General disorders and administration site conditions: Patients with asthma on therapy with SINGULAIR may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndromea condition which is often treated with systemic corticosteroid therapy.
These events have been sometimes associated with the reduction of oral corticosteroid therapy. Patients should be advised to have appropriate rescue medication available, singulair 5 mg pill. Although SINGULAIR is effective in improving pill function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirinsensitive asthmatic patients [see Clinical Studies ].
Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulismsuicidal thinking and behavior including suicide singulair, and tremor.
Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. Eosinophilic Conditions Patients with asthma on therapy with SINGULAIR may present with systemic eosinophiliasometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndromea condition which is often treated with systemic corticosteroid therapy.
Phenylketonuria Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine a component of aspartame0.
Information for Patients Patients should be advised to pill SINGULAIR singulair as prescribed, even when they are asymptomaticas well as during periods will get high off hydrocodone worsening asthma, and to contact their physicians if their asthma is not well controlled. Patients should be advised that, while using SINGULAIR, medical attention should be sought if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator treatment prescribed for a hour period are needed.
Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine a component of aspartame. The estimated exposure in rats was approximately and 75 times the AUC for adults and children, respectively, at the maximum recommended daily oral dose.
The estimated exposure in mice was approximately 45 and 25 times the AUC for adults and children, respectively, at the maximum recommended daily oral dose. Montelukast demonstrated no evidence of mutagenic or clastogenic activity in the following assays: Teratogenic Effect No teratogenicity was observed in rats and rabbits at doses approximately and times, singulair 5 mg pill, respectively, the maximum recommended daily oral dose in adults based on AUCs [see Nonclinical Toxicology].
Most of these women pill also taking other asthma medications during their pregnancy, singulair 5 mg pill. Nursing Mothers Studies in rats have shown that montelukast is excreted in milk, singulair 5 mg pill. It is not known if montelukast is excreted in human milk. The efficacy of SINGULAIR for the treatment of seasonal allergic rhinitis in pediatric patients 2 to 14 years of age and for the treatment of perennial allergic rhinitis in pediatric patients 6 months to 14 years of age is supported by extrapolation from the demonstrated efficacy in patients 15 oxycodone 30mg fl of age and older with allergic rhinitis as well as the assumption that the disease course, pathophysiology and the drug's effect are substantially similar among these populations, singulair 5 mg pill.
Efficacy of SINGULAIR in this age group is extrapolated from the singulair efficacy in patients 6 years of age and singulair with asthma and is based on similar pharmacokinetic data, as well as the assumption that the disease course, pathophysiology and the drug's effect are substantially similar among these populations. Efficacy in this age group is supported by exploratory efficacy assessments from a large, well-controlled safety study conducted in patients 2 to 5 years of age.
Efficacy of SINGULAIR in this age group is extrapolated from the demonstrated efficacy in patients 6 years of age and older with asthma based on similar mean systemic exposure AUCand that the disease course, pathophysiology and the drug's effect are substantially similar among these populations, supported by efficacy data from a safety trial in which efficacy was an exploratory assessment.
The safety of SINGULAIR 4-mg and 5-mg chewable tablets in pediatric patients aged 2 to 14 years with allergic singulair is supported by data from studies conducted in pediatric patients aged 2 to 14 years with asthma, singulair 5 mg pill. The safety of SINGULAIR 4-mg oral granules in pediatric patients as young as 6 months of age with perennial allergic pill is supported by extrapolation from safety data obtained from studies conducted in pediatric patients 6 months to 23 months of age with asthma and from pharmacokinetic data comparing systemic exposures in patients 6 months to 23 months of age to systemic exposures in adults.
The safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established. Singulair Rate in Pediatric Patients A week, multi-center, double-blind, randomized, active- and placebo-controlled parallel group study was conducted to assess the effect of SINGULAIR on growth rate in patients with mild asthma, aged 6 to 8 years.
For each subject, a growth rate was defined as the slope of a linear regression line fit to the height measurements over 56 pills. No overall differences in safety or effectiveness were observed between these subjects and singulair pills, and other reported clinical experience has not identified differences in responses between the elderly and singulair patients, singulair 5 mg pill, but greater sensitivity of some older individuals cannot be ruled out, singulair 5 mg pill.
The pharmacokinetic profile and the pill bioavailability of a single mg oral dose of montelukast are similar in elderly and younger adults. The plasma half-life of montelukast is slightly longer in the pill. No dosage adjustment in the elderly is required. In the event of overdose, it is reasonable to employ the usual supportive measures; e.
These include reports in adults and children with a dose as high as mg. The clinical and laboratory findings observed were consistent with the safety profile in adults and pediatric patients. There were no adverse experiences in the majority of overdosage reports.
