MEPTIN Tablet Ref.[51010] Active ingredients: Procaterol

In clinical trials involving 22,757 subjects, a total of 644 patients (2.83%) showed adverse reactions including abnormal laboratory values (Figures represent total cases of reported at the time of approval of the initial application, completion of reexamination, and approval of an additional indication for the oral formulations: MEPTIN Tablets, MEPTIN-Mini Tablets, MEPTIN Granules, and MEPTIN Syrup). The following summary of data includes adverse reactions reported after marketing without data on the incidence.

(1) Clinically significant adverse reactions (*incidence unknown)

1) Shock, anaphylaxis: Shock or anaphylaxis may occur. Patients should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.

2) Significant decreases in serum potassium levels have been reported in patients receiving procaterol hydrochloride hydrate. If xanthine derivatives, corticosteroids, or diuretics are coadministered 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.

(2) Other adverse reactions

Note 1) If symptoms of hypersensitivity occur, the drug should be discontinued immediately
^* The incidences of adverse reactions reported voluntarily after marketing or those reported outside Japan are not known.

Careful Administration (Meptin Tablets should be administered with care in the following patients.)

(1) Patients with hyperthyroidism (The disease may be exacerbated.)

(2) Patients with hypertension (Blood pressure may further increase.)

(3) Patients with heart disease (Palpitation, arrhythmia, exacerbation of heart disease, and other symptoms may occur.)

(4) Patients with diabetes mellitus (The disease may be exacerbated.)

(5) Patients during pregnancy or suspected pregnancy (See Use during Pregnancy, Delivery or Lactation section.)

Important Precautions

(1) The mainstay of long term management of bronchial asthma is antiinflammatory agents such as inhaled corticosteroids. Meptin tablets 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 Meptin tablets.

As Meptin tablets are 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 corticosteroid or to stop use of inhaled corticosteroids and switch to monotherapy with Meptin tablets unless specifically instructed to do so by their physician, even if they have felt symptomatic improvement with the use of Meptin tablets.

(2) During the long-term management of bronchial asthma with Meptin tablets, 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 Meptin tablets, such as short-acting inhaled β₂ stimulants, if acute asthma episodes occur during treatment with Meptin tablets.

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, antiinflammatory therapy should be consolidated by adequate measures, such as increasing the dosage of inhaled corticosteroids.

(3) If the desired therapeutic effect of Meptin tablets cannot be achieved at the recommended dose, the drug should be discontinued.

(4) 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 dose of this drug.

Other Precautions

(1) Tissue damage in cardiac muscle was noted at 30 mg/kg/day in 14-week repeated dose toxicity study in rats and at 10 mg/kg/day or higher in a 26-week repeated dose toxicity study in 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.

(2) Dietary administration of procaterol hydrochloride hydrate for 104 weeks was reported to cause mesovarian leiomyoma in SD rats. However, the tumor is rat species specific and tends to develop during the long-term administration of β₂-adrenergic stimulants.

This drug tends to inhibit skin reactions in allergen tests. The drug should be withdrawn 12 hours prior to such tests.

Precautions for coadministration (Meptin Tablets should be administered with care when coadministered with the following drugs.)

This drug should be administered to pregnant or possibly pregnant women only if the expected therapeutic benefit is thought to outweigh any possible risk. (The safety of this drug during pregnancy has not been established.)

Nursing should be interrupted before starting treatment with the drug. (Rat studies showed that procaterol hydrochloride hydrate is excreted in the breast milk.)

The safety of Meptin Tablets in low birth weight infants, newborns, suckling infants, infants, and children has not been established. (There is no clinical experience in low birth weight infants, newborns, and suckling infants. Clinical experience in infants and children is insufficient.)

Dosage adjustment or other appropriate measures should be considered when prescribing Meptin tablets to elderly patients because these patients may be physiologically more sensitive to the drug than younger patients.