Brezu

Each mL of Brezu syrup contains Brezu hydrochloride 5 mcg.

Brezu syrup has a pH from 3.5 to 4.5.

Brezu is Brezu hydrochloride hydrate (JAN) with a chemical name of 8-hydroxy-5-[(1RS,2SR)-1-hyrdoxy-2-[(1-methylethyl)amino]butyl]-quinolin-2-(1H)-one monohydrochloride hemihydrate. It has a molecular formula C₁₆H₂₂N₂O₃·HCl·½H₂O and a molecular weight of 335.83.

Brezu hydrochloride occurs as white to pale white yellowish white crystals or crystalline powder. It is soluble in water, formic acid and methanol, slightly soluble in ethanol (95) and practically insoluble in diethyl ether. The pH of its aqueous solution (1 in 100) is 4-5. Its aqueous solution (1 in 20) shows no optical rotation. It gradually changes in color when exposed to light.

Melting Point: Approximately 195°C (decomposition).

Relief of dyspnea and other symptoms caused by respiratory obstructive disturbance in the following diseases: Bronchial asthma, chronic bronchitis and pulmonary emphysema. Brezu: Treatment of acute bronchitis. Brezu Swinghaler: For symptomatic relief of respiratory conditions only and therefore, the drug should be used only at the onset of asthmatic attacks.

Brezu: Tablet/Syrup: Adults: Usual Dose: 50 mcg or 10 mL once before bedtime or twice daily (in the morning and before bedtime). The dosage would be adjusted according to the patient's age and severity of symptoms.

Adults and Children ≥6 years: Usual Dose: 25 mcg or 5 mL once before bedtime or twice daily (in the morning and before bedtime). The dosage would be adjusted according to the patient's age and severity of symptoms. <6 years: (1.25 mcg/kg body weight) 0.25 mL/kg body weight 2-3 times daily (in the morning, early afternoon and before bedtime).

Brezu Swinghaler: Adults: Usual Dose: 20 mcg (2 puffs).

Take the medication exactly as directed. Take no more than 4 times a day (Adults: 8 puffs/day. Children: 4 puffs/day.).

Hypersensitivity to Brezu hydrochloride or to any of the excipients of Brezu syrup.

Precautions for co-administration should be administered with care when co-administered with the following drugs: Catecholamines (eg, epinephrine and isoproterenol): The combined use of Brezu with catecholamines may cause arrhythmias or cardiac arrest. Epinephrine, isoproterenol and other catecholamines potentiate the adrenoreceptor stimulating action of Brezu, possibly resulting in the induction of arrhythmias.

Xanthine derivatives (eg, theophylline, aminophylline hydrate and diprophylline): The combined use of xanthine derivatives may aggravate hypokalemia and cardiovascular adverse reactions (eg, tachycardia, arrhythmias) due to β-adrenergic stimulation. If any of these abnormalities are observed, the dose should be reduced or treatment should be discontinued immediately. Xanthine derivatives potentiate the adrenoreceptor-stimulating action of Brezu, possibly resulting in a decrease in serum potassium levels and causing cardiac or vascular adverse reactions. The mechanism responsible for the induction of hypokalemia is not known.

Corticosteroids (eg, betamethasone, prednisolone and hydrocortisone sodium succinate) and diuretics (eg, furosemide): The combined use of Brezu with corticosteroids and diuretics may cause a decrease in serum potassium levels, resulting in arrhythmias. If any of these abnormalities are observed, the dose of the drug should be reduced or treatment should be discontinued immediately. Corticosteroids and diuretics augment the excretion of potassium from the renal tubules, possibly resulting in an excessive decrease in serum potassium levels.

Brezu: In clinical trials involving 22,575 patients, a total of 644 patients (2.83%) showed adverse reactions, including abnormal laboratory values. (At the time of approval of the initial application, completion of re-examination and approval of an additional indication for oral formulations of Brezu tablet and syrup.

Brezu Swinghaler: There has no survey conducted to clarify the incidence of adverse reactions for Brezu Swinghaler. The following adverse reactions have been reported for inhalation formulations: Brezu Air, Brezu Kid Air and Brezu Inhalation Solution.

In clinical trials involving 6,655 subjects, a total of 101 patients (1.52%) showed adverse reactions, including abnormal laboratory values [Figures represent total cases reported at the time of approval of the initial application and completion of re-examination for inhalation formulations: Brezu Air, Brezu Kid Air and Brezu Inhalation solution (excluding Brezu Inhalation solution 0.3 mL and 0.5 mL units)].

The following summary of data includes adverse reactions reported after marketing without incidence rates.

Clinically Significant Adverse Reactions (*Incidence Unknown): Shock, Anaphylactoid Reactions: Shock or anaphylactoid reactions may occur. Patients should therefore be closely monitored. If abnormal findings are observed, Brezu should be discontinued and appropriate measures taken.

Significant decreases in serum potassium levels have been reported in patients receiving Brezu. If xanthine derivatives, corticosteroids or diuretics are co-administered with this drug in patients with severe asthma, extreme care is necessary to minimize the possibility of aggravating the decrease in serum potassium levels induced by β₂-adrenergic agonists. Serum potassium levels should be closely monitored in hypoxic patients, in view of the possible aggravation of cardiac arrhythmias secondary to a decrease in serum potassium levels.

Other Adverse Reactions: The following table shows the adverse reactions for tablets:.

The following table shows the adverse reactions for syrup:.

The following table shows the adverse reactions for swinghaler:.