“My child has a severe cough and was prescribed Montelukast sodium at the hospital today. I’ve read articles about the FDA’s black box warning before, can I not use it?”
“The otolaryngologist said my child has rhinitis and prescribed Montelukast sodium. Is it safe to use? I’ve heard that some children become irritable and aggressive after taking Montelukast…”
Today, let’s have a thorough discussion about the so-called wonder drug, Montelukast sodium.
We can understand the pharmacology of Montelukast sodium through a short story.
However, this villain has a weakness, he needs a partner to do evil deeds — the leukotriene receptor.
Targeting this weakness, the drug “leukotriene receptor antagonists” enters the scene, its task is to take away the villain’s partner, then the villain can’t cause trouble.
Montelukast sodium is a leukotriene receptor antagonist and is currently the only leukotriene receptor antagonist in our country. Some countries also have zafirlukast and pranlukast, but this article will not discuss them further.
First, let’s clarify a few points:
- Leukotriene receptor antagonists such as Montelukast sodium are not the first-choice drugs for asthma;
(Whether it is to prevent the occurrence of asthma or long-term control treatment of asthma, inhaled corticosteroids are usually the first choice) - Guidelines also do not recommend using Montelukast sodium as an emergency medication for asthma;
- Guidelines do not advocate using Montelukast sodium for monotherapy in moderate or severe persistent asthma, but it can be used as an adjuvant therapy.
There are four situations where asthma can consider using Montelukast sodium.
Situation one, patients with mild persistent asthma who are unwilling to use or intolerant to inhaled corticosteroids, can consider using Montelukast sodium as a first-line control medication. A real-world study (Real World Study, RWS), including 306 asthma patients treated in primary care institutions, confirmed that Montelukast sodium as a first-line control is comparable to inhaled corticosteroids.
Situation two, when inhaled corticosteroids do not fully control asthma,
adding Montelukast sodium may be able to reduce asthma attacks.
Situation three, exercise-induced symptoms. Anti-leukotriene drugs are usually very effective in preventing exercise-induced bronchospasm (EIB), and Montelukast sodium is particularly useful for young children with EIB who may engage in vigorous exercise at any time. However, short-acting beta-agonists (such as salbutamol) are usually recommended for these patients, which can both prevent and relieve bronchoconstriction.
Situation four, for asthma patients with aspirin-exacerbated respiratory disease. These patients have higher levels of leukotrienes, and when they take aspirin or any nonsteroidal anti-inflammatory drugs (NSAIDs), they produce an excessive amount of leukotrienes. In this case, using leukotriene modifiers may improve the overall control of asthma.
Montelukast sodium is also effective for allergic rhinitis. China’s “Guidelines for the Diagnosis and Treatment of Pediatric Allergic Rhinitis, 2022, Revised Edition” points out that Montelukast sodium has a better effect on improving nasal congestion symptoms than second-generation oral antihistamines, and is recommended for children with allergic rhinitis who have comorbid asthma, adenoid hypertrophy, and upper airway cough syndrome.
However, due to the higher risk of neuropsychiatric symptoms associated with the use of Montelukast sodium, it is suitable for patients who have poor tolerance or poor response to other treatment plans.
(We will discuss neuropsychiatric symptoms later.)
Not all “adenoid hypertrophy” requires surgical treatment. For mild or moderate pediatric obstructive sleep apnea caused by adenoid hypertrophy (especially in patients with seasonal allergic reactions), oral Montelukast sodium or the use of nasal corticosteroids can be considered as alternative treatments or adjuvant treatments for adenoid and tonsillectomy. Or it can also be used as a temporary measure during the follow-up observation period before implementing other interventions.
However, the neuropsychiatric risks associated with Montelukast sodium may increase, and doctors should inform parents of these risks in detail.
Side effects of Montelukast sodium and black box warning
In March 2020, the US FDA issued a safety warning about Montelukast sodium on its official website –
the “serious psychiatric adverse reactions” originally written in the “adverse reactions” section of the drug instructions were upgraded to a black box warning.
In fact, many drugs have black box warnings, and the purpose of doing so is:
- To require a balance of pros and cons, to grasp indications more strictly, and to appropriately limit its use;
- To suggest using other alternative drugs as much as possible to minimize the risk of serious adverse drug reactions.
So, if a child has the situations mentioned earlier and may need to use Montelukast sodium, how to use it safely? We have summarized a few points:
It is recommended that both doctors and patients
discuss the benefits and risks of Montelukast sodium and make decisions together. If
the patient itself suffers from certain neuro/psychiatric diseases, the use of this drug should be more cautious.
We need to pay attention to changes in the child’s behavior or emotions related to emotions, ⚠️if there are relevant behavioral or emotional changes, it is recommended to stop taking the medicine and feedback to the doctor in time:
- Anxiety and restlessness, including aggressive behavior or hostility
- Attention problems
- Nightmares
- Depression
- Feeling disoriented or confused
- Feeling anxious
- Hallucinations
(seeing or hearing things that are not there) - Irritability
- Memory problems
- Obsessive-compulsive disorder
- Restlessness
- Sleepwalking
- Stuttering
- Suicidal thoughts and behaviors
- Tremors or shaking
- Insomnia
- Involuntary muscle movements
If
they have never had neuro/psychiatric system abnormalities and the condition requires continued use, it is possible to continue taking it.
How should it be taken if the child really needs it?
Domestic instructions indicate children over 12 months old, but the US Food and Drug Administration (FDA) has approved it for children over 6 months old.
Note that the duration of treatment varies for different diseases; even for the same disease, there are individual differences, and doctors need to assess follow-up based on the condition and symptom control.
In addition, Montelukast sodium comes in several different dosage forms and specifications:
- 4mg specification, including Montelukast sodium granules and Montelukast sodium chewable tablets, suitable for children under 6 years old and toddlers.
- 5mg specification, Montelukast sodium chewable tablets, suitable for children and adolescents aged 6 to 14.
- 10mg specification, Montelukast sodium tablets, suitable for adolescents and adults over 15 years old.
Montelukast sodium can be taken with or without food.
Note that Montelukast sodium needs to be protected from light, so Montelukast sodium granules can be taken directly (like eating sugar, pour it directly into the mouth), or dissolved in breast milk, formula milk, or fruit juice for consumption, but should not be dissolved in transparent liquids (such as water) for consumption, but water can be drunk after taking.
Additionally, it is recommended to open the package just before taking and take it within 15 minutes.
For asthma patients or patients with asthma and allergic rhinitis, since asthma patients are prone to attacks in the early morning at night, the plasma concentration of Montelukast sodium peaks at 2-4 hours, so taking it before bedtime can more effectively prevent nocturnal asthma symptoms. Therefore, it is recommended to take it once a day, before going to bed.
For patients with pure allergic rhinitis, take it once a day, as needed. If the rhinitis symptoms are mainly obvious during the day, it can be chosen to take in the morning or during the day.
For the prevention of exercise-induced bronchospasm, it is recommended to take Montelukast sodium 2 hours before exercise.
Zhuozheng Children’s Respiratory Specialist
Master of Shanghai Jiao Tong University Medical College
| Content Team
Disclaimer: The purpose of the article is to provide general health information, please consult a doctor for personal medical issues. For article reprint, please contact: medicine@distinctclinic.com.
