• Relief of dyspnea and other symptoms caused by respiratory obstructive disturbance in the following diseases: bronchial asthma, chronic bronchitis, and pulmonary emphysema.
Dosage and Administration
• The usual adult dosage is 10 mL of Meptin® syrup (50 mcg of procaterol hydrochloride) once before bed or twice (in the morning and before bed) a day by the oral route.The dosage in children 6 years of age or older is 5 mL of Meptin® syrup (25 mcg of procaterol hydrochloride) once before bed or twice (in the morning and before bed) a day by the oral route. The dosage in children less than 6 years of age is 0.25 mL of Meptin® syrup (1.25 mcg of procaterol hydrochloride) per kg body weight once before bed or twice (in the morning or before bed) a day by the oral route.
Meptin® 50 mcg
The usual adult dose of Meptin® tablet is one tablet (50 mcg), orally once before bed or twice (once in the morning and before bed) per day. The dosage should be adjusted according to the patient's age and severity of symptoms.
Meptin® 25 mcg
The usual dose of Meptin® 25 mcg tablet is two tablets (50 mcg) once before bed or twice (in the morning and before bed) per day by the oral route. The dosage in children 6 years of age or older is one tablet (25 mcg), once before bed or twice (in the morning and before bed) per day by the oral route. The dosage should be adjusted according to the patient's age and severity of symptoms.
• Meptin® syrup and Meptin® tablet is contraindicated in patients with a history of hypersensitivity to any of the ingredients of this drug.
1. Careful Administration (Meptin® should be administered with care in the following patients.)
a. Patients with hyperthyroidism (the disease may be exacerbated.)
b. Patients with hypertension (Blood pressure may further increase.)
c. Patients with heart disease (Palpitation, arrhythmias, exacerbation of heart disease, and other symptoms may occur.)
d. Patients with diabetes mellitus (The disease may be exacerbated.)
e. Patients during pregnancy or suspected pregnancy (See Use during Pregnancy or Lactation section.)
2. Important Precautions
a. If the desired therapeutic effect of Meptin® syrup has not been achieved at the recommended dose, the drug should be discontinued
b. 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.
• In clinical trials involving 22,757 subjects, a total of 644 patients (2.83%) showed adverse reactions including abnormal laboratory values. The following summary of data includes adverse reactions reported after marketing without incidence rates (Figures are to
tal cases reported at the time of approval of the initial application, completion of reexamination, and approval of an additional indication for the oral formulations: Meptin® 25 mcg/ 50 mcg tablet, Meptin® syrup).
Clinically significant adverse reactions (*incidence unknown)
1. Shock, anaphylactoid reaction: Shock or anaphylactoid reaction may occur. Patient 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. 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 ß2-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.
Use during Pregnancy, Delivery or Lactation
1. The 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).
2. Nursing should be interrupted before starting treatment with the drug. (Rat studies showed that procaterol hydrochloride is excreted in breast milk).
• Meptin® syrup: Bottles of 60 mL (5 mcg/mL), Meptin® tablets: Box of 50 mcg tablet x 100's, Box of 25 mcg tablet x 100's. Nebulizing Solution: Bottles of 30mL (100mcg/mL)
• Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.