Onriva Plus Bexicap 110+50

Indications

This medication is intended for the long-term, once-daily maintenance treatment of airflow obstruction in patients diagnosed with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is not suitable for acute bronchospasm episodes and is not indicated for asthma treatment.

Composition

Each capsule of the dry powder inhaler contains:

• Indacaterol 110 mcg as Indacaterol Maleate INN (Micronized)
• Glycopyrronium 50 mcg as Glycopyrronium Bromide BP (Micronized)

Pharmacology

This inhalation powder combines Glycopyrronium (an anticholinergic) and Indacaterol (a LABA) for oral inhalation delivery. Indacaterol stimulates adenyl cyclase, which increases cyclic AMP levels, leading to bronchial smooth muscle relaxation. Glycopyrronium acts as a long-acting muscarinic antagonist, primarily inhibiting M3 receptors in the airways, thereby promoting bronchodilation.

Dosage & Administration

For adults (18 years and older), administer one inhalation daily at the same time each day. It should not be used more than once every 24 hours.

Limitations of Use This medication is not intended for acute bronchospasm relief or asthma treatment.

Geriatric Use The recommended dose is suitable for elderly patients (65 years and older).

Use in Children & Adolescents This medication is not approved for use in individuals under 18 years old.

Renal Impairment It can be used in patients with mild to moderate renal impairment. Use in severe renal impairment or end-stage renal disease requiring dialysis should be carefully considered based on potential benefits versus risks.

Hepatic Impairment Use in patients with mild to moderate hepatic impairment is acceptable. Caution is advised for patients with severe hepatic impairment due to limited data.

Interactions

No specific interaction studies have been conducted for the combination of Glycopyrronium and Indacaterol. Caution is recommended with concomitant use of β-adrenergic blockers, anticholinergics, or sympathomimetic agents.

Contraindications

This medication is contraindicated in patients with hypersensitivity to Glycopyrronium or Indacaterol, or any other component of the formulation. It is also contraindicated in patients with severe hypersensitivity to milk proteins and in asthma patients not using a long-term control medication.

Side Effects

Common adverse reactions may include cough and oropharyngeal pain. Less common but serious reactions may involve cardiovascular effects, urinary retention, and gastrointestinal disorders.

Pregnancy & Lactation

Category C medication during pregnancy; use only if potential benefits justify potential risks. It is not known whether Indacaterol or Glycopyrronium pass into human milk; breastfeeding should be considered only if benefits outweigh risks.

Precautions & Warnings

Use caution in patients with cardiovascular disorders, convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. Avoid use in acute COPD exacerbations or asthma attacks.

Overdose Effects

Clinical overdose information is limited; symptoms may include tachycardia, tremors, and metabolic disturbances. Supportive care is recommended in case of overdose.

Therapeutic Class

This medication belongs to the class of combined bronchodilators.

Storage Conditions

Store in a cool, dry place away from direct sunlight. Keep out of reach of children and away from eyes.