Singulair

Singulair

montelukast

Manufacturer:

Merck Sharp & Dohme

Marketer:

Transfarma Medica Indah
Full Prescribing Info
Contents
Montelukast sodium.
Action
Pharmacotherapeutic Group: SINGULAIR (montelukast sodium) is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT1 receptor.
Pharmacology: Pharmacodynamics:
Montelukast causes potent inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatic patients. Doses as low as 5 mg cause substantial blockage of LTD4-induced bronchoconstriction.
Montelukast causes bronchodilation within 2 hours of oral administration; these effects were additive to the bronchodilation caused by a β-agonist.
Clinical studies in adults 15 years of age and older demonstrated that there is no additional clinical benefit to montelukast doses above 10 mg once daily. This was shown in two chronic asthma studies using doses up to 200 mg once daily and in one exercise challenge study using doses up to 50 mg, evaluated at the end of the once-daily dosing interval.
Mechanism of Action:
The cysteinyl leukotrienes (LTC4, LTD4, LTE4), are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils. These important pro-asthmatic mediators 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 a number of airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment.
Montelukast is a potent, orally active compound that significantly improves parameters of asthmatic inflammation. Based on biochemical and pharmacological bioassays, it binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors such as the prostanoid, cholinergic, or β-adrenergic receptor). Montelukast potently inhibits physiologic actions of LTC4, LTD4, and LTE4 at the CysLT1 receptor without any agonist activity.
Clinical Studies: Adults ≥15 years: The efficacy of Singulair for the chronic treatment of asthma in adults ≥15 years was demonstrated in 2 (US and Multinational) similarly designed 12-week double-blind, placebo-controlled studies in 1325 patients (795 treated with Singulair and 530 treated with placebo). Patients were symptomatic and using approximately 5 puffs of β-agonist per day on an "as-needed" basis. The mean baseline percent of predicted forced expiratory volume in 1 sec (FEV1,) was 66% (approximate range 40-90%). In these studies, asthma symptoms, asthma-related outcomes, respiratory function and "as-needed" β-agonist use were measured. Endpoints were analyzed in each study and in a combined analysis according to a prespecified data analysis plan. The following clinical results were observed:
Asthma Symptoms and Asthma-Related Outcomes: Singulair 10 mg once daily in the evening, significantly improved measurements of patient-reported daytime symptoms and night time awakenings in each study and in the combined analysis, compared with placebo. In patients with nocturnal awakenings of at least 2 nights per week, reduced the nocturnal awakenings by 34% from baseline, significantly better than the reduction of 14% for the placebo group (combined analysis). Singulair, compared with placebo, significantly improved asthma-related outcome measurements. In the combined analysis, Singulair compared with placebo, decreased asthma attacks by 37%, corticosteroid rescue by 39%, discontinuations due to worsening asthma by 65%, asthma exacerbations by 38% and increased asthma-free days by 42%. Physicians' and patients' global asthma evaluations and asthma-specific quality-of-life evaluations (in all domains, including normal daily activity and asthma symptoms) were significantly better with Singulair compared with placebo in each study and in the combined analysis.
Respiratory Function: Compared with placebo, Singulair caused significant improvements in parameters of respiratory function [FEV1 and peak expiratory flow rate (PEFR)] in each study and in the combined analysis (see Table 1).


