Duoneb Information
Duoneb (Ipratropium bromide,albuterol sulfate) Description
The active components in Duoneb (Ipratropium bromide,albuterol sulfate) Inhalation Solution are albuterol sulfate and ipratropium bromide.
Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β-adrenergic bronchodilator chemically described as α-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (CHNO)•HSO. 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.
Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is CHBrNO•HO. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons.
Each 3 mL vial of Duoneb (Ipratropium bromide,albuterol sulfate) contains 3.0 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride, hydrochloric acid to adjust to pH 4, and edetate disodium, USP (a chelating agent).
Duoneb (Ipratropium bromide,albuterol sulfate) is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Duoneb (Ipratropium bromide,albuterol sulfate) Inhalation Solution, 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-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Duoneb (Ipratropium bromide,albuterol sulfate) should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see ).
Duoneb (Ipratropium bromide,albuterol sulfate) Clinical Pharmacology
Duoneb (Ipratropium bromide,albuterol sulfate) Inhalation Solution is a combination of the β-adrenergic bronchodilator, albuterol sulfate, and the anticholinergic bronchodilator, ipratropium bromide.
In a 12 week, randomized, double-blind, positive-control, crossover study of albuterol sulfate, ipratropium bromide, and Duoneb (Ipratropium bromide,albuterol sulfate) , 863 COPD patients were evaluated for bronchodilator efficacy comparing Duoneb (Ipratropium bromide,albuterol sulfate) with albuterol sulfate and ipratropium bromide alone.
Duoneb (Ipratropium bromide,albuterol sulfate) demonstrated significantly better changes in FEV, as measured from baseline to peak response, when compared with either albuterol sulfate or ipratropium bromide. Duoneb (Ipratropium bromide,albuterol sulfate) was also shown to have the rapid onset associated with albuterol sulfate, with a mean time to peak FEV of 1.5 hours, and the extended duration associated with ipratropium bromide with a duration of 15% response in FEV of 4.3 hours.
This study demonstrated that each component of Duoneb (Ipratropium bromide,albuterol sulfate) contributed to the improvement in pulmonary function, especially during the first 4 to 5 hours after dosing, and that Duoneb (Ipratropium bromide,albuterol sulfate) was significantly more effective than albuterol sulfate or ipratropium bromide alone.
Duoneb (Ipratropium bromide,albuterol sulfate) Indications And Usage
Duoneb (Ipratropium bromide,albuterol sulfate) is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.
Duoneb (Ipratropium bromide,albuterol sulfate) Contraindications
Duoneb (Ipratropium bromide,albuterol sulfate) is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.
Duoneb (Ipratropium bromide,albuterol sulfate) Precautions
1. Effects Seen with Sympathomimetic Drugs
As with all products containing sympathomimetic amines, Duoneb (Ipratropium bromide,albuterol sulfate) should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. Additionally, β-agonists may cause a decrease in serum potassium in some patients, possibly through intracellular shunting. The decrease is usually transient, not requiring supplementation.
The action of Duoneb (Ipratropium bromide,albuterol sulfate) should last up to 5 hours. Duoneb (Ipratropium bromide,albuterol sulfate) should not be used more frequently than recommended. Patients should be instructed not to increase the dose or frequency of Duoneb (Ipratropium bromide,albuterol sulfate) without consulting their healthcare provider. If symptoms worsen, patients should be instructed to seek medical consultation.
Patients must avoid exposing their eyes to this product as temporary papillary dilation, blurred vision, eye pain, 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,albuterol sulfate) , they should contact their healthcare provider about use of Duoneb (Ipratropium bromide,albuterol sulfate) .
See the illustrated in the product package insert.
Duoneb (Ipratropium bromide,albuterol sulfate) Adverse Reactions
Adverse reaction information concerning Duoneb (Ipratropium bromide,albuterol sulfate) was derived from the 12-week controlled clinical trial.
Additional adverse reactions reported in more than 1% of patients treated with Duoneb (Ipratropium bromide,albuterol sulfate) included constipation and voice alterations.
In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, including skin rash, pruritus, and urticaria.
Additional information derived 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, wheezing, exacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain, sore throat, 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.
Duoneb (Ipratropium bromide,albuterol sulfate) Overdosage
The effects of overdosage with Duoneb (Ipratropium bromide,albuterol sulfate) are expected to be related primarily to albuterol sulfate, since ipratropium bromide is not well-absorbed systemically after oral or aerosol administration. The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmia, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of pharmacological effects listed in . Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of Duoneb (Ipratropium bromide,albuterol sulfate) . Treatment consists of discontinuation of Duoneb (Ipratropium bromide,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,albuterol sulfate) .
