**Off Market Drug**
This medication is no longer available in the United States. Information provided here is for reference purposes only.
- Ultibrol Breezhaler
- Utibron Neohaler
long-acting beta2-adrenergic agonists (LABAs)
Maintenance treatment of airflow obstruction in patients with COPD.
Indacaterol– a beta2 -adrenergic agonist that stimulates adenyl cyclase, resulting in accumulation of cyclic adenosine monophosphate at beta2 –adrenergic receptors resulting in bronchodilation glycopyrrolate– acts as an anticholinergic by inhibiting M3 muscarinic receptors in bronchial smooth muscle resulting in bronchodilation.
Bronchodilation with decreased airflow obstruction.
Absorption: Indacaterol– some systemic absorption from lungs and GI tract (43–45%); glycopyrrolate– some systemic absorption from lungs and GI tract (40%).
Distribution: Indacaterol– extensively distributed; glycopyrrolate– unknown.
Metabolism and Excretion: Indacaterol– 54% excreted unchanged in feces; absorbed drug is mostly metabolized; 23% excreted in feces as metabolites; glycopyrrolate– undergoes hydroxylation to inactive metabolite; eliminated primarily unchanged in the urine and bile.
Half-life: Indacaterol– 45.5–126 hr; glycopyrrolate– 33–53 hr.
TIME/ACTION PROFILE (blood levels)
- Hypersensitivity to any component;
- Acutely deteriorating COPD or acute respiratory symptoms;
- Lactation: Discontinue drug or discontinue breast feeding.
Use Cautiously in:
- History of cardiovascular disorders (coronary insufficiency, arrhythmias, hypertension);
- History of seizures;
- Narrow-angle glaucoma;
- Urinary retention, prostatic hyperplasia, bladder-neck obstruction;
- Severe hepatic impairment;
- OB: Use only if potential maternal benefit justifies potential fetal risk; indacaterol may interfere with uterine contractility during labor;
- 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
CV: hypertension, tachycardia
EENT: nasopharyngitis, rhinitis
F and E: hypokalemia
Resp: paradoxical bronchospasm, respiratory tract infection
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA, URTICARIA, OR RASH)
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
- 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.
- Concurrent use with strong dual inhibitors of CYP3A4 and P-glycoprotein, including ketoconazole, erythromycin, verapamil, or ritonavir , may ↑ risk of adverse cardiovascular effects of indacaterol (use cautiously).
Inhaln (Adults): 1 capsule (indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg) twice daily.
Dry powder capsules for inhalation: indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg
- 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 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 serum potassium.
- Ineffective airway clearance (Indications)
- Inhaln Administer as 1 inhalation twice daily, morning and evening.
- Remove capsule from blister pack immediately before use. Use only with Neohaler. Always use new Neohaler provided with each Rx. Powder is only for oral inhalation and capsules must not be swallowed. To make sure full dose is taken, open inhaler to check that no powder left in capsule. If capsule is empty, full dose was delivered.
- 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.
- 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.
- Utibron Neohaler: Make sure piercing buttons are to left and right of inhaler (not up and down). Exhale completely, and then close lips firmly around mouthpiece. Breathe in rapidly but steadily, as deeply as possible. As you breathe in through inhaler, capsule spins around in chamber and you should hear a whirring noise. If you do not hear whirring noise, capsule may be stuck in capsule chamber. Open inhaler and carefully loosen capsule by tapping base of inhaler. You may experience a sweet flavor as you inhale the medicine. Hold breath for 5–10 seconds to ensure deep instillation of medication. Remove inhaler from mouth and breathe out gently. Open inhaler to see if powder is left in capsule. If powder left in capsule, close inhaler and repeat inhalation. Capsule is usually emptied with 1 or 2 inhalations. Allow 1–2 min between inhalations. Remove empty capsule by tipping it out of capsule chamber, and throwing it away; do not leave empty capsule in chamber. (See medication administration techniques).
Bronchodilation with decreased airflow obstruction.
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