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Beta-agonist Use: Compared with placebo, Singulair significantly decreased the use of "as-needed" β-agonist by 26.1% from baseline compared with 4.6% in the placebo group in the combined analysis. The decreases were also significant in each of the studies (p≤0.001).
Onset of Action and Maintenance of Benefits: In each study and in the combined analysis, the treatment effect of Singulair measured by daily diary card parameters, including symptom scores, "as-needed" β-agonist use and PEFR measurements, was achieved after the 1st dose and was maintained throughout the dosing interval (24 hrs). Treatment effect also remained constant during continuous once-daily administration in extension studies for up to 1 year. Withdrawal of Singulair in asthmatic patients after 12 weeks of continuous use did not cause rebound worsening of asthma (see Effects on Exercise-Induced Bronchoconstriction as follows).
Effects Relative to Inhaled Corticosteroids: In one of the two 12-week double-blind studies in adults (Multinational), Singulair was compared with inhaled beclomethasone (200 mcg twice daily with a spacer device). Singulair demonstrated a more rapid initial response, although over the full duration of the study beclomethasone provided a greater average treatment effect. However, a high percent of patients treated with Singulair achieved similar clinical responses compared with inhaled beclomethasone.
Effects on Exercise-Induced Bronchoconstriction: The efficacy of Singulair 10 mg when given as a single dose 2 hrs before exercise for the prevention of exercise-induced bronchospasm (EIB) was investigated in 3 (U.S. and Multinational), randomized, double-blind, placebo-controlled crossover studies that included a total of 160 adult and adolescent patients ≥15 years with EIB. Exercise challenge testing was conducted at 2 hrs, 8.5 or 12 hrs, and 24 hrs following administration of a single-dose of study drug (Singulair 10 mg or placebo). The primary endpoint was the mean maximum percent fall in FEV1 following the 2 hrs post-dose exercise challenge in all 3 studies (Study A, Study B and Study C). In Study A, a single dose of Singulair 10 mg demonstrated a statistically significant protective benefit against EIB when taken 2 hrs prior to exercise. Some patients were protected from EIB at 8.5 and 24 hrs after administration; however, some patients were not. The results for the mean maximum percent fall at each timepoint in Study A are shown in Table 2 and are representative of the results from the other 2 studies (see Table 2).