The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 540 times the maximum recommended daily inhalation dose of Duoneb (Ipratropium bromide,albuterol sulfate) on a mg/m basis). The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 and 2000 mg/kg respectively (approximately 240 and 1100 times the maximum recommended daily inhalation dose of Duoneb (Ipratropium bromide,albuterol sulfate) on a mg/m basis, respectively). The inhalation median lethal dose has not been determined in animals. The oral median lethal dose of ipratropium bromide in mice, rats and dogs is greater than 1000 mg/kg, approximately 1700 mg/kg and approximately 400 mg/kg, respectively (approximately 1400, 4600, and 3600 times the maximum recommended daily inhalation dose in adults on a mg/m basis, respectively).
Duoneb (Ipratropium bromide,albuterol sulfate) Dosage And Administration
The recommended dose of Duoneb (Ipratropium bromide,albuterol sulfate) is one 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,albuterol sulfate) beyond these guidelines 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,albuterol sulfate) have not been studied.
The use of Duoneb (Ipratropium bromide,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.
A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver Duoneb (Ipratropium bromide,albuterol sulfate) to each patient in one U.S. clinical study. The safety and efficacy of Duoneb (Ipratropium bromide,albuterol sulfate) delivered by other nebulizers and compressors have not been established.
Duoneb (Ipratropium bromide,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,albuterol sulfate) How Supplied
Duoneb (Ipratropium bromide,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.
NDC 49502-672-30 30 vials per carton/5 vials per foil pouchNDC 49502-672-60 60 vials per carton/5 vials per foil pouch
Store between 2°C and 25°C (36°F and 77°F). Protect from light.
Duoneb (Ipratropium bromide,albuterol sulfate) is a registered trademark of Dey Pharma L.P.
Dey A Mylan Company
Dey Pharma L.P., Napa, CA 94558
03-485-32
MAR 11
Duoneb (Ipratropium bromide,albuterol sulfate) Duoneb
Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication as you may want to read them again.
Duoneb (Ipratropium bromide,albuterol sulfate) should only be used under the direction of a physician. Your physician and pharmacist have more information about Duoneb (Ipratropium bromide,albuterol sulfate) and the condition for which it has been prescribed. Contact them if you have additional questions.
Store Duoneb (Ipratropium bromide,albuterol sulfate) between 2°C and 25°C (36°F and 77°F). Vials should be protected from light before use, therefore, keep unused vials in the foil pouch or carton. Do not use after the expiration (EXP) date printed on the carton.
Duoneb (Ipratropium bromide,albuterol sulfate) is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed. Use one new vial for each nebulizer treatment.
Dey A Mylan Company
Dey Pharma L.P., Napa, CA 94558
03-485-32
MAR 11
Duoneb (Ipratropium bromide,albuterol sulfate) Patient Information
Duoneb (Ipratropium bromide,albuterol sulfate) is a combination of two medicines called bronchodilators. Duoneb (Ipratropium bromide,albuterol sulfate) contains albuterol sulfate, which is a beta-adrenergic agonist, and ipratropium bromide, which is an anticholinergic. These two medicines work together to help open the airways in your lungs. Duoneb (Ipratropium bromide,albuterol sulfate) is used to help treat airway narrowing (bronchospasm) that happens with chronic obstructive pulmonary disease (COPD) in adult patients who need to use more than one bronchodilator medicine.
Duoneb (Ipratropium bromide,albuterol sulfate) has not been studied in patients younger than 18 years of age.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Duoneb (Ipratropium bromide,albuterol sulfate) and other medicines can interact. This may cause serious side effects. Especially tell your doctor if you take:
Ask your doctor or pharmacist if you are not sure if you take any of these types of medicines. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacists when you get a new medicine.
Duoneb (Ipratropium bromide,albuterol sulfate) can cause a serious eye problem called narrow-angle glaucoma or worsen the narrow-angle glaucoma you already have.
The most common side effects with Duoneb (Ipratropium bromide,albuterol sulfate) include lung disease, sore throat, chest pain, constipation, diarrhea, bronchitis, urinary tract infection, leg cramps, nausea, upset stomach, voice changes, and pain.
These are not all the side effects with Duoneb (Ipratropium bromide,albuterol sulfate) . For a complete list, ask your doctor or pharmacist.
Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. Do not use Duoneb (Ipratropium bromide,albuterol sulfate) for a condition for which it was not prescribed. Do not give Duoneb (Ipratropium bromide,albuterol sulfate) to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about Duoneb (Ipratropium bromide,albuterol sulfate) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Duoneb (Ipratropium bromide,albuterol sulfate) that is written for healthcare professionals. You can also call the company that makes Duoneb (Ipratropium bromide,albuterol sulfate) toll free at 1-800-395-3376 or visit their website at www.dey.com.
Dey Pharma L.P., Napa, CA 94558; 1-800-395-3376; www.dey.com
© 2004 Printed in U.S.A.
U.S. Pat. No. 6,632,842
M9-356-00 April 2006
Duoneb (Ipratropium bromide,albuterol sulfate)
