SINGULAIR (montelukast sodium)

There are 0 contraindications.

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Depression
Suicidal ideation

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Aggressive behavior
Cutaneous vasculitis
Eosinophilia
Phenylketonuria

There are 33 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Influenza	Bronchitis Infectious gastroenteritis Myopia Skin and skin structure infection

Rare/Very Rare

Angioedema Chickenpox Cholestatic hepatitis Conjunctivitis Eosinophilia Eosinophilic granulomatosis with polyangiitis Eosinophilic pneumonia Epistaxis Erythema multiforme Erythema nodosum Gastroenteritis Hepatocellular damage Hostility Hypersensitivity angiitis Hypersensitivity drug reaction Jaundice Night terror Pancreatitis Pneumonia Pyuria Seizure disorder Stevens-johnson syndrome Suicidal Suicidal ideation Thrombocytopenic disorder Toxic epidermal necrolysis Urticaria

There are 54 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Cough Diarrhea Fever Headache disorder Otitis Pharyngitis Rhinorrhea Sinusitis Upper respiratory infection	Acute bacterial otitis media Atopic dermatitis Dizziness Fatigue General weakness Nasal congestion Skin rash Toothache

Rare/Very Rare

Acute cognitive impairment Aggressive behavior Agitation Arthralgia Bruising Cramps Depression Disturbance of attention Dream disorder Drowsy Dyspepsia Eczema Edema Hallucinations Hypoesthesia Insomnia Irritability Laryngitis Memory impairment Motor tic disorder Myalgia Nausea Nervousness Nightmares Obsessive-compulsive disorder Palpitations Paresthesia Pruritus of skin Sleep disorder Sleep walking disorder Stuttering Symptoms of anxiety Tremor Urinary incontinence Viral infection Vomiting

Montelukast crosses the placenta following oral dosing in rats and rabbits. Reproduction studies in rats using oral dosages up to 400 mg/kg daily (estimated exposure approximately 100 times the AUC for adults at the maximum recommended daily oral dose) and in rabbits using oral dosages up to 300 mg/kg daily (estimated exposure approximately 110 times the AUC for adults at the maximum recommended daily oral dose) have not revealed evidence of harm to the fetus. There are no adequate and well-controlled studies to date using montelukast in pregnant women, and the manufacturer states that montelukast should be used during pregnancy only when clearly needed.

The American College of Obstetricians and Gynecologists (ACOG) generally recommends use of leukotriene modifiers as an alternative to a long-acting beta2-agonist in pregnant women with moderate persistent asthma who are inadequately controlled with low to medium dosages of an inhaled corticosteroid. (See Uses: Asthma.) During postmarketing experience with montelukast, congenital limb defects have been reported rarely in the children of women treated with the drug; however, most of these women were receiving other antiasthmatic agents during their pregnancies. A causal relationship between montelukast use and the development of these congenital anomalies has not been established.

The manufacturer maintains a registry to monitor pregnancy outcomes in women exposed to montelukast during pregnancy. Patients may be enrolled by calling 800-986-8999.

Montelukast is distributed into milk in rats. Since it is not known whether montelukast is distributed in human milk, the drug should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.