formoterol

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Related to Perforomist: Symbicort

formoterol

(for-mo-te-role) ,

Foradil

(trade name),

Perforomist

(trade name)

Classification

Therapeutic: bronchodilators
Pharmacologic: adrenergics
Pregnancy Category: C

Indications

As concomitant therapy for the treatment of asthma and the prevention of bronchospasm in patients who are currently taking but are inadequately controlled on a long-term asthma-control medication (e.g., inhaled corticosteroid) (Foradil only).Prevention of exercise-induced bronchospasm (Foradil only).Maintenance treatment to prevent bronchospasm in chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Action

Produces accumulation of cyclic adenosine monophosphate (cAMP) at beta-adrenergic receptors, resulting in relaxation of airway smooth muscle.
Relatively specific for beta2 (pulmonary) receptors.

Therapeutic effects

Bronchodilation.

Pharmacokinetics

Absorption: Following inhalation, majority of inhaled drug is swallowed and absorbed.
Distribution: Unknown.
Metabolism and Excretion: Mostly metabolized by the liver; 10–18% excreted unchanged in urine.
Half-life: 10 hr.

Time/action profile (bronchodilation)

ROUTEONSETPEAKDURATION
Inhaln15 min1–3 hr12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Acute attack of asthma (onset of action is delayed);Patients not receiving a long-term asthma-control medication (e.g. inhaled corticosteroid);Patients whose asthma is currently controlled on low- or medium-dose inhaled corticosteroid therapy.
Use Cautiously in: Cardiovascular disease (including angina, hypertension, and arrhythmias);Diabetes;Seizure disordersGlaucoma;Hyperthyroidism;Pheochromocytoma;Excessive use (may lead to tolerance and paradoxical bronchospasm); Obstetric / Lactation / Pediatric: Pregnancy, lactation, or children <5 yr (may inhibit contractions during labor; use only if potential benefits outweigh risks; in children, a fixed-dose combination product containing formoterol and an inhaled corticosteroid should be strongly considered to ensure adherence).

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • fatigue
  • headache
  • insomnia
  • malaise
  • nervousness

Respiratory

  • asthma-related death (life-threatening)
  • paradoxical bronchospasm (life-threatening)

Cardiovascular

  • angina
  • arrhythmias
  • hypertension
  • hypotension
  • palpitations
  • tachycardia

Gastrointestinal

  • dry mouth
  • nausea

Fluid and Electrolyte

  • hypokalemia

Metabolic

  • hyperglycemia
  • metabolic acidosis

Musculoskeletal

  • muscle cramps

Neurologic

  • tremor

Dermatologic

  • rash

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use with MAO inhibitors, tricyclic antidepressants, or other agents that may prolong the QTc interval may result in serious arrhythmias and should be undertaken with extreme caution.↑ risk of hypokalemia with theophylline, corticosteroids, potassium-losing diuretics.Beta blockers may ↓ therapeutic effects.↑ adrenergic effects may occur with concurrent use of adrenergics.

Route/Dosage

Asthma

Inhalation (Adults and Children ≥5 yr) 1 capsule (12 mcg) every 12 hr using the Aerolizer Inhaler.

Prevention of Exercise-Induced Bronchospasm

Inhalation (Adults and Children ≥5 yr) 1 capsule (12 mcg) at least 15 min before exercise on an occasional as-needed basis; additional doses should not be used for at least 12 hr.

COPD

Inhalation (Adults) Foradil—1 capsule (12 mcg) every 12 hr using the Aerolizer Inhaler; Perforomist—20 mcg/2 mL-unit-dose vial twice daily via jet nebulizer.

Availability

Capsule for Aerolizer use (Foradil): 12 mcg
Inhalation solution for nebulization (Perforomist): 20 mcg/2 mL
In combination with: budesonide (Symbicort) and mometasone (Dulera); see combination drugs).

Nursing implications

Nursing assessment

  • Assess lung sounds, pulse, and BP before administration and during peak of medication. Note amount, color, and character of sputum produced. Closely monitor patients on higher dose for adverse effects.
  • Monitor pulmonary function tests before initiating and periodically during therapy to determine effectiveness.
  • Observe for paradoxical bronchospasm (wheezing, dyspnea, tightness in chest) and hypersensitivity reaction (rash; urticaria; swelling of the face, lips, or eyelids). If condition occurs, withhold medication and notify physician or other health care professional immediately.
  • Monitor ECG periodically during therapy. May cause prolonged QTc interval.
  • Monitor patient for signs of anaphylaxis (dyspnea, rash, laryngeal edema) throughout therapy.
  • Lab Test Considerations: May cause ↑ serum glucose and decreased serum potassium.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)

Implementation

  • Do not confuse Foradil with Fortical (calcitonin) or Toradol (ketorolac).
  • Formoterol should be used along with an inhaled corticosteroid, not as monotherapy. Patients taking formoterol twice daily should not use additional doses for exercise-induced bronchospasm.
  • Inhalation: For use with inhaler: Place capsule in the well of the Aerolizer Inhaler with dry hands; do not expose to moisture. The capsule is pierced by pressing and releasing the buttons on the side of the device. Medication is dispersed into the airstream when patient inhales rapidly and deeply through mouthpiece. Capsules are only to be used with Aerolizer Inhaler and should not be taken orally. Store capsules in the blister and only remove immediately before use. Store inhaler in a level, horizontal position. Aerolizer Inhaler should never be washed and should be kept dry.
    • Do not use a spacer with formoterol.
  • To use, pull off the Aerolizer cover. Hold the base of the inhaler firmly, and twist mouthpiece in the direction of the arrow to open. Push the buttons in to make sure 4 pins are visible in the capsule well on each side. Remove capsule from blister pack immediately before use. Separate one blistered capsule by tearing at perforations. With foil-side up, fold back along perforation and flatten. Starting at slit, tear off corner; separate and peel foil from paper backing and remove capsule. Place capsule in the capsule chamber in the base of the Aerolizer Inhaler. Never place a capsule directly into the mouthpiece. Twist the mouthpiece back to the closed position. With the mouthpiece upright, simultaneously press both buttons only once. A click should be heard as the capsule is being pierced. Release buttons; if buttons stick in depressed position grasp wings on buttons and retract before inhalation. With patient sitting or standing in a comfortable upright position, exhale fully. Do not exhale into the device. Tilt head back slightly and breathe in rapidly but steadily. A sweet taste will be experienced and a whirring noise heard. If no whirring is heard, the capsule may be stuck. Open inhaler and loosen capsule allowing it to spin freely. Do not repeatedly press buttons to loosen capsule. Hold breath for as long as comfortably possible after removing inhaler from mouth. Open inhaler to see if any powder is still in capsule. If powder is found, repeat inhalation steps. After use, open, remove and discard empty capsule.
  • Inhalation: For use with nebulizer: Administer via standard jet nebulizer via mouthpiece or face mask. Remove vial from foil immediately prior to use and discard via after use. May be stored in refrigerator for up to 3 mo.

Patient/Family Teaching

  • Instruct patient to take fomoterol as directed. Do not discontinue therapy without discussing with health care professional, even if feeling better. If a dose is missed skip dose and take next dose at regularly scheduled time. Do not double doses. Use a rapid-acting bronchodilator if symptoms occur before next dose is due. Caution patient not to use more than 2 times a day or less than 12 hr apart; may cause adverse effects, paradoxical bronchospasm, or loss of effectiveness of medication. Instruct patient to review medication guide with each Rx refill.
  • Advise patient to have a rapid-acting bronchodilator available for use at all times for symptomatic relief of acute asthma attacks.
  • Instruct patient to contact health care professional immediately if shortness of breath is not relieved by medication or nausea, vomiting, shakiness, headache, fast or irregular heartbeat, or sleeplessness occur.
  • Instruct patient to notify health care professional if there is no response to the usual dose or if contents of one canister are used in less than 2 wk. Asthma and treatment regimen should be re-evaluated and corticosteroids should be considered. Need for increased use to treat symptoms indicates decrease in asthma control and need to re-evaluate patient’s therapy.
  • Advise patient to consult health care professional before taking any Rx, OTC, or herbal products or alcohol concurrently with this therapy. Caution patient also to avoid smoking and other respiratory irritants.
  • Advise patient to notify health care professional if pregnancy is planned or suspected, or if nursing.
  • Inhaler: Instruct patient on correct technique for use of Aerolizer Inhaler. Advise patient always to use new Aerolizer Inhaler that comes with each refill. Take sticker with "use by" date written by pharmacist from the outside of the box and place it on the Aerolizer Inhaler cover. If the date is blank, count 4 mo from the date of purchase and write date on sticker. Use new inhaler and blister pack following the "use by" date.
  • Inform patient that formoterol may increase the risk of asthma-related death.
  • Inform patient that in rare cases capsule might break into small pieces. These pieces should be retained by the screen in the inhaler, however in rare instances tiny pieces may reach mouth or throat after inhalation. Shattering of capsule is less likely to happen if storage conditions are strictly followed, capsules removed from blister immediately before use, and capsules are only pierced once.

Evaluation/Desired Outcomes

  • Prevention of bronchospasm.

formoterol

A long-acting beta-2 agonist drug that can be used in ASTHMA patients on inhaled steroids who continue to have symptoms. Brand names are Foradil, Oxis Turbohaler and, with BUDESONIDE, Symbicort.
References in periodicals archive ?
This patent covers Dey's Perforomist Solution, and its term extends until June 22, 2021.
Mylan CEO Heather Bresch commented: "The court's decision to recognize the validity of the patents covering Mylan's Perforomist Inhalation Solution not only affirms the strength of our intellectual property on this product, but also our broader respiratory portfolio, including Mylan's combination product currently in development.
Nasdaq: MYL) today announced that the United States District Court for the Northern District of West Virginia has granted Mylan's motion for partial summary judgment finding that the production and marketing of Teva's generic version of Mylan's Perforomist Inhalation Solution infringes one of Mylan's Orange Book listed patents (U.
The Order states that five of Mylan's patents related to its Perforomist Inhalation Solution are valid and enforceable.
and has reversed the District Court's decision invalidating five of Mylan's patents related to Perforomist.
Critical Therapeutics and DEY entered into an agreement in June 2007 for the co-promotion of Perforomist.
including, without limitation, statements regarding our commercial launch of ZYFLO CR, possible therapeutic benefits, market acceptance and future sales of ZYFLO CR and ZYFLO, the anticipated success of our co-promotion arrangements with DEY, the anticipated commercial launch of Perforomist, the progress and timing of our drug development programs and related trials, the efficacy of our drug candidates, our strategy, future operations, financial position, future revenues and projected costs, including our net cash expenditures for 2007, prospects, plans and objectives of management, and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.
PARI is the only nebulizer company that has demonstrated clinical success in trials for Xopenex, Brovana, DuoNeb, AccuNeb, Perforomist, TOBI, and Cayston.
Twice-daily Perforomist is approved for the long-term maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis.
Food and Drug Administration (FDA) approved DEY's new drug application for Perforomist for the long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).
The segment's main products are the EpiPen Auto-Injector (severe allergies) and Perforomist Inhalation Solution (a formoterol fumarate inhalation solution for the treatment of chronic obstructive pulmonary disorder).