Desloratadina Labormed

Quick links

Choose a section

Quick links to important sections

Advertisements

Desloratadina Labormed

Advertisements
Advertisements

Overview of Desloratadina Labormed

Property Description
Active Ingredient Desloratadine (INN)
Form Film-coated tablet, Oral solution
Pharmacological Class Second-generation Antihistamine
General Purpose Symptomatic relief of allergic conditions
Origin Synthetic metabolite of loratadine

What Type of Medicine is Desloratadina Labormed?

Desloratadina Labormed is a distinct pharmaceutical product defined by its sole active ingredient, Desloratadine (INN), which belongs to the functional group of second-generation antihistamines. This product, associated with the manufacturer Labormed, is typically supplied as a prescription-only medicine (POM) in many regions. The classification places it within the broader pharmacological class of antihistamines for systemic use, indicating its purpose is to address widespread allergic manifestations throughout the body. Desloratadine is a synthetic compound, chemically identified as the major active metabolite of the older H1 antagonist, loratadine, and is a tricyclic antihistamine. Functionally, Desloratadine acts as a selective peripheral histamine H1-receptor antagonist.

Composition and Available Forms (Tablet, Solution)

The medicine is composed solely of the active ingredient Desloratadine, combined with pharmaceutical excipients necessary to create its delivery format, such as cellulose, starch, and coating materials in solid forms. For administration via the oral route, Desloratadina Labormed is commonly available as a film-coated tablet or an oral solution. The oral solution form is often positioned to facilitate administration for patient groups, such as children, who may experience difficulty swallowing tablets. Structurally, Desloratadine is classified as a descarboethoxyloratadine.

General Purpose and Non-Sedating Characteristic

The general purpose of Desloratadina Labormed is to provide symptomatic relief by controlling the body’s undesirable reactions during allergic conditions. It achieves this through selective histamine H1 receptor blockade, a mechanism recognized for its effectiveness in controlling allergic symptoms. Critically, this medication is characterized by its non-sedating nature, a key feature of its second-generation classification, as the active substance exhibits limited ability to cross the blood-brain barrier, thereby offering relief without the unwanted drowsiness associated with older antihistamines.

Regulatory References

  1. European Medicines Agency (EMA) Overview of Desloratadine
Advertisements

What side effects are possible with Desloratadina Labormed?

Possible Side Effects and Safety Information

The official safety profile for Desloratadina Labormed details adverse reactions classified by frequency and grouped by the affected organ system, according to regulatory standards (e.g., EMA SmPC). This framework provides a standardized view of the medicine’s risk landscape.


Frequency-Classified Adverse Reactions

The most commonly reported adverse reactions identified in clinical trials, classified as Common (ge 1/100 to < 1/10), include Headache, Fatigue (Asthenia), and Dry mouth. Less frequent adverse reactions, classified as Very Rare (< 1/10,000), involve various System Organ Classes, such as Nervous System (e.g., Dizziness, Somnolence, Seizures) and Gastrointestinal (e.g., Nausea, Vomiting, Diarrhoea).

Post-marketing reports of Frequency Not Known include increased appetite, weight gain, and specific cardiac disorders like QT prolongation, Arrhythmia, and Bradycardia.


Serious Adverse Reactions and Safety Cautions

Serious Adverse Reactions explicitly documented in regulatory labeling include severe Hypersensitivity Reactions (such as Anaphylaxis and Angioedema) and Hepatitis.

Specific Safety Cautions are noted for certain populations and pre-existing conditions:

  • Paediatric Population: An increased incidence of new-onset Seizure is noted in patients aged 0 to 19.
  • Organ Impairment: Caution is noted for use in individuals with severe renal insufficiency or severe hepatic impairment.
  • Restrictions: The medicine is formally contraindicated in individuals with known hypersensitivity to the active substance, Desloratadine, or to its parent compound, Loratadine.
Advertisements

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory information describes that overdosage with Desloratadine results in an adverse event profile similar to that seen with therapeutic doses, potentially of a higher magnitude. Clinical trials involving doses up to 45 mg—nine times the recommended daily dose—for ten days reported no clinically relevant effects such as QTc interval prolongation.

Official Management and Actions

Overdose Aspect Regulatory-Mandated Information
Symptom Profile Events reported include somnolence and drowsiness.
Required Management Symptomatic and supportive treatment is recommended. Medical professionals may consider standard measures to remove unabsorbed active substance.
Antidote/Removal The substance is not eliminated by haemodialysis.

