indacaterol

(redirected from Onbrez Breezhaler)

indacaterol

(in-da-kat-e-role) ,

Arcapta Neohaler

(trade name),

Onbrez Breezhaler

(trade name)

Classification

Therapeutic: bronchodilators
Pharmacologic: adrenergics
Pregnancy Category: C

Indications

Long-term maintenance treatment of airflow obstruction associated with chronic obstructive pulmonary disease (COPD).

Action

Produces accumulation of cyclic adenosine monophosphate (cAMP) at beta2-adrenergic receptors. Relatively specific for pulmonary receptors.
Acts as a long-acting beta-agonist (LABA).

Therapeutic effects

Bronchodilation, with improvement in symptoms of COPD.

Pharmacokinetics

Absorption: Some systemic absorption from lungs and GI tract (43–45%).
Distribution: Extensively distributed.
Metabolism and Excretion: 54% excreted unchanged in feces; absorbed drug is mostly metabolized; 23% excreted in feces as metabolites.
Half-life: 45.5–126 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
Inhalnunknown15 min24 hr†
† Bronchodilation.

Contraindications/Precautions

Contraindicated in: HypersensitivityAcutely deteriorating COPD or acute respiratory symptoms;Asthma.
Use Cautiously in: Obstetric: Use during pregnancy only if potential benefit justifies potential fetal risks; may interfere with uterine contractility during labor; Pediatric: Safety and effectiveness not established.
Exercise Extreme Caution in: Concurrent use of MAO inhibitors, tricyclic antidepressants or drugs that prolong the QTc interval (↑ risk of adverse cardiovascular reactions).

Adverse Reactions/Side Effects

Central nervous system

  • headache

Ear, Eye, Nose, Throat

  • nasopharyngitis
  • oropharyngeal pain

Respiratory

  • paradoxical bronchospasm (life-threatening)
  • cough

Gastrointestinal

  • nausea

Miscellaneous

  • allergic reactions (life-threatening)

Interactions

Drug-Drug interaction

↑ risk of serious adverse cardiovascular effects with MAO inhibitors, tricyclic antidepressants, drugs that prolong the QTc interval ; use with extreme caution.Effectiveness may be ↓ by beta-blockers; use cautiously and only when necessary.Concurrent use with other adrenergics may ↑ adrenergic adverse reactions (↑ heart rate, BP, jitteriness).↑ risk of hypokalemia or ECG changes with xanthine derivatives, corticosteroids, diuretics, or non-potassium sparing diuretics.Use with caffeine-containing herbs (cola nut, guarana, mate, tea, coffee) ↑ stimulant effect.

Route/Dosage

Inhalation (Adults) 75 mcg once daily.

Availability

Capsules for inhalation: 75 mcg

Nursing implications

Nursing assessment

  • Assess respiratory status (rate, breath sounds, degree of dyspnea, pulse) before administration and at peak of medication. Consult health care professional about alternative medication if severe bronchospasm is present; onset of action is too slow for patients in acute distress. If paradoxical bronchospasm (wheezing) occurs, withhold medication and notify health care professional immediately.
  • Monitor for signs and symptoms of allergic reactions (difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash). Discontinue therapy if symptoms occur.
  • Lab Test Considerations: May cause transient hypokalemia and hyperglycemia.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Risk for activity intolerance (Indications)

Implementation

  • Inhalation: Pull cap off Neohaler. Open inhaler by holding the base and tilting the mouthpiece. Tear perforation to separate one blister from blister card; peal away protective back to expose foil. With dry hands, push capsule through foil to remove. Insert capsule into capsule chamber; do not swallow capsule or place directly into mouthpiece. Close inhaler until it clicks. Press both buttons fully 1 time; click is heard as capsule is pierced; do not press piercing buttons more than 1 time. Release buttons fully. Breathe out; do not blow into mouthpiece. Close lips around mouthpiece; hold inhaler with buttons left and right (not up and down). Breathe in rapidly and steadily, as deep as possible, a whirring noise is heard. Continue to hold breath as long as possible while removing inhaler from mouth. Open inhaler, if powder remains in capsule, close inhaler and inhale again. Usually requires 1–2 breaths. Remove capsule.

Patient/Family Teaching

  • Instruct patient in the correct use of capsules and Neohaler. Advise patient not to discontinue without consulting health care professional; symptoms may recur.
  • Inform patient that indacaterol is not a bronchodilator and should not be used for treating sudden breathing problems.
  • Advise patient to notify health care professional if signs and symptoms of allergic reaction, worsening symptoms; decreasing effectiveness of inhaled, short-acting beta2-agonists; need for more inhalations than usual of inhaled, short-acting beta2-agonists; or significant decrease in lung function occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products without consulting health care professional.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decrease in the number of flare-ups or the worsening of COPD symptoms (exacerbations).
References in periodicals archive ?
Limited Tenders are invited for Supply of Rotacap Formoterol 6 mcg+Budesonide 100 mcg, Rotacaps Beclomethasone 100+Salbutamol200, Rotacaps Budesonide 200 mcg, 100 mcg, Rotacaps Salbutamol 100 mcg, Rotacaps Salmeterol+Fluticasone 100 mcg, Rotacaps Tiotropium bromide 18mcg, Misc Rotahaler, Onbrez Breezhaler 150 mcg and 300 mcg.
The INSTEAD switch study also showed similar symptomatic benefits in terms of shortness of breath and health status after 12 and 26 weeks in patients treated with Onbrez Breezhaler compared to those on SFC.
These positive results help inform the switch from salmeterol/fluticasone to Onbrez Breezhaler in patients with moderate COPD and who are at low risk of exacerbations.
We also note that other than QVA149, Novartis' COPD portfolio includes Onbrez Breezhaler (indacaterol maleate) which was launched in the US under the brand name Arcapta Neohaler and in Japan under the name Onbrez Inhalation Capsules where it is being co-promoted by Eisai and Co.
Indacaterol was first approved in November 2009 in the European Union under the brand-name Onbrez Breezhaler.
QAB149 is approved at 150 and 300 mcg once-daily doses in more than 50 countries worldwide under the brand-name Onbrez Breezhaler.
Novartis Gets EU Approval for Onbrez Breezhaler II-47