Xyzall 5mg

Quick links

Choose a section

Quick links to important sections

Advertisements

Xyzall 5mg

Advertisements
Advertisements

Treatment option:

Advertisements

Overview of Xyzall 5mg

Property Description
Active ingredient Levocetirizine dihydrochloride
Form 5 mg Film-coated tablets
Pharmacological class Second-generation Histamine H1-receptor antagonist
Common use Antiallergic agent
Origin Synthetic R-enantiomer derivative (of Cetirizine)

What Type of Medicine is Xyzall 5mg?

Xyzall 5mg is the brand name for a prescription-only medicine whose active component is levocetirizine dihydrochloride, classified as a highly selective second-generation Histamine H1-receptor antagonist. This compound is clinically recognized for its targeted action against the systemic effects of histamine released during an allergic response. As an antiallergic agent, its primary purpose is to address the discomfort associated with conditions like seasonal allergies. Xyzall is supplied as 5 mg film-coated tablets designed for oral intake.

Composition and Unique Origin of Levocetirizine

The active substance, levocetirizine dihydrochloride, is a synthetic single active ingredient product. The key differentiating feature of levocetirizine is its unique origin: it is the purified R-enantiomer—the pharmacologically active isomer—derived from the older, racemic mixture cetirizine. This purification enhances the compound's selectivity. This structure gives it a high binding affinity for the target H1-receptors, which is the foundational chemical property of its action. The 5 mg strength of the levocetirizine dihydrochloride is contained within the tablet, along with solid pharmaceutical excipients.

High-Level Purpose of Selective H1 Blockade

The overall purpose of this medicine is to provide relief by initiating a selective H1 blockade to interrupt the body's cycle of allergic response. The mechanism involves preventing the natural substance histamine, released by the body during an allergic episode, from binding to and activating the peripheral H1-receptors that trigger common symptoms. This targeted inhibition forms the foundation for the medicine's antiallergic effect, mitigating the physical discomfort associated with histamine release.

Regulatory References

  1. Levocetirizine H1-receptor Antagonist Classification
Advertisements

What side effects are possible with Xyzall 5mg?

Adverse Reactions and Safety Warnings

Adverse reactions associated with levocetirizine (Xyzall 5mg) primarily involve the Central Nervous System (CNS) and include somnolence, fatigue, and asthenia. Other common effects in adults and adolescents (rate ge 2% and > placebo) are nasopharyngitis, dry mouth, and pharyngitis. In children 6 to 12 years of age, pyrexia (fever), somnolence, cough, and epistaxis (nosebleed) were commonly reported.

Serious and Post-Marketing Reactions

Serious adverse reactions reported in regulatory documents include Hypersensitivity reactions, ranging from urticaria (hives) to anaphylaxis (a life-threatening allergic reaction). Post-marketing reports, for which frequency is classified as Not Known, encompass a broader range of system-organ classes, including psychiatric disturbances (e.g., aggression, hallucination, suicidal ideation), nervous system effects (e.g., convulsions, syncope), and gastrointestinal symptoms (e.g., nausea, vomiting, hepatitis). Of note, a risk of rare but severe pruritus (itching) has been reported upon discontinuing long-term, daily use of levocetirizine.

Safety Restrictions and Considerations

Use of levocetirizine is contraindicated in patients with a known hypersensitivity to the drug, cetirizine, or any other piperazine derivatives. It is also contraindicated in patients with End-Stage Renal Disease (Creatinine Clearance < 10 mL/min) and in children 6 months to 11 years of age with any degree of renal impairment. The drug must be used with caution in individuals with predisposing factors for urinary retention; discontinuation is required if retention occurs. The CNS depressant effects necessitate caution against engaging in hazardous activities, such as driving or operating machinery. Concurrent use with alcohol or other CNS depressants should be avoided due to the potential for increased impairment of alertness.

Advertisements

Overdose and Emergency Response

Xyzall 5mg Overdose and When to Seek Help

The official overdose profile for levocetirizine dihydrochloride (Xyzall 5mg) is strictly defined by documented clinical manifestations and regulator-mandated emergency procedures.

Documented Overdose Manifestations

Overdose presentations primarily involve Central Nervous System (CNS) effects. In adults, the most commonly documented sign is drowsiness. The profile for children is noted to differ, showing initial symptoms of agitation and restlessness that are subsequently followed by drowsiness. This differentiation in manifestation is documented in official regulatory labeling.

