Ultibro Breezhaler

Ultibro Breezhaler

indacaterol + glycopyrronium

Manufacturer:

Novartis Indonesia
Full Prescribing Info
Contents
Indacaterol, glycopyrronium.
Description
Each capsule contains indacaterol maleate equivalent to indacaterol base 110 mcg and glycopyrronium bromide equivalent to glycopyrronium base 50 mcg.
Indications/Uses
Once-daily maintenance bronchodilator treatment to relieve symptoms and reduce exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD) who inadequately controlled with indacaterol alone or glycopyrronium alone.
Dosage/Direction for Use
Adults: Recommended Dose: Once daily inhalation of the content of one 110/50 mcg capsule using the Ultibro Breezhaler inhaler.
Special Populations: Renal Impairment: Can be used at recommended dose in patients with mild to moderate renal impairment. Should be used only if expected benefit outweighs the potential risk in patients with severe renal impairment or end-stage renal disease requiring dialysis.
Hepatic Impairment: Can be used at the recommended dose in patients with mild and moderate hepatic impairment. No data are available for subjects with severe hepatic impairment.
Elderly: Can be used at recommended dose in patients ≥75 years.
Administration: Ultibro Breezhaler capsules must be administered by the oral inhalation route and only using the Ultibro Breezhaler inhaler. Capsules must not be swallowed. It should be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible. Patients should be instructed not to take >1 dose daily. Capsules must always be stored in the blister to protect from moisture and only removed immediately before use. Patients should be instructed on how to administer the product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.
Contraindications
Hypersensitivity to indacaterol or glycopyrronium or to any of the excipients of Ultibro Breezhaler.
Special Precautions
Ultibro Breezhaler should not be administered concomitantly with other long-acting β-agonists or long-acting muscarinic-antagonists.
Asthma: Should not be used in asthma, long-acting β2-adrenergic agonists may increase the risk of asthma-related serious adverse reactions, including asthma-related deaths, when used for treatment of asthma.
Not for Acute Use: Should not be used as rescue therapy.
Hypersensitivity: If hypersensitivity reaction occurs, Ultibro Breezhaler should be discontinued immediately and alternative therapy must be instituted.
Paradoxical Bronchospasm: As with other inhalation therapy, administration may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, Ultibro Breezhaler should be discontinued immediately and alternative therapy must be instituted.
Anticholinergic Effects Related to Glycopyrronium: Use with caution in patients with narrow-angle glaucoma and urinary retention.
Systemic Effects of β-Agonists: As with other β2-adrenergic agonists, should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension); in patients with convulsive disorders or thyrotoxicosis; in patients who are unusually responsive to β2-adrenergic agonists.
Patients with Severe Renal Impairment: To be used only if expected benefit outweighs potential risk in patients with severe renal impairment including end-stage renal disease requiring dialysis.
Cardiovascular Effects of β-Agonists: Like other β2-adrenergic agonists, may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms, electrocardiogram (ECG) changes.
Hypokalemia with β-Agonists: β2-adrenergic agonists may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. In patients with severe COPD, hypokalemia may be potentiated by hypoxia and concomitant treatment which may increase the susceptibility to cardiac arrhythmias.
Hyperglycemia with β-Agonists: Clinically notable changes in blood glucose (4.1%) at the recommended dose than on placebo (2.3%). Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled.
Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ultibro Breezhaler.
Impairment of Fertility: Reproduction studies or other data in animals did not reveal a problem or potential problem concerning fertility in either males or females.
Use in pregnancy: Should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.
Women of Childbearing: There are no special recommendations for women of childbearing potential.
Labor and Delivery: Information Related to Indacaterol: Like other β2-adrenergic agonist containing drugs, Ultibro Breezhaler may inhibit labor due to a relaxant effect on uterine smooth muscle.
Use in lactation: Should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
Use in children <18 years: Should not be used in patients <18 years.
Use In Pregnancy & Lactation
Use in pregnancy: Should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.
Women of Childbearing: There are no special recommendations for women of childbearing potential.
Labor and Delivery: Information Related to Indacaterol: Like other β2-adrenergic agonist containing drugs, Ultibro Breezhaler may inhibit labor due to a relaxant effect on uterine smooth muscle.
Use in lactation: Should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
Adverse Reactions
Very Common (≥10%): Upper respiratory tract infection. Common (≥1% to <10%): Nasopharyngitis, urinary tract infection (UTI), sinustitis, rhinitis, dizziness, headache, cough, oropharyngeal pain including throat irritation, dyspepsia, dental caries, musculoskeletal pain, pyrexia, chest pain. Uncommon (≥0.1 to <1%) and Potentially Serious: Glaucoma, hypersensitivity, diabetes mellitus and hyperglycemia, ischemic heart disease, atrial fibrillation. Uncommon (≥0.1% to <1%): Insomnia, paresthesia, tachycardia, palpitations, epistaxis, dry mouth, pruritus/rash, muscle spasm, myalgia, bladder obstruction including urinary retention, peripheral edema, fatigue. Not Known: Angioedema.
Some serious adverse events, including hypersensitivity and ischemic heart disease, have been reported as adverse drug reactions for Ultibro Breezhaler (0.1% vs 0% for placebo and 0.4% vs 0.3% for placebo, respectively).
Elderly Patients Only: UTI.
Additional Adverse Reactions from Individual Components: Not Known and Potentially Serious: Paradoxical bronchospasm. Not Known: Gastroenteritis, pain in extremity.
Drug Interactions
No specific drug-drug interaction studies were conducted with Ultibro Breezhaler. Information on the potential for interactions is based on the potential for each of its 2 components. Should not be given together with β-adrenergic blockers (including eye drops) unless there are compelling reasons for their use. Should be administered with caution to patients being treated with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), or drugs known to prolong the QT-interval. Drugs known to prolong the QT-interval may increase the risk of ventricular arrhythmia. Concomitant administration of other sympathomimetic agents may potentiate the adverse reactions. Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate the possible hypokalemic effect of β2-adrenergic agonists. Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-gp, has no impact on safety of therapeutic doses. Co-administration with other inhaled anticholinergic-containing drugs has not been studied and is therefore not recommended. No clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of the organic cation transport.
ATC Classification
R03AL04 - indacaterol and glycopyrronium bromide ; Belongs to the class of combination of adrenergics with anticholinergics, that may also include a corticosteroid. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Inhalation powd cap 1 x 6's + 1 inhaler, 2 x 6's + 1 inhaler, 5 x 6's + 1 inhaler.
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