What are the main uses of Singulair. How does Singulair work to control asthma and allergy symptoms. What are the recommended dosages for different age groups and conditions. What are the most common side effects of Singulair. How has litigation affected the use of Singulair.

Understanding Singulair: A Powerful Asthma and Allergy Medication

Singulair, also known by its generic name montelukast, is a prescription medication that has revolutionized the treatment of asthma and allergies. Developed by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Singulair received FDA approval in 1998 and has since become a widely prescribed medication for managing respiratory conditions.

How does Singulair work to alleviate asthma and allergy symptoms? The medication targets leukotrienes, chemicals in the body that play a crucial role in the inflammatory cascade. By blocking these chemicals, Singulair helps prevent the tightening of airway muscles and the production of excess fluid and mucus, effectively controlling asthma and allergy symptoms.

The Versatility of Singulair: From Asthma Prevention to Allergy Relief

Singulair’s versatility makes it a valuable tool in the management of various respiratory conditions. Its primary uses include:

• Preventing asthma symptoms such as difficulty breathing, chest tightness, wheezing, and coughing
• Preventing exercise-induced asthma symptoms
• Relieving hay fever (allergic rhinitis) symptoms

Is Singulair suitable for all types of asthma attacks? It’s important to note that Singulair is not intended for the treatment of sudden asthma attacks. Patients should follow their healthcare provider’s instructions for managing acute asthma episodes, which may include the use of rescue inhalers.

Dosage and Administration: Tailoring Treatment to Individual Needs

Singulair is available in various forms and strengths to accommodate different age groups and conditions. The medication comes in:

• 10 mg tablets
• 5 mg chewable tablets
• 4 mg chewable tablets
• 4 mg oral granules

How should Singulair be taken for optimal effectiveness? The dosage and administration of Singulair vary depending on the patient’s age and the condition being treated. Here’s a breakdown of the recommended dosages:

Asthma Treatment

The dosage for asthma treatment ranges from 4 mg to 10 mg, with specific recommendations based on age:

• Adults and adolescents 15 years and older: 10 mg tablet once daily
• Children 6 to 14 years old: 5 mg chewable tablet once daily
• Children 2 to 5 years old: 4 mg chewable tablet or oral granules once daily
• Children 12 to 23 months old: 4 mg oral granules once daily

Exercise-Induced Bronchoconstriction Prevention

For preventing exercise-induced breathing problems, Singulair should be taken at least two hours before exercise:

• People 15 years and older: One 10 mg tablet
• Children 6 to 14 years old: One 5 mg chewable tablet

Allergic Rhinitis (Hay Fever) Treatment

For allergy symptom relief, Singulair can be taken once daily, either in the morning or evening:

• Adults and adolescents 15 years and older: One 10 mg tablet
• Children 6 to 14 years old: One 5 mg chewable tablet
• Children 2 to 5 years old: One 4 mg chewable tablet or one packet of 4 mg oral granules

The Science Behind Singulair: Unraveling Its Mechanism of Action

To fully appreciate Singulair’s effectiveness, it’s crucial to understand its mechanism of action. Dr. Caleb Alexander, a professor at Johns Hopkins Bloomberg School of Public Health and co-director of the Center for Drug Safety and Effectiveness, explains, “While Singulair is not a steroid and is not typically considered an immunosuppressant, it nevertheless does interfere with immune pathways by limiting the production of leukotrienes, chemicals in the body that are part of the ‘inflammatory cascade.'”

How do leukotrienes contribute to asthma and allergy symptoms? When the body encounters an allergen, it releases leukotrienes as part of its immune response. These chemicals cause the airway muscles to tighten and stimulate the production of fluid and mucus. By blocking leukotriene activity, Singulair effectively reduces these symptoms, providing relief to asthma and allergy sufferers.

Timing Matters: Optimizing Singulair’s Effectiveness

The timing of Singulair administration has been a topic of discussion among healthcare professionals. While the drug’s label recommends taking it at night, this recommendation is based on the timing of clinical trials rather than a proven superiority of nighttime dosing.

Dr. Alexander provides insight into this matter, stating, “Sometimes we dose Singulair at night because many people have worse asthma symptoms at night than during the day. However, many people take Singulair during the morning rather than evening, and what works for one person may not work for another. In other words, there is no one-size-fits-all approach, and it’s more important to take it regularly than it is to take it at a certain hour of the day.”

Can Singulair be taken with or without food? The flexibility in timing extends to food intake as well. Patients can take Singulair with or without food, allowing for easy integration into their daily routines.

Side Effects: Understanding the Risks and Benefits

As with any medication, Singulair can cause side effects. However, most side effects associated with this medication are mild, and it is generally well-tolerated by patients taking it for asthma or allergies.

