Brezu Special Precautions

Careful Administration [Procaterol Hydrochloride (Brezu) Syrup should be administered with care in the following patients]: Patients with hyperthyroidism, where the disease may be exacerbated.
Patients with hypertension, where blood pressure may further increase.
Patients with heart disease (Palpitation, arrhythmia, exacerbation of heart disease and other symptoms may occur).
Patients with diabetes mellitus, where the disease may be exacerbated.
Patients during pregnancy or suspected of being pregnant (See Use in Pregnancy & Lactation).
Important Precautions: The mainstay of long-term management of bronchial asthma is anti-inflammatory agents such as inhaled corticosteroids.
Procaterol Hydrochloride (Brezu) Syrup should therefore be used only as additional therapy for patients whose symptoms are not adequately controlled by inhaled corticosteroids or other asthma medications, or whose disease severity clearly warrants initiation of treatment with Procaterol Hydrochloride (Brezu) Syrup. As Procaterol Hydrochloride (Brezu) Syrup is not a substitute for inhaled corticosteroids and other anti-inflammatory agents, the patient or their guardian or other legally authorized person should be instructed not to reduce the dosage of inhaled corticosteroids or to stop use of inhaled corticosteroids and switch to monotherapy with Procaterol Hydrochloride (Brezu) Syrup unless specifically instructed to do so by their physician, even if they have felt symptomatic improvement with the use of Procaterol Hydrochloride (Brezu) Syrup.
During the long-term management of bronchial asthma, chronic bronchitis and Pulmonary emphysema with Procaterol Hydrochloride (Brezu) Syrup, the patient may develop acute asthma episodes. The patient or their guardian or other legally authorized person should therefore be instructed to use adequate drugs other than Procaterol Hydrochloride (Brezu) Syrup, such as short-acting inhaled β₂ stimulants, if acute asthma episodes occur during treatment with Procaterol Hydrochloride (Brezu) Syrup. In addition, if the use of such drugs becomes more frequent or sufficient therapeutic effect is not observed with the initial dose of the drugs, the patient's asthma may not be adequately controlled. The patient or their guardian or other legally authorized person should be instructed to consult a physician as soon as possible and receive adequate medication in such cases. In addition, as such conditions may be life-threatening, anti-inflammatory therapy should be consolidated by adequate measures, such as increasing the dosage of inhaled corticosteroids.
If the desired therapeutic effect of Procaterol Hydrochloride (Brezu) Syrup cannot be achieved at the recommended dose, the drug should be discontinued.
Continuous administration of excessive amounts of this drug may cause cardiac arrhythmia and cardiac arrest. Special care should therefore be taken not to exceed the recommended dosage of this drug.
Effects on Laboratory Tests: This drug tends to inhibit skin reactions in allergen tests. The drug should be withdrawn 12 hours prior to such tests.
Other Precautions: Tissue damage in cardiac muscle was noted at 30 and 10 mg/kg/day or higher in the subacute and chronic toxicity studies, respectively, using rats. The damage was also observed in dog studies.
However, the damage has been reported with other β₂-adrenergic agonists in both rats and dogs.
Dietary administration of procaterol hydrochloride for 104 weeks was reported to cause mesovarian leiomyoma in SD rats. The tumor, however, is rat-specific and tends to develop during long-term use of β₂ adrenergic agonists.
Use in Children: The safety of this drug in low birth weight infants and neonates has not been established. (There is no clinical experience in low-birth weight infants and neonates.)
Use in the Elderly: Dosage adjustment or other appropriate measures should be considered when prescribing Procaterol Hydrochloride (Brezu) Syrup to elderly patients, because these patients may be physiologically more sensitive to the drug than younger patients.