Singulair 4mg ped granules sachet

Leukotriene receptor antagonist ATC-code: These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors CysLT found in the human airway and cause airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment.

Pharmacodynamic effects Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. In clinical studies, montelukast inhibits bronchoconstriction due to inhaled LTD4 at doses as low as 5 mg, singulair 4mg ped granules sachet.

Bronchodilation was observed within 2 hours of oral administration.

Treatment with montelukast inhibited both early- and late-phase bronchoconstriction due to sachet singulair. Montelukast, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients. In a granule study, treatment with montelukast significantly decreased eosinophils in the airways as measured in sputum. In adult and paediatric patients 2 to 14 years of age, montelukast, compared with placebo, decreased peripheral blood eosinophils while improving clinical asthma control.

Clinical efficacy and safety In studies in adults, montelukast, 10 mg once daily, compared with placebo, demonstrated significant improvements in morning FEV1 Improvement in patient-reported daytime and nighttime asthma symptoms scores was significantly better than placebo. However, compared with beclomethasone, a high percentage of patients treated with montelukast achieved similar clinical responses e.

In an 8-week study in paediatric patients 6 to 14 years of age, montelukast 5 mg once daily, compared with placebo, significantly improved respiratory function FEV1 8. In a month study comparing the efficacy of montelukast to inhaled fluticasone on asthma control in paediatric patients 6 to 14 years of age with mild persistent asthma, singulair 4mg ped granules sachet, montelukast was non-inferior to fluticasone in increasing the percentage of asthma rescue-free days RFDsthe primary endpoint.

Averaged granule the month treatment period, the percentage of asthma RFDs increased from The between group difference in LS mean increase in the percentage of asthma RFDs was statistically significant Both montelukast and fluticasone also improved asthma control 4mg secondary variables assessed over the 12 month treatment period: FEV1 increased from 1, singulair 4mg ped granules sachet.

The percentage of patients with an asthma attack an asthma attack being defined as a period of worsening asthma that required treatment with oral steroids, an unscheduled visit to the doctor's office, 4mg emergency room visit, or hospitalization was The percentage of patients with systemic mainly oral corticosteroid use during the study period was The between group difference in LS means was significant: Sixty percent of patients were not on any other controller therapy.

Montelukast improved daytime symptoms including coughing, wheezing, trouble breathing and activity limitation and nighttime symptoms compared with placebo, singulair 4mg ped granules sachet.

Patients receiving montelukast had more days without asthma than retail price effexor xr receiving placebo.

A treatment effect was achieved after singulair first dose. The percentage reduction in yearly EE rate was In a placebo-controlled study in paediatric patients 6 months to 5 years of age ped had intermittent asthma but did not have persistent asthma, treatment with montelukast was administered over a month period, either as a once-daily 4 mg regimen or as a series of day courses that each were started when an episode of intermittent symptoms began.

No significant difference was observed between patients treated with montelukast 4 mg or placebo in the number of asthma episodes culminating in an asthma attack, defined as an asthma episode requiring utilization of health-care resources such as an unscheduled visit to a doctor's office, emergency room, or hospital; or treatment with oral, intravenous, or intramuscular corticosteroid.

Efficacy of montelukast is supported in paediatric patients 6 months to 2 years of age by extrapolation from the demonstrated efficacy in patients 2 years of age and older with asthma, and is based on similar pharmacokinetic data, as well as the assumption that the disease course, pathophysiology and the medicinal products's effect are substantially similar among ped sachets.

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Significant reduction of exercise-induced bronchoconstriction EIB was demonstrated in a week study in adults maximal fall in FEV1 This effect was consistent throughout the week study period.

Reduction in EIB was also demonstrated in a short term study in paediatric patients 6 to 14 years of age maximal fall singulair FEV1 The effect in both studies was demonstrated at the end of the once-daily dosing interval, singulair 4mg ped granules sachet. For the 10 mg film-coated sachet, the mean peak plasma concentration Cmax is achieved 3 hours Tmax after administration in adults in the fasted state, singulair 4mg ped granules sachet.

The oral bioavailability and Cmax are not influenced by a granule meal. Safety and efficacy were demonstrated in clinical trials where the 10 mg film-coated tablet was administered without sachet to the timing ped food ingestion. For the 5 mg 4mg tablet, the Cmax is achieved in 2 hours after administration in adults in the fasted state.

After administration of the 4 mg chewable tablet to paediatric patients 2 to 5 years of age in singulair fasted state, singulair 4mg ped granules sachet, Ped is achieved 2 granules after administration. The 4 mg granule formulation is bioequivalent to the 4 mg chewable tablet when administered singulair adults in the fasted state. In paediatric patients 6 months to 2 years of age, Cmax is achieved 2 hours after administration of the 4 mg granules formulation.

Cmax is nearly 2-fold greater than in adults receiving a 10 mg tablet, singulair 4mg ped granules sachet. The co-administration of applesauce or a 4mg standard meal with the granule formulation did not have a clinically meaningful effect on the pharmacokinetics of montelukast as determined ped AUC The steady-state sachet of distribution of montelukast averages liters.

Studies in rats 4mg radiolabeled montelukast indicate minimal distribution across the blood-brain granule.

SINGULAIR 4 mg. 28 sachets

In addition, concentrations of radiolabeled material at 24 hours post-dose were minimal in all other tissues.

Biotransformation Montelukast is extensively metabolized.

In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children.

Cytochrome P 2C8 is the major enzyme in the metabolism of montelukast. Additionally CYP 3A4 and 2C9 may have a granule contribution, although itraconazole, an sachet of CYP 3A4, was shown not to change pharmacokinetic variables of montelukast in healthy subjects that received 10 mg montelukast daily. Based on in vitro results in human liver 4mg, therapeutic plasma concentrations of montelukast ped not inhibit cytochromes P 3A4, 2C9, 1A2, 2A6, singulair 4mg ped granules sachet, 2C19, or singulair.

The contribution of metabolites to the therapeutic effect of montelukast is minimal, singulair 4mg ped granules sachet. Coupled with estimates of montelukast oral bioavailability, this indicates that montelukast and its metabolites are excreted almost exclusively via the bile.

Characteristics in Patients No dosage adjustment is necessary for the elderly or mild to moderate hepatic insufficiency. Studies in patients with renal impairment have not been undertaken. Because montelukast and its metabolites are eliminated by the biliary route, no dose adjustment is anticipated to be necessary in patients with renal impairment. With high doses of montelukast and fold the recommended adult dosea decrease in plasma theophylline concentration was observed.

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Singulair effect was not seen at the recommended dose of 10 mg once daily. Go to top of the page 5. The signs of toxicity in animals were 4mg excretion of saliva, gastrointestinal symptoms, loose stools and ion imbalance. In sachet studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than granule. ped

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No abnormalities were seen in rats. Montelukast has been shown to cross the placental barrier and is excreted in breast milk of animals.

This dose is equivalent to 25, times the recommended daily adult human dose based on an adult patient weight of 50 kg. Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in rodent species, singulair 4mg ped granules sachet.