Product Information:

VILANTO-U 62.5mcg + 25mcg is a fixed-dose combination dry powder inhaler (DPI) containing:

1. Glycopyrronium Bromide 62.5mcg – a long-acting muscarinic antagonist (LAMA) that blocks acetylcholine-induced bronchoconstriction
2. Mometasone Furoate 25mcg – an inhaled corticosteroid (ICS) that reduces airway inflammation

This dual-combination therapy is primarily indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults, particularly those with a history of exacerbations or persistent symptoms despite bronchodilator therapy.

⚠️ Important Note:

While LAMA/ICS combinations are used off-label in some asthma cases, VILANTO-U is not approved as first-line therapy for asthma. It is primarily formulated for COPD management.

Uses of (VILANTO-U 62.5 + 25mcg):

1. Maintenance treatment of moderate to severe COPD (FEV₁ <70% predicted)
2. Patients with history of exacerbations or ongoing symptoms (dyspnea, cough, sputum)
3. Alternative to LABA/ICS in COPD patients who benefit more from anticholinergic than beta-agonist therapy

Key Benefits of (VILANTO-U 62.5 + 25mcg):

1. Dual action: bronchodilation (LAMA) + anti-inflammatory (ICS)
2. Reduces frequency of COPD flare-ups
3. Improves lung function, breathlessness, and quality of life
4. Once-daily dosing for consistent 24-hour control

How To Use (VILANTO-U 62.5 + 25mcg):

1. Insert one capsule into the compatible DPI device (e.g., Breezhaler®).
2. Pierce the capsule and inhale quickly and deeply through the mouthpiece.
3. Hold breath for 5–10 seconds, then exhale gently.
4. Dosage: One capsule once daily at the same time each day.
5. Rinse mouth with water after each use to prevent oral thrush.
6. Not for acute bronchospasm—always carry a rescue inhaler (e.g., salbutamol).

🚫 Do not swallow the capsule—for inhalation only.

When Not to Use (VILANTO-U 62.5 + 25mcg):

Do not use if you have:

1. Hypersensitivity to glycopyrronium, mometasone, or any excipients
2. Narrow-angle glaucoma or urinary retention (due to anticholinergic effects)
3. Active untreated respiratory infections (e.g., tuberculosis, fungal infection)
4. Acute COPD exacerbation requiring emergency treatment

Side Effects of (VILANTO-U 62.5 + 25mcg):

Common:

1. Dry mouth (due to glycopyrronium)
2. Oral candidiasis (thrush)—reduced by rinsing mouth
3. Headache, nasopharyngitis
4. Cough, throat irritation

Less common:

1. Blurred vision (if powder contacts eyes—rinse immediately)
2. Urinary retention (in men with BPH)
3. Hoarseness, dysphonia

Serious (rare):

1. Acute narrow-angle glaucoma (eye pain, redness, blurred vision)—seek emergency care
2. Pneumonia (increased risk with ICS in COPD—watch for fever, increased sputum)
3. Paradoxical bronchospasm—discontinue if breathing worsens
4. Seek medical help if eye pain, breathing difficulty, or signs of lung infection occur.

Dosage: (VILANTO-U 62.5 + 25mcg):

1. Adults with COPD: One capsule once daily
2. Maximum: One capsule per 24 hours
3. Not for children or asthma as primary indication

Who It’s For (VILANTO-U 62.5 + 25mcg):

Adults with symptomatic COPD and a history of exacerbations who require both bronchodilation and anti-inflammatory therapy, especially those intolerant to beta-agonists or with predominant cholinergic tone.

Warnings & Precautions:

1. For inhalation only—do not swallow
2. Avoid contact with eyes—may trigger acute glaucoma
3. Use caution in patients with prostatic hyperplasia or bladder neck obstruction
4. Monitor for pneumonia symptoms (common in COPD patients on ICS)
5. Not a rescue medication—use salbutamol for acute symptoms

Drug Interactions:

1. Other anticholinergics (e.g., ipratropium, oxybutynin): Additive side effects (dry mouth, urinary retention)
2. Strong CYP3A4 inhibitors (ketoconazole): May increase systemic corticosteroid exposure
3. Always inform your doctor about all medications.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep capsules in original blister until use. Do not use after the expiration date. Available by prescription only in Pakistan.