Budesonide suspension for inhalation

Budesonide suspension for inhalation: This product is not a halogen-containing adrenocortical hormone drug. It has the effects of inhibiting respiratory inflammatory response, reducing respiratory hyperresponsiveness, and relieving bronchospasm. Budesonide is an anti-inflammatory corticosteroid drug with strong glucocorticoid activity and weak mineralocorticoid activity. In standard in vitro models and animal models, the affinity of budesonide to glucocorticoid receptors is about 200 times that of cortisol, and its local anti-inflammatory ability is about 1000 times that of the latter (rat croton oil-induced ear edema test). As a result of systemic activity evaluation, budesonide is about 40 times more effective than cortisol in subcutaneous administration in the rat thymus involution test, while its oral administration is about 25 times more effective than the latter. The activity of budesonide suspension for inhalation comes from its active drug budesonide. In the glucocorticoid receptor affinity study, the activity of the 22R configuration is about twice that of its diastereomer 22S configuration. In vitro studies have shown that the two configurations of budesonide do not convert into each other. The exact mechanism of action of glucocorticoids in asthma inflammation is still unclear. Inflammation is an important part of the pathogenesis of asthma. Glucocorticoids have been shown to have a wide range of inhibitory effects on allergic or non-allergic inflammation involving multiple cell types (such as mast cells, eosinophils, neutrophils, macrophages and lymphocytes) and mediators (such as histamine, eicosanoids and cytokines). The therapeutic effect of glucocorticoids on asthma may be attributed to their anti-inflammatory effects. In a series of studies on a wide range of inhaled budesonide preparations with different formulations and delivery systems, including inhaled propellants, multi-dose dry powder inhalers, and nebulized inhalation suspensions for asthma patients, local anti-inflammatory activity showed advantages over systemic glucocorticoid therapy. This phenomenon can be explained by the relatively higher local anti-inflammatory effect obtained by local administration, which avoids the significant first-pass liver degradation effect (85%-95%) of orally absorbed drugs and low-efficiency metabolites. See the inner package insert for details. Terbutaline sulfate nebulizer: Terbutaline is an adrenergic β2 receptor agonist that dilates the bronchi by selectively stimulating β2 receptors. Terbutaline can increase the mucociliary cleaning function that is reduced due to obstructive pulmonary disease, thereby accelerating the clearance of mucus secretions.

Budesonide suspension for inhalation: budesonide. Terbutaline sulfate nebulizer: The active ingredient of this product is terbutaline sulfate.

This product is a fine particle suspension. Fine particles will precipitate after standing and become a white or off-white suspension after shaking.

No data yet

Budesonide suspension for inhalation: For detailed instructions on use, please refer to "Introduction to Use". If asthma worsens, the number of budesonide doses and/or the total amount of budesonide per day need to be increased. Budesonide suspension for inhalation should be administered via a suitable nebulizer. Depending on the nebulizer, the actual dose inhaled by the patient is 40-60% of the labeled amount. Nebulization time and output drug volume depend on the flow rate, nebulizer volume and liquid volume. For most nebulizers, the appropriate liquid volume is 2-4 ml. Budesonide suspension for inhalation will undergo some sedimentation during storage. If a completely stable suspension cannot be formed after shaking, it should be discarded. Starting dose, dose during severe asthma or when reducing oral corticosteroids Adults: 1-2 mg once, twice a day. Children: Once

Budesonide Inhalation Suspension: Incidence 1% to ≤3% by body system The following information includes all adverse events with an incidence between 1 and ≤3% and for which at least one incidence in the budesonide inhalation suspension treatment group exceeded that in the placebo group, regardless of relevance to drug therapy. Systemic reactions: allergic reactions, chest pain, fatigue, flu-like symptoms Respiratory system: wheezing Impaired defense mechanisms: herpes simplex, external ear infections, infections Central and peripheral nervous system: dysphonia, hypermobility Skin and skin appendages: eczema, pustular rash, pruritus Hearing and vestibular: ear pain Visual: eye infections Psychiatric: anorexia, emotional lability Musculoskeletal system: fractures, myalgia Site of administration: contact dermatitis Platelets, bleeding and coagulation: purpura Leukocytes and immunity: cervical lymphadenopathy In three open-label studies, 447 children with asthma who received budesonide inhalation suspension (mean total daily dose 0.5-1 mg) and 223 children who received conventional treatment had similar rates of adverse events after 1 year of follow-up. In the published literature, the results of long-term open clinical trials, or the post-marketing reports of all inhalable budesonide preparations worldwide, occasional adverse events (<1%) include: immediate or delayed allergic reactions, including rash, contact dermatitis, urticaria, angioedema, and bronchospasm; symptoms of adrenocortical insufficiency and adrenal hyperfunction; glaucoma, cataracts; psychiatric symptoms, including depression, aggressive reactions, irritability, anxiety, and psychosis; and bone diseases, including avascular necrosis of the femoral head and osteoporosis. Budesonide is well tolerated. Most adverse reactions are mild and local. The systemic effects and oropharyngeal complications caused by budesonide are dose-related. See the inner package insert for details. Terbutaline sulfate nebulizer: The degree of adverse reactions is dose-related. The incidence of systemic adverse reactions is low when using the recommended dose. Most adverse reaction reports are characteristic reactions of sympathomimetic amines, which generally subside gradually after 1-2 weeks of medication.

Allergic to budesonide or any other ingredient.

Precautions for children: Budesonide suspension for inhalation: See [Usage and Dosage]. See the inner package insert for details. Terbutaline sulfate nebulizer: See [Usage and Dosage]. Precautions for pregnancy and lactation: Budesonide suspension for inhalation: Teratogenic effects of medication for pregnant women: The FDA classifies it as pregnancy safety category B - budesonide, like other corticosteroids, is teratogenic and embryotoxic to rabbits and rats. In a study, rabbits received 25ugug/kg (based on ug/m[sup]2[/sup], which is lower than the maximum recommended daily inhalation dose for adults) and rats received 500ug/kg (based on ug/m[sup]2[/sup], which is about 4 times the maximum recommended daily inhalation dose for adults) subcutaneous administration, resulting in fewer fetuses and reduced weight of pups. In another study in rats, a dose of 250ug/kq (based on ug/m[sup]2[/sup], approximately the maximum recommended dose for adults) was used. Elderly Note: Budesonide suspension for inhalation: Same as adults [Usage and Dosage]. In three clinical trials of budesonide suspension for inhalation in adult patients, 65 (30%) of the 215 patients were over 65 years old and 22 (10%) were over 75 years old. These patients did not differ in safety indicators compared with younger patients. Other clinical reports or medical observations have not found differences between elderly and younger patients. Terbutaline sulfate nebulizer: Same as adults.

Budesonide suspension for inhalation: In clinical studies, co-administration of budesonide with other drugs was common, increasing the incidence of adverse events. The main metabolic pathway of budesonide, as well as other steroid drugs, is metabolism through cytochrome P450 (CYP) 3A4 (CYP3A4). Oral administration of ketoconazole (a strong CYP3A4 inhibitor) will lead to an increase in the average plasma drug concentration of oral budesonide. When co-administered with other known CYP3A4 inhibitors (such as itraconazole, clarithromycin, erythromycin, etc.), the metabolism of budesonide may be inhibited and the systemic exposure of budesonide may be increased. Caution should be exercised when budesonide is co-administered with long-term ketoconazole or other known CYP3A4 inhibitors. Ometra

Sealed and protected from light.

2ml:1mg

24 months