Foradil


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Related to Foradil: Aerospan

formoterol fumarate

Atimos Modulite (UK), Foradil (UK), Foradil Aerolizer, Oxeze (CA), Oxis (UK), Perforomist

Pharmacologic class: Sympathomimetic; long-acting, selective beta2-adrenergic receptor agonist

Therapeutic class: Bronchodilator

Pregnancy risk category C

Action

Stimulates intracellular adenylate cyclase, relaxing bronchial smooth muscle and inhibiting release of mediators of immediate hypersensitivity

Availability

Capsules for oral inhalation (used with Aerolizer inhaler): 12 mcg

Indications and dosages

Long-term maintenance of asthma; prevention or long-term maintenance of bronchospasm in patients with chronic obstructive pulmonary disease

Adults and children ages 5 and older: Contents of 1 capsule inhaled orally via Aerolizer q 12 hours

Acute prevention of exercise-induced bronchospasm (on occasional, as-needed basis)

Adults and children ages 5 and older: Contents of 1 capsule inhaled orally via Aerolizer at least 15 minutes before start of exercise. Wait 12 hours after initial dose before giving repeat dose.

Contraindications

• Hypersensitivity to drug or its components
• Tachyarrhythmias

Precautions

Use cautiously in:
• acute asthma symptoms, deteriorating asthma, cardiovascular disorders, seizure disorders, thyrotoxicosis, diabetes, possible hypokalemia
• patients older than age 75
• labor
• pregnant or breastfeeding patients
• children younger than age 5.

Administration

• Be aware that drug is not intended for acute asthma attacks.
• Use capsules only with Aerolizer inhaler supplied.
• Keep capsules in blister until immediately before use.

Make sure patient doesn't swallow capsules.

Adverse reactions

CNS: tremor, dizziness, insomnia, anxiety

CV: chest pain

EENT: sinusitis, pharyngitis, tonsillitis

GI: dry mouth

Metabolic: hypokalemia, hyperglycemia

Musculoskeletal: muscle cramps, back pain, leg cramps

Respiratory: bronchitis, chest infection, dyspnea, upper respiratory tract infection, increased sputum

Skin: pruritus, rash

Other: dysphonia, viral infection, fever

Interactions

Drug-drug.Adrenergics: potentiation of formoterol's sympathomimetic effects

Beta-adrenergic blockers: partial or total inhibition of formoterol's effects

Cardiac glycosides, methylxanthines, potassium-wasting diuretics, steroids: potentiation of formoterol's hypokalemic effects, increased risk of arrhythmias

Disopyramide, MAO inhibitors, quinidine, phenothiazines, procainamide, tricyclic antidepressants: prolonged QTc interval, increased risk of ventricular arrhythmias

Halogenated hydrocarbon anesthetics: increased risk of arrhythmias

Levodopa, levothyroxine, oxytocin: impaired cardiac tolerance of formoterol

Drug-diagnostic tests.Blood glucose: increased level

Potassium: decreased level

Drug-behaviors.Alcohol use: impaired cardiac tolerance of formoterol

Patient monitoring

• Monitor pulmonary function test results.
• Monitor potassium and glucose levels.

Patient teaching

• Teach patient how to use capsules and Aerolizer inhaler provided.
• Instruct patient to keep capsules in blisters until immediately before use.
• Caution patient not to swallow capsules.
• Tell patient not to use drug for acute asthma attacks.

Instruct patient to contact prescriber immediately if difficulty in breathing persists after using drug or if condition worsens.
• Caution patient to take drug exactly as prescribed and not to stop therapy even if he feels better.
• Tell patient to consult prescriber if he has been taking inhaled, short-acting drugs on a regular basis.
• Advise female patient to tell prescriber if she is pregnant or breastfeeding or if she plans to become pregnant.
• Caution patient to avoid alcohol during therapy.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

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.

Foradil

(fôr′ə-dĭl)
A trademark for a preparation of the drug formoterol fumarate.

Foradil

A brand name for EFORMOTEROL (formoterol).
References in periodicals archive ?
The investigational fixed-dose combination of ASMANEX and FORADIL, both of which are currently approved and marketed as individual products, is in Phase III development for the treatment of asthma and COPD.
The LABA products approved in the United States are Serevent (salmeterol) and Foradil (formoterol), which contain the LABA alone, and Advair (salmeterol plus fluticasone) and Symbicort (formoterol plus budesonide), which contain the LABA and an ICS.
The other, Foradil (formoterol) also works for 12 hours, "The long-acting bronchodilators are very effective in COPD, and the inhaled route is safer than oral doses for these patients who are older and have comorbidities," he said.
FORADIL AEROLIZER should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.
Serevent and Foradil also are approved for COPD, so they will remain on the market, but the warnings about not using them without an ICS in patients with asthma likely will be strengthened.
FORADIL AEROLIZER, a long-acting beta2 agonist for asthma and chronic obstructive pulmonary disease.
Foradil Aerolizer (formoterol fumarate), made by Novartis AG, is included in the health advisory.
Comment: In a Novartis-supported study of 780 patients with COPD, Foradil was better than placebo and ipratropium bromide in improving lung function over 12 weeks.
A spokesperson for Novartis, the manufacturer (with Schering-Plough) of Foradil, said that the company was working with the FDA on the most appropriate language for the package label and medication guide.
The Committee recommended the continued availability of long-acting beta-2 agonists Advair (fluticasone propionate and salmeterol) and Symbicort (budesonide/formoterol fumarate dihydrate) but said Serevent (salmeterol xinafoate) and Foradil (formoterol fumarate) should no longer be used for treating asthma.