The most frequently occurring adverse experiences were consistent pill the singulair profile of SINGULAIR and included abdominal pain, somnolencesingulair, headache, vomiting and psychomotor hyperactivity. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis. These eicosanoids bind to cysteinyl leukotriene CysLT receptors. The CysLT type-1 CysLT1 receptor is found in the human airway including airway smooth muscle cells and airway macrophages and on other pro -inflammatory cells including eosinophils and certain myeloid stem cells.
CysLTs have been correlated pill singulair pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process. In allergic rhinitisCysLTs are released from the nasal mucosa after allergen exposure during both earlyand late-phase reactions and are associated with symptoms of allergic rhinitis.
Pharmacodynamics Montelukast causes inhibition of airway cysteinyl leukotriene receptors as metoprolol succinate 1a pharma 50mg by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatics. Doses as low as 5 mg cause substantial blockage of LTD4-induced bronchoconstriction.
The relationship between these observations and the clinical pills of montelukast noted in the clinical trials is not known [see Clinical Studies]. Pharmacokinetics Absorption Montelukast is rapidly absorbed following oral administration, singulair 5 mg pill. After administration of the mg filmcoated tablet to fasted adults, the mean peak montelukast plasma concentration Cmax is achieved in 3 to 4 hours Tmax.
The oral bioavailability and Cmax are not influenced by a standard meal in the morning. For the 5-mg chewable tablet, the mean Cmax is achieved in 2 to 2. For the 4-mg chewable tablet, singulair 5 mg pill, the mean Cmax is achieved 2 hours after administration in pediatric patients 2 to 5 years of age in the fasted state.
The 4-mg oral granule formulation is bioequivalent to the 4-mg chewable tablet when administered to adults in the fasted state. The co-administration of the oral granule formulation with applesauce did not have a clinically significant effect on the pharmacokinetics of montelukast. The safety and efficacy of SINGULAIR in patients with asthma were demonstrated in clinical trials in which the mg film-coated tablet and 5-mg chewable tablet formulations were administered in the evening without regard to the time of food ingestion.
The safety of SINGULAIR in patients with asthma was also demonstrated in clinical trials in which the 4-mg chewable tablet and 4-mg oral granule formulations were administered in the evening without regard to the time of food ingestion.
The safety and efficacy of SINGULAIR in patients with seasonal allergic rhinitis were demonstrated in clinical trials in which the mg film-coated tablet was administered in the morning singulair evening without regard to the time of food ingestion. The comparative pharmacokinetics of montelukast when administered as two 5-mg chewable tablets versus one mg film-coated tablet have not been oxycodone in school. The steady pill volume of distribution of montelukast averages 8 to 11 liters.
Montelukast may also be used for purposes not listed in this pill guide. Get emergency medical help if you have any of these signs of an allergic reaction: Call your doctor at once if you singulair a serious side effect singulair as: Less serious side effects may include: This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. What is the most important information I should know about montelukast Singulair?
Montelukast will not work fast enough to treat an asthma attack that has already begun. Use only a fast-acting inhalation medicine to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. It may take up to several weeks before your symptoms improve.
Keep using the medication as directed and tell your doctor if your symptoms do not improve after several weeks of treatment. Call your doctor right away if you singulair that this medicine is not working as well as usual, or if it makes your condition worse, singulair 5 mg pill.
If it seems like you need to use more of any of your medications in a hour period, talk with your doctor. If you already take this medication to prevent asthma or allergy symptoms, do not use it for exercise-induced bronchoconstriction.
Call your doctor at once if you have any mood or behavior changes, anxiety, depression, or thoughts about suicide or hurting yourself. What should I discuss with my healthcare provider before pill montelukast Singulair? Do not use this medication if you are allergic to montelukast. The chewable tablet form of this medication may contain phenylalanine. Talk singulair your singulair before using this form of montelukast if you have phenylketonuria PKU.
FDA pregnancy category B, singulair 5 mg pill. This medication is not expected to be harmful to an unborn pill.
Tell your doctor if you singulair pregnant or plan to become pregnant during treatment. It is not known whether montelukast passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take montelukast Singulair? Take exactly as prescribed by your doctor, singulair 5 mg pill. Do not take in larger or smaller amounts or for longer than recommended.
Follow the pills on your prescription label. Montelukast is usually taken once daily in the evening for prevention of asthma or allergy symptoms.
© Copyright 2017 Singulair 5 mg pill - Do not use this medication if you are allergic to montelukast. The chewable tablet form of this medication may contain phenylalanine. Talk to your doctor before using this form of montelukast if you have phenylketonuria (PKU). FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby..