What are the primary uses of Singulair 10mg oral tablet. How does Singulair work to control asthma and allergies. What are the potential side effects and warnings associated with Singulair. How should Singulair be taken for maximum effectiveness.

Understanding Singulair: A Powerful Medication for Asthma and Allergies

Singulair, also known by its generic name montelukast, is a widely prescribed medication used to manage asthma and allergy symptoms. This oral tablet, typically available in a 10mg dosage, has become a cornerstone in the treatment of respiratory conditions. But what exactly is Singulair, and how does it work to alleviate symptoms?

Singulair belongs to a class of drugs called leukotriene receptor antagonists. It works by blocking the action of leukotrienes, which are substances in the body that cause inflammation in the airways and contribute to allergy symptoms. By inhibiting these substances, Singulair helps to reduce inflammation, making breathing easier for those with asthma and alleviating allergy symptoms.

The Diverse Applications of Singulair in Respiratory Health

Singulair’s versatility in treating various respiratory conditions has made it a popular choice among healthcare providers. What are the primary uses of this medication?

• Control and prevention of asthma symptoms
• Prevention of exercise-induced bronchospasm
• Relief of seasonal allergic rhinitis (hay fever) symptoms
• Management of perennial allergic rhinitis

For asthma patients, Singulair can help reduce the frequency of asthma attacks and decrease the need for rescue inhalers. In the case of exercise-induced bronchospasm, taking Singulair before physical activity can help prevent breathing difficulties during exercise.

When it comes to allergies, Singulair offers relief from common symptoms such as sneezing, stuffy or runny nose, and itching. However, it’s important to note that other allergy medications may be considered safer options, and Singulair should be used for allergy relief only when other treatments have proven ineffective.

Proper Usage and Dosing Guidelines for Singulair

To maximize the benefits of Singulair while minimizing potential risks, it’s crucial to follow the prescribed dosing regimen. How should patients take Singulair for optimal results?

• Take the medication orally, with or without food
• Adhere to a consistent dosing schedule, typically once daily
• For asthma and combined asthma/allergy treatment, take in the evening
• For allergy-only treatment, take either in the morning or evening
• For exercise-induced bronchospasm, take at least 2 hours before physical activity

The dosage of Singulair is based on age and medical condition. It’s essential not to adjust the dose or stop taking the medication without consulting a healthcare provider. Consistent use is key to maintaining control over asthma and allergy symptoms.

Special Considerations for Different Formulations

Singulair is available in various formulations to accommodate different patient needs. The 10mg oral tablet is the standard adult dosage, but chewable tablets are also available for younger patients or those who have difficulty swallowing pills. When using chewable tablets, it’s important to chew them thoroughly before swallowing.

Navigating Potential Side Effects and Warnings

While Singulair is generally well-tolerated, it’s essential to be aware of potential side effects and warnings associated with its use. What are the most significant concerns patients should be vigilant about?

• Mental/mood changes (e.g., agitation, anxiety, depression)
• Memory or attention problems
• Hallucinations
• Sleep disturbances
• Behavioral changes (e.g., aggression, hostility)
• Suicidal thoughts or attempts

These mental health-related side effects are rare but serious. They can occur during treatment or even after discontinuation of the medication. Patients and their caregivers should be alert to any changes in behavior or mood and report them to a healthcare provider immediately.

Other Potential Side Effects

While less severe, other side effects may occur and should be monitored:

• Numbness or tingling in arms or legs
• Sinus pain or swelling
• Muscle weakness
• Uncontrolled muscle movements
• Stuttering

Although rare, severe allergic reactions to Singulair can occur. Patients should seek immediate medical attention if they experience signs of an allergic reaction, such as rash, itching, swelling, severe dizziness, or difficulty breathing.

Interactions and Precautions: Ensuring Safe Use of Singulair

To maximize the safety and efficacy of Singulair, it’s crucial to be aware of potential drug interactions and take necessary precautions. What should patients and healthcare providers consider when using this medication?

Drug interactions with Singulair are generally minimal, but it’s essential to inform healthcare providers about all medications, supplements, and herbal products being used. Some medications that may interact with Singulair include:

• Rifampin (an antibiotic that can decrease Singulair’s effectiveness)
• Phenobarbital and phenytoin (seizure medications that may affect Singulair levels)
• Gemfibrozil (a cholesterol-lowering medication that can increase Singulair levels)

Patients with liver disease may need dose adjustments, as Singulair is metabolized in the liver. Additionally, individuals with phenylketonuria should be cautious with chewable tablets, as they contain aspartame.

