Glycopyrronium Bromide And Indacaterol Maleate
Pronunciation: glye-koe-PIE-roe-nee-um / in-da-KA-ter-ol.
- Generic name
- glycopyrronium bromide and indacaterol maleate
- Brand names
- Indacron-G, Ultibro Breezhaler, Ultibro, Indacip-G, Ultibro Inhaler, Indabreez
- Drug class
- Long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA) combination
Availability and supply rules vary by country
Trade names by country: India
Australia: · Full directory
What glycopyrronium bromide and indacaterol maleate is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how glycopyrronium bromide and indacaterol maleate works
Glycopyrronium is a long-acting muscarinic antagonist (LAMA) that inhibits acetylcholine-mediated bronchoconstriction by blocking M3 receptors in airway smooth muscle. Indacaterol is a long-acting beta2-adrenergic agonist (LABA) that stimulates beta2-receptors, leading to relaxation of bronchial smooth muscle. The combination provides dual bronchodilation, improving airflow and reducing COPD symptoms.
What glycopyrronium bromide and indacaterol maleate is used for
Chronic obstructive pulmonary disease (COPD)
Indicated as a maintenance bronchodilator to relieve symptoms in adult patients with COPD, including chronic bronchitis and emphysema. (2)
Bronchospasm associated with COPD
Helps relieve the airway tightening (bronchospasm) that contributes to breathlessness, cough, and wheezing in COPD. (2)
Maintenance treatment of airflow obstruction in COPD
Used once daily as long-term maintenance therapy to keep airways open; it is not a rescue inhaler for sudden symptoms. (2)
Before taking glycopyrronium bromide and indacaterol maleate
Do not take / not appropriate for
- Hypersensitivity to glycopyrronium, indacaterol, or excipients. (Contraindication) (2)
- severe milk protein allergy. (Contraindication)
Tell your clinician about
(2)How to take glycopyrronium bromide and indacaterol maleate
- General Instructions: Use one capsule via the Breezhaler inhaler once daily, at the same time each day. Do not swallow the capsule.. Adult Dosing: The usual dose is one capsule (containing 110 mcg indacaterol and 50 mcg glycopyrronium as the metered dose in the capsule; the amount actually delivered from the mouthpiece is 85 mcg indacaterol and 43 mcg glycopyrronium) inhaled once daily.. Pediatric Dosing: Safety and efficacy in children and adolescents under 18 years have not been established; not recommended for pediatric use.. Administration: Insert the capsule into the Breezhaler device, pierce the capsule, and inhale the powder deeply. Discard the empty capsule after use.. When To Stop: Do not stop using this medication without consulting your doctor, even if you feel better. Stopping suddenly may worsen symptoms.. Storage: Store capsules in the original blister pack at room temperature, away from moisture and heat. Do not remove capsules until ready to use.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once.
Overdose
If you inhale more than the prescribed dose, seek medical attention immediately. Symptoms of overdose may include fast or irregular heartbeat, chest pain, tremors, or severe shortness of breath. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Nasopharyngitis
Incidence: Reported in the clinician-authored database; frequency not established
Cough
Incidence: Reported in the clinician-authored database; frequency not established
Urinary tract infection
Incidence: Reported in the clinician-authored database; frequency not established
Muscle spasms
Incidence: Reported in the clinician-authored database; frequency not established
Palpitations
Incidence: Reported in the clinician-authored database; frequency not established
Dizziness
Incidence: >=3% (per EMA/emc SmPC)
Dyspepsia (indigestion)
Incidence: >=3% (per EMA/emc SmPC)
Dental caries
Incidence: >=3% (per EMA/emc SmPC)
Paradoxical bronchospasm — sudden worsening of wheezing or breathing difficulty right after using the inhaler
Incidence: Rare but potentially life-threatening; stop this inhaler and seek immediate medical attention
New or worsening eye pain/vision changes (possible glaucoma) or difficulty passing urine (possible urinary retention)
Incidence: Uncommon but should be evaluated promptly
Serious warnings
Not for use in acute asthma or sudden breathing problems — serious
Symptoms: Not for use in acute asthma or sudden breathing problems. May cause paradoxical bronchospasm — a potentially life-threatening worsening of breathing right after a dose — which requires stopping this inhaler immediately and switching to an alternative treatment if it happens. Use with caution in patients with cardiovascular disorders (coronary artery disease, prior heart attack, arrhythmias, or hypertension), since this medicine can increase heart rate and blood pressure. May increase risk of urinary retention and narrow-angle glaucoma (no specific safety data exist for this product in those conditions). Contains lactose; avoid if you have severe milk protein allergy.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications: Hypersensitivity to glycopyrronium, indacaterol, or excipients; severe milk protein allergy. Precautions: Use with caution in patients with cardiovascular disease, arrhythmias, narrow-angle glaucoma, urinary retention, prostatic hyperplasia, seizure disorders, and uncontrolled diabetes. Not recommended for asthma or acute bronchospasm.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Glycopyrronium/Indacaterol may interact with other anticholinergic or beta-agonist medications, increasing the risk of side effects. Use caution with other inhaled medicines, certain antidepressants, beta-blockers, and drugs that prolong the QT interval. Always inform your healthcare provider about all medications and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
No human pregnancy data are available. Indacaterol, a beta2-agonist, may inhibit labor because of its relaxant effect on uterine smooth muscle. This medicine should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus, as decided together with the treating clinician. (2)
Breastfeeding
There is not enough data to confirm the safety of this medicine during breastfeeding. A decision to use it while breastfeeding should be made only if the benefit to the mother clearly outweighs any potential risk to the infant, in discussion with the treating clinician. (2)
Children
Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Safety not established in children. (2)
Renal_impairment
Renal impairment: standard dosing is used for mild-to-moderate impairment; in severe renal impairment, glycopyrronium exposure can increase up to about 2.2-fold, so this medicine is used only if the expected benefit outweighs the risk. Hepatic impairment: standard dosing is used for mild-to-moderate impairment; caution is advised in severe hepatic impairment because of limited safety data. (2)
Hepatic_impairment
Renal impairment: standard dosing is used for mild-to-moderate impairment; in severe renal impairment, glycopyrronium exposure can increase up to about 2.2-fold, so this medicine is used only if the expected benefit outweighs the risk. Hepatic impairment: standard dosing is used for mild-to-moderate impairment; caution is advised in severe hepatic impairment because of limited safety data. (2)
Monitoring
(2)Storage
Do not store above 25°C. Keep the capsules in the original blister pack to protect them from moisture, and do not remove a capsule from the blister until ready to use.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Chronic obstructive pulmonary disease (COPD)
Dose summary: One inhalation once daily (metered dose per capsule: indacaterol 110 mcg / glycopyrronium 50 mcg; delivered dose: indacaterol 85 mcg / glycopyrronium 43 mcg).
