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Singulair

Singulair (generic name: montelukast sodium; brand names in some markets include: Montair / Montus / Romilast) is a leukotriene receptor antagonist that helps control asthma and allergic rhinitis by blocking cysteinyl-leukotrienes, inflammatory mediators that tighten airway muscles, fuel mucus production, and drive nasal congestion and sneezing. By targeting this pathway, montelukast reduces airway inflammation and helps prevent bronchoconstriction. For some patients with persistent asthma, combining controller strategies is important; adding an inhaled bronchodilator such as Combivent may provide additional symptom relief when directed by a clinician. Montelukast is not a steroid, and it is not a rescue medication for sudden breathing symptoms. It is a maintenance therapy taken regularly to help keep symptoms under control and to prevent exercise-induced bronchoconstriction.

What Singulair is used for today reflects both its benefits and important safety updates. It is FDA-approved for the long-term management of asthma in adults and children 12 months and older; for the prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older; and for relief of symptoms of seasonal allergic rhinitis (outdoor allergies) in adults and children 2 years and older, and perennial allergic rhinitis (year-round indoor allergies) in adults and children 6 months and older. In 2020, the FDA added a Boxed Warning about serious neuropsychiatric events. Because of this, montelukast should be reserved for allergic rhinitis only in patients who have not responded adequately to, or cannot tolerate, alternative treatments such as intranasal corticosteroids or oral antihistamines. For asthma, it remains an established non-steroidal controller option that can be used alone in milder disease or alongside inhaled corticosteroids for additional control, depending on guideline-based care and individual response.

Recommendations

Use Singulair exactly as prescribed. The following guidance summarizes typical use; your healthcare provider may tailor directions to your age, condition severity, and other medications. Montelukast can be taken with or without food. Take it at the same time each day to build a consistent routine, as steady daily exposure is key to its anti-inflammatory effects.

  • Asthma (maintenance): Once daily in the evening is commonly recommended. This timing matches the circadian pattern of airway inflammation and can improve morning symptom control.
  • Allergic rhinitis: Take once daily at a consistent time that fits your routine (morning or evening). Due to the Boxed Warning, montelukast should be reserved for allergic rhinitis when alternative therapies are ineffective or not tolerated.
  • Exercise-induced bronchoconstriction (EIB): Take a single dose at least 2 hours before exercise. Do not take more than one dose within 24 hours. If you already take montelukast daily, do not add an extra dose for exercise on the same day.

Age-based dosing commonly used in practice:

  • Adults and adolescents 15 years and older: 10 mg tablet once daily.
  • Children 6 to 14 years: 5 mg chewable tablet once daily.
  • Children 2 to 5 years: 4 mg chewable tablet or 4 mg oral granules once daily.
  • Children 6 to 23 months (for perennial allergic rhinitis) and 12 to 23 months (for asthma): 4 mg oral granules once daily.

Formulations and administration tips:

  • Film-coated tablets (10 mg): Swallow whole with water. Suitable for adults and adolescents.
  • Chewable tablets (4 mg, 5 mg): Chew thoroughly before swallowing. These contain phenylalanine (see PKU precaution below).
  • Oral granules (4 mg): Administer directly into the mouth or mix with a small amount of soft food (such as applesauce) and use within 15 minutes; do not store mixtures for later use. Follow the product instructions for acceptable vehicles and avoid mixing in liquids unless the label specifically allows.

Important use reminders:

  • Do not use Singulair to treat an acute asthma attack. Keep a fast-acting rescue inhaler with you as directed by your clinician.
  • Do not abruptly stop or reduce inhaled or oral corticosteroids when starting montelukast. Any changes to steroid therapy should be gradual and supervised.
  • If you miss a dose, take it when you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not double doses.
  • Store at room temperature, protected from moisture and light. Keep out of reach of children.
  • If you are using montelukast primarily for allergic rhinitis, reassess the need regularly with your clinician, especially if your symptoms are mild and alternatives could suffice.

When to expect benefits: Some patients notice better nighttime control or reduced rescue inhaler use within a day or two, but it can take several days of consistent dosing to see full benefit. For seasonal allergies, daily use throughout the allergen season is generally necessary for sustained relief.

