formoterol (Rx)

Brand and Other Names:Perforomist
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for inhalation

  • 20mcg/2mL

Chronic Obstructive Pulmonary Disease (COPD)

Indicated for long-term maintenance treatment of bronchoconstriction in patients with COPD

Perforomist: 20 mcg inhaled via nebulizer q12hr

Safety and efficacy not established

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Interactions

Interaction Checker

and formoterol

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Viral infection (17.2%)

            1-10%

            Bronchitis (4.6%)

            Chest infection (2.7%)

            Dyspnea (2.1%)

            Chest pain (1.9%)

            Tremor (1.9%)

            Dizziness (1.6%)

            Frequency Not Defined

            Angina

            Arrhythmias

            Hypo/hypertension

            Tachycardia

            Hypokalemia

            Hyperglycemia

            Metabolic acidosis

            Headache

            Insomnia

            Paradoxical bronchospasm

            Severe asthma exacerbation

            Postmarketing Reports

            Immune system disorders: Rare reports of anaphylactic reactions, including severe hypotension and angioedema

            Metabolism and nutrition disorders: Hypokalemia, hyperglycemia

            Respiratory, thoracic and mediastinal disorders: Cough

            Skin and subcutaneous tissue disorders: Rash

            Cardiac disorders: Angina pectoris, cardiac arrhythmias (eg, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia)

            Investigations: Electrocardiogram QT prolonged, blood pressure increased (including hypertension)

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            Warnings

            Contraindications

            Hypersensitivity

            Asthma treatment without an inhaled corticosteroid

            Cautions

            Coexisting conditions including cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertension, aneurysm, and pheochromocytoma

            Life-threatening paradoxical bronchospasm can occur; discontinue immediately

            Immediate hypersensitivity reactions may occur (eg, anaphylactic reactions, urticaria, angioedema, rash, bronchospasm)

            Available data do not suggest an increased risk of death with use of LABA in patients with COPD

            As with other inhaled beta2-adrenergic drugs, inhalation solution should not be used more often, at higher doses than recommended, or in conjunction with other medications containing long-acting beta2-agonists; an overdose may result; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs

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

            Beta-agonist medications may produce transient hyperglycemia in some patients; clinically significant changes in serum potassium and blood glucose were infrequent during clinical studies with long-term administration of inhalation solution at recommended dose

            Cardiovascular effects

            • Inhalation solution, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms; if such effects occur, inhalation solution may need to be discontinued
            • Beta-agonists have been reported to produce ECG changes, such as flattening of T wave, prolongation of QTc interval, and ST segment depression; the clinical significance of these findings is unknown
            • Inhalation solution, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines; doses of related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis

            Serious asthma related events

            • Safety and efficacy in patients with asthma not established; not indicated for treatment of asthma; use of long-acting beta2-adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death
            • LABA as monotherapy also increases risk of asthma-related hospitalization in pediatric and adolescent patients; these findings are considered a class effect of LABA monotherapy; 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
            • Available data do not suggest increased risk of death with use of LABA in patients with COPD

            Acute COPD episodes

            • Inhalation solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition; inhalation solution has not been studied in patients with acutely deteriorating COPD; use of inhalation solution in this setting is inappropriate
            • Not for use in relief of acute symptoms, ie, as rescue therapy for treatment of acute episodes of bronchospasm; inhalation solution not studied in relief of acute symptoms and extra doses should not be used for that purpose; acute symptoms should be treated with an inhaled short-acting beta2-agonist
            • When beginning therapy, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (eg, four times a day) should be instructed to discontinue regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms
            • When prescribing inhalation solution, healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct patient how it should be used; increasing inhaled beta2-agonist use is a signal of deteriorating disease for which prompt medical attention is indicated
            • COPD may deteriorate acutely over a period of hours or chronically over several days or longer; if inhalation solution no longer controls symptoms of bronchoconstriction, or patient’s inhaled, short-acting beta2-agonist becomes less effective or the patient needs more inhalation of short-acting beta2-agonist than usual, these may be markers of deterioration of disease; in this setting, undertake a re-evaluation of patient and the COPD treatment regimen at once
            • Increasing daily dosage of inhalation solution beyond recommended 20 mcg twice daily dose is not appropriate in this situation
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk, use 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.

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            Pharmacology

            Mechanism of Action

            Long-acting selective beta-2 agonist

            Bronchial smooth muscle relaxation

            Absorption

            Peak Plasma Time: 5 min

            Peak Plasma Concentration: 92 pg/mL

            Distribution

            Protein Bound: 61-64%

            Metabolism

            Metabolized by CYP2D6, CYP2C19, CYP2C9, CYP2A6

            Elimination

            Half-Life: 10 hr

            Clearance: 150 mL/min

            Excretion: Urine 66%; feces 33%

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.