Special Populations and Considerations

Certain groups require special attention when using Singulair:

• Pregnant women: Singulair should be used during pregnancy only if clearly needed
• Breastfeeding mothers: It’s unknown if Singulair passes into breast milk
• Children: Dosages vary based on age and formulation
• Elderly patients: No specific precautions, but monitoring for side effects is important

Maximizing the Benefits of Singulair in Asthma Management

While Singulair is an effective medication for controlling asthma symptoms, it’s important to understand its role within a comprehensive asthma management plan. How can patients optimize their use of Singulair to achieve the best possible outcomes?

Singulair is not a rescue medication and should not be used to treat acute asthma attacks. Patients should always have a quick-relief inhaler available for sudden symptoms. The key to Singulair’s effectiveness lies in its consistent, long-term use as a preventive measure.

Integrating Singulair into Your Asthma Action Plan

To maximize the benefits of Singulair in asthma management:

• Take the medication regularly, even when feeling well
• Continue using other prescribed asthma medications as directed
• Monitor symptoms and peak flow readings regularly
• Follow your asthma action plan and adjust treatment as needed
• Attend regular check-ups with your healthcare provider

It’s crucial to communicate any changes in asthma symptoms or frequency of rescue inhaler use to your healthcare provider. This information can help in adjusting your treatment plan for optimal asthma control.

Singulair and Allergy Relief: Finding the Right Balance

While Singulair is FDA-approved for allergy relief, its use in this context requires careful consideration. How can patients and healthcare providers determine if Singulair is the right choice for managing allergy symptoms?

The decision to use Singulair for allergies should be made after considering other available treatments. Antihistamines and nasal corticosteroids are often the first-line treatments for allergic rhinitis due to their established safety profiles and effectiveness.

When to Consider Singulair for Allergies

Situations where Singulair might be appropriate for allergy management include:

• When other allergy medications have proven ineffective
• In cases of combined asthma and allergies
• For patients who cannot tolerate traditional allergy medications
• As part of a comprehensive allergy management plan

It’s important to weigh the potential benefits against the risks, particularly the rare but serious mental health side effects associated with Singulair use.

Long-term Use and Monitoring: Ensuring Continued Safety and Efficacy

For many patients, Singulair becomes a long-term component of their respiratory health management. What considerations should be kept in mind for those using Singulair over extended periods?

Long-term use of Singulair requires ongoing monitoring to ensure continued safety and effectiveness. Regular check-ups with healthcare providers are essential to assess the medication’s impact and make any necessary adjustments to the treatment plan.

Key Aspects of Long-term Singulair Use

Patients on long-term Singulair therapy should be aware of the following:

• The importance of regular health assessments
• The need for periodic reevaluation of the medication’s necessity
• Potential for rare long-term side effects
• The possibility of developing tolerance over time
• The need to report any changes in symptoms or new health concerns

Healthcare providers may recommend periodic breaks from the medication or dose adjustments to minimize the risk of side effects while maintaining symptom control.

Alternative Treatments and Complementary Approaches

While Singulair is an effective medication for many, it’s not the only option for managing asthma and allergies. What alternative treatments and complementary approaches can be considered alongside or instead of Singulair?

For asthma management, other medication classes include:

• Inhaled corticosteroids
• Long-acting beta-agonists
• Combination inhalers
• Biological therapies for severe asthma

For allergy relief, alternatives include:

• Antihistamines (oral and nasal)
• Nasal corticosteroids
• Decongestants
• Immunotherapy (allergy shots or sublingual tablets)

Complementary Approaches

In addition to medication, several complementary approaches can support respiratory health:

• Allergen avoidance strategies
• Air purifiers and humidity control
• Breathing exercises and yoga
• Dietary modifications (e.g., anti-inflammatory diets)
• Stress management techniques

It’s important to discuss any alternative or complementary treatments with a healthcare provider to ensure they are safe and appropriate for individual circumstances.

Patient Education and Self-Management: Empowering Singulair Users

Effective use of Singulair goes beyond simply taking the medication as prescribed. How can patients become active participants in their treatment and optimize their respiratory health?

Patient education plays a crucial role in the successful management of asthma and allergies. Understanding the medication, its effects, and potential side effects empowers patients to make informed decisions about their health.

Key Components of Patient Education for Singulair Users

• Understanding the mechanism of action and expected benefits
• Recognizing the importance of consistent use
• Learning to identify and report potential side effects
• Developing skills for proper inhaler technique (if applicable)
• Creating and following an asthma action plan
• Implementing lifestyle modifications to support respiratory health

Self-management strategies, such as keeping a symptom diary or using peak flow meters, can help patients track their progress and communicate effectively with healthcare providers.

The Future of Asthma and Allergy Treatment: Beyond Singulair

As medical research advances, new treatments for asthma and allergies continue to emerge. What developments on the horizon might impact the future use of Singulair and other respiratory medications?

Ongoing research is exploring several promising areas:

• Targeted biological therapies for severe asthma
• Gene therapy approaches
• Novel drug delivery systems
• Personalized medicine based on genetic profiles
• Immunomodulatory treatments for allergies

These advancements may lead to more effective and personalized treatment options, potentially reducing the reliance on medications like Singulair for some patients.

The Evolving Role of Singulair

As new treatments emerge, the role of Singulair in asthma and allergy management may evolve. It may become part of more tailored treatment approaches, combined with newer therapies, or reserved for specific patient populations where it demonstrates the greatest benefit.

Patients currently using Singulair should stay informed about new developments and discuss any potential changes to their treatment plan with their healthcare providers.

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.

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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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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.

Singulair (Montelukast) – Side Effects, Interactions, Uses, Dosage, Warnings

uses

What is Singulair (Montelukast) used for?

• Allergic Rhinitis
• Asthma — Maintenance
• Bronchospasm Prophylaxis

warnings

What is the most important information I should know about Singulair (Montelukast)?

You should not use montelukast if you are allergic to it.

Tell your doctor if you have ever had:

• mental illness or psychosis; or
• asthma, or a history of severe allergic reaction (sneezing, runny or stuffy nose, wheezing, shortness of breath) after taking aspirin or another NSAID.

The chewable tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant or breastfeeding.

Do not give this medicine to a child without a doctor’s advice.

User Reviews & Rating

Overall rating for Singulair (Montelukast)

2.9

out of  5

Side Effects

Easy to Use

Effectiveness

Read Singulair (Montelukast) Reviews

Side Effects

What are the side effects of Singulair (Montelukast)?

Get emergency medical help if you have signs of an allergic reaction: hives, blisters, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have signs of blood vessel inflammation: flu-like symptoms, severe sinus pain, a skin rash, numbness or a “pins and needles” feeling in your arms or legs.

Some people using montelukast have had new or worsening mental problems. Stop taking this medicine and call your doctor right away if you have unusual changes in mood or behavior, such as:

• agitation, aggression, feeling restless or irritable;
• anxiety, depression, confusion, problems with memory or attention;
• stuttering, tremors, uncontrolled muscle movements;
• suicidal thoughts or actions;
• hallucinations, sleep problems, vivid, dreams, sleep-walking; or
• compulsive or repetitive behaviors.

Common side effects may include:

• stomach pain, diarrhea;
• fever or other flu symptoms;
• ear pain or full feeling, trouble hearing;
• headache; or
• cold symptoms such as runny or stuffy nose, sinus pain, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Singulair (Montelukast) if I’m pregnant or breastfeeding?

Tell your doctor if you are pregnant or breastfeeding.

Interactions

What drugs and food should I avoid while taking Singulair (Montelukast)?

Avoid situations or activities that may trigger an asthma attack.

If your asthma symptoms get worse when you take aspirin, avoid taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Dosage Guidelines & Tips

How to take Singulair (Montelukast)?

Use Singulair (Montelukast) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

What should I do if I missed a dose of Singulair (Montelukast)?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Overdose Signs

What happens if I overdose on Singulair (Montelukast)?

If you think you or someone else may have overdosed on: Singulair (Montelukast),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn’t breathing after taking Singulair (Montelukast), call 911

911

What to Expect

Montelukast starts to lower leukotriene levels in your body right away, but it may take about a week before you notice the full benefits.

You can safely use this medicine for a long period of time. It will only work while you’re taking it.

Secondary Uses

Singulair is sometimes prescribed “off-label” to treat other medical conditions, such as hives or chronic obstructive pulmonary disorder (COPD).

