Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA

Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA have removed this

For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to AstraZeneca at 1-800-236-9933 or the FDA at 1-800-FDA-1088 or www. Iodinated 1-125 Albumin Injection (Jeanatope 1-125)- FDA is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.

Its structural formula is:Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7. PULMICORT RESPULES (budesonide inhalation suspension) is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80, and Water for Injection.

For PULMICORT RESPULES (budesonide inhalation suspension)like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA. The mean nebulization time was 5 minutes Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA less.

PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.

The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table. In symptomatic children not responding to non-steroidal therapy, a starting dose of 0. In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved. Abstral (Fentanyl Sublingual Tablets)- Multum RESPULES should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.

Ultrasonic nebulizers are not suitable for the adequate administration of PULMICORT RESPULES and, therefore, are NOT recommended.

The effects of mixing PULMICORT RESPULES with other nebulizable medications have not been adequately assessed. A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver PULMICORT RESPULES to each patient in 3 U. The safety and efficacy neuropsychology journal PULMICORT RESPULES delivered by other nebulizers and compressors have not been established.

PULMICORT RESPULES is available in three strengths, each containing 2 mL: 0. PULMICORT RESPULES is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose RESPULES ampules together with patient instructions for use. There are 30 RESPULES ampules in a carton. Each single-dose RESPULES ampule contains 2 mL of sterile liquid suspension. When an envelope has been opened, the shelf life of the unused RESPULES ampules is 2 weeks when protected.

After opening the aluminum foil envelope, the unused RESPULES ampules should be returned to the aluminum foil envelope to protect them from light. Any opened RESPULES ampule must be used promptly. Gently shake the RESPULES ampule using a circular motion before use. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.

Revised: Oct 2019Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidence of common adverse Omnicef (Cefdinir)- Multum is based on three double-blind, placebo-controlled, randomized U. The following adverse reactions have been reported during post-approval use of PULMICORT RESPULES. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Some of these adverse reactions may also have been observed in clinical studies with PULMICORT RESPULES. The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4).

After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA coadministration of PULMICORT RESPULES with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.

In Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (Tripedia)- FDA trials with PULMICORT RESPULES, localized infections with Candida albicans occurred in the mouth and pharynx in some patients. The incidences of localized infections of Candida albicans were similar between the placebo and PULMICORT RESPULES treatment groups.

Patients should rinse the mouth after inhalation of PULMICORT RESPULES. PULMICORT RESPULES is not a bronchodilator and is not indicated for the rapid relief of acute bronchospasm or other acute episodes of asthma. Patients should be instructed to contact their physician immediately if episodes of asthma not responsive to their usual doses of bronchodilators occur during the course of treatment with PULMICORT RESPULES.

During such episodes, patients may require therapy with oral corticosteroids. Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of PULMICORT RESPULES.

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases, or been properly immunized, particular care should be taken to avoid exposure.

How the dose, route, and duration of Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA administration affect the risk of developing a disseminated infection is not known. If exposed to chickenpox, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see the respective package inserts for complete VZIG and IG Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA information).

If chicken pox develops, treatment with antiviral agents may be considered. The clinical course of chicken pox or measles infection in patients on inhaled corticosteroids has not been studied.

However, a clinical study has examined the immune responsiveness of asthma patients 12 months to 8 years of age who were treated with PULMICORT RESPULES. An open-label non-randomized clinical study examined the immune responsiveness of varicella vaccine in 243 asthma patients 12 months to 8 years of age who were treated with PULMICORT RESPULES 0. No patient treated with PULMICORT RESPULES developed chicken pox as a result of vaccination. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA-axis suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, infection (particularly Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA or other conditions associated with severe electrolyte loss.

Although PULMICORT RESPULES may provide control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticosteroid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.

During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in Dexamethasone Sodium Phosphate for Injection (Dexlido)- FDA doses) immediately and to contact their physicians for further instructions.



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