DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Xopenex Inhalation (Levalbuterol Hydrochloride Inhalation) - Side Effects and Adverse Reactions

 


Nutrilib.com
A comprihensive source of nutritional information

ADVERSE REACTIONS (CHILDREN 6-11 YEARS OLD)

Adverse events reported in >/=2% of patients in any treatment group and more frequently than in patients receiving placebo in a 3-week, controlled clinical trial are listed in Table 6.

Table 6: Most Frequently Reported Adverse Events (>/=2% in Any Treatment
Group) and More Frequently Than Placebo During the Double-Blind Period (ITT Population, 6-11 Years Old)
Body System
Preferred Term
Percent of Patients
Placebo
(n=59)
Xopenex
0.31 mg
(n=66)
Xopenex
0.63 mg
(n=67)
Racemic
albuterol
1.25 mg
(n=64)
Racemic
albuterol
2.5 mg
(n=60)
Body as a Whole
Abdominal pain 3.4 0 1.5 3.1 6.7
Accidental injury 3.4 6.1 4.5 3.1 5.0
Asthenia 0 3.0 3.0 1.6 1.7
Fever 5.1 9.1 3.0 1.6 6.7
Headache 8.5 7.6 11.9 9.4 3.3
Pain 3.4 3.0 1.5 4.7 6.7
Viral Infection 5.1 7.6 9.0 4.7 8.3
Digestive System
Diarrhea 0 1.5 6.0 1.6 0
Hemic and Lymphatic
Lymphadenopathy 0 3.0 0 1.6 0
Musculoskeletal System
Myalgia 0 0 1.5 1.6 3.3
Respiratory System
Asthma 5.1 9.1 9.0 6.3 10.0
Pharyngitis 6.8 3.0 10.4 0 6.7
Rhinitis 1.7 6.1 10.4 3.1 5.0
Skin and Appendages
Eczema 0 0 0 0 3.3
Rash 0 0 7.5 1.6 0
Urticaria 0 0 3.0 0 0
Special Senses
Otitis Media 1.7 0 0 0 3.3
Note: Subjects may have more than one adverse event per body system and preferred term.

Changes in heart rate, plasma glucose, and serum potassium are shown in Table 7. The clinical significance of these small differences is unknown.

Table 7: Mean Changes from Baseline in Heart Rate at 30
Minutes and in Glucose and Potassium at 1 Hour
after First Dose (Day 1) and Last Dose (Day 21) in Children 6-11 years old
Treatment Mean Changes (Day 1)
Heart Rate
(bpm)
Glucose
(mg/dL)
Potassium
(mEq/L)
Xopenex 0.31 mg, n=66 0.8 4.9 -0.31
Xopenex 0.63 mg, n=67 6.7 5.2 -0.36
Racemic albuterol 1.25 mg, n=64 6.4 8.0 -0.27
Racemic albuterol 2.5 mg, n=60 10.9 10.8 -0.56
Placebo, n=59 -1.8 0.6 -0.05
Xopenex 0.31 mg, n=60 Mean Changes (Day 21)
Heart Rate
(bpm)
Glucose
(mg/dL)
Potassium
(mEq/L)
0 2.6 -0.32
Xopenex 0.63 mg, n=66 3.8 5.8 -0.34
Racemic albuterol 1.25 mg, n=62 5.8 1.7 -0.18
Racemic albuterol 2.5 mg, n=54 5.7 11.8 -0.26
Placebo, n=55 -1.7 1.1 -0.04

Page last updated: 2006-12-12

-- advertisement -- The American Red Cross

We comply with
HONcode standard.
Verify here.
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2008