Images

SINGULAIR, MSD 117

Color: brown

Shape: square

Imprint: SINGULAIR, MSD 117

54 157

Color: brown

Shape: round

Imprint: 54 157

54 144

Color: pink

Shape: oval

Imprint: 54 144

Singular 10 mg n14 tablets

Indications

Prevention and long-term treatment of bronchial asthma in adults and children aged 6 years and older, including:

– prevention of daytime and nighttime symptoms of the disease;

– treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid;

– prevention of exercise-induced bronchospasm.

Relief of day and night symptoms of seasonal allergic rhinitis (in adults and children aged 6 years and over) and persistent allergic rhinitis (in adults and children aged 6 years and over).

Pharmacological action

Leukotriene receptor antagonist. Montelukast inhibits cysteinyl leukotriene receptors in the epithelium of the respiratory tract, while simultaneously showing the ability to inhibit bronchospasm caused by inhalation of cysteinyl leukotriene LTD ₄ in patients with bronchial asthma. Doses of 5 mg are sufficient to relieve bronchospasm induced by LTD ₄ . The use of montelukast in doses exceeding 10 mg / day. 1 time / day, does not increase the effectiveness of the drug.

Montelukast causes bronchodilation within 2 hours of oral administration and may supplement bronchodilation induced by beta ₂ beta-agonists.

Pharmacokinetics

Absorption

After oral administration, montelukast is rapidly and almost completely absorbed from the gastrointestinal tract. Regular meals do not affect plasma C _max and the bioavailability of coated tablets and chewable tablets. In adults, when taken on an empty stomach, film-coated tablets at a dose of 10 mg C _max in plasma is achieved after 3 hours. Bioavailability when taken orally is 64%.

After oral administration on an empty stomach, the drug in the form of chewable tablets at a dose of 5 mg C _max in adults is achieved after 2 hours. Bioavailability is 73%.

Distribution

Binding of montelukast to plasma proteins is more than 99%. V _d averages 8-11 liters.

With a single dose of the drug in the form of coated tablets, at a dose of 10 mg 1 time / day. there is a moderate (about 14%) accumulation of the active substance in plasma.

Metabolism

Montelukast is extensively metabolized in the liver. When used in therapeutic doses, the concentration of montelukast metabolites in plasma in an equilibrium state in adults and children is not determined.

It is assumed that cytochrome P450 isoenzymes (3A4 and 2C9) are involved in the metabolism of montelukast, while at therapeutic concentrations montelukast does not inhibit cytochrome P450 isoenzymes: 3A4, 2C9, 1A2, 2A6, 2C19 and 2D6.

Elimination of

T _1/2 montelukast in young healthy adults ranges from 2.7 to 5.5 hours. Montelukast clearance in healthy adults averages 45 ml/min. After oral administration of montelukast, 86% is excreted in the feces within 5 days and less than 0.2% in the urine, which confirms that montelukast and its metabolites are excreted almost exclusively in the bile.

Pharmacokinetics in special clinical situations

The pharmacokinetics of montelukast remains almost linear after oral administration of more than 50 mg.

When taking montelukast in the morning and evening, no differences in pharmacokinetics are observed.

Pharmacokinetics of montelukast in women and men is similar.

When taken orally coated tablets at a dose of 10 mg 1 time / day. pharmacokinetic profile and bioavailability are similar in elderly and young patients.

In patients with mild to moderate hepatic insufficiency and clinical manifestations of liver cirrhosis, a slowdown in the metabolism of montelukast was noted, accompanied by an increase in AUC of approximately 41% after a single dose of the drug at a dose of 10 mg. The excretion of montelukast in these patients is slightly increased compared with healthy subjects (T _1/2 averages 7.4 hours). Dose modification of montelukast is not required in patients with mild to moderate hepatic impairment. There are no data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale).

Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast have not been evaluated in patients with renal insufficiency. Dose adjustment in this category of patients is not required.

There were no differences in clinically significant pharmacokinetic effects in patients depending on race.

Instructions for use / dosage

The drug is taken orally 1 time per day. regardless of food intake. For treatment of bronchial asthma Singular should be taken in the evening. When treatment of allergic rhinitis the drug can be taken at any time of the day.

Adults and adolescents aged 15 years and older the drug is prescribed at a dose of 10 mg (1 coated tablet) per day.

