Budesonide Suspension
Product Images NDC 47335-633

This appears to be instructions on how to use Budesonide Inhalation Suspension, a medication intended for inhalation only. The text explains how to prepare and use the suspension along with details of the active ingredients present in the medication. It includes information about the manufacturer, storage instructions, recommended dosage, and precautions to be taken.*

This is a set of instructions for using Budesonide Inhalation Suspension, which is prescribed for patients with breathing problems. The text explains how to open and use a single-dose ampule of the medication with a nebulizer, how to store the medication safely, and where to find more information about its proper use. The instructions also include details about the manufacturer and distributor of the medication.*

This text provides instructions for using Budesonide Inhalation Suspension. The user is instructed to open the sealed foil pouch and remove one ampule, shaking it gently and then opening it by twisting the top off. The open end of the ampule should be placed into the nebulizer cup, and all of the contents are to be slowly squeezed out to begin nebulizing the medication. The nebulizer should be used as directed, and patients should follow the enclosed patient instructions. The budesonide suspension is intended for inhalation only and is supplied in 2mL single-dose ampules. The suspension should be used immediately once opened and stored at controlled room temperature, protected from light. The package insert should be consulted for full prescribing information.*

The text is a figure 1 of a 12-week trial in pediatric patients with asthma on different doses of medicine (0.25 mg, 0.5 mg, and 1 mg). The graph shows the change in nighttime asthma symptoms from baseline over the course of the study. The p-value for each dose is also given.*

This is a figure from a 12-week trial in pediatric patients who were previously maintained on inhaled corticosteroid therapy. The figure shows the mean change from baseline in nighttime asthma symptoms over the 12-week period, with data points taken at various intervals throughout the study. There were three treatment groups represented: placebo, 0.25 mg twice daily, and 0.5 mg twice daily. The p-values for the 0.25 mg and 0.5 mg groups were 0.022 and 0.021, respectively.*

This appears to be a figure illustrating the results of a 12-week trial in pediatric patients who were maintained on either bronchodilators alone or inhaled corticosteroid therapy prior to study entry. The chart shows changes in nighttime asthma from baseline at various time intervals over the course of the study, comparing a placebo group to four different dosages of an unknown medication. The chart also includes p-values for each dosage in comparison to placebo.*

This is a description of a medication called Budesonide Inhalation Suspension that comes in a 2mL sterile suspension containing 0.5 mg of budesonide USP (micronized), for inhalation only. It also contains edetate disodium, sodium chloride, polysorbate 80, citric acid monohydrate, sodium citrate, and water for injection. The medication's use should be directed by a physician, and the patient should follow their instructions before using it. The opened ampules should only be used within two weeks of opening. The medication should be shaken gently before use and used immediately after opening. It's not recommended to use it in an ultrasonic nebulizer. The medication should be stored at a temperature of 20° to 25°C (68°F to 77°F) with minor deviations permitted between 15° and 30°C (59°F and 86°F). It should not be frozen, and the foil pouch shouldn't be discarded until the last ampule is used. Further instructions can be found on the manufacturer's website.*

NDC 4733563148 is a prescription medication for inhalation containing 0.25 mg of budesonide USP (micronized) in a sterile suspension, associated with edetate disodium, sodium chloride, polysorbate 80, citric acid monohydrate, sodium citrate, and water for injection. It is intended to be used with a nebulizer and should not be used in an ultrasonic nebulizer. It is stored in the foil pouch placed upright, protected from light, at a temperature ranging from 20° to 25°C (68°10 to 77°F). The package insert must be read and the product used as directed by a physician. The patient instructions for use are available at https://www.sunpharma.com/usajproducts. The opened ampules should be used within two weeks, and the foil pouch must not be discarded until the last ampule is used.*

Budesonide Inhalation Suspension is a sterile suspension designed for use in a nebulizer only, and it delivers 1 mg of micronized budesonide USP per 2 mL single-dose ampule. The suspension consists of edetate disodium, sodium chloride, Water for Injection, polysorbate, lactic acid monohydrate, and sodium citrate. Patients must follow their physicians' directions and the Patient Instructions when using the suspension. After opening an ampule, it should be used immediately. It should be used within two weeks of opening the foil pouch. The suspension must not be used in an ultrasonic nebulizer. The foil pouch should be kept until the last ampule is used. The product should be stored upright in the carton, in the foil pouch, at room temperature between 15°C and 30°C. The product should be protected from light, kept out of reach of children, and not frozen. The website mentioned at the end offers the patient instructions for use.*