Formulation and evaluation of a montelukast sodium orally disintegrating tablet with a similar dissolution profile as the marketed product.
This leaflet answers some common questions about montelukast.
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 the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
In a separate crossover study in adults, a similar effect was observed after two once-daily 10-mg doses of SINGULAIR. Patients with known aspirin sensitivity should be advised to continue avoidance of aspirin or nonsteroidal anti-inflammatory agents while taking SINGULAIR. These doses were approximately 100 and 110 times the maximum recommended daily oral dose in adults, respectively, based on AUCs. Musculoskeletal and connective tissue disorders arthralgia, myalgia including muscle cramps.
The safety of SINGULAIR 4-mg oral granules in pediatric patients 12 to 23 months of age with asthma has been demonstrated in an analysis of 172 pediatric patients, 124 of whom were treated with SINGULAIR, in a 6-week, double-blind, placebo-controlled study see ADVERSE REACTIONS. There were no adverse experiences in the majority of overdosage reports.
Patients should be advised to continue taking Montelukast 10 mg film-coated tablets even if their asthma is under control, as well as during periods of worsening asthma. For adults and adolescents 15 years of age and older one 10-mg tablet.
Ask your doctor before use if you are taking the following medications:
People with low body weight may have a higher risk of side effects, such as nausea and vomiting.
Geriatric patients, due to the concomitant thinning of the skin that occurs with aging, may be at increased risk for this effect.
The safety in patients 6 to 23 months of prescription is supported by data from pharmacokinetic and safety and efficacy studies in asthma in this pediatric population and from adult pharmacokinetic studies. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.
Healthwise, Healthwise for every health decision, and the Healthwise logo are trademarks of Healthwise, Incorporated. If you have reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.