| About AccuNeb® Inhalation Solution |
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| For many years, the short-acting bronchodilator, albuterol, has been the primary fast-acting medicine for asthma attacks. For this reason, it is often included in a child's asthma treatment plan. However, many children who suffer from asthma—especially very young children ages 24 months to 5 years—have been overmedicated with full-strength adult doses of albuterol.1
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| When children receive a too-heavy dose of albuterol, they can experience side effects such as2:
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- Excitability
- Nervousness
- Inability to sleep
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| Recognizing that young children have unique medical needs that require pharmaceuticals with pediatric-specific dosing, Dey, L.P. developed AccuNeb® brand to treat asthma in children as young as 24 months. AccuNeb® solution is a short-acting albuterol inhalation therapy that relieves symptoms such as coughing, chest tightness, shortness of breath, and wheezing. |
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| AccuNeb® product is available in 2 reduced strengths: 0.63 mg and 1.25 mg (quarter-strength and half-strength doses of full-strength albuterol sulfate inhalation solution, respectively). It is sold in sterile, preservative-free unit-dose vials and is premixed and premeasured for convenience and accuracy.
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| AccuNeb® Inhalation Solution is delivered by a nebulizer, a device that uses an air compressor to deliver medication as a fine mist for inhalation through a mask. Nebulizer treatments are generally easier to use, especially for young children, than manipulating a hand-held metered dose inhaler (MDI). |
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| For very young children, nebulization with AccuNeb® solution lowers the risk of side effects that may be caused by full-strength albuterol. The product also provides accurate and appropriate dosing for older children who may actually risk undermedication due to poor MDI technique or other factors. |
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| AccuNeb® solution of quarter-strength and half-strength follows the National Asthma Education and Prevention Program (NAEPP) lower-dosing guidelines for pediatric asthma patients. AccuNeb® product is the only branded albuterol inhalation solution that follows these guidelines without requiring mixing or dilution. Mixing and dilution from full-strength albuterol or multidose bottles of albuterol concentrate potentially can create conditions for incorrect dosing and/or product contamination.
The sterile unit-dose packaging of AccuNeb®
solution reduces this source of error. |
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Effective
control with fewer side effects |
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Asthma disease management is designed to stabilize patients over time, introducing different therapies as needed to prevent the cascade of destructive symptoms that occur in an asthma attack. Depending on the patient's immediate need, the goal of asthma management is to maintain control using the least amount of medication while exposing the patient to the lowest risk of side effects.3 |
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| When an actual asthma attack threatens, albuterol has become the drug of choice over several decades of clinical practice for fast relief of symptoms. Children who require albuterol inhalation therapy can benefit from AccuNeb® solution, because it provides them the efficacy of full-strength albuterol with reduced risk of side effects. |
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| In a clinical trial evaluating lower-dose AccuNeb® brand for children with moderately severe asthma, AccuNeb® solution side effects included less than 1% incidence of tremors, changes in heart rates, and nervousness. The lower dose of AccuNeb® solution still provided effective relief, offering significant improvement in breathing capacity compared to placebo.1 |
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User-friendly and
convenient |
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AccuNeb® Inhalation Solution is designed to provide convenience, speed, and safety in nebulizing children to control asthma symptoms. The product is:
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Pediatrically precise: flexible dosing for children as young as 24 months at quarter-strength and half-strength concentrations of full-strength albuterol sulfate inhalation solution
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Safe and effective: as demonstrated in a clinical trial
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Premixed and premeasured: quick time to nebulization
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Accurately dosed: premixed single vials guarantee precise dosing and eliminate guesswork
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Sterile: no product contamination, reduced risk of respiratory infection
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Preservative-free: no allergic reactions induced by BAC preservatives
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Convenient: TwistFlex™ vials are easy to open
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| AccuNeb® solutions provide ease of use and accurate dosing to help ensure patient compliance, resulting in improved disease management for pediatric asthma patients. |
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| AccuNeb® (albuterol sulfate) Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease). |
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| Important Safety Information |
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| In a clinical trial with AccuNeb® Inhalation Solution 0.63 mg, AccuNeb® Inhalation Solution 1.25 mg, and placebo, the most commonly reported adverse events were asthma exacerbations (11.1%, 13%, 8.5%), otitis media (0.9%, 4.3%, 0%), allergic reaction (3.4%, 0.9%, 1.7%), gastroenteritis (3.4%, 0.9%, 0.9%), and flu syndrome (2.6%, 2.6%, 1.7%). |
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| Like other beta-adrenergic agonists, AccuNeb® Inhalation Solution can produce paradoxical bronchospasm, which may be life-threatening. AccuNeb® Inhalation Solution should be used with caution in patients with cardiovascular disorders and patients being treated with epinephrine, oral sympathomimetics, beta-blockers, MAOIs, or tricyclic antidepressants. |
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| Please see Patient Prescribing Information. |
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| TwistFlex is a trademark of Dey, L.P. |
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| References |
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| 1.
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Kemp J, Nayak AS, Noonan M, Oren J, Kaplan A, Covington P. Reduced doses of nebulized albuterol are effective for maintenance treatment of children with asthma. Accepted for publication. |
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MedlinePlus Web site. Albuterol. http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a607004.html. Accessed May 11, 2007.
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| 3.
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National Asthma Education and Prevention Program (NAEPP). Pharmacologic Therapy for Pediatric Asthma. Dey; 2003. Publication D-349-01.
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| 4.
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AccuNeb Inhalation Solution [package insert]. Napa, Calif: Dey, L.P.; January 2007. http://www.accuneb.com/common/Accu_PI_New.pdf. Accessed May 11, 2007. |
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