Side Effects

Like all medicines, Singulair can cause side effects. Most are mild and transient, but some can be serious. The FDA added a Boxed Warning to montelukast due to reports of serious neuropsychiatric events; this risk should be discussed before you start therapy, and you should be monitored throughout treatment.

Common side effects may include:

  • Headache
  • Upper respiratory symptoms such as sore throat, nasal congestion, or cough
  • Abdominal pain, nausea, diarrhea, or indigestion
  • Ear pain or infection (in children), fever, or flu-like symptoms
  • Fatigue or mild dizziness

Neuropsychiatric effects (Boxed Warning):

  • Agitation, irritability, restlessness, or aggressive behavior
  • Anxiety, depression, mood changes, or emotional lability
  • Sleep disturbances, including insomnia, vivid dreams, or nightmares
  • Hallucinations, disorientation, tremor, or attention problems
  • Suicidal thoughts or actions

These symptoms can occur during treatment or after stopping; they have been reported in adults and children, with or without prior mental health history. If you or your child experience new or worsening mood or behavior changes, stop montelukast and contact a healthcare professional promptly to evaluate risks and benefits of continuing therapy. For allergic rhinitis, consider alternative treatments if these issues arise. If suicidal thoughts occur, seek immediate help.

Other serious but uncommon reactions:

  • Hypersensitivity reactions, including rash, hives, facial swelling, or difficulty breathing
  • Elevation of liver enzymes or hepatitis (rare; watch for persistent fatigue, right-upper abdominal pain, dark urine, or jaundice)
  • Eosinophilic conditions, including systemic eosinophilia and features consistent with eosinophilic granulomatosis with polyangiitis (formerly Churg–Strauss syndrome), most often reported in the setting of corticosteroid dose reduction; symptoms can include vasculitic rash, worsening pulmonary symptoms, cardiac involvement, and neuropathy
  • Severe skin reactions (very rare); seek urgent care for widespread rash, blistering, or mucosal involvement

Pediatric considerations: Clinical studies have not shown an adverse effect of montelukast on growth velocity in children. However, caregivers should be counseled to monitor for behavior or sleep changes, especially in the first weeks of therapy and when doses are adjusted or other medications are added.

Precautions

Before taking Singulair, discuss your full medical history and medication list with your healthcare provider to minimize risks and interactions.

  • Allergies: Do not use if you are hypersensitive to montelukast or any component of the formulation.
  • Mental health: Inform your clinician of any history of depression, anxiety, sleep disorders, or other psychiatric conditions. Shared decision-making is important given the Boxed Warning.
  • Liver disease: Use with caution in patients with hepatic impairment. Report signs of liver injury promptly.
  • Phenylketonuria (PKU): The 4 mg and 5 mg chewable tablets contain phenylalanine (from aspartame). Consider the phenylalanine content in dietary planning.
  • Pregnancy: Available data do not suggest an increased risk of major birth defects, but high-quality controlled studies are limited. Use if the potential benefit justifies the potential risk; discuss with your obstetric provider, especially if asthma control is suboptimal.
  • Breastfeeding: Montelukast is expected to be present in breast milk at low levels. Consider the benefits of breastfeeding, the mother’s clinical need, and any potential adverse effects on the breastfed child.
  • Driving and alertness: Dizziness or drowsiness can occur. Use caution with driving or operating machinery until you know how the medicine affects you.
  • Not a rescue therapy: Do not rely on montelukast for sudden asthma symptoms. Always carry and know how to use a fast-acting inhaler as prescribed.
  • Stepwise care: Do not stop or reduce inhaled or oral steroids abruptly when starting montelukast. Any taper must be supervised to avoid loss of control and to monitor for eosinophilic complications.

Drug interactions: Montelukast is metabolized in the liver, mainly via CYP2C8 and to a lesser extent CYP3A4 and CYP2C9. Clinically important interactions are uncommon but can occur:

  • Enzyme inducers such as rifampin, carbamazepine, phenytoin, and phenobarbital may decrease montelukast levels and reduce efficacy; alternative regimens or closer monitoring may be needed.
  • Strong CYP2C8 inhibitors such as gemfibrozil can increase montelukast exposure; caution and clinical monitoring are advised.
  • Herbal supplements and over-the-counter products can interact unpredictably; share everything you take with your healthcare team.

