能倍乐使用说明书

Instructions for use

[Drug Name] Slivar Respimat (Tiotropium Bromide Spray)

[Indications] It is used to treat dyspnea caused by bronchial asthma, chronic bronchitis, wheezing bronchitis, emphysema and other airway obstructive diseases. It is especially suitable for patients who need to take long-term adrenergic β2 receptor agonists and patients with nocturnal asthma.

[Usage and Dosage] This product can only be used by inhalation. The recommended dose for adults is to inhale once a day through the Resplmat inhalation device at the same time, and take 2 puffs each time. Please refer to the instructions for details.

[Ingredients] Tiotropium bromide.

【Character】This product is a colorless clear solution. See the instructions inside the package for details.

[Adverse Reactions] 1. Overview In a clinical trial in which 906 patients received tiotropium bromide for 1 year, the most frequently occurring adverse reaction was dry mouth. Dry mouth occurs in approximately 14% of patients. Dry mouth reactions are usually mild and resolve with continued treatment. 2. Listed in the table below is the reporting rate of this adverse reaction. These data come from clinical trials of patients receiving tiotropium bromide for 1 year (according to WHO organ system classification). Frequency of adverse reactions: Systemic allergic reactions: Rare (i.e., >0.1%, <1%) Gastrointestinal system disorders: dry mouth Very common (i.e., >10%) Constipation Common (i.e., >1%, <10%) Heart rate and rhythm disorders: Tachycardia Uncommon (i.e., >0.1%, <1%) Palpitations Uncommon (i.e., >0.1%, <1%) Immune system disorders: Candida infection Common (i.e., >1%, <10%) Respiratory disorders: Sinusitis Common (i.e., >1%, <10%) Pharyngitis Common (i.e., >1%, <10%) Urinary disorders: Dysuria Uncommon (i.e., >0.1%, <1%) Urinary retention Rare (i.e., >0.1%, <1%) All adverse events listed as common refer to a reported frequency of greater than 1% to 2% compared to placebo. Postmarketing Experience: Spontaneous adverse reaction reports of nausea, hoarseness, and dizziness have been received. 3. Regarding individual serious and/or frequently occurring adverse reactions. The most common adverse reaction of anticholinergic treatment in COPD patients is dry mouth. Dry mouth symptoms are mild in most cases. In general, dry mouth occurs between the 3rd and 5th week after treatment. Dry mouth symptoms usually resolve as patients continue treatment. In a 1-year clinical trial of 906 patients, 3 patients (accounting for 0.3% of the total number of patients treated) terminated the trial due to adverse reactions of dry mouth. In the 1-year clinical trial of the drug, constipation and urinary retention were the serious and persistent adverse reactions reported in individual cases. Urinary retention is only seen in older men with predisposing factors (eg, enlarged prostate). Ventricular tachycardia and atrial fibrillation have occurred in individual cases after the use of tiotropium bromide, usually in susceptible patients. As with all inhaled treatments, tiotropium may cause bronchospasm due to inhaled irritation. Spontaneous adverse reactions Reported allergic reactions include angioedema, rash, urticaria, and pruritus. 4. Pharmacological classification of adverse reactions There are many organ systems and functions that are controlled by the parasympathetic nervous system and are therefore susceptible to the effects of anticholinergic agents. Adverse reactions that may be associated with systemic anticholinergic effects include dry mouth, dry throat, increased heart rate, blurred vision, glaucoma, dysuria, urinary retention, and constipation. In addition, upper respiratory tract irritation may occur in patients who inhale tiotropium bromide. The incidence of dry mouth and constipation increases with age.

【Taboo】

1. It is prohibited to be used by those who are allergic to tiotropium bromide or other ingredients contained in this product such as lactose.

2. It is prohibited to be used by those allergic to atropine or atropine derivatives.

【Notes】

1. This product is not recommended for patients under 18 years old.

2. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, and pregnant and lactating women.

3. This product is used as a once-daily maintenance bronchodilator and cannot be used as a rescue treatment drug for acute attacks of bronchospasm.

4. Patients with moderate or severe renal insufficiency (creatinine clearance ≤50ml/min) should be monitored when using this product.

5. Allergic reactions may occur after inhaling this product.

6. Long-term application of this product may cause dental caries.

7. Care must be taken to avoid getting this product into the eyes, otherwise it may cause or aggravate symptoms of narrow-angle glaucoma, eye pain or discomfort, temporary blurred vision, visual halos or color images accompanied by red eyes and corneal edema caused by conjunctival congestion; if signs of narrow-angle glaucoma occur, stop use immediately.

【Drug Interaction】

1. After young healthy volunteers inhale this product, the absolute bioavailability is 19.5%, and food does not affect its absorption. At steady state, when patients with chronic obstructive pulmonary disease (COPD) inhale 18 mcg of this product, the plasma concentration reaches a peak value (17~19 pg/ml) in 5 minutes, and then decreases rapidly in a multi-compartment model, with the plasma trough concentration at steady state being 3~4 pg/ml. The plasma protein binding rate of this product is 72%, and the distribution volume is 32L/kg. This product cannot pass the blood-brain barrier.

2. The elimination half-life of this product is 5 to 6 days after inhalation. 14% of the dose is excreted in urine and the rest is excreted in feces. The renal elimination rate of this product is greater than the creatinine clearance rate, indicating that the drug is secreted into the urine. COPD patients continue to inhale every day, and the pharmacokinetic steady state is reached within 2 to 3 weeks, and there is no further drug accumulation thereafter.

[Storage] 2.5μg*60 shots/bottle (one Respimat inhalation device and one 4.5ml cartridge).

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