Montelukast Chew 4mg

Leukotriene Receptor Antagonist

“ALERT: US Boxed Warning

Serious neuropsychiatric events:

Serious neuropsychiatric (NP) events have been reported with the use of montelukast. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast use are currently not well understood.

Because of the risk of NP events, the benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast.

Discuss the benefits and risks of montelukast with patients and caregivers when prescribing montelukast. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast and contact a health care provider immediately.”

CSA NA – FDA Approved – REMS (N) – Can Ship

Selective leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor. Cysteinyl leukotrienes and leukotriene receptor occupation has 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.  Montelukast has drawn interest recently due to its ability to increase neurogenesis, decrease microglia activation and restore blood-brain-barrier function.

Officially indicated for allergic rhinitis, asthma, and exercise induced bronchoconstriction.  It may also be prescribed off label for chronic urticaria and neuroinflammation.

Patients should be instructed to notify their doctor if they experience any behavioral changes (i.e. abnormal dreams, agitation, aggression, anxiety, attention deficit, depression, disorientation, hallucinations, hostility, insomnia, irritability, memory disturbances, restlessness, suicide ideation/behavior).

Oral: Take 10mg once daily.

Pros

Well tolerated

Cons

Weak evidence

How Do You Use Montelukast:  Can be taken (morning or evening) without regard to food.

Is Montelukast Safe to Use During Pregnancy:  Based on available data, Montelukast has not been linked to an increased risk of teratogenic effects in pregnancy.

Well tolerated, most side effects are transient and mild to moderate in nature.  The most common side effects include:

1-10%

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%)