Montelukast (Lexi-Drugs)

Pronunciation

(mon te LOO kast)

Brand Names: US

Singulair

Brand Names: Canada

ACH-Montelukast [DSC]; APO-Montelukast; Auro-Montelukast; BIO-Montelukast; DOM-Montelukast; DOM-Montelukast FC; JAMP-Montelukast; Mar-Montelukast; MINT-Montelukast; MYLAN-Montelukast [DSC]; PMS-Montelukast; PRIVA-Montelukast FC; RAN-Montelukast; RIVA-Montelukast FC; SANDOZ Montelukast; Singulair; TEVA-Montelukast

Pharmacologic Category

Leukotriene Receptor Antagonist

Dosing: Adult

Note: Patients with both asthma and allergic rhinitis should take only one dose in the evening.

Allergic rhinitis (perennial or seasonal): Oral: 10 mg once daily

Asthma: Oral: 10 mg once daily (in the evening)

Bronchoconstriction, exercise-induced (prevention): Oral: 10 mg at least 2 hours prior to exercise. Note: Additional doses should not be administered within 24 hours. Daily administration to prevent exercise-induced bronchoconstriction has not been evaluated. Patients receiving montelukast for another indication should not take an additional dose to prevent exercise-induced bronchoconstriction.

Chronic urticaria (off-label use): Oral: 10 mg once daily (DiLorenzo 2004; Nettis 2004)

Urticaria (nonsteroidal anti-inflammatory drug-induced) (off-label use): Oral: 10 mg once daily (Pacor 2001)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Mild-to-moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in manufacturer’s labeling; has not been studied.

Dosing: Pediatric

Note: Patients with both asthma and allergic rhinitis should take only 1 dose in the evening.

Allergic rhinitis:

Perennial: Oral:

Infants ≥6 months and Children <6 years: 4 mg once daily

Children ≥6 years and Adolescents <15 years: 5 mg once daily

Adolescents ≥15 years: 10 mg once daily

Seasonal: Oral:

Children 2 to 5 years: 4 mg once daily

Children ≥6 years and Adolescents <15 years: 5 mg once daily

Adolescents ≥15 years: 10 mg once daily

Asthma, maintenance therapy: Oral:

12 months to 5 years: 4 mg once daily in the evening

6 to 14 years: 5 mg once daily in the evening

≥15 years: 10 mg once daily in the evening

Asthma, acute exacerbation, adjunct therapy: Limited data available: Children 2 to 5 years: Oral: 4 mg as a single dose; in a double-blind, placebo-controlled trial of 52 children with acute asthma exacerbation, a single dose of montelukast (4 mg) with concomitant short-acting beta2-agonist (salbutamol) showed lower respiratory rate and improved pulmonary indices compared to placebo (Harmanci 2006)

Exercise-induced bronchospasm, prevention: Note: Additional doses should not be administered within 24 hours. Daily administration to prevent exercise-induced bronchospasm has not been evaluated. Patients receiving montelukast for another indication should not take an additional dose to prevent exercise-induced bronchoconstriction. Oral:

Children ≥6 years and Adolescents <15 years: 5 mg at least 2 hours prior to exercise

Adolescents ≥15 years: Tablet: 10 mg at least 2 hours prior to exercise

Urticaria (nonsteroidal antiinflammatory drug-induced): Oral: Adolescents ≥15 years: 10 mg once daily (Pacor 2001)

Dosing: Renal Impairment: Pediatric

No adjustment necessary.

Dosing: Hepatic Impairment: Pediatric

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling; has not been studied.

Use: Labeled Indications

Allergic rhinitis (perennial or seasonal): Relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis

Asthma: Prophylaxis and chronic treatment of asthma

Bronchoconstriction, exercise-induced (prevention): Prevention of exercise-induced bronchoconstriction.

Note: American Academy of Otolaryngology, Head and Neck Surgery (AAO-HNS) and American Academy of Allergy, Asthma, and Immunology (AAAAI) and American College of Allergy, Asthma, and Immunology (ACAAI) guidelines recommend against montelukast use as first-line therapy for allergic rhinitis (except in patients with concurrent asthma) (Dykewicz 2017; Seidman 2015).