Who should consider Singulair?

  • Patients with mild persistent asthma who prefer a non-steroidal daily controller or who cannot tolerate inhaled corticosteroids.
  • Patients with concomitant allergic rhinitis and asthma, where a single agent may address both conditions.
  • Patients with exercise-induced bronchoconstriction who need pre-exercise protection and for whom beta-agonist pre-treatment is not sufficient or not preferred.

Who may be better served by alternatives?

  • Patients with mild allergic rhinitis only, who have not yet tried or responded to standard first-line therapies (intranasal corticosteroids, oral or intranasal antihistamines).
  • Patients with a history of serious neuropsychiatric reactions to montelukast.
  • Patients with moderate to severe persistent asthma who require inhaled corticosteroids with or without a long-acting bronchodilator as primary therapy per guidelines.

Ingredients

Active ingredient: montelukast sodium.

Available strengths and forms may include:

  • 10 mg film-coated tablets (typically for adults and adolescents)
  • 5 mg chewable tablets (typically for children 6 to 14 years)
  • 4 mg chewable tablets (typically for children 2 to 5 years)
  • 4 mg oral granules in unit-dose packets (for young children)

Inactive ingredients vary by manufacturer and formulation. Chewable tablets often contain aspartame (source of phenylalanine), mannitol, microcrystalline cellulose, and flavoring agents. If you have allergies to excipients, phenylketonuria, or specific dietary restrictions, review the package insert for the exact formulation dispensed to you and consult your pharmacist if unsure.

Additional Information

Therapeutic role: As a leukotriene pathway inhibitor, Singulair offers a non-steroidal option for chronic asthma control and allergy symptom relief. For asthma, it may reduce wheeze, cough, nighttime awakenings, and the need for rescue inhalers. It is often used as monotherapy in mild disease or as an add-on to inhaled corticosteroids when additional control is needed. It does not replace inhaled corticosteroids in patients who require them.

Allergic rhinitis strategy: For seasonal or perennial allergic rhinitis, intranasal corticosteroids and antihistamines remain first-line options for most patients. Montelukast can help when congestion, rhinorrhea, and sneezing persist despite those therapies, or when those options are not tolerated. Because of the Boxed Warning, the decision to use montelukast for rhinitis should weigh symptom severity, prior treatment response, and patient preference after a clear discussion of risks and benefits.

Exercise-induced bronchoconstriction: Singulair taken at least 2 hours before activity can help prevent EIB for many patients aged 6 years and older. The protective effect may persist up to 24 hours in some individuals, but the response is variable. Do not take additional doses within 24 hours. Some athletes still need a short-acting bronchodilator pre-exercise, depending on triggers and intensity; your asthma action plan should specify exactly what to do.

What to monitor: Track symptom frequency, nighttime awakenings, and rescue inhaler use. If your asthma control deteriorates, or if allergy symptoms persist despite treatment, contact your clinician to reassess dose, inhaler technique, adherence, and environmental triggers. If you experience any mood or behavior changes, stop the medicine and seek advice promptly.

Environmental and lifestyle measures: Pharmacotherapy works best alongside trigger reduction and healthy routines. For asthma and allergic rhinitis, consider:

  • Allergen control: Use high-efficiency particulate air (HEPA) filtration, encase bedding for dust mites, wash linens in hot water, and minimize indoor mold and pet dander when relevant.
  • Smoking avoidance: Avoid tobacco smoke and vaping aerosols; both trigger airway inflammation.
  • Respiratory hygiene: Manage upper respiratory infections proactively, and get recommended vaccinations (e.g., influenza) per your clinician’s advice.
  • Exercise and conditioning: Maintain regular, appropriate physical activity once medically cleared; a well-planned warm-up can reduce EIB.

Costs and access: Montelukast is widely available as a generic, often at lower cost than brand-name Singulair. Prices can vary by pharmacy, dosage form, and insurance coverage. If cost is a barrier, ask about generics, manufacturer savings programs, or pharmacy discount options. When purchasing online, use licensed, legitimate pharmacies that verify prescriber orders and comply with state and federal regulations. Avoid sources that dispense prescription drugs without appropriate clinical review.