When to Seek Immediate Medical Help

Official government guidance requires immediate medical attention for specific severe manifestations. You must immediately call emergency services or the poison control helpline if the person has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Advertisements

Therapeutic Uses of Desloratadina Labormed

Desloratadina Labormed provides supportive symptomatic relief for conditions involving inflammatory or irritative states and is generally applied across domains where additional symptomatic support is needed. The medication is commonly used to help manage both respiratory and cutaneous symptoms that create noticeable physiological strain and interfere with daily functioning.

The primary indications for which the medication is relevant include allergic rhinitis (covering both seasonal hay fever and perennial forms) and Chronic Idiopathic Urticaria (CIU), a condition marked by persistent hives. It is applied during phases when symptoms become more noticeable, such as during seasonal peaks or recurrent chronic episodes. The support provided may help ease the overall symptom load, which is relevant when acute or recurrent allergic manifestations are disruptive.

By contributing to relief over an extended period, the medication may assist with mitigating secondary issues like sleep disturbance caused by nighttime symptoms. This supports patients during difficult episodes, helping to maintain a sense of stability when symptoms are more noticeable.


Symptomatic Focus: Itching (Pruritus) The medication plays a role in managing the intense, generalized itching associated with chronic skin conditions like urticaria, as well as the itching symptoms affecting the nose and eyes during allergic rhinitis episodes.

Regulatory References

  1. European Medicines Agency (EMA) therapeutic overview
Advertisements

Eligibility and Restrictions for Use

Official Population Eligibility and Restrictions

The eligibility profile for Desloratadina Labormed, based on its active ingredient Desloratadine, is strictly defined by regulatory documents, which establish mandated contraindications, age limits, and conditional use for specific populations.

Eligibility Group Regulatory Status Condition/Restriction
Absolute Contraindication Contraindicated Known hypersensitivity to desloratadine, its parent drug loratadine, or any excipients.
Approved Age Group Approved for use Adults and adolescents ge 12 years of age.
Pediatric Limitations Use Not Established Safety and efficacy have not been established for the 5 mg film-coated tablets in children below 12 years.
Organ Impairment Use with Caution Patients with severe renal or hepatic impairment are eligible only under a modified, labeled dose regimen.
Pregnancy Preferable to Avoid Use during pregnancy is generally considered preferable to avoid as a precautionary measure.
Lactation Not Recommended Use is not recommended during breastfeeding, as desloratadine is excreted in breast milk.

The medicine's regulatory status requires additional caution for patients with a medical or familial history of seizures.

This structure ensures use is limited to groups for whom safety has been established or where risks are managed under specific, officially documented conditions.

Advertisements

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Desloratadine focuses on documented changes in drug exposure and specific substance co-administration cautions, strictly based on government regulatory documentation. No medicines are formally listed as strictly contraindicated for co-administration with single-ingredient Desloratadine.

Pharmacokinetic Interactions

Clinical studies confirm that co-administration with strong inhibitors, such as the antifungal Ketoconazole and the antibiotic Erythromycin, results in increased systemic exposure (AUC and Cmax) of Desloratadine and its active metabolite. However, regulatory authorities have concluded that these increases in exposure resulted in no clinically relevant changes to the safety profile.

Substance Official Interaction Pattern
Ketoconazole / Erythromycin Increased plasma exposure of Desloratadine.
Azithromycin, Cimetidine, Fluoxetine No clinically relevant interaction observed.

Pharmacodynamic and Substance Interactions

Caution is officially recommended for concomitant use with alcohol. While controlled clinical trials showed Desloratadine did not potentiate the performance-impairing effects of alcohol, post-marketing reports of alcohol intolerance and intoxication have been documented. The absorption of Desloratadine is not affected by food, meaning the medicine can be administered regardless of mealtimes.

Population-Specific Exposure

The systemic exposure (AUC) of Desloratadine is significantly increased in patients with hepatic impairment (up to 2.4-fold higher) and severe renal impairment (up to 2.5-fold higher) due to reduced clearance, as noted in official prescribing information.

Advertisements

Mechanism of Action

Desloratadine functions as a peripherally selective antagonist of the H1 histamine receptor. This interaction involves high-affinity binding to the receptor, which effectively prevents the endogenous ligand, histamine, from initiating its characteristic signaling response.

The consequence of this receptor blockade is the modulation of downstream cellular events typically mediated by histamine.

In addition to H1 antagonism, desloratadine exhibits inhibitory effects on the release of pro-inflammatory mediators from activated human mast cells and basophils. This activity modulates the cascade by stabilizing these cells. The drug further acts to reduce the expression of various pro-inflammatory cytokines, including interleukins and adhesion molecules, a process potentially linked to the inhibition of the NF-kappa B transcription factor activation. Its structure allows for negligible penetration across the blood-brain barrier, conferring high peripheral selectivity.

Advertisements

Dosage and Administration Information

How Desloratadina Labormed is Used

The administration of Desloratadine is strictly via the oral route, utilizing the available formulations—the film-coated tablet (typically 5 mg) or the oral solution (0.5 mg/mL). The medicine is taken once daily and may be administered with or without food.

Standard Dosage Regimens

The dose of Desloratadine is standardized across its main approved uses, and no additional clinical benefit is gained from exceeding the recommended dose.

Population Standard Daily Dose
Adults and Adolescents (12+ years) 5 mg once daily
Children 6 to 11 years 2.5 mg once daily
Children 12 months to 5 years 1.25 mg once daily
Infants 6 to 11 months 1 mg once daily

Administration Rules and Adjustments

Dosing for Organ Impairment: For adult patients with known renal or hepatic impairment, a reduced starting dose of 5 mg every other day (alternating days) is typically utilized due to altered drug clearance.

Duration of Use: The treatment pattern depends on symptom characteristics. For intermittent use (symptoms present less than 4 days a week or less than 4 weeks), the medication may be discontinued when symptoms are resolved and reinitiated upon recurrence. For persistent use, continuous daily treatment may be maintained during periods of allergen exposure.

Missed Dose: If a daily dose is missed, it should be taken as soon as the patient remembers, and the normal dosing schedule should be resumed the following day. It is an explicit instruction not to take a double dose to compensate for the missed amount.

Advertisements

Recent Clinical Evidence

Recent Clinical Evidence for Desloratadine

Desloratadine is a second-generation, non-sedating histamine H1-receptor antagonist used in the symptomatic treatment of allergic rhinitis (AR) and chronic idiopathic urticaria (CIU). Clinical research, including randomized, double-blind, placebo-controlled trials, has been conducted to evaluate its association with symptom relief and tolerability.


Key Findings in Allergic Rhinitis (AR)

Meta-analyses of clinical studies in patients with both seasonal and perennial AR have consistently found that desloratadine is associated with statistically significant reductions in total symptom scores when compared with a placebo. The evidence suggests an improvement across several metrics:

  • Nasal Symptoms: Reduction in scores for symptoms such as rhinorrhea (runny nose), sneezing, and nasal itching.
  • Non-Nasal Symptoms: Reduction in scores for symptoms like itching eyes and tearing.

The improvement in symptoms has been observed within the first 24 hours of treatment and generally maintains efficacy throughout the 24-hour dosing interval.


Key Findings in Chronic Idiopathic Urticaria (CIU)

For patients with CIU, trials have shown that desloratadine is associated with significant improvements compared to placebo across measures of disease activity. This includes:

  • Pruritus (Itching) Severity: A decrease in the reported intensity of itching.
  • Wheals: A reduction in the number and size of hives/lesions.

In studies of patients whose symptoms were not adequately controlled by the standard dose, higher doses of desloratadine were investigated and were associated with further reductions in disease severity scores and reported improvements in quality of life.


Tolerability and Safety Profile

Clinical data consistently demonstrate that the incidence of adverse events (AEs) reported with desloratadine is generally comparable to that of placebo across adult and pediatric populations. The most commonly reported AEs include headache, fatigue, and dry mouth. Studies have shown that, at therapeutic doses, desloratadine does not appear to impair cognitive or psychomotor performance compared to placebo, nor does it typically prolong the QTc interval on an electrocardiogram.

Advertisements

Frequently Asked Questions (FAQ)

Common questions about Desloratadina Labormed (FAQ)


Q: Is Desloratadina Labormed the same thing as Claritin?

Official information indicates that Claritin is a common trade name for the older active ingredient, Loratadine. Desloratadine, the active ingredient in Desloratadina Labormed, is described in regulatory documents as the major active metabolite of Loratadine.


Q: What are the most commonly mentioned side effects of Desloratadina Labormed on patient forums?

Regulatory safety profiles list adverse reactions based on formal clinical trial data. According to this official data, the most Common side effects reported are headache, fatigue (tiredness), and dry mouth.


Q: Is feeling tired a common experience when taking this medicine?

Fatigue (or asthenia) is classified in official drug documents as a Common side effect. This means that it is an effect reported by at least 1 in 100 patients during clinical trials.


Q: Can taking Desloratadina Labormed affect sleep patterns?

Official documents list Somnolence (drowsiness) as a Very Rare adverse reaction. Clinical evidence themes in patients with chronic hives have suggested that treatment with Desloratadine may be associated with improvements in related sleep disturbances.


Q: Are there any specific foods that are described as interacting with Desloratadina Labormed?