Use: Off-Label: Adult

  Chronic urticariaLevel of Evidence [B, G]

Data from controlled, double-blind trials regarding the use of montelukast in combination with antihistamines for the management of chronic urticaria are conflicting. Based on clinical practice guidelines from the American Academy of Allergy, Asthma and Immunology (AAAAI); the American College of Allergy, Asthma, and Immunology (ACAAI); the Joint Council of Allergy, Asthma and Immunology (JCAAI); and the World Allergy Organization for the diagnosis and management of acute and chronic urticaria, a leukotriene receptor antagonist may be added to antihistamine therapy in patients who do not respond to antihistamines. Access Full-Off Label Monograph

  Urticaria (nonsteroidal anti-inflammatory drug-induced)Level of Evidence [B]

Data from a double-blind, placebo-controlled comparison of montelukast and cetirizine in patients with chronic urticaria and intolerance to food additives and/or aspirin supports the use of montelukast in the treatment of patients experiencing urticaria related to the use of nonsteroidal anti-inflammatory drugs Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Use: Unsupported: Adult
Eosinophilic esophagitis

In a small case series and prospective review including adult patients, montelukast demonstrated a symptomatic but not histologic improvement, and was not effective in maintaining steroid-induced remission of eosinophilic esophagitis (Alexander 2017; Attwood 2003; Lucendo 2011). Guidelines from the American College of Gastroenterology (ACG); consensus recommendations from the American Gastroenterological Association (AGA)/North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN); and guidelines from the United European Gastroenterology (UEG), the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), the European Academy of Allergy and Clinical Immunology (EAACI), and the European Society of Eosinophilic Oesophagitis (EUREOS) regarding diagnosis and management of eosinophilic esophagitis state that the efficacy of montelukast in patients with eosinophilic esophagitis has not been established and its use is not recommended (Dellon 2013; Liacouras 2011; Lucendo 2017). Access Full-Off Label Monograph

Clinical Practice Guidelines

Allergic Rhinitis:

AAAAI and ACAAI, “Treatment of seasonal allergic rhinitis,” 2017 Update

Asthma:

Canadian Thoracic Society, “Asthma Management Continuum – 2010 Consensus Summary for Children Six Years of Age and over, and Adults,” January/February 2010

Global Strategy for Asthma Management and Prevention (GINA), 2018 Update

NHLBI and NAEPP The Expert Panel Report 3: “Guidelines for the Diagnosis and Management of Asthma,” Full Report 2007

Exercise-induced Bronchoconstriction:

AAAAI and ACAAI, “Exercise-induced Bronchoconstriction,” Update – 2016

Administration: Oral

When treating asthma, administer dose in the evening. Patients with allergic rhinitis may individualize administration time (morning or evening). Patients with both asthma and allergic rhinitis should take a single dose in the evening. May administer without regard to food or meals.

Granules: May be administered directly in the mouth, dissolved in 5 mL of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature applesauce, carrots, rice, or ice cream; do not add to any other liquids or foods. Administer within 15 minutes of opening packet.

Administration: Pediatric

Oral: When treating asthma, administer dose in the evening. Patients with allergic rhinitis may individualize administration time (morning or evening). Patients with both asthma and allergic rhinitis should take their dose in the evening. May administer without regard to food or meals.

Granules: May be administered directly into the mouth, dissolved in 5 mL of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature applesauce, carrots, rice, and ice cream; do not add to any other liquids or foods; administer within 15 minutes of opening the packet; liquids may be taken subsequent to administration.

Dietary Considerations

Some products may contain phenylalanine.

Storage/Stability

Store at room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in original package. Protect from moisture and light. Granules must be used within 15 minutes of opening packet.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience cough, diarrhea, headache, common cold symptoms, pharyngitis, abdominal pain, rhinitis, or rhinorrhea. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice); signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting); signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), sleepwalking, hallucinations, behavioral changes, memory impairment, nightmares, restlessness, difficulty focusing, abnormal movements, seizures, difficulty breathing, flu-like symptoms, sinus pain, angina, abnormal heartbeat, bruising, bleeding, confusion, burning or numbness feeling, ear pain, tremors, insomnia, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to montelukast or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Eosinophilia and vasculitis: In rare cases, patients may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss), a condition which is often treated with systemic corticosteroid therapy. Health care providers should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between montelukast and these underlying conditions has not been established.

• Neuropsychiatric events: Postmarketing reports of behavioral changes (eg, abnormal dreams, agitation, aggression, anxiety, attention deficit, depression, disorientation, hallucinations, hostility, insomnia, irritability, memory disturbances, restlessness, sleep disturbance, suicide ideation/behavior, and tremor) have been noted in pediatric, adolescent, and adult patients. In a retrospective analysis performed by Merck, serious behavior-related events were rare (Philip 2009a); assess patients for behavioral changes. Patients should be instructed to notify the prescriber if behavioral changes occur.