Clinical caveats and myths:

  • Not a bronchodilator: Montelukast reduces inflammation and leukotriene-mediated constriction but does not provide immediate airway opening in acute episodes.
  • Not a steroid: It does not carry steroid-specific side effects like oral thrush or systemic steroid risks, though it has its own safety considerations, particularly neuropsychiatric effects.
  • Effect is additive: In some patients, adding montelukast to inhaled steroids yields extra control, especially when allergies are prominent triggers.

How long should you use it? For chronic asthma or perennial allergies, montelukast may be used long term if it contributes meaningfully to control and is well tolerated. For seasonal allergies, it may be used during the relevant allergen season only. Periodic re-evaluation helps determine whether you still need it and whether the benefits continue to outweigh any risks.

When to call for help:

  • Immediate medical care: Severe shortness of breath unrelieved by rescue inhaler; signs of anaphylaxis (e.g., swelling of lips or tongue, difficulty breathing, wheezing, hives); signs of severe skin reaction; suicidal thoughts or behavior.
  • Prompt clinical advice: New or worsening mood or sleep changes; persistent cough, chest tightness, or wheeze; signs of liver trouble; unexpected bleeding or severe fatigue.

Singulair U.S. Sale and Prescription Policy

Singulair (montelukast) is a prescription medication in the United States. Federal and state laws require that prescription drugs be dispensed pursuant to a valid prescription issued by a licensed clinician after an appropriate evaluation. Online sales must comply with these regulations, including identity verification, secure e-prescribing, pharmacist review, and recordkeeping.

HealthSouth Rehabilitation Hospital of Jonesboro operates within a legal and structured framework to support access to Singulair. For eligible patients, we offer pathways that do not require you to submit a prior paper prescription: a licensed clinician conducts an appropriate assessment (often via telehealth), determines whether montelukast is clinically indicated and safe for you, and, if appropriate, issues a valid prescription that is then filled through licensed pharmacy channels. This process follows applicable federal and state requirements and is not a substitute for emergency care. Patients must meet clinical criteria, comply with identity verification, and reside in jurisdictions where affiliated clinicians and pharmacies are authorized to practice and dispense.

We do not dispense Singulair for acute breathing emergencies, and we do not supply montelukast without clinician review. If you are experiencing severe breathing symptoms, use your rescue inhaler as prescribed and seek urgent medical attention.

Singulair FAQ

What is Singulair (montelukast) and how does it work?

Singulair is a leukotriene receptor antagonist that blocks inflammatory chemicals called leukotrienes. By doing so, it helps reduce airway swelling and mucus, improving asthma control and relieving allergy symptoms like sneezing and nasal congestion.

What conditions is Singulair used to treat?

Singulair is approved for the prevention and long-term control of asthma, relief of seasonal and perennial allergic rhinitis, and prevention of exercise-induced bronchoconstriction (EIB). It can also help in aspirin-exacerbated respiratory disease with asthma and nasal symptoms.

Is Singulair a rescue medication for asthma attacks?

No. Singulair is a controller medication for prevention and daily management. It does not relieve sudden asthma symptoms—use a fast-acting rescue inhaler (such as albuterol) for acute attacks.

How quickly does Singulair start to work?

Many people notice benefits within 24 hours of starting therapy, with further improvement over several days. For exercise-induced bronchoconstriction, protection typically begins within about 2 hours after a dose.

How should I take Singulair, and what time of day is best?

Take Singulair once daily, with or without food. For asthma, many clinicians recommend evening dosing; for allergic rhinitis, it can be taken at any convenient time, consistently each day.

What are common side effects of Singulair?

Common effects include headache, stomach pain, cough, and mild upper respiratory symptoms. Less common but serious neuropsychiatric effects (mood changes, agitation, sleep disturbances, depression, suicidal thoughts) can occur and warrant prompt medical evaluation.

What is the FDA boxed warning for Singulair?

Singulair carries a boxed warning for serious neuropsychiatric events, including agitation, nightmares, depression, and suicidal ideation or behavior. Because of this risk, it is not first-line for mild allergic rhinitis unless benefits outweigh risks.

