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PROAIR DIGIHALERTM(albuterol sulfate)inhalation powder(五)
2018-12-28 18:23:13 来源: 作者: 【 】 浏览:9364次 评论:0
cts [see Warnings and Precautions (5.4)]
• Immediate hypersensitivity reactions [see Warnings and Precautions (5.6)]
• Hypokalemia [see Warnings and Precautions (5.8)]
6.1 Clinical Trials Experience
A total of 1289 subjects were treated with albuterol sulfate inhalation powder (ProAir RespiClick hereafter referred to asalbuterol sulfate MDPI) during the clinical development program. The most common adverse reactions (≥1% and>placebo) were back pain, pain, gastroenteritis viral, sinus headache, and urinary tract infection. Because clinical trials areconducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot bedirectly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults and Adolescents 12 years of Age and Older: The adverse reaction information presented in Table 1 belowconcerning albuterol sulfate MDPI is derived from the 12-week blinded treatment period of three studies which comparedalbuterol sulfate MDPI 180 mcg four times daily with a double-blinded matched placebo in 653 asthmatic patients 12 to
76 years of age.
Table 1: Adverse Reactions Experienced by Greater Than or Equal to 1.0% of Adult and AdolescentPatients in the Albuterol sulfate MDPI Group and Greater Than Placebo in three 12-Week Clinical
Trials1
Preferred Term Number (%) of patients
Albuterol sulfate
MDPI 180 mcg QID
N=321
Placebo
N=333
Back pain 6 (2%) 4 (1%)
Pain 5 (2%) 2 (<1%)
Preferred Term Number (%) of patients
Albuterol sulfate
MDPI 180 mcg QID
N=321
Placebo
N=333
Gastroenteritis viral 4 (1%) 3 (<1%)
Sinus headache 4 (1%) 3 (<1%)
Urinary tract
infection
4 (1%) 3 (<1%)
1. This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug)which occurred at an incidence rate of greater than or equal to 1.0% in the albuterol sulfate MDPI groupand greater than placebo.
In a long-term study of 168 patients treated with albuterol sulfate MDPI for up to 52 weeks (including a 12-week doubleblindperiod), the most commonly reported adverse events greater than or equal to 5% were upper respiratory infection,nasopharyngitis, sinusitis, bronchitis, cough, oropharyngeal pain, headache, and pyrexia.
In a small cumulative dose study, tremor, palpitations, and headache were the most frequently occurring (≥5%) adverseevents.
Pediatric Patients 4 to 11 Years of Age: The adverse reaction information presented in Table 2 below concerningalbuterol sulfate MDPI is derived from a 3-week pediatric clinical trial which compared albuterol sulfate MDPI 180 mcgfour times daily with a double-blinded matched placebo in 185 asthmatic patients 4 to 11 years of age.
Table 2: Adverse Reactions Experienced by Greater Than or Equal to 2.0% of Patients 4 to 11 Years of Agein the Albuterol sulfate MDPI Group and Greater Than Placebo in the 3 Week Trial
Preferred Term Number (%) of patients
Albuterol sulfate
MDPI 180 mcg QID
N=93
Placebo
N=92
Nasopharyngitis 2 (2%) 1 (1%)
Oropharyngeal pain 2 (2%) 1 (1%)
Vomiting 3 (3%) 1 (1%)
6.2 Postmarketing Experience
In addition to the adverse reactions reported from clinical trials with albuterol sulfate MDPI, the following adverse eventshave been reported during use of other inhaled albuterol sulfate products: Urticaria, angioedema, rash, bronchospasm,hoarseness, oropharyngeal edema, and arrhythmias
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