or dizziness. Pregnant women should always inform their healthcare providers about all medications, supplements, and herbal products they are taking to avoid potentially harmful interactions.

Managing Xyzal Side Effects During Pregnancy

While Xyzal is generally well-tolerated, some women may experience side effects during pregnancy. How can these side effects be managed effectively? Here are some strategies:

• For drowsiness: Take Xyzal in the evening before bedtime
• For dry mouth: Stay well-hydrated and use sugar-free gum or lozenges
• For fatigue: Ensure adequate rest and discuss iron levels with a healthcare provider
• For weight gain: Maintain a balanced diet and regular exercise routine as approved by a healthcare provider

If side effects persist or worsen, it’s crucial to consult with a healthcare provider. They may suggest adjusting the dosage or switching to an alternative allergy management strategy.

The Role of Allergy Management in Pregnancy Health

Effectively managing allergies during pregnancy is not just about comfort—it can have significant implications for overall pregnancy health. Uncontrolled allergies can lead to poor sleep, increased stress, and in some cases, complications such as sinusitis or asthma exacerbations.

By properly managing allergy symptoms with medications like Xyzal under medical supervision, pregnant women can potentially reduce these risks. This underscores the importance of finding a balance between managing allergy symptoms and ensuring the safety of both mother and fetus.

Post-Pregnancy Considerations for Xyzal Use

As pregnancy transitions to the postpartum period, new mothers may have questions about continuing Xyzal use, especially if they plan to breastfeed. The considerations for Xyzal use while breastfeeding differ somewhat from those during pregnancy.

While Xyzal does pass into breast milk, the amounts are generally considered too small to be harmful to most infants. However, as mentioned earlier, there are potential concerns about reduced milk supply and infant drowsiness with higher doses. New mothers should discuss their specific situation with a healthcare provider to make an informed decision about Xyzal use while breastfeeding.

Future Research and Developments in Pregnancy-Safe Antihistamines

As medical research continues to advance, what developments can we expect in the field of pregnancy-safe antihistamines? While Xyzal and similar second-generation antihistamines are considered relatively safe during pregnancy, there is ongoing research to develop even safer and more effective options for pregnant women.

Future developments may include:

• More comprehensive human studies on the long-term effects of antihistamine use during pregnancy
• Development of antihistamines specifically designed for use during pregnancy
• Improved methods for managing allergies without medication during pregnancy
• Better understanding of the interaction between maternal allergies and fetal development

These advancements could provide pregnant women with more options and greater peace of mind when managing allergy symptoms during pregnancy.

The Importance of Individualized Care

While general guidelines provide a framework for using Xyzal during pregnancy, it’s crucial to remember that every pregnancy is unique. Factors such as the severity of allergy symptoms, overall health status, and individual risk factors all play a role in determining the most appropriate allergy management strategy.

Healthcare providers can offer personalized advice based on a comprehensive assessment of an individual’s situation. This may involve weighing the benefits of symptom relief against potential risks, considering alternative treatments, or adjusting treatment plans as the pregnancy progresses.

By working closely with healthcare providers and staying informed about the latest research and recommendations, pregnant women can make confident decisions about using Xyzal or other allergy medications during this important time in their lives.

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.