Bambuterol Hydrochloride Capsules

Pharmacological action: This product is a prodrug of the selective beta 2 receptor agonist terbutaline. After oral absorption, it is metabolized to terbutaline under the action of enzymes. Terbutaline mainly activates the beta 2 receptors of bronchial smooth muscle, thereby relaxing the bronchial smooth muscle. In addition, this product also has the effect of inhibiting the release of inflammatory mediators from mast cells. Toxicological study: Repeated dose toxicity: Wistar rats and Beagle dogs were orally administered with a dose of 108 mg/Kg/day and 34.42 mg/Kg/day for 90 consecutive days, respectively. 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: This product was orally administered at a dose of 180 mg/Kg/day for 10 consecutive days. No obvious toxic reactions were observed in pregnant Wistar rats, and no obvious appearance, visceral, or skeletal deformities were observed in the fetuses.

The main ingredient of this product is bambuterol hydrochloride.

This product is a hard capsule, and the contents are white granules.

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, which can be increased to 20 mg after 1-2 weeks of medication based on clinical effects. For patients with renal insufficiency (creatinine clearance less than 50 ml/min), the initial dose is recommended to be 5.0 mg.

The side effects that have been found include tremor, headache, rigid muscle spasm and palpitations, which are common characteristics of oral bronchodilators. However, the adverse reactions of this drug are milder than those of other similar drugs. The intensity of the side effects is positively correlated with the dose, and most side effects will disappear on their own within the first 1-2 weeks of treatment. A very small number of people may experience mild elevation of transaminase, dry mouth, dizziness, stomach discomfort, etc.

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

Precautions for children: The dosage for children under 12 years old and pediatrics has not been established, so it should be used with caution or under the doctor's advice. Precautions for pregnancy and lactation: Although the drug has not been found to have teratogenic effects in animal experiments, it should still be used with caution in the first three months of pregnancy. In addition, this product can relax uterine smooth muscle, so it can inhibit the uterine activity and delivery of pregnant women. It is not yet certain whether bambuterol or its intermediate metabolites will be secreted into breast milk, but its metabolite terbutaline will be secreted into breast milk. Although it will not cause adverse effects on infants at therapeutic doses, it should still be used with caution by lactating women. Precautions for the elderly: It is not yet clear.

Bambuterol hydrochloride may prolong the muscle relaxant effect of succinylcholine due to a partial, dose-dependent inhibition of cholinesterase production by bambuterol hydrochloride that is fully reversible.

Keep in a dark, airtight, cool place.

10mg

36 months

Sichuan Guorui Pharmaceutical Co., Ltd.

• Founded in:

  2005-12-07

• Address:

  North Section of Fenghuang Road, Yujin Town, Qianwei County, Leshan City

• Tax NO.:

  91511123782279383G

• Registered Funds:

  20 million yuan

• Email:

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