What are the most common side effects of Singulair? According to clinical trials involving 2,950 adult and adolescent patients, the most frequently reported side effects occurring in 5% or more of participants and at a higher rate than placebo include:

• Upper respiratory infection
• Fever
• Headache
• Pharyngitis (sore throat)
• Cough
• Abdominal pain
• Diarrhea

Dr. Alexander notes, “Of course, all medicines have risks, and most medicines have rare but serious risks. In the case of Singulair, the most common adverse effects include upper respiratory infections, fevers, headaches and sore throat. Of course, it is often difficult to know for sure whether these types of symptoms represent an adverse drug reaction or some other process.”

Singulair and Exercise-Induced Asthma: A Game-Changer for Athletes

For individuals who experience asthma symptoms triggered by physical activity, Singulair offers a valuable solution. The medication’s ability to prevent exercise-induced bronchoconstriction has made it a popular choice among athletes and fitness enthusiasts.

How should Singulair be used to prevent exercise-induced asthma? To maximize its effectiveness, patients should take Singulair at least two hours before engaging in physical activity. This timing allows the medication to build up in the system and provide optimal protection against exercise-induced symptoms.

It’s important to note that patients already taking Singulair for regular asthma management should not take an additional dose before exercise. The existing regimen should provide sufficient protection against exercise-induced symptoms.

Singulair in the Treatment of Allergic Rhinitis: Year-Round Relief

Beyond its applications in asthma management, Singulair has proven to be an effective treatment for allergic rhinitis, commonly known as hay fever. This versatility makes it a valuable option for patients who experience both asthma and allergy symptoms.

How does Singulair compare to traditional antihistamines in treating allergies? Unlike antihistamines, which primarily target histamine-related symptoms, Singulair’s leukotriene-blocking action provides a different mechanism for allergy relief. This can be particularly beneficial for patients who don’t respond well to or experience side effects from traditional antihistamines.

Can Singulair be used for both seasonal and perennial allergies? Yes, Singulair is approved for the treatment of both seasonal and perennial allergic rhinitis. For perennial allergies, some healthcare providers may recommend taking the medication as needed, providing flexibility in managing long-term allergy symptoms.

Navigating Singulair Use: Important Considerations and Precautions

While Singulair is generally well-tolerated, there are important considerations and precautions that patients and healthcare providers should keep in mind:

• Singulair is not a rescue medication for acute asthma attacks. Patients should always have a fast-acting inhaler available for emergency situations.
• Patients should not abruptly discontinue Singulair without consulting their healthcare provider, as this may lead to worsening of asthma symptoms.
• Individuals with a known hypersensitivity to montelukast or any of its components should avoid using Singulair.
• Patients should inform their healthcare provider of all medications they are taking, as Singulair may interact with certain drugs.
• Monitoring for potential neuropsychiatric events is recommended, especially in children and adolescents.

What should patients do if they miss a dose of Singulair? If a dose is missed, patients should not double up on the next dose. Instead, they should wait until the next scheduled dose and continue with their regular regimen.

The Future of Singulair: Ongoing Research and Potential Applications

As our understanding of asthma and allergies continues to evolve, researchers are exploring new potential applications for Singulair and similar leukotriene receptor antagonists. Some areas of ongoing research include:

• The potential use of Singulair in treating other inflammatory conditions
• Combination therapies that pair Singulair with other asthma and allergy medications for enhanced efficacy
• Long-term studies on the safety and efficacy of Singulair in various patient populations
• Investigations into the role of leukotrienes in other respiratory and immunological disorders

What new insights might future research provide about Singulair’s mechanism of action? As our knowledge of the immune system and inflammatory processes deepens, we may uncover additional ways in which Singulair impacts the body, potentially leading to new therapeutic applications or improved treatment strategies.

Singulair and Patient Empowerment: Making Informed Decisions

The effective use of Singulair relies heavily on patient education and empowerment. Patients who understand how the medication works, its potential benefits, and its limitations are better equipped to manage their asthma and allergy symptoms successfully.

How can patients maximize the benefits of Singulair treatment? Here are some key strategies:

• Maintain open communication with healthcare providers about symptoms, side effects, and concerns
• Adhere to the prescribed dosing regimen and timing recommendations
• Keep track of symptom improvements and any changes in overall health
• Combine Singulair use with other asthma and allergy management strategies, such as trigger avoidance and proper inhaler technique
• Stay informed about new research and developments related to Singulair and asthma/allergy treatment

By taking an active role in their treatment, patients can work collaboratively with their healthcare providers to optimize their use of Singulair and achieve better control over their respiratory health.

Uses, Side Effects, Interactions, Litigation

Singulair, also known as montelukast, is a prescription medication used to prevent symptoms of asthma, such as difficulty breathing, chest tightness, wheezing and coughing. It’s also used to prevent asthma symptoms during exercise and to relieve hay fever (allergies).

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., markets Singulair in the United States. The U.S. Food and Drug Administration originally approved the drug in 1998. It’s sold under its brand name and in generic form.

“While Singulair is not a steroid and is not typically considered an immunosuppressant, it nevertheless does interfere with immune pathways by limiting the production of leukotrienes, chemicals in the body that are part of the ‘inflammatory cascade,’” Dr. Caleb Alexander, a professor at Johns Hopkins Bloomberg School of Public Health and co-director of the Center for Drug Safety and Effectiveness, told Drugwatch.

The body releases leukotrienes after coming in contact with an allergen. The chemicals cause tightening of the airway muscles and produce fluid and mucus. Singulair blocks these chemicals to help control asthma and allergy symptoms.

Singulair isn’t for sudden asthma attacks. Patients should follow instructions from their health care provider for treating asthma attacks, such as using an inhaler.

How to Take Singulair

Singulair is available in 10 mg tablets, 5 mg and 4 mg chewable tablets and 4 mg oral granules. This medicine can be used in people 12 months or older for asthma, and the dosage varies by age.

The FDA also approved it to treat exercise-induced asthma in people 6 years and older and allergic rhinitis in people 2 years and older, also called hay fever.

People can take this medication with or without food. If you miss a dose, don’t take two doses at the same time — wait until your next scheduled dose.

Asthma

The recommended dose varies by age from 4 mg to 10 mg depending on age and may include tablets, chewable tablets and granules.

The drug’s label recommends taking the drug at night because the drug wasn’t tested in the morning during clinical trials, but the medication guide instructs people to take their medicine as prescribed by their medical providers.

“Sometimes we dose Singulair at night because many people have worse asthma symptoms at night than during the day,” Alexander said. “However, many people take Singulair during the morning rather than evening, and what works for one person may not work for another. In other words, there is no one-size-fits-all approach, and it’s more important to take it regularly than it is to take it at a certain hour of the day.”

Preventing Exercise-Induced Bronchoconstriction

In addition to treating asthma, Singulair can help people with breathing problems brought on by exercise. People should take the drug at least two hours before exercise, according to the drug’s label.

People 15 years of age and older take one 10 mg tablet. Children six to 14 years of age take one 5 mg chewable tablet.

Don’t take another dose within 24 hours of the previous dose. If you are already taking Singulair for asthma, don’t take an additional dose before exercise.

Allergic Rhinitis (Hay Fever)

People treating allergies should take Singulair once daily in the morning or evening. In clinical trials, the drug worked just as well regardless of the time of day or if taken with or without food.

The drug can also be taken as needed for perennial allergies as recommended by a medical provider.

Recommended doses:

• Adults and adolescents 15 years of age and older, one 10-mg tablet
• 
  Children six to 14 years of age, one 5-mg chewable tablet
• 
  Children two to five years of age, one 4-mg chewable tablet or one packet of 4-mg oral granules

Side Effects

Most side effects associated with Singulair are mild. In general, the medication is well tolerated in people taking it for asthma or allergies, according to Alexander.

“Of course, all medicines have risks, and most medicines have rare but serious risks. In the case of Singulair, the most common adverse effects include upper respiratory infections, fevers, headaches and sore throat,” he said. “Of course, it is often difficult to know for sure whether these types of symptoms represent an adverse drug reaction or some other process.”

Singulair was tested in 2,950 adult and adolescent patients, and 1,955 people received the drug. In 2022 clinical trials, the most common side effects occurred in 5% or more of people who took Singulair.

Side effects with an incidence of 5% or more and greater than placebo in clinical trials include:

• Upper respiratory infection
• 
  Fever
• 
  Headache
• 
  Pharyngitis (sore throat)
• 
  Cough
• 
  Abdominal pain
• 
  Diarrhea
• 
  Otitis media (ear inflammation or infection)
• 
  Influenza (flu)
• 
  Rhinorrhea (runny nose)
• 
  Sinusitis (sinus infection)

Other minor, less common side effects include body pain, fatigue, fever, indigestion, dizziness, rash and abnormal liver enzymes.

If you experience side effects, please inform your medical provider.

Drug Interactions

Singulair may interact with other substances. Make sure to tell your medical provider about all medications, supplements, herbs or vitamins you are taking.

The prescription information doesn’t list any specific drug interactions, but it recommends that people with aspirin sensitivity avoid aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) while taking Singulair.

LAWSUIT INFORMATION

People who were diagnosed with a mental health disorder after taking Singulair are filing lawsuits against the drug’s manufacturer.

View Lawsuits

Black Box Warning for Serious Neuropsychiatric Events

In March 2020, the FDA required Merck to place a black box warning — the agency’s most prominent warning — on Singulair drug labels warning about the risk of serious mental health problems, also called neuropsychiatric events. These include: agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide).

“We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions. The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Dr. Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The benefits of Singulair might not outweigh the risks in some people with allergic rhinitis. The FDA recommends the drug only be used in people who don’t respond to or cannot use other allergy treatments. Talk about the risks and benefits of this medication with your medical provider.

Mental health symptoms may occur in people with or without a history of mental health issues, according to the drug’s medication guide. Notify your medical provider right away if you experience changes in thoughts or behavior.

Unusual thinking or behavior may include:

• Agitation, including aggressive behavior or hostility
• 
  Attention problems
• 
  Bad or vivid dreams
• 
  Depression
• 
  Disorientation (confusion)
• 
  Feeling anxious
• 
  Hallucinations (seeing or hearing things that are not really there)
• 
  Irritability
• 
  Memory problems
• 
  Obsessive-compulsive symptoms
• 
  Restlessness
• 
  Sleep walking
• 
  Stuttering
• 
  Suicidal thoughts and actions (including suicide)
• 
  Tremor
• 
  Trouble sleeping
• 
  Uncontrolled muscle movements

Litigation over Side Effects

After the FDA placed the black box warning on the drug, some people filed Singulair lawsuits against Merck claiming the drugmaker failed to warn about the risk of suicidal thoughts and other neuropsychiatric problems.

One plaintiff from Wisconsin filed a lawsuit on behalf or her child in September 2020. According to her complaint, Merck ignored studies that showed Singulair could cause neuropsychiatric events.

After taking Singulair, her child was admitted to a psychiatric center and was diagnosed with “major depressive disorder, anxiety disorder, obsessive-compulsive disorder, ego-dystonic and intrusive thoughts about homicidal, suicidal, and sexual thoughts, and poor coping.”

“Originally, the Singulair label contained no warnings regarding neuropsychiatric events. Over the past 22 years Defendant has slowly and belatedly added grossly insufficient warnings regarding neuropsychiatric events to the product label,” her lawsuit claimed.

Merck hasn’t issued a statement about the lawsuits.

Singulair Facts

Please seek the advice of a medical professional before making health care decisions.

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Singulair Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

This medication may rarely cause serious mental/mood changes. These effects may occur even after the medication has been stopped. Tell your doctor right away if you or a caregiver/family member notice symptoms such as agitation, anxiety, abnormal dreams, depression, memory/attention problems, hallucinations, trouble sleeping, or changes in behavior (such as aggression, hostility, restlessness, sleepwalking, suicidal thoughts/attempts). Talk to your doctor about the risks and benefits of this medication.

Warnings:

This medication may rarely cause serious mental/mood changes. These effects may occur even after the medication has been stopped. Tell your doctor right away if you or a caregiver/family member notice symptoms such as agitation, anxiety, abnormal dreams, depression, memory/attention problems, hallucinations, trouble sleeping, or changes in behavior (such as aggression, hostility, restlessness, sleepwalking, suicidal thoughts/attempts). Talk to your doctor about the risks and benefits of this medication.

.. . Show More

Uses

Montelukast is used to control and prevent symptoms caused by asthma (such as wheezing and shortness of breath). It is also used before exercise to prevent breathing problems during exercise (bronchospasm). This medication can help decrease the number of times you need to use your quick relief inhaler.Montelukast is also used to relieve symptoms of hay fever and allergic rhinitis (such as sneezing, stuffy/runny/itchy nose). Since there are other allergy medications that may be safer (see also Warning section), this medication should be used for this condition only when you cannot take other allergy medications or they do not work well.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.This drug works by blocking certain natural substances (leukotrienes) that may cause or worsen asthma and allergies. It helps make breathing easier by reducing swelling (inflammation) in the airways.

How to use Singulair oral

Read the Medication Guide provided by your pharmacist before you start taking montelukast and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your age and medical condition.

If you are using the chewable tablets, chew them thoroughly before swallowing. If your child cannot safely chew and swallow them, consult the doctor or pharmacist for advice.

Take this medication at the same time each day. If you are taking this medication for asthma or for both asthma and allergies, take your dose in the evening. If you are taking montelukast to prevent only allergies, take your dose either in the morning or the evening.

If you are taking this medication to prevent breathing problems during exercise, take your dose at least 2 hours before exercise. Do not take more than one dose in 24 hours. Do not take a dose before exercise if you are already taking this medication daily for asthma or allergies. Doing so may increase the risk of side effects.

Do not increase or decrease your dose or stop using this medication without consulting your doctor. Continue to use this medication regularly to keep your asthma under control, even during sudden asthma attacks or periods when you have no asthma symptoms. Continue to also take other medications for asthma as directed by your doctor. This medication works over time and is not meant to relieve sudden attacks of asthma. If an asthma attack or other breathing problem occurs, use your quick-relief inhaler as prescribed. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.

Get medical help right away if your asthma symptoms worsen and your quick-relief inhaler is not helping. Tell your doctor promptly if asthma symptoms, breathing problems, allergy symptoms, number of times you use your rescue inhaler last or get worse.

Side Effects

See also Warning section.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling/shooting pain in the arms or legs, sinus pain/swelling, muscle weakness, uncontrolled muscle movements, stuttering.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www. fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking montelukast, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this drug, tell your doctor or pharmacist your medical history, especially of: liver disease, mental/mood problems (such as anxiety, depression, thoughts of suicide).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The chewable tablets may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Does Singulair oral interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: thirst, drowsiness, inability to keep still, vomiting, or severe stomach pain.

Do not share this medication with others.

Lab and/or medical tests (such as lung function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Do not take more than 1 dose in 24 hours.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Singulair 5 mg chewable tablet

Color: pinkShape: roundImprint: MSD 275 SINGULAIR

This medicine is a pink, round, cherry, chewable tablet imprinted with “MSD 275” and “SINGULAIR”.

Singulair 10 mg tablet

Color: beigeShape: square (rounded corners)Imprint: MSD 117 SINGULAIR

This medicine is a pink, round, cherry, chewable tablet imprinted with “MSD 275” and “SINGULAIR”.

Singulair 5 mg chewable tablet

Color: pinkShape: roundImprint: SINGULAIR MRK 275

This medicine is a pink, round, cherry, chewable tablet imprinted with “MSD 275” and “SINGULAIR”.

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Drug Survey

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This survey is being conducted by the WebMD marketing sciences department.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

90,000 SINGURERS – Buyer reviews and experience using

Singular Reviews

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believes that the goods are excellent

from 600  ₽

My child has frequent obstructive bronchitis and the threat of bronchial asthma. The doctor advised me to buy Singular, which is a non-hormonal drug. This medicine is very helpful. After the course, which lasted 2 months, we have no problems for a long time, the child forgets about bronchitis and allergies, and a long-term remission occurs. The child has no side effects, the medicine is well tolerated.

Thinks the product is excellent

from 1 239  ₽

I take Singular as a course, regularly. It helps me fight bronchial asthma and do without hormonal drugs. I buy it at a pharmacy, at a price of about 900 r per pack. After the course, there is a long remission. I am pleased with the result, the attacks became much less frequent, I stopped suffocating after cold air and heavy loads. This is important for me because I work as a loader.

Thinks the product is good

from 1 239  ₽

I prescribe Singulair as maintenance therapy for bronchial asthma, frequent bronchitis, and manifestations of allergies. It provides long-term remission and is a non-hormonal drug. Another important advantage is ease of use. The method of its use is one tablet per day. Singular has found application in pediatric practice, it is used for atopic dermatitis, allergic rhinitis, bronchitis and asthma.

Thinks the product is excellent

from 600  ₽

Singulair appointed an allergist to my son with bronchial asthma. The drug can be bought at a pharmacy at a price of about 1000 r. The son takes this medicine in a course of 2-3 months. The positive effect of Singular is clearly visible. The son stopped suffocating after physical exertion, seizures stopped during viral infections. I am satisfied with the result, the drug suited us.

Thinks the product is bad

from 1 239  ₽

I was prescribed Singulair for frequent bronchitis and severe allergies, the doctor considered that there was a threat of asthma. The drug is expensive, I bought it at a price of about 900 r and only under the order in a pharmacy. I took the medicine for two months. I didn’t notice any positive effect. An upset stomach appeared, as well as sleep and well-being worsened, the mood worsened from this, tearfulness appeared, which had never happened before. He may be good, but he didn’t suit me.

Thinks the product is excellent

from 1 239  ₽

I was prescribed Singulair for the threat of bronchial asthma. I take it as a course, about 3 months, and you can buy it for about 900 r per package and on order, in a pharmacy. After taking the drug, bronchitis goes away faster, I get sick without complications, I take less medication, I do without hospitalization. I do not observe side effects, this medicine turned out to be a salvation for me.

Montelukast drives patients to suicide

Image: Photographee.eu/Adobe Stock.
Posted inNEWS, REGULATORS

A popular asthma and allergy drug can help you lose your mind.

by Roman Dmitriev 06/11/2020 09/15/2022

Main

The US Food and Drug Administration (FDA) has raised serious concerns about the safety of montelukast, a popular drug known by the brand name Singulair and used by children and adults for prevention and chronic asthma therapy, to prevent exercise-induced bronchospasm, as well as to relieve symptoms of seasonal and persistent allergic rhinitis.

US regulators say physicians and patients underestimate the risks of montelukast associated with mental health adverse reactions, including suicidal thoughts, behaviors and behaviors.

The existence of a certain probability of developing neuropsychiatric disorders outweighs the benefit that montelukast can bring. And because the FDA insists that doctors be more restrained and prudent about the issue of prescribing treatment with montelukast. This is especially true if the symptoms of the disease are mild, and the disease itself is quite amenable to therapy with other drugs.

For example, in cases of allergic rhinitis, also known as hay fever, montelukast should be retained as a fallback drug, given only after other drugs have failed or are intolerable. Among a wide range of those: antihistamine loratadine (loratadine), fexofenadine (fexofenadine), cetirizine (cetirizine), levocetirizine (levocetirizine), diphenhydramine (diphenhydramine) and intranasal steroid sprays fluticasone (fluticasone), triamcinolone (triamcinolone), budesonide (budesonide). Do not forget about allergen-specific immunotherapy.

Most of the time, mental health symptoms occurred during montelukast therapy and they resolved after the drug was discontinued. However, there have been cases of neuropsychiatric disorders that manifested or persisted even after the abolition of montelukast. All of the above is true for patients both with a history of mental illness and without previous mental disorders.

A two-year-old child strangles his mother, trying to gouge out her eyes. A young man sets fire to his parents’ house. A teenager sits on the roof of a high-rise building and relishes the future of suicide. A woman cannot escape from her nightly nightmares. The ten year old goes into berserk mode, smashing furniture, gnashing her teeth, and changing her facial expressions of rage. A five-year-old child, languishing from an unbearable longing for aimless years, plunges into a deep depression.

Episodes of montelukast use.

The problems of montelukast associated with its negative effect on the psyche were first revealed in 2008. And now, in connection with the continuing increase in the number of cases of neuropsychiatric disorders, we can safely say that there is a direct connection with the use of montelukast.

Montelukast should be stopped immediately if there are any changes in behavior or mood. Among such signal changes:

• restless state;
• excitement, including aggressive behavior or hostility;
• hallucinations;
• disorientation or confusion;
• depression;
• sleepwalking;
• memory disorders;
• speech disorders;
• uncontrolled muscle movements
• obsessive-compulsive symptoms;
• bad or realistic dreams;
• attention problems;
• sleep problems;
• irritability;
• suicidal thoughts and actions;
• tremor or shivering;
• feeling of anxiety.

By the way, patients taking drugs from the same class of antileukotrienes as montelukast, zafirlukast and zileuton, also experience adverse reactions in the form of neuropsychiatric disorders.

Scientific base

The FDA has conducted a thorough investigation into the safety of montelukast. The investigators assessed trends in the FAERS adverse event reporting system by checking reports of neuropsychiatric events with montelukast. An observational study of data collected in the Sentinel system, which tracks the safety of medicines, vaccines and medical products, was also carried out. In addition, the results of observational studies and animal studies published in the scientific literature were reviewed.

Thus, in the FAERS database for the period from February 1998 to May 2019, 82 cases of completed suicides associated with montelukast were found: many reports spoke of the appearance of concomitant neuropsychiatric symptoms before the moment of suicide. The statistics are as follows:

• 45 suicides were committed by patients over 17 years of age, 19 by 17 years of age and younger, for the remaining 18 no information was provided on the age of the patients.

• For more than half of the cases (n=48/82), there was no complete data package that would allow a thorough assessment of the association between montelukast and the onset of a suicidal event. We are talking about such key information as the time elapsed before the completed suicide; the use of other drugs; the presence of comorbid conditions in the past and present, including mental ones; degree of pharmacological control of asthma; presence of other risk factors for suicide.

• The remaining 34 cases are better documented and contain information about additional risk factors related to suicide, such as drug use or comorbidities, which are associated with an increased chance of harming oneself or developing behavioral disorders. In 6 cases, the facts were reported that the medical worker was not specifically aware of the possibility of neuropsychiatric side effects when using montelukast.

The Sentinel system for the period January 2010 to September 2015 painted the following picture with the hypothesis of an increased risk of inpatient or outpatient treatment of depressive disorders, as well as cases of self-harm or suicide associated with the use of montelukast compared with the use of inhaled corticosteroids ( ICS). The data covered 457 thousand patients aged 6 years and older:

• The difference in the risks of hospitalization due to depressive disorder was not significant among those who received montelukast or ICS (hazard ratio [HR] 1.06 [95% CI: 0.90–1.24]). There was no significant risk among men, women, patients aged 12 years and older, patients with a history of mental illness.

• Montelukast was significantly associated with a reduced risk of outpatient treatment for depressive disorder (HR 0.91 [95% CI: 0.89–0.93]). There was a decrease in risk among patients with a history of mental illness, patients aged 12-17 years and aged 18 years and older, men and women.

• Montelukast therapy was not associated with risks of self-harm (HR 0.92 [95% CI: 0.69-1.21]) or modified self-harm (HR 0.81 [95% CI: 0.63-1.05 ]).

• Four cases of suicide (two each in the montelukast and ICS groups) were recorded among patients over 18 years of age and with a history of mental illness.

It should be understood that the data collected by Sentinel is subject to certain limitations. Thus, the study relied only on clinical outcomes, according to which patients sought medical care recorded in the case histories. In other words, it did not evaluate the full range of neuropsychiatric events or events that did not require medical intervention, but only the discontinuation of montelukast. Again, after the change in the instructions for the use of the drug in 2008, patients, it is possible, became more aware of the risks of adverse neuropsychiatric events, and therefore tracked their onset in a timely manner, refusing montelukast. Finally, the study is not adjusted to the socioeconomic status of the patients, although a review of the literature found no evidence that montelukast and ICS are administered out of proportion to this indicator. It is possible, however, that people with higher incomes are more likely to visit doctors in the course of asthma therapy, and therefore find themselves in the group of increased monitoring of the manifestation of neuropsychiatric events.

Animal studies have shown that montelukast is able to act directly on brain cells: orally administered montelukast has been found in brain tissue and cerebrospinal fluid in rodents, thus confirming that it can bypass the blood-brain barrier.

Montelukast: mechanism of action

Leukotrienes (LT) are a family of inflammatory mediators that are metabolic products of arachidonic and eicosapentaenoic acids and are released by various cell types, including mast cells, eosinophils, and basophils. Leukotrienes are responsible for the regulation of immune responses. Their cellular excretion is often accompanied by the release of histamine and prostaglandins, which also act as inflammatory mediators.

The key function of leukotriene D4 (LTD4), a so-called cysteinyl leukotrienes, is to induce smooth muscle contraction leading to bronchial and vascular constriction, as well as to increase microvascular permeability and mucus secretion. The role of leukotriene E4 (LTE4), which is a stable variant of LTD4, is generally the same.

Montelukast is a highly selective leukotriene receptor antagonist (LTRA) that binds with high affinity to the cysteinyl leukotriene receptor 1 (CYSLTR1). When montelukast binds to CYSLTR1, the ligands of which are LTD4 and LTE4 and which is expressed by cells of the respiratory tract, including macrophages and smooth muscle cells, the physiological leukotriene effects are suppressed, and without any agonist activity. In the case of asthma, this inhibition is reflected by the containment of the pathophysiological effects associated with airway edema, smooth muscle contraction, and changes in cellular activity during the inflammatory process. In allergic rhinitis, CYSLTR1 is released from the nasal mucosa after exposure to the allergen, and therefore its suppression eliminates the signs and symptoms of this disease.

What drugs contain Mandelukast

List of Mandelukasta Trade Names

Abbatin, Avadil, Avakast (AWAKAST), Averkaz (Averkaz), Admont (Admont (Admont (Admont ), Actamone, Alecast, Alergokast, Aliento, Almont , Alukast, Albocast ( Albokast), “Alvokast” (Alvokast), “Amekast” (Amekast), “Amikast” (Amikast), “Aminofer” (Aminofer), “Amisped” (Amisped), “Andiar” (Andiar), “Anxokast” (Anxokast ), Antaluk (Antaluk), Apilon (Apilone), Apomontessan (ApoMontessan), Aria (Aria), Arovent (Arovent), Arocast (Arokast), Asventol (Asventol) , “Ascolin” (Ascolin), “Asmaakt” (Asmaact), “Asmavitan” (Asmavitan), “Asmakast” (Asmakast), “Asmalar” (Asmalair), “Asmatab” (Asmatab), “Asmaflo” (Asmaflo), Asmenol, Asmont, Aspira, Astair, “Astator” (Astator / Asthator) , “Astel” (Astel), “Astmasan” (Astmasan), “Astmatin” (Asthmatin), “Astmir” (Astmir), “Astmireks” (Astmirex), “Astmodil” ( Astmodil), Asthmon, Asthmont, Asfree, Atentus, Aerokast, Aerokids, Aeromax ), Aerolan (Aerolan), Aeron (Aeron), Aerotel (Aerotel).

Bizi (Beasy), Belar (BelAIR), Belokast (Belokast), Bloktiene (Bloktiene), Brekar (Brecare), Breezy (Breasy), Brocast (Brocast / Brokast), “Brolyt” (Brolyt), “Brolukat” (Brolukat), “Bronast” (Bronast), “Brondilat” (Brondilat), “Bronquis” (Bronkeez), “Bronkonorm” (Bronkonorm).

Valtrover, Vansear/Onceair, Velukast, Ventair, Ventek, Ventilar, Ventilar ( Ventilair), “Vestair” (Westair), “Vizendo” (Vizendo).

Glemont Glenmont.

Delpomont, Denverkast, Denk-Air, Dilar, Diffalon, Diuk Lafrancol, Duramont

Zakomoxit, Zespira, Zylcas

Idular (Idulair), Izyast (Easyast), Ezevent (Ezevent), Ingalst (Inhalst), Inletar (Inletair), Inmunobron (Inmunobron), Inmunokast (Inmunokast) , Inspirol (Inspirol), Inspra (Inspra), Inuvik (Inuvic).

Yekast.

Capturan, Kast, Kastair, Kastel, Kastmar, Kastol, Kastorion , Castspirir, Kemtelo, Kipres, Clast/Klast , Clear Air, Kokast, Conkast, Croma, Xalar, Xigenast, Ximpruv ( Ximprove), Xyflo (Xyflo), Kulair (Kulair), Culento (Culento), Kurost (Curost).

Lanair, Langair, Lasma, Lelipel, Leukast, Leucotren, Leukotris , Liam, Loctril, Lukavent, Lukair, Lukakline, Lukamont, Lukanex, Lucaratio, Lukas, Lukasm, Lukasma, Lukast , Lukastang , Lukastin , Lukastma , Lukema , Lukema , Luxat , Lulast ( Lulast), “Lumenta” (Lumenta), “Lumona” (Lumona), “Lumont” (Lumont).

