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montelukast (Rx)Brand and Other Names:Singulair

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 10mg

tablet, chewable

  • 4mg
  • 5mg

oral granules

  • 4mg/packet
more...

Asthma

Prophylaxis and maintenance treatment

10 mg (single 10-mg tablet) PO once daily in evening

Exercise-Induced Bronchospasm

Prophylaxis

10 mg PO 2 hours before exercise; do not take additional dose within 24 hours

If taking drug for another indication, do not take additional dose to prevent exercise-induced bronchospasm (EIB)

Allergic or Perennial Rhinitis

10 mg (single 10-mg tablet) PO once daily

Administration

Patients aged ≥12 years with both asthma and allergic rhinitis: 1 dose PO at bedtime

Patients with allergic rhinitis: Dosing time may be individualized to patient needs

Granules may be taken directly; mixed in applesauce, carrots, rice, or ice cream; or dissolved in 5 mL of breast milk or baby formula (administer within 15 minutes of opening)

Dosage Forms & Strengths

tablet

  • 10mg

tablet, chewable

  • 4mg
  • 5mg

oral granules

  • 4mg/packet
more...

Asthma

Prophylaxis and maintenance treatment in patients aged ≥12 months

<12 months: Safety and efficacy not established

12-24 months: 4 mg (granules) PO once daily in evening

2-6 years: 4 mg (chewable tablet or granules) PO once daily in evening

6-15 years: 5 mg (chewable tablet) PO once daily in evening

>15 years: 10 mg (conventional tablet) PO once daily in evening

Exercise-Induced Bronchospasm

Prophylaxis

6-15 years: 5 mg (chewable tablet) PO 2 hours before exercise; do not take additional dose within 24 hours

>15 years: 10 mg PO 2 hours before exercise; do not take additional dose within 24 hours

If taking drug for another indication, do not take additional dose to prevent EIB

Perennial Allergic Rhinitis

<6 months: Safety and efficacy not established

6-24 months: 4 mg (granules) PO once daily

2-6 years: 4 mg (chewable tablet or granules) PO once daily

6-15 years: 5 mg (chewable tablet) PO once daily

>15 years: 10 mg (conventional tablet) PO once daily

Seasonal Allergic Rhinitis

<2 years: Safety and efficacy not established

2-6 years: 5 mg (chewable tablet) or 4 mg (granules) PO once daily

6-15 years: 5 mg (chewable tablet) PO once daily

>15 years: 10 mg (conventional tablet) PO once daily

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Interactions

Interaction Checker

montelukast and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Some adverse drug reactions vary by age group

            >10%

            Headache (18.4%; similar to placebo)

            1-10%

            Abdominal pain (≥2%)

            Eczema (≥2%)

            Influenza (≥2%)

            Laryngitis (≥2%)

            Pharyngitis (≥2%)

            Viral infection (≥2%)

            Wheezing (≥2%)

            Dental pain (2%)

            Dizziness (2%)

            Dyspepsia (2%)

            Elevated liver function tests (2%)

            Fever (2%)

            Gastroenteritis (2%)

            Nasal congestion (2%)

            Otitis (2%)

            Rash (2%)

            Urticaria (2%)

            Bronchitis (≥1%)

            Cough (≥1%)

            Sinusitis (≥1%)

            Upper respiratory tract infection (≥1%)

            <1%

            Allergic granulomatous angiitis (Churg-Strauss syndrome; rare)

            Cholestatic hepatitis (rare)

            Aggressive behavior, altered behavior, suicidal thoughts

            Postmarketing Reports

            Hematologic: Increased bleeding tendency, thrombocytopenia

            Immunologic: Hypersensitivity reactions (eg, anaphylaxis, hepatic eosinophilic infiltration)

            Psychiatric: Agitation, including aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tremor

            Neurologic: Drowsiness, paresthesia or hypesthesia, seizures

            Cardiac: Palpitations

            Respiratory, thoracic, mediastinal: Epistaxis, pulmonary eosinophilia

            Gastrointestinal: Diarrhea, dyspepsia, nausea, pancreatitis, vomiting

            Hepatobiliary: Cases of cholestatic hepatitis, hepatocellular liver injury, and mixed-pattern liver injury have been reported, mostly occurring in combination with other confounding factors (eg, use of other medications, administration to patients who had underlying potential for liver disease [eg, alcohol use or other forms of hepatitis])

            Dermatologic: Angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, urticaria

            Musculoskeletal: Arthralgia, myalgia (including muscle cramps)

            General: Edema

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Not to be given for acute asthma attacks, including status asthmaticus

            Advise patients to have appropriate rescue medication available

            Inhaled corticosteroid may be reduced gradually; do not abruptly substitute montelukast for inhaled or oral corticosteroids

            Patients with known aspirin sensitivity should continue to avoid aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) while taking montelukast; not to be given for treatment of bronchoconstriction resulting from aspirin or NSAID intake

            Neuropsychiatric events (eg, abnormal dreams, agitation) reported

            Systemic eosinophilia reported, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome; these events are usually (but not always) associated with tapering of PO corticosteroid therapy

            Use with caution in phenylketonuria; 4-mg and 5-mg chewable tablets contain phenylalanine

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Unknown whether agent is excreted in breast milk, use with caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Blocks binding of leukotriene D4 to its receptor; alters pathophysiology associated with inflammatory process that contributes to signs and symptoms of asthma

            Absorption

            Bioavailability: 64% (mean)

            Peak plasma time: Tablet, 3-4 hr; chewable tablet, 2-2.5 hr; granules, 1-3 hr

            Distribution

            Protein bound: >99%

            Vd: 8-11 L

            Metabolism

            Metabolized by CYP3A4 and CYP2C9

            Elimination

            Half-life: 2.7-5.5 hr

            Clearance: 45 mL/min

            Excretion: Feces (86%), urine (0.2%)

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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