Onriva Plus 110 mcg+50 mcg (Inhalation Capsule)

Indications

• Long-term once-daily maintenance bronchodilator treatment
• Airflow obstruction
• Chronic obstructive pulmonary disease (COPD)
• Chronic bronchitis
• Emphysema

Composition

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

Pharmacology

• Delivery of combination of Glycopyrronium and Indacaterol via oral inhalation
• Stimulation of intracellular adenyl cyclase by Indacaterol
• Relaxation of bronchial smooth muscle by increased cyclic AMP levels
• Pharmacological effects of Glycopyrronium through inhibition of M3 receptor at the smooth muscle
• Long-acting muscarinic antagonist (anticholinergic)

Dosage & Administration

• Once daily maintenance treatment for COPD
• Not for relief of acute bronchospasm or for the treatment of asthma
• Recommended dose for elderly patients
• Not indicated for use in children and adolescents
• Use with caution in patients with renal impairment
• Use with caution in patients with hepatic impairment

Interaction

• No specific interaction studies for Glycopyrronium and Indacaterol combination
• Concomitant use with β-adrenergic blockers, anticholinergics, or sympathomimetic agents is not recommended
• Caution required with concomitant use of hypokalemic treatment

Contraindications

• Hypersensitivity to Glycopyrronium or Indacaterol
• Severe hypersensitivity to milk proteins
• All LABA contraindicated in patients with asthma without use of a long-term asthma control medication

Side Effects

• Cardiovascular effects
• Ocular disorders
• Urinary retention
• Gastrointestinal disorders
• Dry mouth
• Cough
• β2-agonist related adverse reactions
• Common adverse drug reactions

Pregnancy & Lactation

• Pregnancy category C
• Use during pregnancy only if expected benefit justifies potential risk to the fetus
• Consideration of use during breastfeeding if expected benefit to the woman is greater than any possible risk to the infant

Precautions & Warnings

• Increased risk of serious asthma-related events with LABA monotherapy
• Do not initiate in acutely deteriorating COPD or asthma
• Caution with additional therapy containing a LABA
• Institute alternative therapy if paradoxical bronchospasm occurs
• Caution in patients with cardiovascular disorders
• Caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis
• Worsening of narrow-angle glaucoma may occur
• Worsening of urinary retention may occur
• Alert to hypokalemia and hyperglycemia

Overdose Effects

• No information on clinically relevant overdosing with Onriva Plus
• Exaggerated effects typical of β2-adrenergic stimulants in overdose
• Anticholinergic effects in overdose
• Supportive and symptomatic treatment indicated
• Hospitalization in serious cases

Therapeutic Class

• Combined bronchodilators

Storage Conditions

• Avoid storage in direct sunlight or heat
• Store in a cool & dry place
• Keep away from eyes
• Keep all medicines out of reach of children

Related Brands

• Ultibro 110 mcg+50 mcg (Inhalation Capsule) - novartis-bangladesh-ltd
• Indica-G 110 mcg+50 mcg (Inhalation Capsule) - acme-laboratories-ltd