Maxair, Medikast, Medlukast, Melarth, Meflort, Miletic, Milukante ) , Minar (Minair), Mingair (Mingair), Mintalos (Mintalos), Miralust (Miralust), Miteka (Myteka), M-Kast (M-Kast), ” M-Lucas “(M-Lucas), “Modrian” (Modrian), “Modular” (Modulair), “Mogular” (Mogulair), “Mokast” (Mokast), “Molikast” (Molicust), “Molly” (Molly ), Molucar, Molukat, Molus, Mon, Monaka, Monax , Monalast, Monalux, Monark, Monas, Mondeo, Moneka , “Monekast” (Monekast), “Monk” (Monk), “Moncas” (Moncas), “Moncast” (Monkast), “Monkasta” (Monkasta) , “Monkon” (Monkon), “Monk-P” (Monk-P), Monxe, Monlast, Monler , Monlucare, Monovas, Monocast, “Monolar” (Monolair), “Monofast” (Monofast), “Monoproks” (Monprox), “Monsefil” (Moncefil), “Monstonol” (Monstonol), “Montair” (Montair), “Montal” (Montal), ” Montalis “(Montalis), “Montan” (Monthan), “Montas” (Montas), “Montasma” (Montasma), “Montast” (Montast), “Montegen” (Montegen), “Montegol” (Montegol), “Montedor “(Montedor), “Montezid” (Montezyd), “Montezim” (Montezim), “Monteil” (Montale), “Montek” (Montec / Montek), “Monteka” (Monteka), “Montekal” (Montekal), ” Montekast “(Montekast), “Montecon” (Montecon), “Monteks” (Montex), “Monteksal” (Montexal), “Monteksin” (Montexin), Montelast , Montela, Montelar (Montelair/Montelar) , Montelast , Montelex (Montelex), Montelo, “Montelon” (Montelon), “Montelubronch” (Montelubronch), “Montelugen” (Montelugen), “Monteluk” (Monteluk), “Montelukast” (Montelukast / Montelucast / Montelucaste), “Montelukastum” (Montelukastum), “Montelus” ( Montelus), Monteluteg, Montelux, Montemac (Montemac / Montemak) , Montemax, Montemed , Montene, Montena, Montenaaf, Montenuzyd, Montep, Monte-R (Monte-R) , “Monterin” (Monterin), “Monteron” (Monteron), “Montespir” (Montespir), “Montessan” (Montessan), “Montest” (Montest), “Montesur” (Montesur), ” Montetrinas (Montetrinas), Montefar (Montefar), Montesher (Montesher), Monte-Air (Monte-Air), Monty (Monti / Monty / Montey), Montiva (Montiva), ” Montiget (Montiget), Montica (Montica / Montika), Montilab (Montilab), Montilak (Montilak), Montilet (Montilet), Montipedia (Montipedia), Montifast (Montifast), Montol (Montol), Mont-R (Mont-R), Montrate (Montrate), Montril (Montril), Montular , Montulind, Mont-heim, Monukast, Moor, Montemak, Monchr “(Monchr), “Moral” (Moral) , “Moscalair” (Moscalair), “Moteki” (Moteqi), “Mofenstra” (Mofenstra), “Mukosoft” (Mucosoft), “Mulpas” (Moolpas), ” Multiler “(Multiler),” Mooncast “(Mooncast).

Nozma, Notta, N-Fess.

Odimont, Odmon, Orilukast, Otelus.

Piemonte, Plenair, Pluralais, Pneumo-Kast, Primeair, Prevenil, Provair “(Provair), “Promonta” (Promonta), “Profilaks” (Profilax), “Pulmokast” (Pulmokast), “Pulmont” (Pulmont).

Reversair, Recast, Relukas, Reokast, Respair, Respikast, Riskal , “Rolast” (Rolast), “Romilast” (Romilast).

Sansibast, SB-Monec (SB-Monec), Sedokast, Selezen, Senloir, Senovital, Silmon “(Silmon), “Singukast” (Singukast), “Singuleks” (Singulex), “Sincast” (Sincast), Simplaer , Sinair, Sinbrux, Singlon/Synglon , Singodem, Singulex , “Singulair” (Singulair) , “Singument-C” (Singument-S), “Sin-Mont” (Sin-Mont), “Sintair” (Sintair), “Sintelukast-Humaniti” (Sintelukast-Humanity), ” Sintrin, Smarti, Speradac, Spirokast, Spiromon, Surfair, Suviar, Simlukast » (Symlukast).

Take Air, Tekast, Telekast, Teluk, Teluka, Telukast, Telumantes ( Telumantes), Telumyl, Terrakast, T Lukast, Topraz, Tordel, Trilucky, Trilok (Trilock).

Urilast.

Flomont, Freegest, Fulmont.

Centokast, Cerrokast.

Everest, Edron, Airbron, Airway, Airfast, Aireez, Aireal , Airing, Aircast, Airlast, Airlukast, Airmol, Airocast (Airokast), Airomed (Airomed), Airon, Airfix, Ektalust , Elukan, Elunkast, Emlucast, Eonic, Ephyra.

Unicast, Uniair.

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