Mandated Emergency Action and Management

In the event of an overdose, regulatory authorities mandate that immediate medical attention must be sought. It is required to get medical help or contact a Poison Control Center right away. Official labeling states that no known specific antidote exists for levocetirizine. Therefore, management is restricted entirely to symptomatic and supportive treatment. Furthermore, the official profile notes that the active substance is not effectively removed by dialysis, a finding that constrains the procedural options available during emergency management. This information governs the required response to the overdose scenario based on regulatory consensus.

Advertisements

Therapeutic Uses of Xyzall 5mg

Main Uses of Xyzall 5mg

Xyzall 5mg is an antihistamine medication containing the active ingredient levocetirizine dihydrochloride. It is primarily utilized to manage symptoms associated with both seasonal and year-round allergic reactions. By blocking the action of histamine—a substance in the body that causes allergic symptoms—the medication helps alleviate the physical discomfort caused by environmental triggers.

Allergic Rhinitis

The medication is frequently used to treat symptoms of allergic rhinitis, which include:

  • Sneezing: Reducing the frequency of sudden sneezing fits.
  • Rhinorrhea: Managing a runny nose or excessive nasal discharge.
  • Nasal Pruritus: Relieving itchiness inside the nasal passages.
  • Ocular Symptoms: Addressing itchy, red, or watery eyes often associated with hay fever.

Chronic Idiopathic Urticaria

In addition to respiratory symptoms, Xyzall 5mg is used to treat the skin manifestations of chronic idiopathic urticaria. This condition is characterized by the repeated appearance of hives or wheals without a clearly identified external cause. The medication helps to:

  • Reduce Itching: Decrease the intensity of skin irritation and pruritus.
  • Limit Hives: Minimize the number and severity of raised, red bumps on the skin.

Benefits of Treatment

As a second-generation antihistamine, the primary benefit of Xyzall 5mg is its ability to provide symptomatic relief from allergens such as pollen, pet dander, dust mites, and mold. The formulation is designed to provide long-acting stabilization of the allergic response, helping individuals maintain their daily activities without the disruption caused by persistent allergy symptoms.

Regulatory References

  1. NIH MedlinePlus overview
Advertisements

Eligibility and Restrictions for Use

Who Can and Cannot Use Xyzall 5mg — Official Eligibility Information

Xyzall (levocetirizine 5 mg) is generally intended for adults and adolescents 12 years of age and older. Use is permissible for children aged 6 to 11 years with normal renal function, although the prescribed dose is typically 2.5 mg (half a tablet).

Contraindications (Must Not Use)

The medicine is contraindicated in several specific populations, meaning it must not be used by:

  • Patients with a known hypersensitivity or allergy to levocetirizine, cetirizine, hydroxyzine, or any other piperazine derivatives.
  • Patients with end-stage renal disease (ESRD), defined as a creatinine clearance (CrCl) less than 10 mL/min, or those undergoing hemodialysis.
  • Pediatric patients between the ages of 6 months and 11 years who have impaired renal function.

Use Restrictions and Special Considerations

  • Age Restriction: The 5 mg film-coated tablet formulation is not recommended for children under 6 years of age because it does not allow for a safe and appropriate dose adjustment for that age group. Pediatric formulations are required.
  • Renal Impairment: Adults and adolescents with mild to severe renal impairment require a reduced dosage or less frequent dosing interval, with the specific schedule determined by the degree of kidney function loss.
  • Pregnancy and Lactation: Use during pregnancy and breastfeeding is generally not recommended by regulatory agencies.
  • Other Restrictions: Patients with predisposing factors for urinary retention (such as an enlarged prostate) or epilepsy/risk of convulsions should exercise caution, as the medicine may increase these risks.
Advertisements

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for levocetirizine (Xyzall 5mg) primarily defines interaction risks based on altered plasma exposure and pharmacodynamic additive effects, as documented by governmental health authorities.

Exposure-Altering Interactions (Pharmacokinetic)

Interacting Substance Official Effect on Levocetirizine
Ritonavir Increases plasma concentration (AUC/Cmax) by approximately 42% due to reduced clearance.
Theophylline Results in a documented reduction in levocetirizine clearance by 16%.

Levocetirizine undergoes minimal metabolism by hepatic enzymes; therefore, clinically relevant pharmacokinetic interactions with typical CYP inhibitors or inducers are not formally noted in labeling.

Additive Effects (Pharmacodynamic)

The co-administration of levocetirizine with alcohol or other Central Nervous System (CNS) depressants is associated with a pharmacodynamic interaction. This combination may result in additive effects on the CNS, which can increase drowsiness and potentially impair attention or psychomotor performance.