Disease related concerns:

• Acute asthma/bronchospasm: Not FDA approved for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Some studies, however, support its use as adjunctive therapy (Cylly 2003; Ferreira 2001; Harmancik 2006). Appropriate rescue medication should be available. Montelukast treatment should continue during acute asthma exacerbation.

• Aspirin-sensitive asthmatics: Montelukast will not interrupt bronchoconstrictor response to aspirin or other NSAIDs. Patients with known aspirin sensitivity should continue to avoid these agents.

Concurrent drug therapy issues:

• Corticosteroids: When inhaled or systemic corticosteroid reduction is considered in patients initiating or receiving montelukast, appropriate clinical monitoring and a gradual dose reduction of the steroid are recommended.

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Chewable tablet: Contains phenylalanine.

Geriatric Considerations

The pharmacokinetic profile in the elderly is similar to younger adults except the half-life is slightly longer in the elderly. Despite this difference, no adjustment in dose is necessary in the elderly. Elimination is mostly fecal and bile with insignificant amounts from renal elimination, which is an advantage for the elderly.

Pregnancy Considerations

Based on available data, an increased risk of teratogenic effects has not been observed with montelukast use in pregnancy (BTS 2016; GINA 2018).

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. When clinically indicated, treatment with montelukast should not be withheld during pregnancy (BTS 2016; GINA 2018).

Breast-Feeding Considerations

Montelukast is present in breast milk (Datta 2017).

The relative infant dose (RID) of montelukast is 0.68% when calculated using an average breast milk concentration compared to a weight-adjusted maternal dose of 10 mg/day (Datta 2017).

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The RID of montelukast was calculated using an average milk concentration of 5.3 ng/mL (average range: 2.87 to 9.12 ng/mL), providing an estimated daily infant dose via breast milk of 0.798 mcg/kg/day. The average milk concentration was obtained following chronic maternal administration of oral montelukast 10 mg daily in 7 patients at 1.4 to 8.2 months’ postpartum. The weight-adjusted maternal dose was calculated using the mean weight (85.7 kg) of the patients included in the study. No adverse events were reported in the breastfeeding persons or their infants (Datta 2017).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Patients with asthma should be encouraged to breastfeed their infants (GINA 2018).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%:

Central nervous system: Headache (children and adolescents: ≥2%), dizziness (adolescents and adults: 2%), fatigue (adolescents and adults: ≤2%)

Dermatologic: Atopic dermatitis (children: ≥2%), dermatitis (children: ≥2%), eczema (children: ≥2%), skin infection (children: ≥2%), urticaria (children: ≥2%), skin rash (2%)

Gastrointestinal: Abdominal pain (children: ≥2%), diarrhea (children and adolescents: ≥2%), nausea (children and adolescents: ≥2%), tooth infection (children: ≥2%), dyspepsia (2%), gastroenteritis (2%), toothache (adolescents and adults: 2%)

Genitourinary: Pyuria (adolescents and adults: 1%)

Hepatic: Increased serum aspartate aminotransferase (adolescents and adults: 2%), increased serum alanine aminotransferase (adolescents and adults: ≥1%)

Infection: Influenza (children and adolescents: ≥2%), varicella zoster infection (children: ≥2%), viral infection (children and adolescents: ≥2%)

Neuromuscular & skeletal: Asthenia (adolescents and adults: ≤2%)

Ophthalmic: Conjunctivitis (children: ≥2%), myopia (children: ≥2%)

Otic: Otalgia (children: ≥2%), otitis (children and adolescents: ≥2%), otitis media (children and adolescents: ≥2%)

Respiratory: Cough (3%), acute bronchitis (children: ≥2%), laryngitis (children and adolescents: ≥2%), pharyngitis (children: ≥2%), pneumonia (children: ≥2%), rhinitis (infective; children: ≥2%), rhinorrhea (children: ≥2%), nasal congestion (adolescents and adults: 2%), epistaxis (adolescents and adults: ≥1%), sinus headache (adolescents and adults: ≥1%), sinusitis (≥1%), upper respiratory tract infection (≥1%)

Miscellaneous: Fever (2%), trauma (adolescents and adults: 1%)

