What are the indications for Zyrcold (levocetirizine) and Ascoril LS Junior (levosalbutamol) in pediatric patients under 12 years old with cough and cold symptoms?

Zyrcold and Ascoril LS Junior: Clinical Indications and Evidence-Based Recommendations

Direct Answer

These combination cough and cold products should not be used in children under 4 years of age, and their use in children under 12 years lacks evidence of efficacy while carrying significant safety risks. 1

Critical Safety Evidence

Over-the-Counter Cough and Cold Medications in Children

The 2020 CHEST guidelines explicitly state that OTC cough medications have little, if any, benefit in symptomatic control of acute cough in children, and preparations containing antihistamine are associated with adverse events including reported deaths from toxicity in young children. 1

• Between 1969-2006, there were 69 fatalities associated with antihistamines in children under 6 years, with 41 deaths occurring in children under 2 years. 2
• The FDA issued warnings against using OTC cough and cold medications in young children, and manufacturers voluntarily relabeled these products "do not use in children under 4 years of age." 1
• In 2018, FDA altered labeling for prescription opioid cough and cold medicines to limit their use to adults ≥18 years. 1

Component-Specific Analysis

Levocetirizine (Zyrcold Component)

Antihistamines have minimal efficacy for relieving cough in children, contrasting sharply with adult data. 1

• A recent review of antihistamine utility in children did not recommend its use for chronic cough. 1
• The efficacy of antihistamines in relieving cough in children is minimal, if at all. 1

Age-appropriate use of levocetirizine:

• Most second-generation antihistamines have approval only starting at age 2 years, with some extending down to 6 months in controlled studies. 2
• For children 2-5 years, cetirizine (similar agent) can be dosed at 2.5 mg once or twice daily with FDA approval. 3
• For infants 6-11 months, cetirizine can be administered at 0.25 mg/kg twice daily. 3

Levosalbutamol (Ascoril LS Junior Component)

Bronchodilators like levosalbutamol are indicated specifically for bronchospasm associated with asthma or reactive airway disease, not for routine cough and cold symptoms. 1

• If cough resolved with bronchodilator use, clinicians should be aware that the child does not necessarily have asthma and should be re-evaluated off treatment, as resolution may occur with spontaneous resolution or transient effect. 1

Evidence-Based Treatment Algorithm for Pediatric Cough

For Acute Cough in Children

CHEST guidelines recommend that OTC cough and cold medicines should not be prescribed until they have been shown to make cough less severe or resolve sooner (which they have not). 1

Recommended alternatives:

• Honey may offer more relief for cough symptoms than no treatment, diphenhydramine, or placebo in children over 1 year. 1, 4
• Vapor rub, zinc sulfate, and buckwheat honey improve symptoms in children. 4
• Nasal saline irrigation provides modest benefit with minimal side effects. 2

For Allergic Rhinitis (If That Is the Actual Diagnosis)

If the child truly has allergic rhinitis rather than simple viral upper respiratory infection:

• Intranasal corticosteroids are the most effective medication class for controlling symptoms in children, with high-quality evidence. 2, 3
• Second-generation antihistamines like levocetirizine can be considered for children ≥2 years for allergic symptoms (sneezing, rhinorrhea, itching), but not for cough relief. 2, 3

Critical Clinical Pitfalls to Avoid

Never use combination cough and cold products in children under 4 years due to lack of efficacy and significant mortality risk. 1, 5

Avoid first-generation antihistamines in children under 6 years due to significant safety concerns including agitated psychosis, ataxia, hallucinations, and death. 2, 3

Do not prescribe bronchodilators for simple viral cough without evidence of bronchospasm or asthma. 1

Cough in children should be treated based on etiology, and there is no evidence for using medications for symptomatic relief of non-specific cough. 1

Appropriate Indications (When Components Used Separately)

Levocetirizine Alone

• Allergic rhinitis in children ≥2 years (for sneezing, rhinorrhea, itching—NOT for cough). 2, 3
• Chronic urticaria in appropriate age groups. 2

Levosalbutamol Alone

• Documented bronchospasm associated with asthma. 1
• Reactive airway disease with objective evidence of airway obstruction. 1

The combination of these agents in a fixed-dose product for "cough and cold" lacks evidence-based support and should be avoided in pediatric patients under 12 years. 1, 5