Food and Elimination Constraints

Consumption of food does not change the total extent of levocetirizine absorption. However, a specific population constraint involves patients with impaired renal function. Since the medicine is eliminated primarily through the kidneys, decreased kidney function is an officially documented consideration that causes accumulation and significantly increases levocetirizine exposure.

Advertisements

Mechanism of Action

How Xyzall 5mg Works

Xyzall (levocetirizine) is pharmacologically classified as a second-generation piperazine H1 antagonist. The primary mechanism of action involves the selective binding to and competitive inhibition of the peripheral H1 histamine receptor. This interaction reduces the overall biological response mediated by endogenous histamine.

At the cellular level, the drug stabilizes the H1 receptor in an inactive conformation. This action blocks the constitutive activity of the receptor and prevents the downstream activation of the G q/ 11 protein signaling pathway. This modulation subsequently reduces the intracellular cascade responsible for the formation of key second messengers, including IP3 (inositol triphosphate) and DAG (diacylglycerol).

The systemic physiological consequence of H1 receptor inhibition is the reduction of histamine-induced vasodilation and a decrease in capillary vascular permeability. This results in the modulation of fluid and cellular extravasation into peripheral tissues.

Advertisements

Dosage and Administration Information

How to Use Xyzall 5mg

Administration of Xyzall (levocetirizine dihydrochloride) follows specific guidelines detailing the route, frequency, and dose adjustments. The medication is an oral preparation and is typically taken once daily, usually in the evening. The 5 mg film-coated tablet may be swallowed whole with liquid, and it can be taken without regard to food consumption.


Labeled Dosage and Administration

The standard prescribed dose for adults and adolescents 12 years and older is 5 mg once daily. A lower dose of 2.5 mg once daily may be used in certain patients, which can be achieved by breaking the scored tablet. For children 6 to 11 years old, the maximum recommended dose is 2.5 mg (half tablet) once daily.


Dosing in Special Populations

The medication requires dose modification in patients with renal impairment (reduced kidney function), determined by creatinine clearance (CLCR). For example, moderate impairment (CLCR 30–50 mL/min) requires reducing the dose to 2.5 mg every other day. Use is contraindicated in patients with end-stage renal disease (CLCR < 10 mL/min). No dosage adjustment is required for patients with solely hepatic (liver) impairment.


Duration of Use

Treatment duration patterns are linked to the nature of the condition. For intermittent symptoms (like seasonal allergies), the daily dose may be stopped when symptoms subside and restarted when they reappear. For persistent conditions, continuous therapy may be indicated during the period of allergen exposure.

Advertisements

Recent Clinical Evidence

Xyzall 5mg: Recent Clinical Evidence

The active component of Xyzall 5mg, levocetirizine dihydrochloride, is an antihistamine studied for its effect on various allergic conditions, primarily Seasonal Allergic Rhinitis (SAR), Perennial Allergic Rhinitis (PAR), and Chronic Idiopathic Urticaria (CIU).


Efficacy in Allergic Rhinitis (SAR and PAR)

Clinical trials have examined levocetirizine's ability to reduce symptoms associated with both seasonal and perennial allergic rhinitis. Research evaluated the impact on key symptoms such as sneezing, nasal pruritus (itching), rhinorrhea (runny nose), and ocular symptoms (itchy, watery eyes).

  • Symptom Reduction: Studies comparing levocetirizine 5mg daily to placebo reported a statistically significant reduction in the total nasal and non-nasal symptom scores in adults and adolescents with SAR and PAR.
  • Onset of Effect: Data from specific trials indicated that the onset of action, defined by a noticeable reduction in allergy symptoms, was observed as early as one hour after the initial 5mg dose in some participants.

Study Findings for Chronic Idiopathic Urticaria (CIU)

For chronic idiopathic urticaria, research focused on levocetirizine's effect on the severity and frequency of hives (wheal) and associated pruritus. Urticaria is a persistent skin condition not caused by a known allergy.

Study Endpoint Finding (Relative to Placebo)
Reduction in Pruritus Severity Statistically significant improvement observed
Reduction in Number of Wheals Statistically significant reduction observed

Long-term data suggests that the reduction in symptoms observed during initial treatment was generally sustained over the full course of the treatment period evaluated in the trials. The majority of clinical trials assessed the 5mg dose administered once daily.

Advertisements

Frequently Asked Questions (FAQ)

Common questions about Xyzall 5mg (FAQ)

Q: Does taking Xyzall at night help with allergy symptoms?