<1%, postmarketing and/or case reports: Abnormal dreams, aggressive behavior, agitation, anaphylaxis, angioedema, anxiety, arthralgia, behavioral changes, bleeding tendency disorder, bruise, eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss), depression, diarrhea, disorientation, drowsiness, edema, eosinophilia (systemic), eosinophilic pneumonitis, epistaxis, erythema multiforme, erythema nodosum, hallucination, hepatic eosinophilic infiltration, hepatitis (mixed pattern, hepatocellular, and cholestatic), hostility, hypersensitivity reaction, hypoesthesia, insomnia, irritability, lack of concentration, memory impairment, mood changes, muscle cramps, myalgia, nausea, obsessive compulsive disorder, palpitations, pancreatitis, paresthesia, pruritus, restlessness, seizure, somnambulism, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, thrombocytopenia, tics, toxic epidermal necrolysis, tremor, urinary incontinence, urticaria, vasculitis, vomiting

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2C8 (minor), CYP2C9 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Gemfibrozil: May increase the serum concentration of Montelukast. Risk C: Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Lumacaftor: May decrease the serum concentration of Montelukast. Risk C: Monitor therapy

Monitoring Parameters

Mood or behavior changes, including suicidal thinking/behavior

Advanced Practitioners Physical Assessment/Monitoring

Not for use in acute asthma attacks. Monitor mental and mood status. Be alert to signs of depression, hallucinations, irritability, agitation, and suicide ideation. Ask patient to inform the practitioner if there is numbness or tingling to extremities, muscle weakness or pain, tremors, or shaking. Since this is a chronic medication, advise patients to take as prescribed even when asymptomatic.

Nursing Physical Assessment/Monitoring

Educate patient about proper use of this medication in contrast to other asthma medications such as various inhalers. Monitor mental and mood status. Be alert to signs of depression, hallucinations, irritability, agitation, and suicide ideation. Some side effects may include include headache, sore throat, sinus infection, earache, runny nose, cough, gastric upset. Notify provider if patient develops a rash; worsening pulmonary symptoms including increased use of rescue inhalers; or has weakness, tingling, tremors, or shaking to extremities.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral:

Singulair: 4 mg (30 ea)

Generic: 4 mg (1 ea, 30 ea)

Tablet, Oral:

Singulair: 10 mg

Generic: 10 mg

Tablet Chewable, Oral:

Singulair: 4 mg, 5 mg [contains aspartame]

Generic: 4 mg, 5 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral:

Singulair: 4 mg (28ea, 30ea)

Generic: 4 mg (30ea)

Tablet, Oral:

Singulair: 10 mg

Generic: 10 mg

Tablet Chewable, Oral:

Singulair: 4 mg, 5 mg [contains ASPARTAME]

Generic: 4 mg, 5 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • R03DC03
Generic Available (US)

Yes

Pricing: US

Chewable (Montelukast Sodium Oral)

4 mg (per each): $5.03 – $5.66

5 mg (per each): $5.03 – $5.66

Chewable (Singulair Oral)

4 mg (per each): $9.13

5 mg (per each): $9.13

Pack (Montelukast Sodium Oral)

4 mg (per each): $5.66 – $8.67

Pack (Singulair Oral)

4 mg (per each): $9.13

Tablets (Montelukast Sodium Oral)

10 mg (per each): $0.09 – $5.66

Tablets (Singulair Oral)

10 mg (per each): $9.13

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Selective leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma. Cysteinyl leukotrienes are also released from the nasal mucosa following allergen exposure leading to symptoms associated with allergic rhinitis (Jarvis, 2000).

Pharmacodynamics/Kinetics

Duration: >24 hours

Absorption: Rapid

Distribution: Vd: 8 to 11 L

Protein binding, plasma: >99%

Metabolism: Extensively hepatic via CYP3A4, 2C8, and 2C9

Bioavailability: Tablet: 10 mg, Mean: 64%; Chewable tablet: 5 mg: 73% (63% when administered with a standard meal)

Half-life elimination: 2.7 to 5.5 hours; Mild-to-moderate hepatic impairment: 7.4 hours

Time to peak: Tablet: 10 mg: 3 to 4 hours (fasting); Chewable tablet: 4 mg (children 2 to 5 years): 2 hours (fasting); Chewable tablet 5 mg: 2 to 2.5 hours (fasting); Granules: 2.3 ± 1 hours (fasting) and 6.4 ± 2.9 hours (with high-fat meal)

Excretion: Feces (86%); urine (<0.2%)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: Following a single 10 mg dose, AUC increased 41% and half-life was prolonged to 7.4 hours in patients with mild-to-moderate hepatic impairment and cirrhosis. Patients with severe hepatic impairment or hepatitis have not been evaluated.