Who should not take Singulair or use it with caution?

Use caution if you have a history of depression, anxiety, or other mental health conditions, or significant liver disease. Report any new or worsening mood or behavior changes immediately.

Can children take Singulair?

Yes. Age-appropriate forms and doses exist: granules for infants/toddlers, chewable tablets for children, and standard tablets for teens/adults. Your clinician will select the right dose based on age and indication.

Can Singulair prevent exercise-induced bronchoconstriction?

Yes. A single dose taken at least 2 hours before exercise can help prevent EIB. Do not take more than one dose in 24 hours, and do not use it as a substitute for a rescue inhaler during acute symptoms.

Does Singulair help with nasal polyps or aspirin-sensitive asthma?

It can reduce asthma symptoms and nasal inflammation in aspirin-exacerbated respiratory disease and may help with nasal polyps as part of a broader treatment plan. Some patients benefit more from specialized therapies like aspirin desensitization or biologics.

What should I do if I miss a dose of Singulair?

Take it when you remember unless it’s close to the next scheduled dose. Skip the missed dose if it’s nearly time for the next one, and never double up.

Can I stop Singulair suddenly?

It is not habit-forming, so tapering is not required. However, stopping abruptly may lead to loss of asthma or allergy control; discuss with your clinician before making changes.

Are there important drug interactions with Singulair?

Strong enzyme inducers like rifampin or certain seizure medicines can lower montelukast levels, while gemfibrozil can raise them. Always review your medication list, including supplements and herbal products, with your clinician.

Will Singulair replace my inhaled corticosteroid?

For persistent asthma, inhaled corticosteroids are generally more effective; Singulair is often used as add-on therapy or an alternative when inhaled steroids are not tolerated. Do not change your regimen without clinical guidance.

Is generic montelukast as effective as brand-name Singulair?

Yes. FDA-approved generics must meet the same quality, safety, and effectiveness standards as the brand.

How do I store Singulair tablets, chewables, and granules?

Store at room temperature, away from moisture and heat. Use granules right after opening, and follow package directions if mixing with soft food or liquid.

What are signs that Singulair is working?

Fewer asthma symptoms and exacerbations, reduced need for rescue inhaler, improved exercise tolerance, and less nasal congestion or sneezing. Track symptoms and peak flows to gauge benefit.

Can Singulair be used seasonally for allergies?

Yes. Some people take montelukast only during their allergy season. Because of the boxed warning, weigh benefits versus risks with your clinician.

Does Singulair cause drowsiness or affect driving?

It is not typically sedating, but some people report dizziness or fatigue. If you feel drowsy or lightheaded, avoid driving until you know how you respond.

Can I drink alcohol while taking Singulair?

Light to moderate alcohol has no direct interaction with montelukast. Heavy drinking can strain the liver and may increase side effect risk, so moderation and caution are advised, especially if you have liver issues.

Is Singulair safe during pregnancy?

Data suggest low teratogenic risk, and many clinicians continue montelukast during pregnancy if it effectively controls asthma or allergies. Inhaled corticosteroids remain first-line for asthma; discuss individualized risks and benefits with your obstetric and pulmonary/allergy providers.

Can I take Singulair while breastfeeding?

Montelukast appears in breast milk in very small amounts and is generally considered compatible with breastfeeding. Monitor the infant and discuss any concerns with your clinician.

Should I stop Singulair before surgery or anesthesia?

Most patients can continue Singulair through surgery; it does not increase bleeding risk or interact with anesthetics in a clinically significant way. Inform your surgical team about all medications and report any mood changes pre- or post-operatively.

What if I have liver disease and need Singulair?

Mild liver impairment usually does not require dose adjustment, but caution is advised in moderate to severe liver dysfunction. Your clinician may monitor liver tests and weigh alternatives if needed.

Does kidney disease affect Singulair dosing?

No dose adjustment is typically needed in renal impairment, as montelukast is primarily metabolized by the liver. Always review your full health history with your clinician.

Can older adults use Singulair safely?

Yes, most older adults tolerate montelukast well without dose adjustments. Monitor for neuropsychiatric effects and potential drug interactions common in polypharmacy.

