Procaterol Hydrochloride Oral Solution

1. Bronchodilator effect: From the effect of inhibiting the increase of airway resistance in dogs, cats and guinea pigs, the bronchodilator effect of Procaterol hydrochloride is the same as or stronger than that of isoproterenol, and stronger than that of salbutamol and metaproterenol. 2. Duration of bronchodilator effect: The duration of bronchodilator effect of Procaterol hydrochloride was studied in dogs, cats and guinea pigs, and it was found that it was longer than that of isoproterenol, thiophene, metaproterenol and salbutamol. 3. Selectivity for beta2-receptors: When studying the selectivity of Procaterol hydrochloride for beta2 receptors in the cardiovascular and respiratory systems using dogs, cats and guinea pigs, it was found that its organ selectivity was better than that of isoproterenol, thiophene, metaproterenol and salbutamol. 4. Anti-allergic effect: The study used the increase in reactive airway resistance in guinea pigs or rats, PCA reaction and histamine release in the lungs, skin reaction in adult bronchial asthma patients, and inhibition of asthma induced by inhaled allergens as indicators and found that the anti-allergic effect of Procaterol hydrochloride was stronger than that of isoproterenol, metaproterenol and salbutamol. 5. Effect on the respiratory secretion system: Procaterol hydrochloride causes hyperactivity of the respiratory cilia in pigeons. 6. Inhibitory effect on exercise-induced asthma attacks: Procaterol hydrochloride can inhibit exercise-induced asthma. 7. Effect on airway hyperresponsiveness: Procaterol hydrochloride can inhibit airway hyperresponsiveness in dogs induced by influenza C virus inoculation. 8. Effect on increased vascular permeability: Procaterol hydrochloride has an inhibitory effect on the increased vascular permeability and edema formation in the subcutaneous air sacs on the back of rats caused by various inflammatory substances, which is basically the same as isoproterenol. In addition, it has an inhibitory effect on the formation of pulmonary edema in guinea pigs caused by inhaled histamine, and this effect is stronger than salbutamol. 9. Effect on cough Procaterol hydrochloride can inhibit cough in patients with acute bronchitis induced by inhaled substance P.

The main ingredient of this product is Procaterol Hydrochloride.

This product is a colorless, clear, slightly viscous liquid with an orange aroma and sweet taste.

This product relieves symptoms such as dyspnea caused by obstructive respiratory disorders in the following diseases: bronchial asthma, chronic bronchitis, acute bronchitis, and asthmatic bronchitis.

1. Generally, adults: once a day, orally before bedtime or twice a day, morning and evening before bedtime, 50ug each time (equivalent to 10ml of oral solution); children over 6 years old: once a day, orally before bedtime or twice a day, morning and evening before bedtime, 25ug each time (equivalent to 5ml of oral solution); infants under 6 years old: twice a day, morning and evening before bedtime or 3 times a day, morning, noon and evening before bedtime, 1.25ug/kg each time (equivalent to 0.25ml/kg of oral solution). 2. In addition, the dosage can be appropriately increased or decreased according to age and symptoms. 3. The dosage standard for children under 6 years old is as follows: under 1 year old: 10-15ug/day (equivalent to 2-3ml of oral solution); 1-3 years old: 15-20ug/day (equivalent to 3-4ml of oral solution); 3-6 years old: 20-25ug/day (equivalent to 4-5ml of oral solution).

1. Serious adverse reactions (1) β2 agonists have been reported to cause severe hypokalemia abroad. Similar to β2 agonists, the effect of lowering serum potassium levels can be enhanced by the combination with xanthine derivatives, steroid preparations and diuretics, so special attention should be paid to patients with severe asthma. In addition, hypoxemia can sometimes enhance the effect of low serum potassium levels on heart rate. It is best to monitor serum potassium levels at this time. (2) Shock and allergic symptoms: Shock and allergic symptoms may occur occasionally, so careful observation should be made. If abnormalities are found, the dosage should be reduced or the drug should be discontinued, and appropriate measures should be taken. 2. Other adverse reactions (1) Cardiovascular system: palpitations, rapid pulse and fever may occur occasionally. (2) Mental and nervous system: muscle tremors, headaches, occasional dizziness, insomnia, etc. may occur occasionally, as well as finger cramps, muscle rigidity and spasms. (3) Digestive system: nausea, vomiting or occasional thirst and stomach discomfort may occur occasionally. (4) Allergies: rashes may occur occasionally. (5) Liver: Sometimes there will be liver dysfunction such as increased GOT, GPT, and LDH. (6) Others: Occasionally there will be general fatigue, nasal congestion, tinnitus, etc. In addition, sometimes there will be a decrease in serum potassium levels.

1. Patients who are currently taking catecholamine preparations (epinephrine, isoproterenol) are contraindicated. 2. Patients with a history of allergy to the ingredients of this product are contraindicated.

Precautions for children: The safety of administration to premature infants and newborns has not been established (no experience). Precautions for pregnancy and lactation: Administration to pregnant and lactating women 1. Since the safety of administration during pregnancy has not been established, it can only be administered to pregnant women or women who may become pregnant when the therapeutic benefits outweigh the risks. 2. Transfer to animal (rat) milk has been reported, so breastfeeding should be avoided during administration of this product. Precautions for the elderly: In general, due to the low physiological function of elderly patients, attention should be paid to reducing the dosage, etc.

1. Do not use with catecholamine preparations (epinephrine, isoproterenol) [cardiac arrhythmia, sometimes there is a risk of cardiac arrest]. 2. When using with xanthine derivatives (sometimes it may enhance the side effects such as hypokalemia), steroid preparations and diuretics (sometimes it may enhance the hypokalemia effect).

Keep in a dark place and tightly sealed at 10℃～30℃.

0.0005%

Year 2

Sichuan OTSUKA Pharmaceutical Co., Ltd.

• Founded in:

  2002-08-13

• Address:

  No. 1, Linjiang North Road, High-tech Industrial Development Zone, Leshan City, Sichuan Province

• Tax NO.:

  91511100740043436K

• Registered Funds:

  $33,627,066

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