Pediatric Use: Eight-hundred and thirty-four children between the ages of 5 and 12 were
treated with HFA beclomethasone dipropionate (HFA-BDP) in clinical trials. The safety
and effectiveness of QVAR in children below 5 years of age have not been established.
Use of QVAR with a spacer device in children less than 5 years of age is not
recommended. In vitro dose characterization studies were performed with QVAR 40
mcg/actuation with the Optichamber and AeroChamber Plus® spacer utilizing inspiratory
flows representative of children under 5 years old. These studies indicated that the
amount of medication delivered through the spacing device decreased rapidly with
increasing wait times of 5 to 10 seconds as shown in Table 1. If QVAR is used with a
spacer device, it is important to inhale immediately.
Based on the average inspiratory flow rates generated by children 6 months to 5 years
old, the projected daily dose derived from QVAR 40 mcg at one puff per day at various
wait times is depicted in the table below:
Oral inhaled corticosteroids have been shown to cause a reduction in growth velocity in
children and teenagers with extended use. If a child or teenager on any corticosteroid
appears to have growth suppression, the possibility that they are particularly sensitive to
this effect of corticosteroids should be considered (see PRECAUTIONS, General).
Geriatric Use: Clinical studies of QVAR did not include sufficient numbers of subjects
aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the
elderly and younger patients. In general, dose selection for an elderly patient should be
cautious, usually starting at the low end of the dosing range, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or
other drug therapy.
ADVERSE REAC TIONS
The following reporting rates of common adverse experiences are based upon 4 clinical
trials in which 1196 Patients (671 female and 525 male adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with QVAR (doses of
40, 80, 160, or 320 mcg twice daily) or CFC-BDP (doses of 42, 168, or 336 mcg twice
daily) or placebo. The following table includes all events reported by patients taking
QVAR (whether considered drug related or not) that occurred at a rate over 3% for either
QVAR or CFC-BDP. In considering these data, difference in average duration of
exposure and clinical trial design should be taken into account.
Adverse Events Reported by at Least 3% of the Patients for Either QVAR or CFC-BDP by Treatment and Daily Dose
Other adverse events that occurred in these clinical trials using QVAR with an incidence
of 1% to 3% and which occurred at a greater incidence than placebo were: dysphonia,
dysmenorrhea and coughing.
No patients treated with QVAR in the clinical development program developed
symptomatic oropharyngeal candidiasis. If such an infection develops, treatment with
appropriate antifungal therapy or discontinuance of treatment with QVAR may be
Pediatric Studies: In two 12-week placebo-controlled studies in steroid naive pediatric
patients 5 to 12 years of age, no clinically relevant differences were found in the pattern,
severity, or frequency of adverse events compared with those reported in adults, with the
exception of conditions which are more prevalent in a pediatric population generally.
Adverse Event Reports from Other Sources: Rare cases of immediate and delayed
hypersensitivity reactions, including urticaria, angioedema, rash, and bronchospasm, have
been reported following the oral and intranasal inhalation of beclomethasone
During postmarketing experience, psychiatric events and behavioral changes such as
aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation
have been reported (primarily in children). Because these events are reported voluntarily
from a population of uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to drug exposure.
There were no deaths over 15 days following the oral administration of a single dose of
3000 mg/kg in mice, 2000 mg/kg in rats, and 1000 mg/kg in rabbits. The doses in mice,
rats, and rabbits were 19,000, 25,000, and 25,000 times, respectively, the maximum
recommended daily inhalation in adults or 36,000, 48,000, and 48,000 times, respectively
the maximum recommended daily inhalation dose in children on a mg/m2 basis.
DIREC TIONS FOR USE
Illustrated Patient’s Instructions for proper use accompany each package of QVAR.
© 2012 Teva Respiratory, LLC
QVAR is a registered trademark of IVAX LLC, a member of the TEVA Group.
Table 1. Projected Daily Dose of QVAR When Used With a Spacer
delivered per dose,
mcg/kg iii, iv
Age 6 months,
0 11.5 7.6 1.2
Age 2 years,
0 14.1 13.5 0.83
Age 2 years,
5 5.4 13.5 0.32
Age 2 years,
10 3.9 13.5 0.23
Age 5 years,
0 17.5 18 0.78
i Summary Report; Pediatric Dose Characterization of QVAR with Spacer; 3M Pharmaceutical
Development, July 21, 2004.
ii CDC Growth charts, developed by the National Center for Health Statistics in collaboration
with the National Center for Chronic Disease Prevention and Health Promotion (2000).
iii Includes an estimated 20% loss in the masks
iv QVAR 40mcg in an average adult without using a spacer delivers approximately 0.4 mcg/kg,
or bid, 0.8 mcg/kg/day.
HEADACHE 9 12 15 8 25 15 14 11 17
PHARYNGITIS 4 8 6 5 27 10 12 9 10
11 9 7 11 5 12 3 9 17
RHINITIS 9 6 8 3 7 11 15 9 10
18 3240814 5 7
2 333267 5 5
SINUSITIS 2 3 3 3 0 4 7 2 4
PAIN <1 212533 5 2
BACKPAIN 1 1 2 <1 4 4 2 4 4
NAUSEA 0 1 <1 1 2 3 5 5 1
DYSPHONIA 2 <1 1 0 4 4 0 0 6