Regulatory information indicates that the absorption of the medicine is not affected by food, meaning its administration is not dependent on mealtimes. Furthermore, specific clinical studies have found no clinically relevant interaction with certain substances such as grapefruit juice.


Q: Is Desloratadina Labormed available over the counter in some countries?

The medicine's legal status is subject to local regulatory requirements and can vary internationally. While it is often available as a prescription-only medicine in many regions, consumer information sheets from some government authorities confirm its availability as an over-the-counter product in their respective jurisdictions.


Q: How long is the effect of Desloratadina Labormed expected to last after taking it?

Official consumer information states that symptom relief is maintained for 24 hours. This duration is consistent with the medicine's recommended once-daily administration.


Q: Is Desloratadina Labormed known to cause weight changes?

Post-marketing reports filed with regulatory authorities have documented instances of increased appetite and weight gain. However, the frequency of these effects based on the official safety profile is currently classified as Not Known.


Q: What is the difference between Desloratadine and Loratadine?

Official documents describe Desloratadine as the major active metabolite of the older antihistamine, Loratadine. This means Desloratadine is the primary substance responsible for the therapeutic effect after Loratadine is processed by the body.


Q: Are there different guidelines for Desloratadina Labormed use in elderly patients?

Regulatory documents do not define a separate standard dose based solely on age for adults. However, a specific modified alternate-day dose regimen is officially recommended for all adult patients, including the elderly, who have documented severe renal or hepatic impairment.


Q: What happens if Desloratadina Labormed is taken past its expiration date?

Regulatory authorities advise that taking medicine past the expiration date is not recommended. This is because the drug may lose its intended strength or quality, and degradation over time may result in unintended chemical compounds.


Q: Is it true that Desloratadina Labormed is not effective for congestion?

Research evidence themes suggest that Desloratadine may be associated with the relief of the symptom of nasal obstruction or congestion in clinical studies of patients with allergic rhinitis, alongside common symptoms like sneezing and runny nose.


Q: How quickly is the medicine eliminated from the body?

Official pharmacokinetic data, which describes how the drug moves through the body, states that the medicine has a mean elimination half-life of approximately 24 to 27 hours.


Q: Is Desloratadina Labormed ever used to treat pet allergies?

The official regulatory indication for this medicine is the symptomatic relief of allergic rhinitis and chronic hives. Allergic rhinitis is the medical condition caused by exposure to various allergens, including those from pets.


Q: Why is the Labormed brand name used, and is it different from other Desloratadine products?

The name Labormed identifies the specific manufacturer or brand of the medicine. Regulatory documents confirm that the active substance in all approved versions of Desloratadine, regardless of the brand, is the same: Desloratadine.


Q: Can Desloratadina Labormed be crushed or split if a person has trouble swallowing?

The medicine is available as a film-coated tablet and an oral solution. The oral solution is the officially available formulation specifically intended for patients who may experience difficulty swallowing tablets. Film-coated tablets do not typically carry instructions for alteration.


Q: Can this medication affect the results of allergy skin tests?

Due to its mechanism of action as an antihistamine, this type of medicine may interfere with the results of allergy skin tests. Due to this fact, medical protocols often advise stopping its use for a specific period before undergoing testing.


Q: What is the mechanism by which Desloratadine helps with itching?

The medicine achieves relief from itching (pruritus) by its action as a selective peripheral histamine H1-receptor antagonist. This mechanism blocks the effects of histamine released by the body that causes the symptom.


Q: What kind of studies support the use of Desloratadina Labormed in children?

The approved use in children is supported by clinical trials, including those registered on government databases, which have evaluated the effectiveness and safety of the oral solution in various pediatric age groups for its approved conditions.


Q: Is Desloratadina Labormed considered a steroid?

Regulatory documents define this medicine by its active ingredient, Desloratadine, which belongs to the functional group of second-generation antihistamines. The medication is classified as an H1-receptor antagonist and is not a steroid.

Advertisements

How should Desloratadina Labormed be stored and disposed of?

Storage and Disposal of Desloratadina Labormed

The storage and disposal instructions for Desloratadine are defined in official government labeling to maintain product stability and ensure public safety.

Official Storage Requirements

Constraint Requirement
Maximum Temperature Do not store above 30 °C.
Protection Store in the original package to protect from moisture.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Regulatory documents mandate that unused or expired Desloratadine must not be thrown away with household trash or poured into wastewater. This measure prevents environmental contamination. Patients should consult a pharmacist for guidance on how to properly dispose of the medicine according to local pharmaceutical waste regulations. The product must remain in its original, protective packaging until ready for use.

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

Available in countries:

Equivalent of Desloratadina Labormed found in:

A-Z Index: