acer and facemask per kilogram of body weight (Table 2). However, clinical studies in children under 4 years of age described above suggest that either the optimal dose of VENTOLIN HFA has not been defined in this age-group or VENTOLIN HFA is not effective in this age-group. The safety and effectiveness of VENTOLIN HFA administered with or without a spacer device in children under 4 years of age has not been demonstrated.
Table 2: In Vitro Medication Delivery Through AeroChamber Plus® Valved Holding Chamber With a Facemask
Age
Facemask
Flow Rate (L/min)
Holding Time (seconds)
Mean Medication Delivery Through AeroChamber Plus (mcg/actuation)
Body Weight 50 th Percentile (kg) *
Medication Delivered per Actuation (mcg/kg) †
6 to 12 Months
Small
4.9
0
2
5
10
18.2
19.8
13.8
15.4
7.5-9.9
1.8-2.4
2.0-2.6
1.4-1.8
1.6-2.1
2 to 5 Years
Small
8.0
0
2
5
10
17.8
16.0
16.3
18.3
12.3-18.0
1.0-1.4
0.9-1.3
0.9-1.3
1.0-1.5
2 to 5 Years
Medium
8.0
0
2
5
10
21.1
15.3
18.3
18.2
12.3-18.0
1.2-1.7
0.8-1.2
1.0-1.5
1.0-1.5
>5 Years
Medium
12.0
0
2
5
10
26.8
20.9
19.6
20.3
18.0
1.5
1.2
1.1
1.1
* Centers for Disease Control growth charts, developed by the National Center for Health Statistics in collaboration with the National Center for Chronic Disease Prevention and Health Promotion (2000). Ranges correspond to the average of the 50 th percentile weight for boys and girls at the ages indicated.
† A single inhalation of VENTOLIN HFA in a 70-kg adult without use of a valved holding chamber and facemask delivers approximately 90 mcg, or 1.3 mcg/kg.
8.5 Geriatric Use
Clinical studies of VENTOLIN HFA 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.
10 OVERDOSAGE
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, sleeplessness. Hypokalemia may also occur.
As with all sympathomimetic aerosol medications, cardiac arre
