It has a molecular weight of It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8azoniabicyclo [3. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons.
Chemical structure of albuterol dual nebulizers bromide, albuterol dual nebulizers. Each 3 mL vial of DuoNeb ipratropium bromide and albuterol sulfate contains 3. DuoNeb ipratropium bromide and albuterol sulfate is a clear, albuterol dual nebulizers, colorless solution.
It does not require dilution prior to administration by nebulization. For DuoNeb ipratropium bromide and albuterol sulfate Inhalation Solution, like aid for arthritis other nebulized treatments, the amount delivered to the lungs will depend on patient factors, albuterol dual nebulizers, albuterol dual nebulizers jet nebulizer utilized, and compressor performance.
The mean nebulization time was 15 minutes or less. DuoNeb ipratropium bromide and albuterol sulfate is indicated for the treatment of bronchospasm associated with COPD albuterol dual nebulizers patients requiring more than one bronchodilator.
The recommended dose of DuoNeb ipratropium bromide and albuterol sulfate is albuterol dual nebulizers 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of DuoNeb ipratropium bromide and albuterol sulfate beyond these albuterol dual nebulizers has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of DuoNeb ipratropium bromide and albuterol sulfate have not been studied.
The use of DuoNeb ipratropium bromide and albuterol sulfate can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy.
The safety and efficacy of DuoNeb ipratropium bromide and albuterol sulfate delivered by other nebulizers and compressors have not been established. DuoNeb ipratropium bromide and albuterol sulfate should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.
DuoNeb ipratropium bromide and albuterol sulfate is supplied as a 3-mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store in pouch until time of use. Supplied in cartons as listed below.
Adverse reaction information concerning DuoNeb ipratropium bromide and albuterol sulfate was derived from the week controlled clinical trial. In the clinical trial, there was albuterol dual nebulizers 0. Additional information albuterol dual nebulizers from the published literature on the use of albuterol sulfate and ipratropium bromide singly or in combination includes precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezingexacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitationsalbuterol dual nebulizers, taste perversion, elevated heart rate, sinusitisback painalbuterol dual nebulizers, sore throat albuterol dual nebulizers, and metabolic acidosis.
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. Although ipratropium bromide is minimally absorbed into the systemic circulationthere is some potential for an additive interaction with concomitantly used anticholinergic medications.
Caution is, therefore, advised in the coadministration of DuoNeb ipratropium bromide and albuterol sulfate with other drugs having anticholinergic properties. Caution is advised in the co-administration of DuoNeb ipratropium bromide and albuterol sulfate and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects. These agents and albuterol sulfate inhibit the effect of each other. DuoNeb ipratropium bromide and albuterol sulfate should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressantsor within 2 weeks of discontinuation of such agents because the action of albuterol sulfate on the cardiovascular system may be potentiated.
In the clinical study of DuoNeb ipratropium bromide and albuterol sulfateparadoxical bronchospasm was not observed, albuterol dual nebulizers. However, paradoxical bronchospasm has been observed with both inhaled ipratropium bromide and albuterol products and can be life-threatening.
If this occurs, DuoNeb ipratropium bromide and albuterol dual nebulizers sulfate should be discontinued immediately and alternative therapy instituted, albuterol dual nebulizers. Fatalities have been reported in association with excessive use of inhaled products containing sympathomimetic amines and with the home use of nebulizers. Although such effects are uncommon for DuoNeb ipratropium bromide and albuterol sulfate at recommended doses, if they occur, albuterol dual nebulizers, the drug may need to be discontinued.
In addition, beta agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, albuterol dual nebulizers, and ST segment depression.
The clinical significance of these findings is unknown. Therefore, DuoNeb ipratropium bromide and albuterol sulfatelike other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiencycardiac arrhythmias, and hypertension. The action of DuoNeb ipratropium bromide and albuterol sulfate should last up to 5 hours. DuoNeb ipratropium bromide and albuterol sulfate should not be used more frequently than recommended, albuterol dual nebulizers.
Patients should be instructed not to increase the dose or frequency of DuoNeb ipratropium bromide and albuterol sulfate without consulting their healthcare provider. If symptoms worsen, patients should albuterol dual nebulizers instructed to seek medical consultation. Patients must avoid exposing their eyes to this product as temporary papillary dilationblurred visioneye pain, albuterol dual nebulizers, or precipitation or worsening of narrow-angle glaucoma may occur, and therefore proper nebulizer technique should be assured, particularly if a mask is used.
If a patient becomes pregnant or begins nursing while on DuoNeb ipratropium bromide and albuterol sulfatethey should contact their healthcare provider about use of DuoNeb, albuterol dual nebulizers. In another study, this effect was blocked by the coadministration of propranolola non-selective beta-adrenergic antagonist. Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleous assay.
Ipratropium bromide was not mutagenic in the Ames test and mouse dominant lethal test. Ipratropium bromide was your failure to plan ahead clastogenic in a mouse albuterol dual nebulizers assay.
Albuterol sulfate has been shown to be teratogenic in mice, albuterol dual nebulizers. A study in CD-1 mice given albuterol sulfate subcutaneously showed cleft palate formation in 5 of 4. The drug did not induce cleft palate formation when administered subcutaneously at a dose of 0.
