Bambuterol Hydrochloride Oral Solution

Pharmacological action: This product is a prodrug of the adrenergic beta 2 receptor agonist terbutaline. After oral absorption, it is metabolized to terbutaline under the action of enzymes. Terbutaline mainly activates beta 2 receptors, leading to relaxation of bronchial smooth muscle. In addition, this product also has the effect of inhibiting the release of inflammatory mediators by mast cells. Repeated dose toxicity: Wistar and Beagle dogs were given oral administration of bambuterol hydrochloride at a dose of 108 mg/kg/d and 34.42 mg/kg/d, respectively, for 90 consecutive days. No toxic reactions were observed in animal behavior, diet, hematology, blood biochemistry, gross anatomy, and pathological histological examinations of major organs. Genetic toxicity: The results of the Ames test, CHL cell chromosome aberration test, and NIH mouse bone marrow micronucleus test were all negative. Reproductive toxicity: Bambuterol hydrochloride was given orally at a dose of 1808 mg/kg/d for 10 consecutive days. No obvious toxic reactions were observed in Wistar pregnant rats, and no obvious appearance, visceral, or skeletal deformities were observed in the fetuses.

Bambuterol Hydrochloride

This product is a colorless or slightly yellow liquid with a sweet taste.

Bronchial asthma, chronic asthmatic bronchitis, obstructive pulmonary emphysema and other lung diseases associated with bronchospasm.

Take orally once every night before going to bed. The initial dose for adults is 10 mg. Depending on the clinical effect, it can be increased to 20 mg after 1 to 2 weeks of medication. For patients with renal insufficiency (GFR 50 ml/min glomerular filtration rate), the recommended initial dose is 5.0 mg. Children aged 2-5: The recommended initial dose for Asian children is 5 mg. Children aged 6-12: 10 mg per day. It is not recommended that Asian children use a dose exceeding 10 mg.

There are tremors, headaches, rigid muscle spasms and palpitations, but the adverse reactions of this drug are milder than other similar drugs. Its intensity is positively correlated with the dose, and most side effects disappear on their own within the first 1 to 2 weeks of treatment. A very small number of people may experience mild elevation of transaminase, dry mouth, dizziness, stomach discomfort, rash, etc.

Patients who are allergic to this product, terbutaline and sympathomimetic amines are contraindicated.

Precautions for children: The dosage for children has not been determined, so infants and young children should use it with caution. Precautions for pregnancy and lactation: Although the drug has not been found to be teratogenic in animal experiments, it should still be used with caution in the first three months of pregnancy. It is not yet certain whether bambuterol or its intermediate metabolites are secreted through breast milk. Terbutaline is secreted into breast milk, but it does not cause adverse effects on infants at therapeutic doses. It has been reported that premature newborns whose mothers were treated with beta-2 receptor agonists will develop temporary hypoglycemia. Precautions for the elderly: It should be used with caution, and the initial dose should be reduced.

1. Since bambuterol can partially inhibit the activity of cholinesterase in plasma, it can prolong the muscle relaxation effect of succinylcholine and is dose-dependent, but can be restored. 2. It should not be used in combination with adrenergic receptor blockers. 3. Since beta 2 receptor agonists can increase blood sugar concentration, it is recommended that patients with diabetes adjust their hypoglycemic drugs when taking this product. 4. When used in combination with other sympathomimetic amines, the effect is enhanced and the toxicity is increased.

Keep sealed.

10ml:10mg

24 months

Nanjing Haijing Pharmaceutical Co., Ltd.

• Founded in:

  1991-07-22

• Address:

  No. 23, Xinke 2nd Road, Jiangbei New District, Nanjing

• Tax NO.:

  9132019113491078X2

• Registered Funds:

  100.361879 yuan

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