Exercise challenge testing was conducted at 2 hours and 24 hours following administration of a single dose of study drug (Singulair 5 mg or placebo). Most of these occurred in combination with other confounding factors, such as use of other medications, or when Singulair was administered to patients who had underlying potential for liver disease such as alcohol use or other forms of hepatitis.Skin and subcutaneous tissue disorders: angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, Stevens-Johnson syndrome/toxic epidermal necrolysis, urticaria.Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps.General disorders and administration site conditions: edema.Patients with asthma on therapy with Singulair may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. While using this site, you agree to have read and accepted our Selecting a region changes the language and/or content on Adobe.com.
Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups.In embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the AUC in humans at the MRHDOD, respectively).A published clinical lactation study reports the presence of montelukast in human milk. Select one or more newsletters to continue. Do not use Singulair for a condition for which it was not prescribed. Patients 15 to 82 years of age with perennial allergic rhinitis as confirmed by history and a positive skin test to at least one relevant perennial allergen (dust mites, animal dander, and/or mold spores), who had active symptoms at the time of study entry, were enrolled.In the study in which efficacy was demonstrated, the median age was 35 years (range 15 to 81); 64.1% were females and 35.9% were males. The packet should not be opened until ready to use. For each subject, a growth rate was defined as the slope of a linear regression line fit to the height measurements over 56 weeks. Presnisone - is a tablet form steriod and has many side affects when taken in longterm doses, most asthmatics are prescribed short term doses to cope with a bad attack so the affects are limited, advair is a comination inhaler, which includes albuterol, so while on this the doses of albuterol are taken only when necessary and singulair once deemed a breakthrough drug can have side affects also. The … In a 56-week, double-blind study evaluating growth rate in pediatric patients 6 to 8 years of age receiving Singulair, the following events not previously observed with the use of Singulair in this age group occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: headache, rhinitis (infective), varicella, gastroenteritis, atopic dermatitis, acute bronchitis, tooth infection, skin infection, and myopia.Singulair has been evaluated for safety in 573 pediatric patients 2 to 5 years of age in single- and multiple-dose studies. Access your plan list on any device – mobile or desktop. "If you or your child misses a dose of Singulair, just take the next dose at your regular time.For adults and children 12 months of age and older with asthma:For people 6 years of age and older for the prevention of exercise-induced asthma:Do not take 2 doses of Singulair within 24 hours (1 day).For anyone 2 years of age and older with seasonal allergic rhinitis, or for anyone 6 months of age and older with perennial allergic rhinitis:Singulair may cause serious side effects, including:“What is the most important information I should know about Singulair?”Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis).Tell your healthcare provider right away if you get one or more of these symptoms:Keep Singulair and all medicines out of reach of children.General information about the safe and effective use of Singulair.How can I give Singulair oral granules to my child?Do not store any leftover Singulair mixture (oral granules mixed with food, baby formula, or breast milk) for use at a later time.Do not mix Singulair oral granules with any liquid drink other than baby formula or breast milk.Keep Singulair and all medicines out of the reach of children.Attention Health Care Professional: Dispense the enclosed Medication Guide to each patient.Dispense the accompanying Medication Guide to each patient.Dispense the accompanying Medication Guide to each patient.Dispense the accompanying Medication Guide to each patient.We comply with the HONcode standard for trustworthy health information - Singulair oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration.
Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients No dose adjustment is needed when Singulair is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. by: Merck Sharp & Dohme Corp., a subsidiary ofFor patent information: www.merck.com/product/patent/home.htmlCopyright © 1998-2020 Merck Sharp & Dohme Corp., a subsidiary of This Instructions for Use contains information on how to use Singulair oral granules.Dist.
Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups.In embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the AUC in humans at the MRHDOD, respectively).A published clinical lactation study reports the presence of montelukast in human milk. Select one or more newsletters to continue. Do not use Singulair for a condition for which it was not prescribed. Patients 15 to 82 years of age with perennial allergic rhinitis as confirmed by history and a positive skin test to at least one relevant perennial allergen (dust mites, animal dander, and/or mold spores), who had active symptoms at the time of study entry, were enrolled.In the study in which efficacy was demonstrated, the median age was 35 years (range 15 to 81); 64.1% were females and 35.9% were males. The packet should not be opened until ready to use. For each subject, a growth rate was defined as the slope of a linear regression line fit to the height measurements over 56 weeks. Presnisone - is a tablet form steriod and has many side affects when taken in longterm doses, most asthmatics are prescribed short term doses to cope with a bad attack so the affects are limited, advair is a comination inhaler, which includes albuterol, so while on this the doses of albuterol are taken only when necessary and singulair once deemed a breakthrough drug can have side affects also. The … In a 56-week, double-blind study evaluating growth rate in pediatric patients 6 to 8 years of age receiving Singulair, the following events not previously observed with the use of Singulair in this age group occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: headache, rhinitis (infective), varicella, gastroenteritis, atopic dermatitis, acute bronchitis, tooth infection, skin infection, and myopia.Singulair has been evaluated for safety in 573 pediatric patients 2 to 5 years of age in single- and multiple-dose studies. Access your plan list on any device – mobile or desktop. "If you or your child misses a dose of Singulair, just take the next dose at your regular time.For adults and children 12 months of age and older with asthma:For people 6 years of age and older for the prevention of exercise-induced asthma:Do not take 2 doses of Singulair within 24 hours (1 day).For anyone 2 years of age and older with seasonal allergic rhinitis, or for anyone 6 months of age and older with perennial allergic rhinitis:Singulair may cause serious side effects, including:“What is the most important information I should know about Singulair?”Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis).Tell your healthcare provider right away if you get one or more of these symptoms:Keep Singulair and all medicines out of reach of children.General information about the safe and effective use of Singulair.How can I give Singulair oral granules to my child?Do not store any leftover Singulair mixture (oral granules mixed with food, baby formula, or breast milk) for use at a later time.Do not mix Singulair oral granules with any liquid drink other than baby formula or breast milk.Keep Singulair and all medicines out of the reach of children.Attention Health Care Professional: Dispense the enclosed Medication Guide to each patient.Dispense the accompanying Medication Guide to each patient.Dispense the accompanying Medication Guide to each patient.Dispense the accompanying Medication Guide to each patient.We comply with the HONcode standard for trustworthy health information - Singulair oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration.
Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients No dose adjustment is needed when Singulair is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. by: Merck Sharp & Dohme Corp., a subsidiary ofFor patent information: www.merck.com/product/patent/home.htmlCopyright © 1998-2020 Merck Sharp & Dohme Corp., a subsidiary of This Instructions for Use contains information on how to use Singulair oral granules.Dist.