salmeterol (Rx)

Brand and Other Names:Serevent Diskus
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder

  • 50mcg/inhalation

Asthma Prevention and Maintenance

Administer as additional therapy for patients currently taking but inadequately controlled on an inhaled corticosteroid (ICS); not for patients whose asthma is adequately controlled on low-or medium-dose ICS

1 inhalation (50 mcg) twice daily; not to exceed twice daily administration

COPD Maintenance

1 inhalation (50 mcg) twice daily; not to exceed twice daily administration

Prevention of Exercise-Induced Asthma

Use as a single agent for the prevention of EIB may be clinically indicated in patients who do not have persistent asthma

1 inhalation 30 minutes before exercise; a second dose not to be administered for another 12 hr; not for use in individuals receiving twice-daily therapy of salmeterol

Dosing considerations

  • In patients with persistent asthma, use for prevention of EIB may be clinically indicated, but treatment of asthma should include an ICS; one inhalation at least 30 minutes before exercise has been shown to protect patients against EIB
  • When used intermittently as needed for prevention of EIB, protection may last up to 9 hr in adults and adolescents and up to 12 hours in patients aged 4-11 years
  • Additional doses should not be used for 12 hours after administration of this drug; patients who are receiving treatment twice daily should not use additional salmeterol for prevention of EIB

Dosage Forms & Strengths

powder

  • 50mcg/inhalation

Asthma Prevention and Maintenance

Administer as additional therapy for patients currently taking but inadequately controlled on an inhaled corticosteroid (ICS); not for patients whose asthma is adequately controlled on low-or medium-dose ICS

< 4 years

  • Safety and efficacy not established

> 4 years

  • 1 inhalation (50 mcg) twice daily; not to exceed twice daily administration

Dosing considerations

  • For patients <18 years who require addition of a LABA to an ICS, a fixed-dose combination product containing both an ICS and a LABA should ordinarily be used to ensure adherence with both drugs
  • In cases where use of separate ICS and a LABA is clinically indicated, take appropriate steps to ensure adherence with both treatment components; if adherence cannot be assured, a fixed-dose combination product containing both an ICS and a LABA is recommended

Prevention of Exercise-Induced Asthma

Use as a single agent for the prevention of EIB may be clinically indicated in patients who do not have persistent asthma

< 4 years

  • Safety and efficacy not established

> 4 years

  • 1 inhalation (50 mcg) twice daily; not to exceed twice-daily administration

Dosing considerations

  • In patients with persistent asthma, use for prevention of EIB may be clinically indicated, but treatment of asthma should include an ICS; one inhalation at least 30 minutes before exercise has been shown to protect patients against EIB
  • When used intermittently as needed for prevention of EIB, protection may last up to 9 hr in adults and adolescents and up to 12 hours in patients aged 4-11 years
  • Additional doses should not be used for 12 hours after administration of this drug; patients who are receiving treatment twice daily should not use additional salmeterol for prevention of EIB
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Interactions

Interaction Checker

and salmeterol

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            Adverse Effects

            >10%

            Headache (13-17%)

            Pain (1-12%)

            1-10%

            Nasal congestion (9%)

            Hypertension (4%)

            Edema (1-3%)

            Dizziness (4%)

            Sleep disturbance (1-3%)

            Migraine (1-3%)

            Contact dermatitis (1-3%)

            Urticaria (3%)

            Hyperglycemia (1-3%)

            Articular rheumatism (1-3%)

            Paresthesia (1-3%)

            Muscular stiffness (1-3%)

            Photodermatitis (1-2%)

            Bronchitis (7%)

            Influenza (5%)

            Rigidity (1-3%)

            hinitis (5%)

            Asthma (3%)

            Frequency Not Defined

            Conjunctivitis

            Hyperglycemia

            Keratitis

            Oral candidiasis

            Chest tightness

            Cataracts

            Hypokalemia

            Myositis

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            Warnings

            Black Box Warnings

            Long-acting beta2-adrenergic agonists (LABA), as monotherapy (without inhaled corticosteroids [ICS]) increase risk of asthma-related death; data from a large placebo-controlled U.S. trial showed an increase in asthma-related deaths in subjects receiving salmeterol alone; use of background ICS was not required in this study; when LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone

            Use of drug for the treatment of asthma as monotherapy without a concomitant ICS is contraindicated; use only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS; do not use drug for patients whose asthma is adequately controlled on low-or medium-dose ICS

            Pediatric and Adolescent Patients

            • Available data from controlled clinical trials suggest that LABA as monotherapy increase risk of asthma-related hospitalization in pediatric and adolescent patients
            • For pediatric and adolescent patients with asthma who require addition of a LABA to an ICS, a fixed-dose combination product containing both an ICS and a LABA should ordinarily be used to ensure adherence with both drugs
            • In cases where use of an ICS and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components; if adherence cannot be assured, a fixed-dose combination product containing both an ICS and a LABA recommended

            Contraindications

            Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to drug or excipients

            Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required

            Treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid

            Cautions

            Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; therapy can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms; although such effects are uncommon after administration of salmeterol at recommended doses, if they occur, the drug may need to be discontinued

            Drug should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs; patients should not use another medicine containing a LABA (e.g., formoterol fumarate, arformoterol tartrate, indacaterol) for any reason

            Use caution in diabetes mellitus and ketoacidosis; clinically significant and dose-related changes in blood glucose and/or serum potassium seen infrequently during clinical trials at recommended doses

            Not for acute asthma; for acute asthma exacerbations, use short-acting beta-agonists (eg, albuterol)

            Not for acute episodes of COPD

            May increase risk of severe, potentially fatal asthma attacks; small but significant increase in asthma-related deaths for patients using salmeterol vs placebo, with greater risk in African-Americans

            Therapy may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has potential to produce adverse cardiovascular effects; decrease in serum potassium is usually transient, not requiring supplementation

            Use caution in patients with hypokalemia, hepatic impairment, seizure disorders, and hyperthyroidism

            Paradoxical bronchospasm may occur with therapy; if it occurs it should be treated immediately with an inhaled, short-acting bronchodilator; treatment should be discontinued immediately and alternative therapy instituted; upper airway symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported in patients receiving therapy

            When initiating and throughout treatment in patients receiving oral or ICS for treatment of asthma, patients must continue taking a suitable dosage of corticosteroids to maintain clinical stability even if they feel better as a result of initiating salmeterol; any change in corticosteroid dosage should be made only after clinical evaluation

            Use Serevent Diskus only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS; do not use Serevent Diskus for patients whose asthma is adequately controlled on low- or medium-dose ICS

            Immediate hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur with therapy; anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose reported

            Use only for shortest duration of time

            Deterioration of disease

            • Not for use in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD, including patients with significantly increased symptoms
            • Worsening or acutely deteriorating asthma is associated with increase in need for inhaled, short-acting beta2-agonists; decreasing response to usual medications; increasing need for systemic corticosteroids; recent emergency room visits; deteriorating lung function
            • Increasing use of inhaled, short-acting beta2-agonists is a marker of deteriorating asthma; in this situation, the patient requires immediate reevaluation with reassessment of treatment regimen, giving special consideration to possible need for adding additional ICS or initiating systemic corticosteroids; patients should not use drug more than 1 inhalation twice daily

            Drug interaction overview

            • Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) not recommended because increased cardiovascular adverse effects may occur
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            Pregnancy & Lactation

            Pregnancy

            Available data from published epidemiological studies and case reports in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Beta-agonists may interfere with uterine contractility

            There are clinical considerations in pregnant women with asthma

            In women with poorly or moderately controlled asthma, there is increased risk of pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate

            Severe asthma during pregnancy has been associated with maternal mortality, fetal mortality, or both

            Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control

            Animal data

            • Oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 50 times maximum recommended human daily inhaled dose (MRHDID) on an AUC basis

            Labor and delivery

            • There are no adequate and well-controlled human studies that have evaluated effects of therapy during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those patients in whom the benefits clearly outweigh the risks

            Lactation

            There is no information regarding presence of salmeterol in human milk, effects on breastfed child, or on milk production

            Drug is detected in rat milk; drug concentrations in human plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be low

            The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from treatment or from underlying maternal condition

            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.

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            Pharmacology

            Mechanism of Action

            Long-acting beta-2 agonist; action on beta-2 receptors relaxes bronchial smooth muscle with little effect on heart rate

            50 times more selective than albuterol

            Pharmacokinetics

            Peak serum time: 20 min

            Half-Life: 5.5 hr

            Onset: 30-48 min (asthma); 2 hr (COPD)

            Duration: 12 hr

            Absorption: Minimal (undetectable)

            Protein Bound: 96%

            Metabolism: Liver

            Excretion: Feces (60%); urine (25%)

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            Formulary

            FormularyPatient Discounts

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            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.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.