Spiriva Respimat (Tiotropium Bromide Hydrate)

Adult use

This medicine is for inhalation use only. The cartridge must be inserted into and used only with the Respimat inhaler. The dose released in 2 actuations from the Respimat inhaler constitutes 1 dose. The recommended daily dose is 5 ㎍ of tiotropium, administered as 2 actuations of the Respimat inhaler once daily at the same time each day. (For detailed instructions, see ‘10. Precautions for Use’) When treating asthma, the full therapeutic benefit of this medicine will become apparent after multiple doses. In adults with severe asthma, this medicine should be used in combination with an inhaled corticosteroid (budesonide 800 ㎍/day or more, or an equivalent dose of another corticosteroid) and at least one other controller. Do not administer doses exceeding the recommended dose. The recommended dose may also be administered to patients with renal impairment. However, as with all medicines that are primarily excreted by the kidneys, patients with moderate to severe renal impairment with creatinine clearance ≤ 50ml/min should be closely monitored for symptoms after administration. The recommended dose may also be administered to patients with hepatic impairment. The recommended dose may also be administered to older adults.

Child use

Pediatric patients (6-17 years), asthma: The recommended daily dose is 5 ㎍ of tiotropium, administered as 2 actuations of the Respimat inhaler once daily at the same time each day. (For detailed instructions, see ‘10. Precautions for Use’ under Precautions for Use) In adolescents (12-17 years) with severe asthma, this medicine should be used in combination with an inhaled corticosteroid (budesonide exceeding 800 ㎍/day – 1,600 ㎍/day, or an equivalent dose of another corticosteroid) and one controller, or in combination with an inhaled corticosteroid (budesonide 400 – 800 ㎍/day, or an equivalent dose of another corticosteroid) and two controllers. In children (6-11 years) with severe asthma, this medicine should be used in combination with an inhaled corticosteroid (budesonide exceeding 400 ㎍/day, or an equivalent dose of another corticosteroid) and one controller, or in combination with an inhaled corticosteroid (budesonide 200–400 ㎍/day, or an equivalent dose of another corticosteroid) and two controllers. The safety and efficacy of this medicine have not been established in pediatric patients with asthma under 6 years of age. Chronic obstructive pulmonary disease is not a common disease in children; therefore, there is no experience with the use of this medicine in pediatric patients under 18 years of age.

This medication is a bronchodilator that should only be used once daily. It should not be used for acute bronchospasm or sudden symptom relief; in such cases, another fast-acting medication should be used. Patients with asthma should not use this medication as a solo treatment and must combine it with anti-inflammatory therapy. An immediate allergic reaction may occur after using the medication, so caution is necessary. Bronchospasm may be triggered during inhalation, so if symptoms worsen during use, consult a healthcare professional immediately. Additionally, take care to avoid contact with the eyes, as it may cause symptoms such as worsened glaucoma; consult a doctor immediately if contact occurs. Using this medication may cause dry mouth; long-term dryness may increase the risk of dental cavities, so maintain good oral hygiene. It should be used only once daily and not at a dosage exceeding the recommended amount. Additives in the medication may cause wheezing or difficulty breathing in asthma patients, so caution is necessary. Patients with known allergies to this medication or similar substances should not use it. Patients with glaucoma, prostate enlargement, bladder issues, or heart rhythm irregularities should use this medication with caution, and those with severely impaired kidney function may face risks from its use. Common side effects include dry mouth, dizziness, headache, cough, and rarely, glaucoma, heart rhythm irregularities, and oral candidiasis can occur. It is preferable to avoid use during pregnancy, and caution should be exercised during breastfeeding as the medication may be excreted in breast milk. The use of this medication is not recommended in children, especially those under 6 years of age, as its safety and efficacy have not been established. Overdose may lead to anticholinergic side effects, but generally serious poisoning symptoms are rare. The inhaler should be cleaned regularly, and the usage instructions should be strictly followed, with attention paid not to miss the cartridge replacement timing. Store this medication out of reach of children, and do not transfer it to other containers outside the original packaging. It should be stored at room temperature and used within 3 months after opening.

• Immediate hypersensitivity
• inhalation-induced bronchospasm
• eye pain
• discomfort
• temporary blurred vision
• conjunctival hyperemia
• corneal edema
• halo
• colored vision
• dry mouth

This medication is sensitive to air and moisture and must be stored in a tightly sealed container. Additionally, it should be stored at room temperature and not be frozen.

Appearance

A colorless, transparent liquid contained in an aluminum cylinder with a 4.5 mL cartridge (a Respimat inhaler may be attached).

Package unit

60 doses/cartridge (multi-dose) 1 unit + 1 Respimat inhaler (multi-dose) 1 unit 60 doses/cartridge (multi-dose) (for refilling) 1 unit