Official guidance describes that Xyzall is typically taken once daily in the evening. The medicine works to relieve allergy symptoms regardless of the time of day it is taken, as long as the established once-daily schedule is followed. The suggested evening administration may be related to the potential for sleepiness.

Q: Is the drowsiness effect of Xyzall common or rare?

According to the official product information, somnolence (sleepiness) and fatigue are reported as common side effects in clinical trials conducted for this medicine. This indicates that a noticeable number of people experience these effects when using the medicine.

Q: Is Xyzall officially categorized as a non-drowsy antihistamine?

Regulatory warnings state that the medicine may cause Central Nervous System (CNS) depression, which affects alertness. Because of this potential effect, caution is required when performing hazardous activities like driving or operating machinery, and the product is not officially classified as non-drowsy.

Q: Does Xyzall build up in the body over a long period of regular use?

Levocetirizine, the active ingredient in Xyzall, is primarily eliminated by the kidneys. Official documents indicate that it is known to accumulate significantly in patients with reduced kidney function, and dose adjustments are officially indicated in those cases. For individuals with normal kidney function, accumulation is generally not noted as a clinical concern.

Q: What is the general difference between Xyzall and first-generation drugs like Benadryl (diphenhydramine)?

Xyzall (levocetirizine) is classified as a second-generation piperazine antihistamine. Studies indicate that second-generation drugs generally target peripheral H1 receptors more selectively than older, first-generation agents.

Q: What are the reasons someone might take Xyzall in the morning versus the evening?

The drug is generally administered once daily. While the evening is a typical time for administration, the once-daily schedule allows the dose to be administered at a different time, based on prescribing information and individual professional guidance.

Q: Are there published studies regarding Xyzall's effectiveness in pediatric populations?

Yes, official clinical studies have examined the use of levocetirizine for conditions such as perennial allergic rhinitis in children within the approved age ranges (6 to 12 years of age). The findings from these studies help inform the regulatory guidance regarding the medicine's use in children.

Q: Can Xyzall be taken with common pain relievers like ibuprofen or Tylenol?

Regulatory documents do not list specific interactions with common pain relievers such as ibuprofen or acetaminophen (Tylenol). However, official interaction warnings are generally focused on substances known to affect clearance, such as Ritonavir and Theophylline.

Q: Why is Xyzall typically prescribed or formulated as a 5mg tablet?

The 5 mg strength is the recommended daily dosage for the majority of adults and adolescents. Official clinical studies, which establish the drug's safety and effectiveness, primarily evaluated this specific dose.

Q: Are headaches a commonly reported side effect of Xyzall 5mg?

In the main clinical trials conducted for adults and adolescents, headaches were not reported at a rate of 2% or greater than placebo. Therefore, headaches were not included among the most commonly reported side effects listed in the official product information.

Q: Does Xyzall 5mg carry any risk of dependence or addiction?

According to the official regulatory information, there is no specific risk of drug dependence or addiction described for levocetirizine. The medicine is not classified as a controlled substance.

Q: Is Xyzall effective against non-allergic or infectious sinus issues?

Official labeling restricts the approved uses to conditions caused by allergic responses, such as allergic rhinitis and chronic urticaria. The medicine is not officially listed for treating non-allergic or infectious issues.

Q: Does Xyzall interact with any common herbal supplements like St. John's Wort?

Specific herbal supplements are not typically listed in detail in the regulatory documents. However, official labeling notes that levocetirizine has minimal interaction potential with substances metabolized by typical liver enzymes.

Q: What should be done if a dose is missed?

Official regulatory guidance describes that the practice for a missed dose is generally to take the next dose at the usual time the following day. The information does not include directions to take a double dose to compensate.

Advertisements

How should Xyzall 5mg be stored and disposed of?

How to Store and Dispose of Xyzall 5 mg Tablets

Official regulatory documents detail specific constraints for the storage and disposal of Xyzall (levocetirizine dihydrochloride) 5 mg tablets.


Storage Requirements

Xyzall tablets must be stored at Controlled Room Temperature, defined as 20° to 25°C (68° to 77°F). The product must be stored out of reach of children. To maintain integrity, the medication should be protected from light. Do not use the tablets if the packaging integrity is compromised, such as a torn or missing foil inner seal.

Disposal Instructions

Unused or expired Xyzall tablets must not be thrown away via wastewater or household trash. Disposal of the medicinal product must be conducted in accordance with local requirements. The official method involves consulting a pharmacist regarding the proper procedure for discarding medicines no longer needed.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Equivalent of Xyzall 5mg found in:

A-Z Index: