glycopyrrolate/formoterol

General

Pronunciation:
glye-koe-pye-roe-late/for-moe-te-rol

Trade Name(s)

  • Bevespi Aerosphere

Ther. Class.
bronchodilators

Pharm. Class.
anticholinergics
long-acting beta2-adrenergic agonists (LABAs)

Indications

Maintenance treatment of airflow obstruction in patients with COPD.

Action

Glycopyrrolate–acts as an anticholinergic by inhibiting M3 muscarinic receptors in bronchial smooth muscle resulting in bronchodilationFormoterol–a beta2-adrenergic agonist that stimulates adenyl cyclase, resulting in accumulation of cyclic adenosine monophosphate at beta2–adrenergic receptors resulting in bronchodilation.

Therapeutic Effect(s):

Bronchodilation with decreased airflow obstruction.

Pharmacokinetics

Absorption: Glycopyrrolate–some systemic absorption from lungs and GI tract (40%). formoterol–majority of inhaled drug is swallowed and absorbed.

Distribution: Glycopyrrolate–unknown. formoterol–unknown.

Metabolism and Excretion: Glycopyrrolate–undergoes hydroxylation to inactive metabolite; eliminated primarily unchanged in the urine and bile. formoterol–mostly metabolized by the liver; 10–18% excreted unchanged in urine.

Half-life: Glycopyrrolate–33–53 hr. formoterol–10 hr.

TIME/ACTION PROFILE (bronchodilation)

ROUTEONSETPEAKDURATION
formoterol–Inhalnwithin 3 min15 minunknown
glycopyrrolate–Inhalnunknownunknownunknown

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity to any component;
  • Acute attack of COPD (onset of action is delayed);
  • Concurrent use with another LABA;
  • Lactation: Discontinue drug or discontinue breast feeding.

Use Cautiously in:

  • History of cardiovascular disorders (coronary insufficiency, arrhythmias, hypertension);
  • History of seizures;
  • Thyrotoxicosis;
  • Narrow-angle glaucoma;
  • Urinary retention, prostatic hyperplasia, bladder-neck obstruction;
  • Hepatic impairment;
  • OB: Use during pregnancy only if potential benefit justifies potential fetal risk;
  • Pedi: Safety and effectiveness not established.

Exercise Extreme Caution in:

Concurrent use of MAO inhibitors, tricyclic antidepressants or drugs that prolong the QTc interval.

Adverse Reactions/Side Effects

Combination

CNS: anxiety, dizziness, headache

CV: chest pain, hypertension, tachycardia

F and E: hypokalemia

GI: dry mouth, vomiting

GU: urinary tract infection

MS: arthralgia, muscle spasms

Resp: cough, paradoxical bronchospasm

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA, URTICARIA, OR RASH)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  • Concurrent use with other adrenergics may ↑ adrenergic adverse reactions (↑ heart rate, BP, jitteriness).
  • ↑ risk of hypokalemia or ECG changes with xanthine derivatives, corticosteroids, loop diuretics or thiazide diuretics.
  • ↑ risk of serious adverse cardiovascular effects with MAO inhibitors, tricyclic antidepressants, QT-interval prolonging drugs; use with extreme caution.
  • Effectiveness may be ↓ by beta-blockers; use cautiously and only when necessary.
  • ↑ risk of anticholinergic adverse reactions when used concurrently with other anticholinergics; avoid concurrent use.

Route/Dosage

Inhaln (Adults) 2 inhalations twice daily.

Availability

Inhalation aerosol: glycopyrrolate 9 mcg/formoterol 4.8 mcg per inhalation in 10.7–g canister (120 inhalations)

Assessment

  • Assess lung sounds, pulse, and BP before administration and during peak of medication. Note amount, color, and character of sputum produced.
  • 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 health care professional immediately.
  • Monitor ECG periodically during therapy. May cause prolonged QTc interval.
  • Monitor patient for signs of hypersensitivity reactions (difficulties in breathing or swallowing, swelling of tongue, lips and face), urticaria, or skin rash) throughout therapy. Discontinue therapy and consider alternative if reaction occurs.

Lab Test Considerations:

May cause ↑ serum glucose and decreased serum potassium.

Potential Diagnoses

Implementation

  • Inhaln Administer as 2 inhalations twice daily, morning and evening. Shake well prior to use. Prime by releasing 4 sprays into air away from face before 1st use and by releasing 2 sprays if unused for more than 7 days. See Appendix for use of metered-dose inhalers.

Patient/Family Teaching

  • Instruct patient to use medication 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; may cause adverse effects, paradoxical bronchospasm, or loss of effectiveness of medication. Instruct patient to review Medication Guide before starting therapy and with each Rx refill in case of changes.
  • Caution patient not to use medication to treat acute symptoms. A rapid-acting inhaled beta-adrenergic bronchodilator should be used for relief of acute asthma attacks. Notify health care professional immediately if symptoms get worse or more inhalations than usual are needed from rescue inhaler.
  • Advise patient to clean inhaler each wk so medicine will not build up and block spray through mouthpiece. Take canister out of the actuator, run warm water through actuator, and allowing actuator to air-dry overnight. Shake and re-prime with 2 sprays before use.
  • 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, sleeplessness, or signs and symptoms of narrow angle glaucoma (eye pain or discomfort, blurred vision, visual halos or colored images, red eyes) or urinary retention (difficulty passing urine, painful urination) occur.
  • 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 breast feeding.

Evaluation/Desired Outcomes

Bronchodilation with decreased airflow obstruction.

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