Does Singulair affect vaccines or immune response?

No known interactions with vaccines, including flu and COVID-19 vaccines. You can receive vaccines while taking montelukast.

Is Singulair allowed in competitive sports?

Yes. Montelukast is not on common anti-doping prohibited lists, and athletes routinely use it for asthma control. Always verify current regulations in your sport.

How does Singulair compare to zafirlukast (Accolate) for asthma control?

Both are leukotriene receptor antagonists and offer modest improvements in asthma control. Singulair is once-daily and widely preferred due to convenience and fewer drug interactions, while zafirlukast requires twice-daily dosing and has more interaction and liver concerns.

What are the dosing and administration differences between Singulair and zafirlukast?

Singulair is taken once daily with or without food. Zafirlukast is typically taken twice daily on an empty stomach (1 hour before or 2 hours after meals), which can affect adherence.

Which has a better side-effect profile: Singulair or zafirlukast?

Both can cause headaches and rare neuropsychiatric effects. Zafirlukast has a higher association with liver enzyme elevations and rare serious liver injury; Singulair’s boxed warning focuses on neuropsychiatric risks.

How do drug interactions differ between Singulair and zafirlukast?

Singulair has relatively few clinically significant interactions, though rifampin lowers and gemfibrozil raises levels. Zafirlukast inhibits CYP2C9 and can markedly increase warfarin levels (raising INR) and interact with several other drugs.

Singulair versus zileuton: which is more effective?

Both improve asthma outcomes; zileuton may offer additional benefit in some patients, particularly those with aspirin-exacerbated respiratory disease, by blocking leukotriene synthesis. However, zileuton’s need for liver monitoring and more frequent dosing reduces its convenience.

How do liver safety and monitoring compare between Singulair and zileuton?

Routine liver monitoring is not required with Singulair, though caution is prudent in liver disease. Zileuton requires baseline and periodic liver function tests due to a higher risk of hepatotoxicity.

Which is easier to take: Singulair or zileuton?

Singulair is once daily, which improves adherence. Zileuton is taken four times daily for immediate-release or twice daily for extended-release, still more complex than Singulair.

Which leukotriene modifier is better for children?

Singulair has labeled pediatric use down to infancy with granules and chewables. Zafirlukast is indicated for children five years and older, and zileuton is typically for ages 12 and up, making Singulair the most flexible pediatric option.

Which works faster for exercise-induced bronchoconstriction: Singulair or other LTRAs?

Singulair provides protection within about 2 hours of dosing and can last up to 24 hours. Other LTRAs also reduce EIB, but Singulair is the most studied and commonly used due to dosing simplicity.

Is Singulair or zileuton better for aspirin-exacerbated respiratory disease (AERD)?

Both can help, but zileuton may provide greater symptom relief in some AERD patients by reducing leukotriene production. Clinicians often start with Singulair for safety and convenience, reserving zileuton when additional benefit is needed and monitoring is feasible.

Which LTRA helps allergic rhinitis more: Singulair or zafirlukast?

In the United States, Singulair is approved for both seasonal and perennial allergic rhinitis, with evidence for nasal symptom relief. Zafirlukast is not approved for allergic rhinitis alone.

How do pregnancy and breastfeeding considerations differ among LTRAs?

Montelukast has the most reassuring human data and is commonly continued when needed. Less data exist for zafirlukast and zileuton; zileuton’s liver risks and interactions further limit its use in pregnancy.

Which leukotriene modifier has the fewest drug interactions?

Singulair generally has the least interaction burden. Zafirlukast and zileuton have multiple CYP-mediated interactions that require careful monitoring.

What about availability and cost among LTRAs?

Montelukast is widely available as a low-cost generic globally. Zafirlukast and zileuton are available in fewer markets, with zileuton often more expensive and requiring monitoring; pranlukast is used in parts of Asia but not approved in the US.

How does Singulair compare with pranlukast?

Both are leukotriene receptor antagonists with similar mechanisms and efficacy. Singulair is widely available and once daily; pranlukast is used in some countries (e.g., Japan, South Korea), often dosed twice daily, with less global access and fewer head-to-head data.