FDA PERMITS ALUPENT/ (METAPROTERENOL SULFATE)
INHALATION SOLUTION FOR ACUTE ATTACKS IN PEDIATRIC ASTHMA
RIDGEFIELD, Conn., Nov. 15 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) yesterday granted a pediatric indication for ALUPENT/(NOTE) (metaproterenol sulfate) Inhalation Solution, Boehringer Ingelheim Pharmaceuticals, Inc. announced today.
ALUPENT/ Inhalation Solution, a bronchodilator that has been effectively used for more than 20 years in the management of bronchial asthma and other bronchospastic conditions in adults and in children over 12, is now indicated for the treatment of acute asthmatic attacks in children age 6 years and older. ALUPENT/ is marketed by Boehringer Ingelheim.
Pediatric asthma is increasing at an alarming rate. More than eight million American children are affected by some form of pediatric asthma, and more than two million children suffer from severe chronic asthma. To date, this chronic affliction does not have a cure.
Unlike other childhood diseases that have been decreasing in frequency, statistics demonstrate a continuous increase in the number of pediatric asthma cases. A recent study found that 7.5 percent of American children between six and 11 have asthma, and the hospitalization rate for pediatric asthma has been increasing steadily. American children have 30 million days of restricted activity per year due to asthma, making it the number one cause of missed school days.
ALUPENT/ Inhalation Solution is a beta-adrenergic stimulant, which works to induce bronchodilation. ALUPENT/ stimulates bronchodilation by activating the level of the enzyme adenylate cyclase. This enzyme then converts the body's natural compound adenosine triphosphate (ATP) to cyclic adenosine monophosphate (cAMP). Increased levels of cAMP allow the bronchial smooth muscle to relax and dilate, thereby alleviating airway constriction. ALUPENT/ has been shown to have fast onset of action, bringing quick relief from the symptoms of acute attack. It has also been documented to have a favorable safety profile.
As with other sympathomimetic agents, ALUPENT/ has some potential side effects. It has been shown to produce a very low incidence of stimulation in some children, as well as low levels of cardiovascular effects, such as tachycardia. In addition it should be used with caution in patients with hypertension, coronary artery disease, or sensitivity to sympathomimetic amines among other conditions, and should not be overused.
The inhalation solution is administered via compressor-driven nebulizers or an intermittent positive pressure breathing (IPPB) apparatus. Nebulizers, which are devices used to administer the drug in an aerosol form through a face mask or mouthpiece, are often easier to use than conventional inhalers.
"Prescribing a medication that is administered via a nebulizer may help to increase proper use of the drug for the asthmatic child with a compliance problem," says William Storms, M.D., Associate Clinical Professor of Medicine, University of Colorado School of Medicine. "An asthma medication that is administered via a machine, such as ALUPENT/ Inhalation Solution through a nebulizer, signifies to the parent -- and the child -- that the asthma condition is serious and requires their full attention in adhering to and monitoring therapy compliance. This has a positive effect on compliance, and in building better communication between parent and child, which is also an important goal of asthma therapy."
Nebulizers can be used at home, thus possibly avoiding frequent hospital visits. Additionally, nebulizers do not require the breathing coordination demanded by metered dose inhalers and may be useful for children who have difficulty timing hand movements with inhalation. The use of home nebulizers can also help to keep treatment costs down, as it may prevent some visits to doctors' offices and emergency rooms.
"Studies have concluded that ALUPENT/ Inhalation Solution is effective for children age 6 and older," says Storms. "With dosing information indicated for this age group, physicians will be able to manage the acute attacks of their pediatric asthmatic patients effectively. So while asthma cannot be cured, it can be managed."
The inhalation solution was initially introduced 20 years ago, and has been used effectively in both adults and children 12 and older worldwide. It is currently available in easy-to-use premixed sterile unit-dose packaging and in bulk solution form. In addition to the inhalation solution, ALUPENT/ is available for adults in the form of inhalation aerosol, syrup and tablets.
Obtaining a pediatric indication for ALUPENT/ Inhalation Solution reflects the continuing commitment of Boehringer Ingelheim Pharmaceuticals, Inc. to the research and treatment of pediatric asthma, one of the nation's most significant childhood health threats. Despite the challenges faced in the testing of drugs indicated for children, Boehringer Ingelheim Pharmaceuticals has made the management of pediatric asthma one of its top priorities.
Boehringer Ingelheim Pharmaceuticals, Inc., a subsidiary of Boehringer Ingelheim Corporation, is an American pharmaceutical company dedicated to the research, development, manufacture and marketing of health care products.
NOTE: See full prescribing information for warnings, precautions and adverse reactions.
/CONTACT: Patricia Morrow of Boehringer Ingelheim, 203-798-5666; or Ellen Herzlich of Porter/Novelli, 212-315-8051, for Boehringer Ingelheim/ CO: Boehringer Ingelheim Pharmaceuticals, Inc. ST: Connecticut IN: MTC SU: PDT JT -- NY039 -- 1492 11/15/91 11:24 EST