For children aged 6 to 14 years, is prescribed at a dose of 5 mg (1 chewable tablet) per day. No dose adjustment is required for this age group.

The therapeutic effect of Singulair on indicators reflecting the course of bronchial asthma develops during the first day. The patient should continue to take Singular both during the period of achieving control of asthma symptoms and during the period of exacerbation of the disease.

For elderly patients, patients with renal insufficiency , patients with mild or moderate hepatic impairment , and also depending on gender, no special dose adjustment is required.

Singular can be added to treatment with bronchodilators and inhaled corticosteroids.

Side effects

Allergic reactions: anaphylaxis, angioedema, rash, itching, urticaria; very rarely – eosinophilic infiltrates of the liver.

From the side of the central nervous system: unusual vivid dreams, hallucinations, drowsiness, irritability, agitation, including aggressive behavior, fatigue, insomnia, paresthesia / hypoesthesia, headache; very rarely – convulsive seizures.

From the digestive system: nausea, vomiting, dyspepsia, diarrhea, abdominal pain.

From the musculoskeletal system: arthralgia, myalgia, including muscle cramps.

Other: tendency to increase bleeding, formation of subcutaneous hemorrhages, palpitations, edema.

In general, Singulair is well tolerated. Side effects are usually mild and usually do not require discontinuation of treatment. Overall frequency of side effects reported with Singulara comparable to placebo.

Contraindications

– hypersensitivity to the components of the drug. Use during pregnancy and lactation The benefit to the mother outweighs the potential risk to the fetus or baby.

Use in hepatic impairment

For patients with mild or moderate hepatic impairment, no special dose adjustment is required.

There are no data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale).

Use for impaired renal function

No special dose adjustment is required for patients with renal insufficiency.

Special instructions

Singular is not recommended for the treatment of acute attacks of bronchial asthma. In the acute course of bronchial asthma, patients should be prescribed medications for therapy that stops and prevents attacks of the disease.

The dose of inhaled GCS used simultaneously with Singular can be gradually reduced under the supervision of a physician. Should not be abruptly replaced Singular therapy with inhaled or oral corticosteroids.

Reducing the systemic dose of corticosteroids in patients receiving anti-asthma drugs, including leukotriene receptor antagonists, was accompanied in rare cases by the appearance of one or more of the following phenomena: eosinophilia, vascular rash, worsening of pulmonary symptoms, cardiac complications and / or neuropathy, sometimes diagnosed as Churg-Ostrich syndrome – systemic eosinophilic vasculitis. Although a causal relationship of these adverse events with therapy with leukotriene receptor antagonists has not been established, with a decrease in the systemic dose of GCS in patients taking Singulair , caution should be exercised and appropriate clinical monitoring should be carried out.

Age differences in the efficacy and safety profile Singulara were not found.

Influence on the ability to drive vehicles and work with mechanisms

Facts indicating that the reception of Singulara affects the ability to drive a car or moving mechanisms have not been identified.

Overdose

Symptoms of overdose Singulara in patients with chronic bronchial asthma when used at a dose exceeding 200 mg / day for 22 weeks and at a dose of 900 mg / day. – within 1 week, not detected.

There are reports of acute overdose of montelukast in children (at a dose of at least 150 mg / day). Clinical and laboratory data at the same time indicate compliance with the safety profile of Singulara in children safety profile in adults and elderly patients. The most common adverse events were thirst, drowsiness, mydriasis, hyperkinesis and abdominal pain.

Treatment: symptomatic therapy.

There are no data on the possibility of excretion of montelukast by peritoneal dialysis or hemodialysis.

Drug interaction

Singular may be given with other medicines traditionally used for the prevention and long-term treatment of asthma. Montelukast at the recommended clinical dose did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / norethindrone 35/1), terfenadine, digoxin and warfarin.

In patients who simultaneously received phenobarbital, the AUC of montelukast decreased by approximately 40%. Dose selection Singulara is not required for this category of patients.

If bronchodilators are ineffective as monotherapy for bronchial asthma, Singulair can be added to the treatment. When a therapeutic effect is achieved (usually after the first dose) during therapy with Singular , the dose of bronchodilators can be gradually reduced.

Treatment Singular provides an additional therapeutic effect in patients receiving inhaled corticosteroids. Upon reaching stabilization of the patient’s condition, it is possible to reduce the dose of corticosteroids. The dose of corticosteroids should be reduced gradually, under the supervision of a physician.