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MONTELUKAST SODIUM (montelukast sodium)
- Allergic rhinitis
- Exercise-induced bronchospasm prevention
- Maintenance therapy for asthma
- Singulair Tablet
- Singulair Oral Granules In Packet
- Singulair Chewable Tablet
- Montelukast Tablet
- Montelukast Oral Granules In Packet
- Montelukast Chewable Tablet
- By Indication
10 mg tablet
- 1 tablet (10 mg) by oral route once daily in the evening
4 mg oral granules in packet
- Dosage information is not available
4 mg chewable tablet
- Dosage information is not available
5 mg chewable tablet
- Chew 2 tablets (10 mg) by oral route once daily in the evening
montelukast 10 mg tablet
- 1 tablet (10 mg) by oral route once daily in the evening
montelukast 4 mg oral granules in packet
- Dosage information is not available
montelukast 4 mg chewable tablet
- Dosage information is not available
montelukast 5 mg chewable tablet
- Chew 2 tablets (10 mg) by oral route once daily in the evening
Allergic rhinitis
- 1 tablet (10 mg) by oral route once daily in the evening
- Chew 2 tablets (10 mg) by oral route once daily in the evening
Exercise-induced bronchospasm prevention
- 1 tablet (10 mg) by oral route once daily in the evening
- Chew 2 tablets (10 mg) by oral route once daily in the evening
Maintenance therapy for asthma
- 1 tablet (10 mg) by oral route once daily in the evening
- Chew 2 tablets (10 mg) by oral route once daily in the evening
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- None
Severe
Moderate
- Anxiety disorder
- Cutaneous vasculitis
- Depression
- Eosinophilia
- Suicidal ideation
MONTELUKAST SODIUM (montelukast sodium)
- Allergic rhinitis
- Exercise-induced bronchospasm prevention
- Maintenance therapy for asthma
- Abnormal hepatic function tests
- Influenza
- Acute abdominal pain
- Cough
- Diarrhea
- Fever
- Headache disorder
- Otitis
- Pharyngitis
- Rhinorrhea
- Sinusitis
- Upper respiratory infection
More Frequent
Severe
Less Severe
- Bronchitis
- Infectious gastroenteritis
- Myopia
- Skin and skin structure infection
- Acute bacterial otitis media
- Atopic dermatitis
- Dizziness
- Fatigue
- General weakness
- Nasal congestion
- Skin rash
- Toothache
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Angioedema
- Chickenpox
- Cholestatic hepatitis
- Conjunctivitis
- Eosinophilia
- Eosinophilic pneumonia
- Epistaxis
- Erythema multiforme
- Erythema nodosum
- Gastroenteritis
- Hepatocellular damage
- Hostility
- Hypersensitivity angiitis
- Hypersensitivity drug reaction
- Night terror
- Pancreatitis
- Pneumonia
- Pyuria
- Seizure disorder
- Stevens-johnson syndrome
- Suicidal
- Suicidal ideation
- Thrombocytopenic disorder
- Toxic epidermal necrolysis
- Urticaria
Less Severe
- Acute confusion
- Aggressive behavior
- Agitation
- Arthralgias
- Bruising
- Cramps
- Depression
- Disturbance of attention
- Dream disorder
- Drowsy
- Dyspepsia
- Eczema
- Edema
- Hallucinations
- Hypesthesia
- Insomnia
- Irritability
- Laryngitis
- Memory impairment
- Motor tic disorder
- Myalgias
- Nausea
- Nervousness
- Nightmares
- Obsessive-compulsive disorder
- Palpitations
- Paresthesia
- Pruritus of skin
- Sleep walking disorder
- Stuttering
- Symptoms of anxiety
- Tremor
- Urinary incontinence
- Viral infection
- Vomiting
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Montelukast
Safety and efficacy not established in pediatrics less than 6 months.
Monitor for behavioral changes. Rare reports of neuropsychiatric events, nocturnal enuresis.
- 1 Day – 179 Days
- Safety and efficacy not established in pediatrics less than 6 months.
- Monitor for behavioral changes. Rare reports of neuropsychiatric events, nocturnal enuresis.
- 180 Days – 18 Years
- Safety and efficacy not established in pediatrics less than 6 months.
- Monitor for behavioral changes. Rare reports of neuropsychiatric events, nocturnal enuresis.
Montelukast
- Severity Level:
2
- Additional Notes: Rare congenital limb defects reported;no causal relationship yet established.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Montelukast
Insufficient human data available.
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Excreted | Not known; no or inclusive data | Insufficient human data available. |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| J30.5 | Allergic rhinitis due to food |
| J30.8 | Other allergic rhinitis |
| J30.81 | Allergic rhinitis due to animal (cat) (dog) hair and dander |
| J30.89 | Other allergic rhinitis |
| J30.9 | Allergic rhinitis, unspecified |
| Exercise-induced bronchospasm prevention | |
| J45.990 | Exercise induced bronchospasm |
| Maintenance therapy for asthma | |
| J45 | Asthma |
| J45.2 | Mild intermittent asthma |
| J45.20 | Mild intermittent asthma, uncomplicated |
| J45.3 | Mild persistent asthma |
| J45.30 | Mild persistent asthma, uncomplicated |
| J45.4 | Moderate persistent asthma |
| J45.40 | Moderate persistent asthma, uncomplicated |
| J45.5 | Severe persistent asthma |
| J45.50 | Severe persistent asthma, uncomplicated |
| J45.9 | Other and unspecified asthma |
| J45.90 | Unspecified asthma |
| J45.909 | Unspecified asthma, uncomplicated |
| 0-9 | A-Z |
|---|---|
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| J30.5 | Allergic rhinitis due to food |
| J30.8 | Other allergic rhinitis |
| J30.81 | Allergic rhinitis due to animal (cat) (dog) hair and dander |
| J30.89 | Other allergic rhinitis |
| J30.9 | Allergic rhinitis, unspecified |
| J45 | Asthma |
| J45.2 | Mild intermittent asthma |
| J45.20 | Mild intermittent asthma, uncomplicated |
| J45.3 | Mild persistent asthma |
| J45.30 | Mild persistent asthma, uncomplicated |
| J45.4 | Moderate persistent asthma |
| J45.40 | Moderate persistent asthma, uncomplicated |
| J45.5 | Severe persistent asthma |
| J45.50 | Severe persistent asthma, uncomplicated |
| J45.9 | Other and unspecified asthma |
| J45.90 | Unspecified asthma |
| J45.909 | Unspecified asthma, uncomplicated |
| J45.990 | Exercise induced bronchospasm |
Formulary Reference Tool