Renal context: Standard dosing for mild-to-moderate renal impairment. In severe renal impairment, glycopyrronium exposure can increase up to about 2.2-fold; use only if the expected benefit outweighs the risk. (2)
Frequently asked questions
What is Glycopyrronium/Indacaterol (Ultibro Breezhaler) used for?
It is used for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, to help improve breathing and reduce symptoms.
How should I use the Ultibro Breezhaler device?
Insert one capsule into the Breezhaler device, pierce the capsule, and inhale the powder deeply. Do not swallow the capsule. Follow the instructions provided with your inhaler.
Can I use this inhaler for sudden breathing problems?
No, Glycopyrronium/Indacaterol is not a rescue inhaler. It should not be used for acute symptoms or sudden breathing attacks. Use a fast-acting inhaler as prescribed for emergencies.
What should I do if I miss a dose?
Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not take two doses at once.
Are there any foods or medicines I should avoid?
Avoid using other inhaled bronchodilators or anticholinergic medications unless directed by your doctor. Inform your healthcare provider about all medicines and supplements you take.
What are the most common side effects?
Common side effects (occurring in 3% or more of patients) include cough, nasopharyngitis (runny/stuffy nose and sore throat), headache, dizziness, indigestion, and dental caries. Muscle spasms, urinary tract infection, and palpitations have also been reported. Serious side effects are rare but require immediate medical attention.
Is it safe to use during pregnancy or breastfeeding?
There is limited data on use in pregnancy or breastfeeding. Discuss with your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
What happens if I take too much Glycopyrronium/Indacaterol (Ultibro Breezhaler)?
Taking too much Glycopyrronium/Indacaterol can lead to symptoms such as increased heart rate, tremors, dry mouth, blurred vision, and urinary retention. In severe cases, it could cause cardiac arrhythmias or seizures. If an overdose is suspected, seek immediate emergency medical attention. Do not attempt to self-treat the symptoms.
Can I drink alcohol while taking Glycopyrronium/Indacaterol (Ultibro Breezhaler)?
While there are no specific contraindications for alcohol consumption with Glycopyrronium/Indacaterol, it is generally advisable to limit alcohol intake. Alcohol can dehydrate the body and may exacerbate some side effects like dry mouth, which is a common anticholinergic effect of glycopyrronium. Consult your healthcare provider for personalized advice regarding alcohol use.
Is Glycopyrronium/Indacaterol (Ultibro Breezhaler) safe during pregnancy?
Glycopyrronium/Indacaterol is not recommended for use during pregnancy unless the potential benefit outweighs the potential risk to the fetus. Animal studies have shown some adverse effects, but there are no adequate and well-controlled studies in pregnant women. It is crucial to consult your doctor to discuss the risks and benefits and determine the safest course of action for your specific situation.
What is the mechanism of action of glycopyrronium bromide and indacaterol maleate?
Glycopyrronium is a long-acting muscarinic antagonist (LAMA) that inhibits acetylcholine-mediated bronchoconstriction by blocking M3 receptors in airway smooth muscle. Indacaterol is a long-acting beta2-adrenergic agonist (LABA) that stimulates beta2-receptors, leading to relaxation of bronchial smooth muscle. The combination provides dual bronchodilation, improving airflow and reducing COPD symptoms.
What is the generic name of Glycopyrronium Bromide And Indacaterol Maleate?
The generic name is glycopyrronium bromide and indacaterol maleate. It is sold under brand names including Indacron-G, Ultibro Breezhaler, Ultibro, Indacip-G, Ultibro Inhaler, Indabreez.
What class of drug is glycopyrronium bromide and indacaterol maleate?
Glycopyrronium Bromide And Indacaterol Maleate is classed as: Long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA) combination.
References
- Glycopyrronium/Indacaterol (Ultibro Breezhaler) — clinician-authored medicine recordMedGuideGlobal · Global · accessed 2026-08-06 · source 1
- Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules — Summary of Product Characteristicselectronic Medicines Compendium (UK) · United Kingdom · accessed 2026-08-06 · source 2
Brand names by country
Single-ingredient glycopyrronium bromide and indacaterol maleate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
India
- Loftair110/50 mcg · Lupin
- Indaglyn50/110 mcg · Zydus Healthcare Limited
- Indaflo Gnot stated in listing · Cipla Limited
- Indactiv Gnot stated in listing · Glenmark Pharmaceuticals
- Glycobreez Inot stated in listing · Mankind Pharmaceuticals Ltd
- Glycopress Indusnot stated in listing · Steris Healthcare