Tudorza (Aclidinium Bromide) – COPD | HongKong DengYue Medicine

Tudorza Application Scope

Tudorza is a long-acting inhaled anticholinergic bronchodilator used for maintenance treatment of chronic obstructive pulmonary disease (COPD).

Characteristics

• Ingredients: Aclidinium Bromide

• Properties: Long‑acting muscarinic antagonist (LAMA); acts on M3 receptors to relax bronchial smooth muscle

• Packaging Specification: Multi-dose dry powder inhaler; 60 or 30 doses per inhaler

• Storage:

  • Room temperature 15–30 °C (59–86 °F)

  • Store in a sealed pouch until use

  • Keep dry

  • Don’t store on vibrating surfaces

• Expiry Date: Discard 45 days after the pouch is opened, or when the counter reaches zero

• Executive Standard: Typically follows pharmacopoeial requirements

• Approval Number: U.S. FDA-approved in July 2012 (NDA 202450)

• Date of Revision: Label revised Feb 2021; Drugs.com updated Jan 20, 2025

• Manufacturer: AstraZeneca (U.S.); under license from Almirall/Circassia

Guidelines for the Use of Tudorza

• Dosage and Administration:

  • One inhalation (400 µg) twice daily, approximately 12 hours apart

  • Use oral inhalation only via the Pressair device

  • Dose confirmed by click and color change

 

• Adverse Reactions:

  • Common (≥1% vs placebo):

    • headache (6–7%)

    • nasopharyngitis (5–6%),

    • cough (~3%),

    • diarrhea,

    • sinusitis

    • rhinitis,

    • toothache,

    • fall,

    • vomiting

  • Postmarketing:

    • hypersensitivity (anaphylaxis, rash, bronchospasm),

    • nausea, dysphonia, blurred vision, urinary retention, tachycardia, stomatitis

• Contraindications: Known severe hypersensitivity to aclidinium bromide, milk proteins, or excipients

• Precautions:

  • Not for acute bronchospasm (rescue use)

  • May cause paradoxical bronchospasm—discontinue if it occurs

  • Use with caution in narrow-angle glaucoma, prostatic hyperplasia

  • Or bladder-neck obstruction; monitor symptoms

Tudorza Interactions

• Drug Interactions:

  • Additive anticholinergic effects when combined with other anticholinergics—avoid duplication (e.g., umeclidinium)

  • No significant interactions with β₂‑agonists, steroids, methylxanthines, or glucocorticoids

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.