Instructions for Tiotropium Bromide and Odaterol Inhalation Spray

1. Generic name: Tiotropium bromide and olodaterol inhalation spray

Product name:STIOLTO RESPIMAT

All names:tiotropium bromide,olodaterol hydrochloride, Respimat

2. Indications:

Tiotropium and Olodaterol Inhalation Spray is a combination of tiotropium and olotaro, indicated for the long-term once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Limitations of Use: Tiotropium bromide and olodaterol inhalation spray are not indicated for the treatment of acute exacerbations of chronic obstructive pulmonary disease or for the treatment of asthma.

3. Usage and dosage:

1. Recommended dosage: Tiotropium bromide and olodaterol inhalation spray are only for oral inhalation. The recommended dosage is two inhalations at the same time every day. Do not use more than two inhalations every 24 hours.

2. Usage management:

Prior to first use, insert the tiotropium olodaterol inhalation spray cartridge into the tiotropium olodaterol inhalation spray inhaler and prime the device. When using the device for the first time, the patient pushes the inhaler toward the ground until the aerosol cloud is visible, then repeats the process three more times. The device is then considered ready for use. If not used for more than 3 days, the patient should prime the inhaler once to prepare the inhaler for use. If it has not been used for more than 21 days, the patient should activate the inhaler until an aerosol cloud is seen and then repeat the process three more times to prepare the inhaler for use.

3. Dose adjustment: For patients with moderate to severe renal impairment, the anticholinergic effects of tiotropium bromide and olodaterol inhalation spray should be closely monitored.

4. Adverse reactions:

The most common serious adverse reactions to tiotropium and olodaterol inhalation spray areCOPD exacerbations and pneumonia. They also include sudden shortness of breath that may be life-threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or hypokalemia that may cause muscle weakness or abnormal heart rhythm.

5. Storage:

Tiotropium bromide and olodaterol inhalation spray are usually stored20°C to 25°C (68°F to 77°F); tolerance is 15°C to 30°C (59°F to 86°F). Avoid freezing. Keep out of reach of children. Do not spray into eyes.

6. Taboo:

1. Olodarol that does not contain inhaled corticosteroids, including tiotropium bromide and olodaterol inhalation spray, is contraindicated in patients with asthma.

2. Tiotropium bromide and olodarol inhalation spray are not suitable for the treatment of asthma. Patients allergic to tiotropium bromide, ipratropium bromide, olodaro or any component of this product are prohibited from using this product.

3. In clinical trials and post-marketing experience with tiotropium bromide, tachyphylaxis, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash, has been reported. Allergic reactions have also been reported in clinical trials of tiotropium and olodaterol inhalation spray.

7. Mechanism of action:

Tiotropium and olodarol inhalation spray contains tiotropium and olodarol. Tiotropium is a long-acting muscarinic antagonist commonly known as an anticholinergic. It has similar affinities to muscarinic receptor subtypes M 1 to M5. In the airways, it exerts its pharmacological action by inhibiting mycoplasma receptors on smooth muscle, causing bronchiectasis. In preclinical in vitro and in vivo studies, prevention of methacholine-induced bronchoconstrictive effects was dose-dependent and lasted over 24 hours. Bronchodilation after inhaled tiotropium bromide is primarily a site-specific effect.

Olodaro is a long-acting β2 adrenergic agonist (LABA). The compound exerts its pharmacological effects by binding to and activating β2-adrenergic receptors after local administration through inhalation. Activation of these receptors in the airways results in stimulation of intracellular adenylyl cyclase, an enzyme that mediates the synthesis of cyclic-3',5' adenosine monophosphate (cAMP). Elevated cAMP levels induce bronchiectasis by relaxing airway smooth muscle cells.

8. Overdose:

Treatment of overdose includes discontinuation of tiotropium and olodaterol inhalation spray and administration of appropriate symptomatic and supportive care. Judicious use of cardioselective beta-blockers may be considered, bearing in mind that this drug can produce bronchospasm. There is insufficient evidence to determine whether dialysis is beneficial in overdose with tiotropium and olodaterol inhalation spray. Cardiac monitoring is recommended in cases of overdose.

The original drug of tiotropium bromide and olodaterol inhalation spray has been launched in China, specifications (The price of each box of 2.5mcg+2.5mcg*60 sprays is around RMB 800. This medicine may be sold in domestic hospitals or pharmacies. The original drug of tiotropium bromide and olodaterol inhalation spray has also been launched overseas. The Turkish version's specifications (2.5mcg+2.5mcg) * 60 sprays are priced at about 200 yuan per box (the price may fluctuate due to exchange rates). The ingredients of the two drugs are basically the same. There are currently no generic versions of tiotropium bromide and olodaterol inhalation spray available on the market.