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In a 12-week, randomized, double-blind, parallel group study of 110 adult and adolescent asthmatics ≥15 years, with a mean baseline FEV1 percent of predicted of 83% and with documented exercise-induced exacerbation of asthma, treatment with Singulair 10 mg once daily in the evening, resulted in a statistically significant reduction in mean maximal percent fall in FEV1 and mean time to recovery to within 5% of the pre-exercise FEV1. Exercise challenge was conducted at the end of the dosing interval (ie, 20-24 hrs after the preceding dose). This effect was maintained throughout the 12-week treatment period indicating that tolerance did not occur. Singulair did not, however, prevent clinically significant deterioration in maximal percent fall in FEV1 after exercise (ie, ≥20% decrease from pre-exercise baseline) in 52% of patients studied. In a separate crossover study in adults, a similar effect was observed after 2 doses of Singulair 10 mg once-daily.
Effects on Asthmatic Inflammation: Several studies have shown Singulair inhibits parameters of asthmatic inflammation. In a placebo-controlled crossover study (n=12), Singulair inhibited early and late phase bronchoconstriction due to antigen challenge by 75 and 57%, respectively.
Because inflammatory cell (eosinophil) infiltration is an important feature of asthma, the effects of Singulair on eosinophils in the peripheral blood and airway were examined. In Phase IIb/III clinical studies in adults, Singulair significantly decreased peripheral blood eosinophils approximately 15% from baseline, compared with placebo.
In a 4-week, randomized, parallel group study (n=40) in adults, Singulair significantly decreased airway eosinophils (as assessed in sputum) by 48% from baseline compared with an increase of 23% from baseline with placebo. In this study, peripheral blood eosinophils significantly decreased, and clinical asthma endpoints improved with treatment with Singulair.
Pharmacokinetics: Absorption: Montelukast is rapidly and nearly completely absorbed following oral administration.
For the 4-mg chewable tablet, 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 coadministration of applesauce or a standard meal with the oral granule formulation did not have a clinically meaningful effect on the pharmacokinetics of montelukast as determined by AUC (1225.7 vs 1223.1 ng·hr/mL with and without applesauce, respectively, and 1191.8 vs 1148.5 ng·hr/mL with and without a standard meal, respectively).
Safety and efficacy were demonstrated in clinical studies where the 4-mg chewable tablet, were administered without regard to the timing of food ingestion. The safety of SINGULAIR was also demonstrated in a clinical study in which the 4-mg oral granules were administered without regard to the timing of food ingestion.
For the 10-mg film-coated tablet, the mean peak plasma concentration (Cmax) is achieved 3 hrs time to peak plasma concentration (Tmax) after administration in adults in the fasted state. The mean oral bioavailability is 64%. The oral bioavailability and Cmax are not influenced by a standard meal.
Safety and efficacy were demonstrated in clinical studies where the 10-mg film-coated tablet was administered without regard to the timing of food ingestion.
Distribution: Montelukast is more than 99% bound to plasma proteins. 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 of radiolabeled material at 24 hours postdose were minimal in all other tissues.
Metabolism: Montelukast is extensively metabolized. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and pediatric patients.
In vitro studies using human liver microsomes indicate that cytochrome P450 3A4, 2C8, and 2C9 are involved in the metabolism of montelukast. Based on further in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6.
Elimination: The plasma clearance of montelukast averages 45 mL/min in healthy adults. Following an oral dose of radiolabeled montelukast, 86% of the radioactivity was recovered in 5-day fecal collections and <0.2% was recovered in urine. Coupled with estimates of montelukast oral bioavailability, this indicates montelukast and its metabolites are excreted almost exclusively via the bile.
In several studies, the mean plasma half-life (t½) of montelukast ranged from 2.7-5.5 hrs in healthy young adults. The pharmacokinetics of montelukast are nearly linear for oral doses up to 50 mg. No difference in pharmacokinetics was noted between dosing in the morning or in the evening. During once-daily dosing with montelukast 10 mg, there is little accumulation of the parent drug in plasma (approximately 14%).
Characteristics in Patients: Gender: The pharmacokinetics of montelukast are similar in males and females.
Elderly: The pharmacokinetic profile and the oral bioavailability of a single 10-mg oral dose of montelukast are similar in elderly and younger adults. The plasma t½ of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required.
Race: Pharmacokinetic differences due to race have not been studied. In clinical studies, there do not appear to be any differences in clinically important effects.
Hepatic Insufficiency: No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency. There are no clinical data in patients with severe hepatic insufficiency (Child-Pugh score >9).
Renal Insufficiency: Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast were not evaluated in patients with renal insufficiency. No dosage adjustment is recommended in these patients.
Adolescents: The plasma concentration profile of montelukast following administration of the 10-mg film-coated tablet is similar in adolescents ≥15 years old and young adults. The 10-mg film-coated tablet is recommended for use in patients ≥15 years old.
Pediatric Patients: Pharmacokinetic studies show that the plasma profiles of the 4-mg chewable tablet in pediatric patients 2 to 5 years of age, were similar to the plasma profile of the 10-mg film-coated tablet in adults. 4-mg chewable tablet in pediatric patients 2 to 5 years of age. Since the 4-mg oral granule formulation is bioequivalent to the 4-mg chewable tablet, it can also be used as an alternative formulation to the 4-mg chewable tablet in pediatric patients 2 to 5 years of age.
Drug Interactions: Montelukast 10 mg once daily to pharmacokinetic steady state: did not cause clinically significant changes in the kinetics of an intravenous dose of theophylline; did not change the pharmacokinetic profile of warfarin or influence the effect of a single 30-mg oral dose of warfarin on prothrombin time or International Normalized Ratio (INR); did not change the pharmacokinetic profile or urinary excretion of immunoreactive digoxin; did not change the plasma concentration profile of terfenadine or its carboxylated metabolite and did not prolong the QTc interval following co-administration with terfenadine 60 mg twice daily.
Montelukast at doses of ≥100 mg daily to pharmacokinetic steady state: did not significantly alter the plasma concentrations of either component of an oral contraceptive containing norethindrone 1 mg/ethinyl estradiol 35 µg; did not cause any clinically significant change in plasma profiles of either prednisone and prednisolone following administration of either oral prednisone or intravenous prednisolone.
Phenobarbital, which induces hepatic metabolism, decreased the AUC of montelukast approximately 40% following a single 10-mg dose of montelukast; no dosage adjustment for SINGULAIR is recommended (see Precautions).
Toxicology: Animal Toxicology: Acute Toxicity: No mortality occurred following a single oral administration of montelukast sodium at doses up to 5000 mg/kg, in mice and rats, (15,000 mg/m2 and 29,500 mg/m2 in mice and rats, respectively) the maximum dose tested (oral LD50 >5000 mg/kg). This dose is equivalent to 25,000 times the recommended daily adult human dose*.
Chronic Toxicity: The toxic potential of montelukast sodium was evaluated in a series of repeated dose toxicity studies of up to 53 weeks in monkeys and rats and up to 14 weeks in infant monkeys and in mice. Montelukast sodium was well tolerated at doses which provide a wide margin of safety based on total dose administered. The no effect level for all toxicological parameters in any of the species tested was at least 125 times the recommended human dose*. There were no findings that would preclude administration at the therapeutic dosage level for both adults and pediatric patients.