Pediatric: In children 6 to 23 months of age, the systemic exposure to montelukast is higher than in adults.

Geriatric: Plasma half-life is slightly longer in elderly patients.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Dental pain.

Effects on Bleeding

Postmarket safety evaluation has identified increased bleeding tendency and thrombocytopenia.

Index Terms

Montelukast Sodium

FDA Approval Date
February 20, 1998
References

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Nelsen LM, Shields KE, Cunningham ML, et al, “Congenital Malformations Among Infants Born to Women Receiving Montelukast, Inhaled Corticosteroids, and Other Asthma Medications,” J Allergy Clin Immunol, 2012, 129(1):251-4.[PubMed 22000568]

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Singulair (montelukast) [prescribing information]. Whitehouse Station, NJ: Merck and Co; December 2016.

Singulair (montelukast) [prescribing information]. Whitehouse Station, NJ: Merck and Co; December 2018.

Brand Names: International

Actamone (SG); Actamone FC (SG); Aeron (LK); Airfast (LB, QA); Airlukast (PE); Altra (MY); Amikast (BD); Anxokast (TW); Asmaact (HK); Asmakast (EG); Asmax (HK); Astair (TH); Asthator (RO, TZ); Asthator 5 (ZW); Asthmatin (HK); Blow (CO); Breathezy (TZ, ZW); Brecare (PH); Broncolast (LB); Clear Air (EG); Cubraxis (MX); Edron (BD); Everest (CR, DO, GT, HN, NI, PA, SV); Glemont (MY); Glemont-CT (PH); Glemont-IR (PH); Inmunobron (PY); Kast (EG); Kastair (PH); Kastair EZ (PH); Kipel (TZ); Kipres (JP); Leukast (PH); Lukair (KR); Lukakline (MY, SG); Lukast (CO, JO, LB, UA); Lumona (BD); Lungair (LK); Mediruka (KR); Milukant (UA); Miralust (MT); Mokast (TW); Monarin (ID); Monas (BD); Monast 10 (ZW); Monest (HR); Monkalus (KR); Monolair (KR); Montair (IN, PH); Montecad (PH); Montegol (VN); Montek-10 (TH); Monteka (TW); Montekast (PH); Montelair (HK, IE, LK, MT, MY, SG); Montelu V (KR); Monteluk (LK); Montelukan (KR); Montelukan QDT (KR); Montemax (PH); Montepect (KR); Montexin (TW); Montiget (PH, VN); Montulair (TH); Oxair (MY); Regulair (SG); Reversair (BD); Romilast (TZ); Sansibast (MX); Singkalus Chewable (KR); Singulair (AE, AR, AT, AU, BB, BE, BG, BH, BM, BO, BR, BS, BZ, CH, CL, CN, CR, CY, CZ, DE, DK, DO, EE, EG, ES, FI, FR, GB, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IS, IT, JM, JO, JP, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SR, SV, TH, TR, TT, TW, UA, UY, VE, VN, ZW); Singular Chew (KR); Sinkast (JO, TW); Sintrine (ZW); Smart-Air (VN); Synglon (UA); Tekast (PH); Telkast (TZ, ZW); Unicast (JO); Valtrover (CR, DO, HN, NI, PA, SV); Valttrover (GT); Vizendo (RO)

Montelukast (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(mon te LOO kast)

