Buy Singulair Online

Singulair (montelukast sodium)

THERAPEUTIC CLASS

Leukotriene receptor antagonist

DEA CLASS

RX

INDICATIONS

Prophylaxis and chronic treatment of asthma in adults and pediatric patients ≥12 months of age. Relief of symptoms of seasonal allergic rhinitis in patients ≥2 yrs of age and perennial allergic rhinitis in patients ≥6 months of age. Prevention of exercise-induced bronchoconstriction (EIB) in patients ≥6 yrs of age.

ADULT DOSAGE

Asthma

Prophylaxis/Chronic Treatment:
10mg tab qpm

Patients w/ both asthma and allergic rhinitis should take only 1 dose qpm

Perennial Allergic Rhinitis

10mg tab qd

Patients w/ both asthma and allergic rhinitis should take only 1 dose qpm

Seasonal Allergic Rhinitis

10mg tab qd

Patients w/ both asthma and allergic rhinitis should take only 1 dose qpm

Exercise-Induced Bronchospasm

Prevention:
10mg tab at least 2 hrs before exercise

Do not take an additional dose w/in 24 hrs of a previous dose

PEDIATRIC DOSAGE

Asthma

Prophylaxis/Chronic Treatment:
12-23 Months:

4mg granules qpm

2-5 Years:
4mg chewable tab or 4mg granules qpm

6-14 Years:
5mg chewable tab qpm

≥15 Years:
10mg tab qpm

Patients w/ both asthma and allergic rhinitis should take only 1 dose qpm

Perennial Allergic Rhinitis

6-23 Months:
4mg granules qd

2-5 Years:

4mg chewable tab or 4mg granules qd

6-14 Years:
5mg chewable tab qd

≥15 Years:
10mg tab qd

Patients w/ both asthma and allergic rhinitis should take only 1 dose qpm

Seasonal Allergic Rhinitis

2-5 Years:
4mg chewable tab or 4mg granules qd

6-14 Years:
5mg chewable tab qd

≥15 Years:
10mg tab qd

Patients w/ both asthma and allergic rhinitis should take only 1 dose qpm

Exercise-Induced Bronchospasm

Prevention:
6-14 Years:

5mg chewable tab at least 2 hrs before exercise

≥15 Years:
10mg tab at least 2 hrs before exercise

Do not take an additional dose w/in 24 hrs of a previous dose

ADMINISTRATION

Oral route

Refer to PI for instructions for administration of granules

HOW SUPPLIED

Granules: 4mg/pkt; Tab, Chewable: 4mg, 5mg; Tab: 10mg

WARNINGS/PRECAUTIONS

Not for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus; have appropriate rescue medication available. Therapy may be continued during acute exacerbations of asthma. Patients who have exacerbations of asthma after exercise should have short-acting inhaled β-agonist available for rescue. Should not be abruptly substituted for inhaled or oral corticosteroids. Eosinophilic conditions reported. Neuropsychiatric events reported; evaluate risks and benefits of continuing treatment if such events occur. Chewable tabs contain phenylalanine; caution with phenylketonuria. Avoid aspirin (ASA) and NSAIDs with known ASA sensitivity; has not been shown to truncate bronchoconstrictor response to ASA and other NSAIDs in ASA-sensitive asthmatic patients.

ADVERSE REACTIONS

Headache, pharyngitis, influenza, fever, sinusitis, diarrhea, URTI, cough, abdominal pain, otitis media, rhinorrhea, otitis.

PREGNANCY AND LACTATION

Category B, caution in nursing.

MECHANISM OF ACTION

Leukotriene receptor antagonist; binds to cysteinyl leukotriene (CysLT) receptors found in the airway (including airway smooth muscle cells and airway macrophages) and on other proinflammatory cells (including eosinophils and certain myeloid stem cells). Inhibits physiologic actions of leukotriene D4 at the CysLT type 1 receptor.

PHARMACOKINETICS

Absorption: Rapid. (10mg tab) Tmax=3-4 hrs; oral bioavailability (64%). (5mg Chewable tab) Tmax=2-2.5 hrs; oral bioavailability: fasted (73%), fed (63%). 2-5 Yrs: (4mg Chewable tab) Tmax=2 hrs (fasted). (4mg Granules) Tmax=2.3 hrs (fasted), 6.4 hrs (fed). Distribution: Vd=8-11L; plasma protein binding (>99%). Metabolism: Liver (extensive); CYP3A4, 2C8, and 2C9. Elimination: Biliary (major), feces (86%), urine (<0.2%); T1/2=2.7-5.5 hrs.

ASSESSMENT

Assess for hypersensitivity to drug, phenylketonuria, asthma status, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for signs/symptoms of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, neuropathy, neuropsychiatric events, hypersensitivity reactions, and other adverse reactions.

PATIENT COUNSELING

Advise to take daily as prescribed, even when asymptomatic, as well as during periods of worsening asthma; instruct to contact physician if asthma is not well controlled. Inform that drug is not for treatment of acute asthma attacks; advise to have appropriate short-acting inhaled β-agonist medication available to treat asthma exacerbations. Advise to seek medical attention if short-acting inhaled bronchodilators are needed more than usual while on therapy or if more than the max number of inhalations of short-acting bronchodilator treatment prescribed for a 24-hr period are needed. Instruct not to decrease dose or d/c other antiasthma medications unless instructed by physician. Instruct to notify physician if symptoms of neuropsychiatric events occur. Advise patients with ASA sensitivity to continue avoiding ASA and NSAIDs while on therapy. Inform phenylketonuric patients that the 4mg and 5mg chewable tabs contain phenylalanine.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light and moisture.

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