Carcinogenicity: Montelukast sodium was not carcinogenic when administered at oral doses of up to 200 mg/kg/day in a 106-week study in rats, or at oral doses of up to 100 mg/kg/day in a 92-week study in mice. These doses are equivalent to 1000 times and 500 times the recommended adult human dose*.
Mutagenesis: Montelukast sodium was found to be neither genotoxic nor mutagenic. Montelukast sodium was negative in the in vitro microbial mutagenesis assay and the V-79 mammalian cell mutagenesis assays, with and without metabolic activation. There was no evidence of genotoxicity in the in vitro alkaline elution assay in rat hepatocytes and the in vitro chromosomal aberration assays in Chinese hamster ovary cells, with or without a microsomal enzyme activation system. Similarly, there was no induction of chromosomal aberrations in bone marrow cells of male or female mice after the administration of oral doses of up to 1200 mg/kg (3600 mg/m2) (6000 times the recommended daily adult dose*).
Reproduction: Fertility and reproductive performance were not affected in studies with male rats given oral doses of up to 800 mg/kg/day or with female rats given doses of up to 100 mg/kg/day. These dosages provide margins of 4000-fold and 500-fold, respectively, above the recommended adult human dose*.
*Based on an adult patient weight of 50 kg.
Development: In developmental toxicity studies, there were no treatment related adverse effects at doses up to 400 mg/kg/day in rats and up to 100 mg/kg/day in rabbits. Fetal exposure of montelukast sodium in rats and rabbits does occur and significant concentrations of drug were observed in milk of lactating rats.
Indications/Uses
SINGULAIR is indicated for prophylaxis and chronic treatment of asthma in adults 15 years old and older (10 mg film-coated tablet) and in pediatric 2-5 years of age (4 mg chewable tablet/oral granules), including the prevention of exercise-induced bronchoconstriction.
Dosage/Direction for Use
Asthma: Film-coated tablet: One 10-mg tablet should be taken once daily in the evening.
Oral granules/chewable tablet: Singulair should be taken once daily in the evening (one-4 mg oral granule or one-4 mg chewable tablet).
Exercise-Induced Bronchoconstriction (EIB): For prevention of EIB, a single dose (10-mg tablet or one-4 mg chewable tablet or one-4 mg oral granule) of SINGULAIR should be taken at least 2 hours before exercise.
An additional dose of SINGULAIR should not be taken within 24 hours of previous dose. Patients already taking SINGULAIR daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist.
Administration: Oral granules: SINGULAIR oral granules can be administered either directly in the mouth, mixed with a spoonful of cold or room temperature soft food (e.g., applesauce), or dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk. The packet should not be opened until ready to use. After opening the packet, the full dose of SINGULAIR oral granules must be administered immediately (within 15 minutes). If mixed with food, or dissolved in baby formula or breast milk, SINGULAIR oral granules must not be stored for future use. SINGULAIR oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration.
Overdosage
No specific information is available on the treatment of overdosage with SINGULAIR. In chronic asthma studies, SINGULAIR has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short-term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.
There have been reports of acute overdosage in postmarketing experience and clinical studies with SINGULAIR. These include reports in adults and children with a dose as high as 1000 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, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.
It is not known whether montelukast is dialyzable by peritoneal- or hemodialysis.
Contraindications
Hypersensitivity to any component of this product.
Special Precautions
The efficacy of oral SINGULAIR for the treatment of acute asthma attacks has not been established. Therefore, oral SINGULAIR should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.
While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids.
Neuropsychiatric events have been reported in patients taking SINGULAIR (see Side Effects). Since other factors may have contributed to these events, it is not known if they are related to SINGULAlR. Physicians should discuss these adverse experiences with their patients and/or caregivers. Patients and/or caregivers should be instructed to notify their physician if these changes occur.
In rare cases patients receiving anti-asthma agents, including leukotriene receptor antagonists, have experienced one or more of the following: eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as Churg-Strauss syndrome, a systemic eosinophilic vasculitis. These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a causal relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended in patients receiving SINGULAIR.
Singulair should not be used as monotherapy for the treatment and management of exercise-induced bronchospasm. Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled-agonist as prophylaxis and have available for rescue a short-acting inhaled-agonist.
Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steoridal antiinflamatory agent while taking Singulair. 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 NSAIDs in aspirin-sensitive asthmatic patients.
Pediatric use: Do not give Singulair 4 mg chewable tablets to children less than 2 years of age. The safety and efficacy of Singulair 4 mg chewable tablets in children less than 2 years of age has not been established.
Use in the elderly: Elderly to take Singulair 10 mg film coated tablet.
Effects on Ability to Drive and Use Machines: There is no evidence that SINGULAIR affects the ability to drive and use machines.
Use In Pregnancy & Lactation
Pregnancy: SINGULAIR has not been studied in pregnant women. SINGULAIR should be used during pregnancy only if clearly needed.
During worldwide marketing experience, congenital limb defects have been rarely reported in the offspring of women being treated with SINGULAIR during pregnancy. Most of these women were also taking other asthma medications during their pregnancy. A causal relationship between these events and SINGULAIR has not been established.
Nursing Mothers: It is not known if SINGULAIR is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SINGULAIR is given to a nursing mother.
Side Effects
SINGULAIR has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy. The overall incidence of adverse effects reported with SINGULAIR was comparable to placebo.
Adults ≥15 Years: SINGULAIR has been evaluated in approximately 2600 adult patients ≥15 years in clinical studies. In 2 similarly designed, 12-week placebo-controlled clinical studies, the only adverse reactions reported as drug related in ≥1% of patients treated with SINGULAIR and at a greater incidence than in patients treated with placebo were abdominal pain and headache. The incidences of these events were not significantly different in the 2 treatment groups.
Cumulatively, 544 patients were treated with SINGULAIR for at least 6 months, 253 for 1 year and 21 for 2 years in clinical studies. With prolonged treatment, the adverse reactions profile did not change.
The safety profile of SINGULAIR when administered as a single dose for prevention of EIB in adult and adolescent patients ≥15 years was consistent with the safety profile previously described for SINGULAIR.
Pediatric Patients 2 to 5 Years of Age with Asthma: SINGULAIR has been evaluated in 573 pediatric patients 2 to 5 years of age. In a 12-week, placebo-controlled clinical study, the only adverse experience reported as drug related in >1% of patients treated with SINGULAIR and at a greater incidence than in patients treated with placebo was thirst. The incidence of thirst was not significantly different in the two treatment groups.
Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with SINGULAIR for at least 3 months, 230 for 6 months or longer, and 63 patients for 12 months or longer. With prolonged treatment, the adverse experience profile did not change.
Postmarketing Experience: (See Table 3.)