Brand Names: US

Singulair

Brand Names: Canada

Singulair

What is this drug used for?
  • It is used to ease allergy signs.
  • It is used to prevent exercise-induced breathing problems.
  • It is used to treat or prevent asthma.
  • It may be given to you for other reasons. Talk with the doctor.
  • For asthma:
  • Do not use this drug to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to montelukast or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • For breathing problems:
  • Do not use this drug to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.
  • Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
  • If you take this drug for asthma or allergy, do not take another dose to prevent exercise-induced breathing problems.
  • If you have asthma and taking aspirin makes it worse, keep avoiding aspirin and NSAIDs while you take this drug.
  • If you are switching to this drug from a steroid, do not stop taking the steroid all of a sudden. The dose of the steroid may need to be slowly lowered to avoid side effects. Talk with the doctor.
  • Chewable tablet:
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • Hallucinations (seeing or hearing things that are not there).
  • Change in how you act.
  • Memory problems or loss.
  • Feeling confused.
  • Not able to focus.
  • Strange or odd dreams.
  • Trouble sleeping.
  • Restlessness.
  • Sleepwalking.
  • Shakiness.
  • Trouble controlling body movements.
  • Seizures.
  • Trouble breathing that is new or worse.
  • Fever.
  • Flu-like signs.
  • Sinus pain.
  • Chest pain.
  • A heartbeat that does not feel normal.
  • Any unexplained bruising or bleeding.
  • A burning, numbness, or tingling feeling that is not normal.
  • Ear pain.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Cough.
  • Diarrhea.
  • Headache.
  • Signs of a common cold.
  • Sore throat.
  • Belly pain.
  • Stuffy nose.
  • Runny nose.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take with or without food.
  • Take even during sign-free periods.
  • If working out or playing sports causes signs, use at least 2 hours before doing it.
  • If this drug is for asthma, take in the evening.
  • To gain the most benefit, do not miss doses.
  • Take this drug at the same time of day.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Chewable tablet:
  • Chew well before swallowing.
  • Granules:
  • Granules may be placed right in the mouth or mixed with cold or room temperature applesauce, baby formula, breast milk, mashed carrots, rice, or ice cream. Do not mix granules in other liquids.
  • Do not open the packet until you are ready to take a dose. If mixing, take your dose within 15 minutes. Do not store for future use.
What do I do if I miss a dose?
  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store in the original container at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Montelukast (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(mon te LOO kast)

Brand Names: US

Singulair

Brand Names: Canada

Singulair

What is this drug used for?
  • It is used to ease allergy signs.
  • It is used to prevent exercise-induced breathing problems.
  • It is used to treat or prevent asthma.
  • It may be given to your child for other reasons. Talk with the doctor.
  • For asthma:
  • Do not give this drug to treat an asthma attack. Use a rescue inhaler. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • For breathing problems:
  • Do not give this drug to treat an asthma attack. Use a rescue inhaler. Talk with the doctor.
  • Call the doctor right away if your child has breathing problems that get worse, if the rescue inhaler does not work as well, or if your child needs to use the rescue inhaler more often.
  • If your child takes this drug for asthma or allergy, do not give another dose to prevent exercise-induced breathing problems.
  • If your child has asthma and taking aspirin makes it worse, make sure your child avoids aspirin and NSAIDs while your child takes this drug.
  • If your child is switching to this drug from a steroid, do not stop giving the steroid to your child all of a sudden. The dose of the steroid may need to be slowly lowered to avoid side effects. Talk with the doctor.
  • Chewable tablet:
  • If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • If your child shows signs of low mood (depression), thoughts of killing him/herself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • Hallucinations (seeing or hearing things that are not there).
  • Change in the way your child acts.
  • Memory problems or loss.
  • Feeling confused.
  • Not able to focus.
  • Strange or odd dreams.
  • Trouble sleeping.
  • Restlessness.
  • Sleepwalking.
  • Shakiness.
  • Trouble controlling body movements.
  • Seizures.
  • Trouble breathing that is new or worse.
  • Fever.
  • Flu-like signs.
  • Sinus pain.
  • Chest pain.
  • A heartbeat that does not feel normal.
  • Any unexplained bruising or bleeding.
  • A burning, numbness, or tingling feeling that is not normal.
  • Ear pain.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Belly pain.
  • Headache.
  • Diarrhea.
  • Signs of a common cold.
  • Cough.
  • Sore throat.
  • Stuffy nose.
  • Runny nose.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug with or without food.
  • Give even during sign-free periods.
  • If working out or playing sports causes your child signs, give at least 2 hours before your child does it.
  • If this drug is for asthma, give in the evening.
  • To gain the most benefit, do not miss giving your child doses.
  • Give this drug at the same time of day.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Chewable tablet:
  • Have your child chew all the way up before swallowing.
  • Granules:
  • Granules may be placed right in the mouth or mixed with cold or room temperature applesauce, baby formula, breast milk, mashed carrots, rice, or ice cream. Do not mix granules in other liquids.
  • Do not open the packet until you are ready to give a dose. If mixing, give your child’s dose within 15 minutes. Do not store for future use.
What do I do if my child misses a dose?
  • Skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store in the original container at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.