Onbrez 300 mcg (Inhalation Capsule)

Indications

• Treatment of airflow obstruction in patients with COPD
• Long-acting β2-adrenergic agonist
• Maintenance bronchodilator treatment of airflow obstruction
• Relaxation of bronchial smooth muscles

Description

• Acts locally in the lung as a bronchodilator
• Pharmacological effects include stimulation of intracellular adenyl cyclase
• Once-daily maintenance bronchodilator treatment

Dosage & Administration

• Once-daily inhalation of specified dosage
• Oral inhalation only
• No dosage adjustment for geriatric patients
• Not indicated for pediatric population

Interaction

• Interaction with Adrenergic Drugs, Xanthine Derivatives, Steroids, or Diuretics
• Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate hypokalemic effect
• Administration with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval
• Interference with the effect of beta-blockers when administered concurrently

Contraindications

• Contraindicated in patients with asthma without use of a long-term asthma control medication
• Contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients

Side Effects

• Commonly reported adverse effects: cough, nasopharyngitis, headache, nausea, oropharyngeal pain
• Other reported effects: hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis, dizziness

Pregnancy & Lactation

• Pregnancy Category C
• Caution during pregnancy if potential benefit justifies potential risk to the fetus
• Caution during nursing as active component may be excreted in human milk

Precautions & Warnings

• Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta agonist
• Not shown to be safe or effective to treat asthma
• Not approved for use in asthma

Overdose Effects

• Signs and symptoms associated with over dosage: excessive beta-adrenergic stimulation, angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps
• Risk of cardiac arrest and even death

Therapeutic Class

• Long-acting selective β-adrenoceptor stimulants

Storage Conditions

• Store in the blister, remove immediately before use
• Keep in a cool & dry place
• Keep out of the reach of children

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