Tritide Unicap 25mcg+100mcg+62.5mcg

✔️ Side Effects

COPD

Common adverse reactions (≥1%) include:

• Upper respiratory tract infection
• Pneumonia, bronchitis
• Oral candidiasis
• Headache, back pain, arthralgia
• Influenza, sinusitis, pharyngitis, rhinitis
• Dysgeusia, constipation, diarrhea
• Urinary tract infection, gastroenteritis
• Oropharyngeal pain, cough, dysphonia

Asthma

Common adverse reactions (≥2%) include:

• Pharyngitis/nasopharyngitis
• Upper or viral respiratory tract infection
• Bronchitis
• Sinusitis/acute sinusitis
• Urinary tract infection
• Rhinitis, influenza
• Headache, back pain

✔️ Each dry powder inhaler capsule contains either:

Vilanterol 25 mcg (as Vilanterol Trifenatate INN)

Fluticasone Furoate 100 mcg (INN)

Umeclidinium 62.5 mcg (as Umeclidinium Bromide INN)

OR

Vilanterol 25 mcg (as Vilanterol Trifenatate INN)

Fluticasone Furoate 200 mcg (INN)

Umeclidinium 62.5 mcg (as Umeclidinium Bromide INN)

✔️ Dosage & Administration

This inhalation capsule must not be swallowed

Use only with the inhaler device

Remove the capsule from the blister pack immediately before use

After inhalation, rinse the mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis

Adults (18 years and older)

Use at the same time each day

Do not use more than once every 24 hours

If shortness of breath or asthma symptoms occur between doses, a short-acting beta₂-agonist (SABA) should be used for immediate relief

Recommended Dose

COPD (maintenance): 1 inhalation capsule once daily

Asthma (maintenance): 1 inhalation capsule once daily

Use as prescribed by a registered physician.

Children & Adolescents: Not indicated; safety and efficacy not established (≤17 years)

Elderly: No dosage adjustment required, though increased sensitivity cannot be ruled out

Renal impairment: Not studied

Hepatic impairment: Not studied

✔️ Drug Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole): Use with caution; may increase systemic corticosteroid and cardiovascular effects

MAO inhibitors and tricyclic antidepressants: Use with extreme caution; may potentiate the vascular effects of vilanterol

Beta-blockers: May reduce bronchodilatory effects and cause severe bronchospasm

Diuretics: Non–potassium-sparing diuretics may increase the risk of ECG changes and hypokalemia when used with beta-agonists

Anticholinergics: Additive effects may occur; avoid concurrent use with other anticholinergic-containing drugs

✔️ Contraindications

Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive intervention

Severe hypersensitivity to milk proteins or any component of the formulation

✔️ Precautions & Warnings

1. LABA monotherapy increases the risk of serious asthma-related events
2. Do not initiate therapy during acute deterioration of COPD or asthma
3. Not intended for treatment of acute symptoms
4. Do not use with additional LABA-containing medications due to overdose risk
5. Oral and pharyngeal candidiasis may occur; advise mouth rinsing after inhalation
6. Increased risk of pneumonia in COPD patients; monitor closely
7. Discontinue if paradoxical bronchospasm occurs
8. Use cautiously in patients with cardiovascular disorders
9. May worsen urinary retention; caution in prostatic hyperplasia or bladder-neck obstruction
10. Use with caution in patients with seizure disorders, thyrotoxicosis, diabetes mellitus, or ketoacidosis

✔️ Pregnancy & Lactation

There are insufficient data on the use of this medication in pregnant women and breastfeeding mothers. Use only if clearly needed and under medical supervision.

✔️ Storage:

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