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 2. If QVAR is used with a spacer device, it is important to inhale immediately.
There is no clinical syndrome associated with an overdosage of cromolyn sodium . In several animal species acute toxicity with cromolyn sodium occurs only with very high exposure levels. No deaths occurred at the highest oral doses tested in mice, 8,000 mg/kg (approximately 5,100 and 2,700 times the maximum recommended daily inhalation doses in adults and children, respectively, on a mg/m 2 basis) or in rats, 8,000 mg/kg (approximately 10,000 and 5,400 times the maximum recommended daily inhalation doses in adults and children, respectively, on a mg/m 2 basis).