Food and Administration Medicine
has approved the new instruction for SINGULAIR (montelukast sodium) to prevent the generated exercise bronchoconstriction (EIB; also heard as induced asthma of the exercise) on patient old 15 years and more old. SINGULAIR - first and only spoken tablet approved for this use.
EIB is USUALLY characterized by shortness of breath, is wheezed and breast tightness happened to on exercise. “EIB INFLUENCES upon broad spectrum of the population of the asthma. EIB LIMITS the ability to participate in exercise or physical activity.” said David S. Pearlman, M.D., Allergy Colorado and Asthma Centre, P.C. “This instruction for SINGULAIR offer new and efficient choice to address the suitable patient with EIB. The Asthma is a complex disease, and row choice processing - it is necessary to control other patient.”
In clinical study, the single tablet mg SINGULAIR 10 prevented EIB when is taken two hours before exercise. Some patients were protected from EIB in 8.5 and 24 soon after that, as administration; however, some patients were not. SINGULAIR must is NOT takeаased immediate relief of the attack of the asthma. The Patients must always have their breathed medicine of the liberation available.
In addition to now approved for use before exercise on approaching patient with EIB, SINGULAIR remains to be a choice for prevention and chronic processing the asthma in adult and pediatric 12 months patient age and more old. The Patients already one tablet daily SINGULAIR (montelukast sodium), - registered trademark Merck & Co., Inc for the other instruction, including chronic asthma, must not take the additional dose to prevent EIB. The Daily administration SINGULAIR for chronic processing the asthma is not installed to prevent the sharp episodes EIB.
SINGULAIR PREVENTED EIB in clinical study
Efficiency SINGULAIR 10 mg. when is given as single dose two hours previously, than exercise for prevention EIB was evaluated in three mixed, double-blind, placebocontrolled transition concerns with on 160 patients old 15 years and more old with EIB. In these study, the primary endpoint was an average maximum fall of the percent in FEV1 (the Forced Volume Expiratory in the first second - an important measure to pulmonary function) follows the exercise in two soon after that, as dosing.
In one analysis, the patients realized two hours, 8.5 hours, and 24 soon after that, as taking or single 10-mg. dose SINGULAIR or In this analysis, the single dose mg SINGULAIR 10 demonstrated the statistical significant defensive profit against EIB when is taken two hours before exercise. Some patients were protected from EIB in 8.5 and 24 soon after that, as administration; however, some patients were not. The Result in this analysis reflected the results from other two studies.
The Safe profile SINGULAIR in these study EIB was corresponding to safe profile previously described for SINGULAIR. In preceding clinical study, side effects in adult and SINGULAIR were usually soft and usually did not force to stop therapy. Most general registered side effects changed to age and included the headache, auditory infection, sore throat and upper infection respiratory.
Dosage and administration for EIB on patient 15 year age and more old.
For prevention EIB, the single dose SINGULAIR must r at least once two hours before exercise. The Additional dose SINGULAIR must not abusive within 24 hours preceding dose. The Patients already one tablet daily for the other instruction (including chronic asthma), must not take the additional dose to prevent EIB. All patients must breathe the medication of the liberation available. Safety and efficiency SINGULAIR for EIB on patient younger than 15 years of the age are not installed. The Daily administration SINGULAIR for chronic processing the asthma is not installed to prevent the sharp episodes EIB.
Important information on SINGULAIR
SINGULAIR is SPECIFIED for preventive and chronic processing the asthma in adult and pediatric 12 months patient age and more old, for relief seasonal allergic rhinitis (SAR) in adult and two years and more old, and for relief eternal allergic rhinitis (the EQUALITY) in adult and poles months and more old. SINGULAIR is SPECIFIED for prevention EIB on patient 15 year age and more old.
Use SINGULAIR for chronic processing the asthma can not avoid need for breathed or spoken corticosteroids. While dose breathed corticosteroid can decrease gradually under medical checking, SINGULAIR must not is sharply replaced breathed or spoken corticosteroids. The Patients with the known sensitivity of the aspirin must continue the exception of the aspirin or ne-steroidal anti-inflammatory agent when taking SINGULAIR. The Patients must will are informed to take SINGULAIR daily as it is given for chronic processing the asthma even when they have not as well as for period of the deterioration of the asthma, and to address to its physician if their asthma well did not finish. The Patients, SINGULAIR daily for chronic asthma or allergic rhinitis must talk with their physician about processing for their EIB.