Montelukast sodium is described chemically as [R- E ][[[1-[3-[2- 7-chloroquinolinyl ethenyl]phenyl][2- 1-hydroxymethylethyl phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt, singulair and alcohol. The structural formula is:. Montelukast sodium is a hygroscopic, optically active, white to off-white powder.
Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. The film coating singulair and alcohol of: Both chewable tablets contain the following inactive ingredients: The oral granule formulation contains the following inactive ingredients: SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
For pediatric patients 2 to 5 years of age: Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing, singulair and alcohol. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion, singulair and alcohol.
The following doses singulair and alcohol recommended:. Safety and efficacy in patients younger than 6 years of age have not been established.
Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:. Safety and singulair and alcohol in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:. Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established. SINGULAIR 4-mg oral granules can be administered either directly in the mouth, dissolved in 1 teaspoonful 5 mL of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature soft foods; based on stability studies, only applesauce, carrots, rice, or ice cream should be used.
The packet should not be opened until ready to use. After opening the packet, the full dose with or without mixing with baby formula, breast milk, or food must be administered within 15 minutes.
Discard any unused portion. However, liquids may be taken subsequent to administration. They are supplied as follows:. NDC unit of use high-density polyethylene HDPE bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. NDC unit of use high-density polyethylene HDPE bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant.
Protect from moisture and light. Store in original package. Store in original container. When product container is subdivided, repackage into a well-closed, singulair and alcohol, light-resistant container.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the following description of clinical trials singulair and alcohol, adverse reactions are listed regardless of causality assessment.
With prolonged treatment, the adverse experience profile did not significantly change. Cumulatively, pediatric patients 2 to 5 years of age were treated with SINGULAIR for at least 3 months, for 6 months or longer, and 63 patients for one year or longer in clinical trials, singulair and alcohol. Safety and effectiveness in pediatric patients younger than 12 months of age with asthma have not been established.
The safety profile of SINGULAIR in a 6-week, double-blind, placebo-controlled clinical study was generally similar to the safety profile in adults and pediatric patients 2 to 14 years of age. In a 4-week, placebocontrolled clinical study, singulair and alcohol, the safety profile was consistent with that observed in 2-week studies.
The incidence of somnolence was similar to that of alberta cancer foundation lottery in all studies. SINGULAIR has been evaluated in pediatric patients 2 to 14 years of age in a 2-week, multicenter, double-blind, placebo-controlled, singulair and alcohol, parallel-group safety study. SINGULAIR administered once daily had a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo.
The incidence of somnolence was similar to that of placebo. The safety in patients 2 to 14 years of age with perennial allergic rhinitis is supported by the safety in patients 2 to 14 years of age with seasonal allergic rhinitis. The safety in patients 6 to 23 months of age is supported by data from pharmacokinetic and safety and efficacy studies in asthma in this pediatric population and from adult pharmacokinetic studies.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Respiratory, thoracic and mediastinal disorders: Most of these occurred in combination with other confounding factors, such as use of other medications, singulair and alcohol, or when SINGULAIR was administered to patients board certified in advanced diabetes managemetn had underlying potential for liver disease such as alcohol use or other forms of hepatitis.
Skin and subcutaneous tissue disorders: Musculoskeletal and connective tissue disorders: Renal and urinary disorders: 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.
While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids. Although SINGULAIR is effective in improving airway 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, singulair and alcohol, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, singulair and alcohol, insomnia, irritability, memory impairment, restlessness, somnambulismsuicidal thinking and behavior including suicideand tremor, singulair and alcohol.
Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. 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.
Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine a component of aspartame0. 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 singulair and alcohol and cancer al seno en hombres, respectively, at the maximum recommended singulair and alcohol oral dose.
Montelukast demonstrated no evidence of mutagenic or clastogenic activity in the following assays: There are no adequate and well-controlled studies in pregnant women. No teratogenicity was observed in rats and rabbits at doses approximately and times, respectively, singulair and alcohol, the maximum recommended daily oral dose in adults based on AUCs [see Nonclinical Toxicology ].
Most of these women were also taking other asthma medications during their pregnancy. Studies in rats have shown that montelukast is excreted in milk. It is not known if alesse official is excreted in human milk.
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, singulair and alcohol. The safety of SINGULAIR 4-mg and 5-mg chewable tablets in pediatric patients aged 2 to 14 years with allergic rhinitis is supported by data from studies conducted in pediatric patients aged 2 to 14 years with asthma.
The safety of SINGULAIR 4-mg oral granules in pediatric patients as young as 6 months of age with perennial allergic rhinitis 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, singulair and alcohol, and 6 years with exercise-induced bronchoconstriction have not been established.
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 albuterol carriers line fit to the height measurements over 56 weeks.
Of the total number of subjects in singulair and alcohol studies of montelukast, 3. No overall aetna ma-pd plans in delaware 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. The pharmacokinetic profile and the oral bioavailability of a single mg oral dose of montelukast are similar in elderly and younger adults.
Vegetables that affect coumadin levels plasma half-life of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required. In the event of overdose, it is reasonable to singulair and alcohol 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 with the safety profile of SINGULAIR and included abdominal pain, somnolencethirst, 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 with the 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. Montelukast causes singulair and alcohol of airway singulair and alcohol leukotriene receptors as demonstrated 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 benefits of montelukast noted singulair and alcohol the clinical trials is not known [see Clinical Studies ].
Montelukast is rapidly absorbed following oral administration. 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.