PULMICORT RESPULES

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Overview

What is PULMICORT RESPULES?

Budesonide, the active component of PULMICORT RESPULES, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is CHO and its molecular weight is 430.5. 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 7.4 is 1.6 x 10.

PULMICORT RESPULES 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. Three dose strengths are available in single-dose ampules (Respules™ ampules): 0.25 mg, 0.5 mg, and 1 mg per 2 mL RESPULES ampule. For PULMICORT RESPULES, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. PULMICORT RESPULES should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces .

What does PULMICORT RESPULES look like?

What are the available doses of PULMICORT RESPULES?

Inhalation suspension: 0.25 mg/2 mL, 0.5 mg/2 mL, 1 mg/2 mL ()

What should I talk to my health care provider before I take PULMICORT RESPULES?

How should I use PULMICORT RESPULES?

PULMICORT RESPULES is an inhaled corticosteroid indicated for:

Limitations of Use:

Not indicated for the relief of acute bronchospasm ()

The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table.

What interacts with PULMICORT RESPULES?

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What are the warnings of PULMICORT RESPULES?

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What are the precautions of PULMICORT RESPULES?

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What are the side effects of PULMICORT RESPULES?

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What should I look out for while using PULMICORT RESPULES?

The use of PULMICORT RESPULES is contraindicated in the following conditions:

What might happen if I take too much PULMICORT RESPULES?

The potential for acute toxic effects following overdose of PULMICORT RESPULES is low. If inhaled corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism or growth suppression may occur .

In mice, the minimal lethal inhalation dose was 100 mg/kg (approximately 410 and 120 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m basis). In rats there were no deaths at an inhalation dose of 68 mg/kg (approximately 550 and 160 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m basis). In mice, the minimal oral lethal dose was 200 mg/kg (approximately 810 and 240 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m basis). In rats, the minimal oral lethal dose was less than 100 mg/kg (approximately 810 and 240 times, respectively, the maximum recommended daily inhalation dose in adults and children 12 months to 8 years of age on a mg/m basis).

How should I store and handle PULMICORT RESPULES?

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. PULMICORT RESPULES is available in three strengths, each containing 2 mL:PULMICORT RESPULES should be stored upright at controlled room temperature 20-25°C (68-77°F) [see USP], and protected from light. 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. Keep out of reach of children. Do not freeze.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. PULMICORT RESPULES is available in three strengths, each containing 2 mL:PULMICORT RESPULES should be stored upright at controlled room temperature 20-25°C (68-77°F) [see USP], and protected from light. 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. Keep out of reach of children. Do not freeze.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. PULMICORT RESPULES is available in three strengths, each containing 2 mL:PULMICORT RESPULES should be stored upright at controlled room temperature 20-25°C (68-77°F) [see USP], and protected from light. 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. Keep out of reach of children. Do not freeze.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. In standard and animal models, budesonide has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol (rat croton oil ear edema assay). As a measure of systemic activity, budesonide is 40 times more potent than cortisol when administered subcutaneously and 25 times more potent when administered orally in the rat thymus involution assay. The clinical significance of these findings is unknown.

The activity of PULMICORT RESPULES is due to the parent drug, budesonide. In glucocorticoid receptor affinity studies, the 22R form was two times as active as the 22S epimer. studies indicated that the two forms of budesonide do not interconvert.

The precise mechanism of corticosteroid actions on inflammation in asthma is not well known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic- and non-allergic-mediated inflammation. The anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Studies in asthmatic patients have shown a favorable ratio between topical anti-inflammatory activities and systemic corticosteroid effects over a wide dose range of inhaled budesonide in a variety of formulations and delivery systems including an inhalation-driven, multi-dose dry powder inhaler and the inhalation suspension for nebulization. This is explained by a combination of a relatively high local anti-inflammatory effect, extensive first pass hepatic degradation of orally absorbed drug (85-95%) and the low potency of metabolites (see below).

Non-Clinical Toxicology

The use of PULMICORT RESPULES is contraindicated in the following conditions:

Warfarin and other Oral Anticoagulants

In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine levels should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication.

Drugs that Inhibit CYP450 Enzymes

Drugs that Induce CYP450 Enzymes

In clinical trials with PULMICORT RESPULES, localized infections with occurred in the mouth and pharynx in some patients. The incidences of localized infections of were similar between the placebo and PULMICORT RESPULES treatment groups. If these infections develop, they may require treatment with appropriate local or systemic antifungal therapy and/or discontinuance of treatment with PULMICORT RESPULES. Patients should rinse the mouth after inhalation of PULMICORT RESPULES.

Systemic and inhaled corticosteroid use may result in the following:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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