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Drug Interactions
SINGULAIR may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma, and in the treatment of allergic rhinitis. In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
The area under the plasma concentration-time curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital. No dosage adjustment for SINGULAIR is recommended.
In vitro studies have shown that montelukast is an inhibitor of CYP 2C8. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of drugs primarily metabolized by CYP2C8) demonstrated that montelukast does not inhibit CYP2C8 in vivo. Therefore, montelukast is not anticipated to alter the metabolism of drugs metabolized by this enzyme (e.g. paclitaxel, rosiglitazone, and repaglinide.)
In vitro studies have shown that montelukast is a substrate of CYP 2C8, 2C9, and 3A4. Data from a clinical drug-drug interaction study involving montelukast and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) demonstrated that gemfibrozil increased the systemic exposure of montelukast by 4.4-fold. Co-administration of itraconazole, a strong CYP 3A4 inhibitor, with gemfibrozil and montelukast did not further increase the systemic exposure of montelukast. The effect of gemfibrozil on systemic exposure of montelukast is not considered to be clinically meaningful based on clinical safety data with doses greater than the 10 mg approved dose in adults (e.g., 200 mg/day to adult patients for 22 weeks, and up to 900 mg/day to patients for approximately one week) where clinically important adverse experiences were not observed. Therefore, no dosage adjustment of montelukast is required upon co-administration with gemfibrozil. Based on in vitro data, clinically important drug interactions with other known inhibitors of CYP 2C8 (e.g., trimethoprim) are not anticipated. In addition, co-administration of montelukast with itraconazole alone resulted in no significant increase in the systemic exposure of montelukast.
Storage
Shelf-Life: Chewable tablet/Oral granules: 24 months.
ATC Classification
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Presentation/Packing
Chewable tab 4 mg x 4 x 7's. FC tab 10 mg x 4 x 7's. Oral granules 4 mg x 28's.
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