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zafirlukast (Rx)Brand and Other Names:Accolate

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablets

  • 10mg
  • 20mg
more...

Asthma

Indicated for chronic asthma treatment and prophylaxis

20 mg PO twice daily

Administration

Take at least 1 hour before or 2 hours after meals

Take at regular intervals

Hepatic Impairment

Contraindicated

Renal Impairment

Dose adjustment not necessary

Dosage Forms & Strengths

tablets

  • 10mg
  • 20mg
more...

Asthma

<5 years: Safety and efficacy not established

5-12 years: 10 mg PO twice daily

>12 years: 20 mg PO twice daily

Administration

Take at least 1 hour before or 2 hours after meals

Take at regular intervals

Hepatic Impairment

Contraindicated

Renal Impairment

Dose adjustment not necessary

Clearance reduced in patients aged 65 yr or older (Cmax and AUC 2- to 3-fold higher than in younger patients)

Potential for increased incidence of adverse effects; use caution

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Interactions

Interaction Checker

zafirlukast and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            headache (12.9% in age >12 yr)

            1-10%

            Abdominal pain (1.8%)

            Infection (3.5%)

            Nausea (3.1%)

            Diarrhea (2.8%)

            Generalized pain (1.8%)

            Vomiting (1.5%)

            Dyspepsia/gastritits (1.3%)

            Increased ALT (1.5%)

            Infection (4%)

            Back pain (2%)

            Weakness (2%)

            Myalgia (2%)

            Frequency Not Defined

            Eosinophilia

            Eosinophilic pneumonia

            Vasculitis

            Malaise

            Bleeding

            Bruising

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            Warnings

            Contraindications

            Hypersensitivity

            Status asthmaticus

            Hepatic impairment, including cirrhosis; Cmax and AUC ~50-60% greater than those of normal adults

            Cautions

            Not immediately effective and not for acute bronchospasm

            Increased risk of infection if age >55 yr

            Discontinue if hepatic dysfunction suspected, do not resume if confirmed

            May cause eosinophilia, eosinophilic pneumonia, or vasculitis consistent with emergence of Churg-Strauss syndrome

            Behavioral changes reported with therapy

            Concomitant use with warfarin can result in clinical significant increase in INR

            Not for use in the treatment of acute asthma attacks, including status asthmaticus

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: Excreted in breast milk; not recommended

            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

            Inhibits bronchoconstriction as competitive receptor antagonist of leukotrienes D4 & E4; receptor occupation and cysteinyl leukotriene production has been associated with the pathophysiology of ashtma

            Pharmacokinetics

            Half-Life: 8-16 hr

            Onset: 3-14 days

            Peak plasma concentration: 326 ng/mL (healthy subjects); 568 ng/mL (asthmatics)

            Peak plasm time: 3 hr (healthy subjects); 3.5 hr (asthmatics)

            Clearance: 20 L/hr; significantly decreased in cirrhosis and age 65 yr

            Protein bound: 99%

            Vd: 70 L

            Bioavailability: Reduced 40% with food

            Metabolism: Hepatic CYP2C9

            Excretion: Feces (90%); urine (10%)

            Enzymes inhibited: Hepatic CYP2C9, CYP3A4

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            Images

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            Formulary

            FormularyPatient Discounts

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            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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