Bronchodilator (long-acting beta-2 adrenergic agonist)
Indacaterol is a long-acting bronchodilator (once daily), used for maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma in adults. It opens the airways and relieves breathlessness, but is not for acute attacks.
Also known as: Indacaterol, Onbrez, Hirobriz
Prontuário Terapêutico do INFARMED (11th ed., 2012) — Beta adrenergic agonists (5.1.1) and QUADRO 2 of Annex 7 (Indacaterol)
Prontuário Terapêutico do INFARMED (11th ed., 2012) — 5.1.1 and QUADRO 2 of Annex 7 (Indacaterol)
Indacaterol + salbutamol: potentiation of sympathomimetic effects with other beta-2 adrenergic agonists (QUADRO 2).
Indacaterol (long-acting LABA) and salbutamol (SABA) both activate beta-2-adrenergic receptors; simultaneous use may potentiate systemic effects: tachycardia, palpitations, tremors and dose-dependent hypokalaemia. QUADRO 2 of Annex 7 records this interaction in the indacaterol section. The risk is higher in patients with cardiovascular disease, hyperthyroidism or pre-existing hypokalaemia. Rescue salbutamol use should be limited to acute need; if the patient needs frequent rescue, reassess control of the underlying disease. Monitor heart rate, potassium and adrenergic symptoms.
Indacaterol + salbutamol: additive beta-2-adrenergic effect — risk of tachycardia, tremors and hypokalaemia; use with caution.
Combining beta-2 agonists (long + short acting) potentiates sympathomimetic effects — tachycardia, tremor, hypokalaemia (QUADRO 2, Indacaterol: "Potentiation of sympathomimetic effects with other beta-2 adrenergic agonists").
Monitor heart rate, tremor and potassium.
Tachycardia, tremor, hypokalaemia with concomitant beta-2 use.
Use the short-acting agonist only as needed (rescue); avoid regular concomitant use.
Prontuário Terapêutico do INFARMED (11th ed., 2012) — Annex 7, QUADRO 2 (Indacaterol)
Indacaterol is given by inhalation; food does not affect its use.
May be inhaled regardless of meals.
EMC-UK (MHRA) — approved Onbrez Breezhaler (indacaterol) SmPC: https://www.medicines.org.uk/emc/product/7794/smpc
No documented disease interactions.
Prontuário 5.1.1 (Beta adrenergic agonists): Annex 1 (Pregnancy) records indacaterol with risk factor C (avoid) — use in pregnancy should be weighed; beta-2 bronchodilation may inhibit uterine contractions (class data).
Risk factor C (Annex 1): avoid in pregnancy; use only if benefit justifies risk.
Annex 2 (Breastfeeding): indacaterol is excreted in milk — weigh breastfeeding during treatment (Prontuário line 42756).
Not specifically documented (no requirements in the label/Prontuário).
Prontuário Terapêutico do INFARMED (11th ed., 2012) — Annex 1 (Pregnancy), Annex 2 (Breastfeeding) and 5.1.1
Clinical and educational support tool. The information does not replace a medical prescription or the opinion of a qualified healthcare professional.
Long-acting bronchodilator (once daily): activation of beta-2 receptors on bronchial smooth muscle; used for maintenance of COPD and asthma (Prontuário 5.1.1).
Selective beta-2 adrenergic receptor agonist (bronchodilation); QUADRO 2 records CYP3A4/P-gp inhibition as an interaction (increases plasma levels up to 2-fold).
Inhalation administration (powder for inhalation, capsules — Hirobriz/Onbrez); absorption is pulmonary.
Metabolism mainly by CYP3A4 (substrate); also a P-gp substrate (QUADRO 2 of Annex 7).
Duration of action ≥ 24 hours (once daily) — long duration of action (Prontuário 5.1.1).
