Oxima Plus

Indications

This medication is prescribed for the long-term, once-daily maintenance treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema. It should not be used for acute bronchospasm or for the treatment of asthma.
Always use this medication as directed by a registered healthcare professional.

Composition

Each dry powder inhaler capsule contains:

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

Pharmacology

This inhalation powder combines Glycopyrronium (a long-acting muscarinic antagonist) and Indacaterol (a long-acting beta2-agonist, or LABA). The action of Indacaterol is mediated through stimulation of intracellular adenylate cyclase, which increases the levels of cyclic AMP. This leads to relaxation of the bronchial smooth muscle and inhibits the release of hypersensitivity mediators, especially from mast cells. Glycopyrronium blocks the M3 muscarinic receptors in the airway smooth muscle, promoting bronchodilation and improving airflow.

Dosage & Administration

• Adults (18 years and older): For oral inhalation only. Administer once daily at the same time each day. Do not exceed one dose within 24 hours.
• Maintenance Treatment for COPD: 1 inhalation daily.
• Limitations: This medication is not intended for acute bronchospasm or asthma management.
• Geriatric Use: Safe for use in elderly patients (65 years or older) at the recommended dose.
• Children & Adolescents: Not recommended for use in patients under 18 years. Safety and efficacy in pediatric patients have not been established.
• Renal Impairment: Can be used in patients with mild to moderate renal impairment. Use with caution in severe renal impairment or end-stage renal disease (eGFR < 30 mL/min/1.73m²).
• Hepatic Impairment: Safe for use in mild to moderate hepatic impairment. No data for severe hepatic impairment; use cautiously.

Consult a registered healthcare professional before use.

Interaction

No specific studies have been conducted on the interaction of Glycopyrronium and Indacaterol. However, it is important to avoid concomitant use with beta-adrenergic blockers, anticholinergics, or sympathomimetic drugs, as these may enhance adverse effects. Caution is advised when using this combination alongside treatments that could cause hypokalemia.

Contraindications

This medication is contraindicated in individuals with:

• Hypersensitivity to any component, including Glycopyrronium or Indacaterol.
• Severe allergy to milk proteins.
• Asthma without the use of a long-term asthma control medication.

Side Effects

Common side effects may include:

• Cardiovascular effects: Tachycardia, arrhythmias, palpitations.
• Ocular issues: Blurred vision.
• Urinary retention, dry mouth, cough.
• Respiratory effects: Bronchospasm, throat irritation.

Other side effects might include headache, insomnia, muscle cramps, nervousness, fatigue, hyperglycemia, and hypokalemia. The most frequently reported adverse reactions (more than 3% of patients) are cough and throat pain.

Pregnancy & Lactation

• Pregnancy: Category C. There is no data available on the safety of this medication during pregnancy. It should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus.
• Breastfeeding: The effects of this combination on breast milk are unknown. Use only if the potential benefit to the mother outweighs the risk to the infant.

Warnings & Precautions

• LABA monotherapy: Increases the risk of serious asthma-related events. Not recommended for use in acute COPD or asthma exacerbations.
• Cardiovascular Concerns: Use with caution in patients with a history of cardiovascular disorders.
• Glaucoma and Urinary Retention: May exacerbate conditions like narrow-angle glaucoma or prostatic hyperplasia. Contact a healthcare provider if symptoms worsen.
• Paradoxical Bronchospasm: If this occurs, discontinue use and seek alternative therapy.
• Hypokalemia and Hyperglycemia: Monitor blood potassium and glucose levels, especially for patients with diabetes or other related conditions.

Overdose Effects

An overdose may result in symptoms commonly associated with beta2-adrenergic stimulants, such as:

• Tachycardia, tremors, palpitations, headache, nausea, vomiting, hypokalemia, and hyperglycemia.
• Anticholinergic effects like increased intraocular pressure, constipation, and urinary retention.

In the event of overdose, provide supportive treatment. Hospitalization may be required for serious cases.

Therapeutic Class

Combined bronchodilators.

Storage Conditions

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