Cleft palate formation also occurred in 22 of 72 A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.
During worldwide marketing experience, various congenital anomalies, albuterol dual nebulizers, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned, a relationship between albuterol use and congenital anomalies has not been established.
Reproduction studies in rats and rabbits demonstrated no evidence of teratogenicity at inhalation doses up to 1. There are no adequate and well-controlled studies of the use of DuoNeb ipratropium albuterol dual nebulizers and albuterol sulfatealbuterol dual nebulizers sulfate, or ipratropium bromide in pregnant women. DuoNeb ipratropium bromide and albuterol sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Oral albuterol sulfate has been shown to delay preterm labor in some reports. Because of the potential of albuterol to interfere with uterine contractility, use of DuoNeb ipratropium bromide and albuterol sulfate during labor should be albuterol dual nebulizers to those patients in whom the benefits clearly outweigh the risks.
It is not known whether the components of DuoNeb ipratropium bromide and albuterol sulfate are excreted in human milk. Although lipid -insoluble quaternary bases pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to an important extent, especially when taken as a nebulized solution.
Because of the potential for tumorigenicity shown for albuterol sulfate in some animals, a decision should be made whether to discontinue nursing or discontinue DuoNeb ipratropium bromide and albuterol sulfatetaking into medicare medical advantage plan the importance albuterol dual nebulizers the drug to the mother.
The safety and effectiveness of DuoNeb ipratropium bromide and albuterol sulfate in patients below 18 years of age have not been established. Of the total number of subjects in clinical studies of DuoNeb ipratropium bromide and albuterol sulfate62 percent were 65 and over, while 19 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between albuterol dual nebulizers elderly and younger patients, but albuterol dual nebulizers sensitivity of some older individuals cannot be ruled out.
The effects of overdosage with DuoNeb ipratropium bromide and albuterol sulfate are expected to be related primarily to albuterol sulfate, since ipratropium bromide is not well-absorbed systemically after oral or aerosol administration.
Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of DuoNeb ipratropium bromide and albuterol sulfate. Treatment consists of discontinuation of DuoNeb ipratropium bromide and albuterol sulfate together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm.
There is insufficient evidence to determine if dialysis is beneficial for overdosage of DuoNeb ipratropium bromide and albuterol sulfate, albuterol dual nebulizers. The inhalation median lethal dose has not been determined in animals. DuoNeb ipratropium bromide and albuterol sulfate is contraindicated in patients with a history of hypersensitivity to any of its components, albuterol dual nebulizers, or to atropine and its derivatives.
The cAMP thus formed mediates the cellular responses. Albuterol dual nebulizers precise function of these receptors, however, is not yet established. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Albuterol sulfate is longer acting than isoproterenol in most patients by any route of administration, because it is not a substrate for the cellular uptake processes for catecholamine nor for the metabolism of catechol-O-methyl transferase.
In structures outside of the blood-brain barrier pineal and pituitary glandsalbuterol concentrations were found to be times those found in whole brain. Studies in laboratory animals minipigs, rodents, and dogs have demonstrated the occurrence of cardiac arrythmias and sudden death with histological evidence of myocardial necrosis when beta-agonists and methyl-xanthines are administered concurrently.
Ipratropium bromide is an anticholinergic parasympatholytic agent, albuterol dual nebulizers, which blocks the muscarinic receptors of acetylcholineand, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the albuterol dual nebulizers of acetylcholine, the transmitter albuterol dual nebulizers released from the vagus nerve. Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate cGMP albuterol dual nebulizers, resulting from the interaction of acetylcholine with the muscarinic receptors of bronchial smooth muscle.
The bronchodilation following inhalation of ipratropium is primarily a local, site-specific effect, not a systemic one. Much of an inhaled dose is swallowed as shown by fecal excretion studies, albuterol dual nebulizers. It is partially metabolized to inactive ester hydrolysis products. Following intravenous administration, approximately one-half is excreted unchanged in the urine.
The half-life of elimination is about 1, albuterol dual nebulizers. Ipratropium bromide that reaches the systemic circulation is reportedly removed by the kidneys rapidly at a rate that exceeds the glomerular filtration rate.
Autoradiographic studies in rats have shown that ipratropium does not penetrate the blood-brain barrier. DuoNeb ipratropium bromide and albuterol sulfate is expected to maximize the response to treatment in patients with chronic obstructive pulmonary disease COPD by reducing bronchospasm through two distinctly different mechanisms: In day studies in Sprague-Dawley rats and Beagle dogs, subcutaneous doses of up to In a double blind, double period, crossover study15 male and female subjects were administered single doses of DuoNeb ipratropium bromide and albuterol sulfate or albuterol sulfate inhalation solution at two times the recommended single doses as two inhalations separated by 15 minutes.
The total nebulized dose of albuterol sulfate from both treatments was 6. Peak albuterol plasma concentrations occurred at 0. The mean peak albuterol concentration following administration of albuterol sulfate alone was 4. Mean AUC values for the two treatments were