Montelukast is a leukotriene (loo-koe-TRY-een) inhibitor that is used to prevent asthma attacks in adults and children at least 2 years old. Montelukast is also used to prevent exercise-induced bronchoconstriction (narrowing of the air passages in the lungs) in adults and children who are at least 6 years old.
Montelukast is also used to treat symptoms of seasonal or year-round (perennial) allergies in adults and children at least 2 years old, after other treatments did not work.
If you already take montelukast to prevent asthma or allergy symptoms, do not use an extra dose to treat exercise-induced bronchoconstriction.
Montelukast may also be used for purposes not listed in this medication guide.
Warnings
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.
Stop taking montelukast and call your doctor right away if you have any unusual changes in mood or behavior (such as agitation, confusion, depression, sleep problems, compulsive behaviors, hallucinations, or suicidal thoughts or actions).
Indications of Montelukast (Singulair):
Allergic rhinitis (perennial or seasonal):
It is indicated for the relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.
Asthma:
It is given for prophylaxis and chronic treatment of asthma.
It is effective in preventing 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).
Note: Patients with both asthma and allergic rhinitis should take only one dose in the evening.
Montelukast (Singulair) Treatment dose of Allergic rhinitis (perennial or seasonal):
10 mg per oral once daily.
Montelukast (Singulair) dose in the treatment of Asthma:
10 mg per oral once daily (in the evening).
Montelukast (Singulair) Dose in the prevention of exercise-induced bronchoconstriction:
10 mg per oral at least 2 hours before 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.
Montelukast (Singulair) Dose in the treatment of Chronic urticaria:
10 mg per oral once daily.
Montelukast (Singulair) dose in the treatment of NSAID-induced Urticaria:
10 mg per oral once daily.
Montelukast Dose in Children:
Note: Patients with both asthma and allergic rhinitis should take only 1 dose in the evening.
Montelukast (Singulair) Dose in the Treatment of 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.
Montelukast (Singulair) Dose in the Maintenance Treatment of Asthma:
12 months to 5 years:
4 mg per oral once daily in the evening.
6 to 14 years:
5 mg per oral once daily in the evening.
≥15 years:
10 mg per oral once daily in the evening.
Montelukast (Singulair) dose in the treatment of acute exacerbation of Asthma (adjunct therapy):
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 beta-agonist (salbutamol) showed lower respiratory rate and improved pulmonary indices compared to placebo.
Montelukast (Singulair) Dose in the prevention of Exercise-induced bronchospasm:
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.
Children ≥ 6 years and Adolescents <15 years:
5 mg per oral at least 2 hours prior to exercise.
Adolescents ≥ 15 years:
Tablet: 10 mg per oral at least 2 hours prior to exercise.
Montelukast (Singulair) Dose in the treatment of NSAID-induced Urticaria:
Adolescents 15 years of age and older:
10 mg per oral once daily.
Montelukast (Singulair) Pregnancy Risk Category: B
It has not been shown that Montelukast is more likely to cause teratogenic effects in pregnant women.
Uncontrolled asthma can lead to adverse pregnancy events such as increased risk of preterm birth, preterm mortality, and low birth weight infants.
Poorly managed asthma or exacerbations of asthma may pose a greater risk to the fetus/maternal health than medications that are properly used.
Montelukast treatment can be continued during pregnancy.
Montelukast use during breastfeeding:
Breast milk contains Montelukast.
Based on a comparison of a maternal dose of 10mg/day and an average breastmilk concentration, the relative infant dose for montelukast was 0.68%.
Breathing is allowed in cases of relative infant doses less than 10%
Montelukast’s RID was calculated using an average milk content of 5.3ng/mL (average range 2.87 to 9.12ng/mL), which gives an estimated daily infant dose via breastmilk of 0.798 mg/kg/day.
After chronic maternal administration of oral montelukast 10mg daily for 7 patients, the average milk concentration was 1.1 to 8.2 months postpartum.
For the calculation of the weight-adjusted maternal dose, the mean weight (85.7kg) of all patients was used.
There were no adverse reactions in breastfeeding mothers or infants.
The risk of infant exposure and the benefits of breastfeeding to the baby during therapy will all play a role in deciding whether to breastfeed.
Asthmatic patients should be encouraged to breastfeed.
Singulair Dose adjustment in renal disease:
No dosage adjustment necessary.
Montelukast (Singulair) Dose adjustment in liver disease:
Mild-to-moderate impairment:
No dosage adjustment necessary.
Severe impairment:
There are no dosage adjustments provided in manufacturer’s labeling.
Side Effects of Montelukast (Singulair):
Central Nervous System:
Headache
Dizziness
Fatigue
Dermatologic:
Atopic Dermatitis
Dermatitis
Eczema
Skin Infection
Urticaria
Skin Rash
Gastrointestinal:
Abdominal Pain
Diarrhea
Nausea
Tooth Infection
Dyspepsia
Gastroenteritis
Toothache
Genitourinary:
Pyuria
Hepatic:
Increased Serum Aspartate Aminotransferase
Increased Serum Alanine Aminotransferase
Infection:
Influenza
Varicella Zoster Infection
Viral Infection
Neuromuscular & Skeletal:
Asthenia
Ophthalmic:
Conjunctivitis
Myopia
Otic:
Otalgia
Otitis
Otitis Media
Respiratory:
Cough
Acute Bronchitis
Laryngitis
Pharyngitis
Pneumonia
Rhinitis
Rhinorrhea
Nasal Congestion
Epistaxis
Sinus Headache
Sinusitis
Upper Respiratory Tract Infection
Miscellaneous:
Fever
Trauma
Contraindications to Montelukast (Singulair):
Hypersensitivity to montelukast and any component of the formula
Warnings and precautions
Eosinophilia, vasculitis:
Montelukast is rarely associated with systemic eosinophilia. However, it can sometimes present with clinical features consistent with vasculitis and eosinophilic-granulomatosis.
Early detection is important for symptoms such as eosinophilia and vasculitic skin rash, worsening of pulmonary symptoms, cardiac complications, neuropathy, and/or vasculitic syndrome.
It has not been proven that montelukast is causally related to these underlying conditions.
Events in neuropsychiatrics:
Children and adults can both experience behavioral changes, including agitation, aggression and depression, disorientation and hostility, hallucinations and hostility, anxiety, attention deficit and depression, disorientation and hallucinations.
Merck performed a retrospective analysis and found that serious behavior-related incidents were very rare. Patients should be evaluated for behavioral changes.
Patients should be directed to inform their prescriber if they notice any behavioral changes.
Acute asthma and Bronchospasm
Although Montelukast has not been approved for the treatment of acute asthma attacks and status asthmaticus, some studies suggest that it could be used as an adjunct therapy.
During acute asthma exacerbations, Montelukast may be continued.
Aspirin-sensitive asthmatics
Montelukast won’t interrupt the bronchoconstrictor response of aspirin and other NSAIDs.
Patients with known aspirin sensitivity should avoid these agents.
Monitoring parameters:
Mood or behavior changes, including suicidal thinking/behavior.
How to administer Montelukast (Singulair)?
It should be given orally without regard to food.
The dose should be given in the evening for treating asthma.
Patients with allergic rhinitis may individualize administration time (morning or evening).
A single dose in the evening should be given to patients with both asthma and allergic rhinitis.
Granules:
May be administered directly in the mouth, or mixed with a spoonful of cold or room temperature applesauce, carrots, rice, or ice cream.
It should not added to any other liquids or foods and used within 15 minutes of opening packet.
Mechanism of action of Montelukast (Singulair):
Montelukast, a selective leukotriene antagonist, works by inhibiting cysteinyl receptor. This is responsible for asthma’s pathophysiology, which includes edema, contraction of smooth muscles, and altered cell activity due to the inflammation process that contributes to asthma symptoms.
After allergen, cytosteinyl leukotrienes also get released from the nasal mucosa. This can lead to symptoms of allergic rhinitis.
Duration:
>24 hours
Absorption:
Rapid
Plasma Protein binding:
>99%
Metabolism:
Extensively occurs in liver via CYP3A4, 2C8, and 2C9
Bioavailability:
Tablet: 10 mg, Mean: 64%.
Chewable tablet: 5 mg: 73% (63% when administered with a standard meal).
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking 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.
International Brand Names of Montelukast:
Singulair
ACH-Montelukast
AG-Montelukast
APO-Montelukast
Auro-Montelukast
BIO-Montelukast
DOM-Montelukast
DOM-Montelukast FC
JAMP-Montelukast
Mar-Montelukast
MINT-Montelukast
MYLAN-Montelukast
PMS-Montelukast
PRIVA-Montelukast FC
RAN-Montelukast
RIVAMontelukast FC
SANDOZ Montelukast
Singulair
TEVA-Montelukast
Actamone
Actamone FC
Aeron
Airfast
Airlukast
Altra
Amikast
Anxokast
Asmaact
Asmakast
Asmax
Astair
Asthator
Asthator 5
Asthmatin
Blow
Breathezy
Brecare
Broncolast
Clear Air
Cubraxis
Edron
Everest
Glemont
Glemont-CT
Glemont-IR
Inmunobron
Kast
Kastair
Kastair EZ
Kipel
Kipres
Leukast
Lukair
Lukakline
Lukast
Lumona
Lungair
Mediruka
Milukant
Miralust
Mokast
Monarin
Monas
Monast
Monast 10
Monest
Monkalus
Monolair
Montair
Montecad
Montegol
Montek-10
Monteka
Montekast
Montelair
Montelu V
Monteluk
Montelukan
Montelukan QDT
Montemax
Montepect
Montexin
Montiget
Montulair
Oxair
Regulair
Respikast
Reversair
Romilast
Sansibast
Shu Ning An
Singkalus Chewable
Singulair
Singular Chew
Sinkast
Sintrine
Smart-Air
Synglon
Tekast
Telkast
Unicast
Valtrover
Valttrover
Vizendo
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