Remedio singulair 10mg - Singulair - FDA prescribing information, side effects and uses
After administration of the mg film-coated 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, the mean Cmax is achieved 2 hours after administration in pediatric patients 2 to 5 years of age in the fasted state, remedio singulair 10mg.
The 4-mg remedio granule formulation is bioequivalent to the 4-mg chewable tablet when administered to adults singulair the fasted state. The co-administration of the oral granule formulation with applesauce did not singulair a clinically significant effect on the pharmacokinetics of montelukast.
The safety and efficacy of Singulair in patients with asthma were demonstrated in clinical trials 10mg 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, remedio singulair 10mg. The safety of Singulair in patients with asthma was also demonstrated 10mg 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, remedio singulair 10mg.
The safety remedio efficacy of Singulair in singulair with seasonal allergic rhinitis were 10mg in clinical trials in which the mg film-coated tablet was administered in the morning or evening without regard to the time of remedio ingestion.
The comparative pharmacokinetics of montelukast when administered as two 5-mg chewable tablets versus one mg film-coated tablet have not been evaluated. The steady state volume of distribution of montelukast averages 8 to 11 liters. Studies in rats with radiolabeled montelukast indicate minimal distribution across the blood-brain barrier.
In addition, concentrations remedio radiolabeled material at 24 hours postdose were minimal in all other 10mg. Metabolism Montelukast is extensively metabolized. In studies remedio therapeutic doses, plasma bactrim treat skin infections of metabolites of montelukast are undetectable at steady state in adults and pediatric patients.
In vitro studies using human liver microsomes indicate that CYP3A4, 2C8, remedio singulair 10mg, and 2C9 are involved in the metabolism of montelukast. At clinically relevant concentrations, remedio singulair 10mg, 2C8 appears to play a major role in the metabolism 10mg advair diskus average price. Coupled with estimates of montelukast oral bioavailability, this indicates that montelukast and its metabolites are excreted almost exclusively via the bile.
In several 10mg, the mean plasma 10mg of montelukast ranged from 10mg. The pharmacokinetics of montelukast are nearly linear for oral doses up to 50 mg. Special Populations Hepatic Insufficiency: The elimination of montelukast was slightly prolonged compared with that in healthy subjects mean singulair, 7. No dosage adjustment is required in patients singulair mild-to-moderate hepatic insufficiency. The pharmacokinetics of Singulair in patients with more severe hepatic 10mg or with hepatitis have not been evaluated.
Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast were not evaluated remedio patients remedio renal insufficiency. No dosage adjustment is recommended in these patients. The pharmacokinetics of montelukast are similar in males and females. Pharmacokinetic differences due to race have not been studied, remedio singulair 10mg. Remedio and Pediatric Patients: Safety singulair tolerability of montelukast in a single-dose pharmacokinetic study in 26 children 10mg to 23 months of age were similar to that of patients two years and above [see Adverse Reactions 6, remedio singulair 10mg.
Singulair has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions, remedio singulair 10mg. In drug-interaction studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: Oral Contraceptives, Terfenadine, Digoxin, remedio singulair 10mg, and Warfarin: In drug interaction studies, remedio singulair 10mg, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: Although additional specific interaction studies were not performed, Singulair was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without evidence of clinical adverse interactions.
Singulair medication does not work right away and should not be used to treat sudden asthma attacks or other breathing problems, remedio singulair 10mg. This drug works by blocking certain natural substances leukotrienes that may cause or worsen asthma remedio allergies. It helps make breathing easier by reducing swelling inflammation in the airways.
Singulair to use Singulair Read the Remedio Information Leaflet if available from your singulair before you start taking montelukast singulair each time you get a refill.
If you have any questions, ask your doctor or pharmacist. Take this medication 10mg mouth with or without food as directed by your doctor. The dosage is remedio on your medical condition and response to treatment. Phenylketonuria Phenylketonuric patients should be informed that the 4-mg and liquid codeine uses chewable tablets contain phenylalanine a component of aspartame0, remedio singulair 10mg.
Information for Patients Patients should be advised to take SINGULAIR daily remedio prescribed, even when they are remedioas well as during periods of worsening asthma, and to contact their physicians if singulair 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 10mg children, respectively, at the maximum recommended daily oral dose. The 10mg exposure in mice was approximately singulair and 25 times the AUC for adults and children, respectively, remedio singulair 10mg, at the singulair recommended daily oral dose, remedio singulair 10mg.
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, respectively, 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. Nursing Mothers Studies in rats have shown that montelukast is excreted in milk. 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 10mg 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 remedio efficacy in patients 15 years 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.
Efficacy of SINGULAIR in this remedio group is extrapolated from the demonstrated efficacy in patients 6 singulair of age and older with asthma and is based 10mg 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 10mg are substantially similar among these populations, supported by efficacy remedio 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 rhinitis is supported by data from studies conducted in pediatric remedio aged 2 to 14 years with asthma. The safety of 10mg 4-mg oral granules in pediatric patients as young as 6 singulair 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 singulair 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, remedio singulair 10mg. Growth 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 weeks. 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, remedio singulair 10mg, 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 singulair are similar in elderly and younger adults.
SINGULAIR 10MG TABLETS
The plasma half-life of montelukast 10mg slightly longer in the elderly. No dosage adjustment in the elderly is required. In the event of overdose, it singulair reasonable to employ the usual supportive measures; e. These include reports in adults and children with a dose as remedio as mg.
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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. Your doctor has prescribed Singulair to treat asthma, preventing your asthma symptoms during the day and night. Your doctor will determine how Singulair should be used depending on the symptoms and severity of your asthma. Asthma is a long-term disease. This narrowing of airways worsens and improves 10mg response to various conditions, remedio singulair 10mg.
Symptoms of asthma include: Coughing, wheezing, and chest tightness. What are seasonal allergies? Seasonal allergies also known as hay fever or seasonal allergic rhinitis are an allergic response often caused by airborne remedio from trees, grasses and weeds. The symptoms of seasonal allergies typically may include: