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Microsoft word - singulairjor5&10mg.doc

SINGULAIR®
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
SINGULAIR® Paediatric 5 mg Chewable Tablets SINGULAIR® 10 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg chewable tablet: 5.2 mg montelukast sodium, which is equivalent to 5 mg montelukast acid. 10 mg film-coated tablet: 10.4 mg montelukast sodium, which is equivalent to 10 mg of montelukast acid. 3. PHARMACEUTICAL FORM
5 mg strength: Pink, round, biconvex chewable tablet (diameter 9.5 mm), with ‘SINGULAIR' engraved on one side and ‘MSD 275’ on the other. 10 mg strength: Beige, rounded square film-coated tablet (size 7.9 mm by 7.9 mm) with 'SINGULAIR' engraved on one side and 'MSD 117' on the other. 4. CLINICAL PARTICULARS
4.1 Therapeutic indications:
‘SINGULAIR’ is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom 'as needed' short-acting β-agonists provide inadequate clinical control of asthma. ‘SINGULAIR’ is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction. No specific safety issues have been identified but experience in the paediatric population is limited (see Section 4.8). 4.2 Posology and method of administration:
The dosage for adults 15 years of age and older is one 10 mg tablet daily to be taken at bedtime with or without food. The dosage for paediatric patients 6-14 years of age is one 5 mg chewable tablet daily to be taken at bedtime. If taken in connection with food, ‘SINGULAIR’ should be taken 1 hour after food or 2 hours after food. No dosage adjustment within this age group is necessary. There are no data on safety and efficacy in children below 6 years of age. General recommendations: The therapeutic effect of 'SINGULAIR' on parameters of asthma control occurs within one day. Patients should be advised to continue taking 'SINGULAIR' even if their asthma is under control, as well as during periods of worsening asthma. No dosage adjustment is necessary for the elderly, or for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients. Therapy with 'SINGULAIR’ in relation to other treatments for asthma: ‘SINGULAIR' can be added to a patient's existing treatment regimen. β-agonist therapy: ‘SINGULAIR' can be added to the treatment regimen of patients who are not adequately controlled on 'as needed' short-acting β-agonist. When a clinical response is evident, (usually after the first dose), the patient may be able to decrease the use of 'as-needed' short-acting β-agonist. Inhaled corticosteroids: Treatment with ‘SINGULAIR' can be used as add-on therapy in patients when other agents, such as inhaled corticosteroids provide inadequate clinical control. ‘SINGULAIR' should not be substituted for inhaled corticosteroids (see Section 4.4). 4.3 Contra-indications:
Hypersensitivity to any component of this product. 4.4 Special warnings and precautions for use:
Patients should be advised never to use oral tablets of montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available. If an acute attack occurs, a short-acting inhaled β-agonist should be used. Patients should seek their doctor's advice as soon as possible if they need more inhalations of short-acting β-agonists than usual. ‘SINGULAIR' should not be substituted for inhaled or oral corticosteroids. There are no data demonstrating that oral corticosteroids can be reduced when ‘SINGULAIR' is given concomitantly. In addition reduction of the oral corticosteroid dose may, in some patients, unmask underlying conditions(e.g. allergic rhinitis, eczema, eosinophilic conditions) controlled by the administration of oral corticosteroids. Reduction in the dose of oral corticosteroids should be considered only when necessary, and with caution. The possibility that leukotriene receptor antagonists may be associated with emergence of Churg-Strauss syndrome cannot be excluded. However, a detailed search of montelukast clinical trials database has not revealed any cases of this syndrome or any evidence that this syndrome is associated with SINGULAIR. Treatment with ‘SINGULAIR' does not alter the need for patients with aspirin-sensitive asthma to avoid taking aspirin, and other non-steroidal anti-inflammatory drugs. Experience in the paediatric population is limited (see Section 4.8). 5 mg chewable tablets contain aspartame which is a source of phenylalanine (0.842 mg phenylalanine per 5 mg chewable tablet). 4.5 Interaction with other medicaments products and other forms of interaction:
Singulair' may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. 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 oestradiol/norethindrone 35/1), terfenadine, digoxin and warfarin. The area under the plasma concentration curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbitone. Since montelukast is metabolised by CYP 3A4, caution should be exercised, particularly in children, when montelukast is co-administered with inducers of CYP 3A4, such as phenytoin, phenobarbitone and rifampicin. 4.6 Pregnancy and lactation:
In pregnant rabbits and pregnant rats, montelukast did not affect fertility or reproductive performance nor was montelukast teratogenic at systemic exposures of >24-fold and >69-fold the systemic exposure observed at the intended clinical dosage in humans, respectively. Montelukast has been shown to cross the placental barrier and is excreted in breast milk of animals. Since there are no controlled studies in pregnant or nursing women, ‘SINGULAIR' should not be used during pregnancy or in nursing mothers unless it is considered to be clearly 4.7 Effects on ability to drive and use machines:
There is no evidence that ‘SINGULAIR' affects the ability to drive and use machines. 4.8 Undesirable effects:
‘SINGULAIR' has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy. SINGULAIR 10 mg SINGULAIR 10 mg film-coated tablets have been evaluated in approximately 2600 adult patients 15 years of age and older in clinical studies. In two similarly designed, 12-week placebo-controlled clinical trials, only abdominal pain and headache were reported as drug-related in ≥1 % of patients treated with SINGULAIR and at a greater incidence than in patients treated with placebo. The incidences of these events were not significantly different in the two treatment groups. Although a causal relationship with montelukast was not established, the following adverse events were reported in ≥1 % of patients and at an incidence equal to or greater than in placebo in clinical trials (% in montelukast-treated patients, % placebo, respectively): Body as a whole: asthenia/fatigue (1.8%, 1.2%), fever (1.5%, 0.9%), abdominal pain (2.9%, 2.5%), trauma (1.0%, 0.8%); Digestive system disorders: diarrhoea (3.1%, 3.1%), dyspepsia (2.1%, 1.1 %), infectious gastro-enteritis (1.5, 0.5%), dental pain (1.7%, 1 .0%); Nervous system/psychiatric: dizziness (1.9%, 1.4%), headache (18.4%, 18.1 %), insomnia (1.3%, 1.3%); Respiratory system disorders: nasal congestion (1.6%, 1.3%), cough (2.7%, 2.4%), influenza (4.2%, 3.9%) Skin/skin appendages disorder: rash (1.6%, 1.2%). With prolonged treatment in clinical trials with a limited number of patients for up to 2 years, the adverse experience profile did not change. SINGULAIR Paediatric SINGULAIR Paediatric 5 mg chewable tablets have also been evaluated in approximately 320 paediatric patients 6 to 14 years of age. Long-term experience (more than one year) in this population is limited to 121. In an 8-week, placebo-controlled clinical trial, only headache was reported as drug-related in ≥1% of patients treated with SINGULAIR and at a greater incidence than in patients treated with placebo. The incidence was not significantly different in the two treatment groups. Although a causal relationship with montelukast was not established the following adverse events were reported in ≥3% of paediatric patients and at an incidence greater than in placebo in clinical trials (% in montelukast-treated patients, % placebo, respectively): Body as a whole: fever (7.5%, 3.7%); Digestive system disorders: diarrhoea (3.0%, 0.70%), nausea (4.0%, 3.7%); Respiratory system disorders: influenza (8.5%, 4.4%), pharyngitis (13.9%, 12.6%), sinusitis (5.5%, 1.5%). With prolonged treatment in clinical trials with a limited number of patients for up to 6 months, the adverse experience profile did not change. 4.9 Overdose:
No deaths occurred following a single oral admistration of montelukast sodium at doses up to 5,000 mg/kg in mice and rats (15,000 mg/m2 and 30,000 mg/m2 in mice and rats respectively) the maximum dose tested. This dose is equivalent to 25,000 times recommended daily adult human dose (based on an adult patient weight of 50 kg). 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 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. It is not known whether montelukast is dialysable by peritoneal- or haemo-dialysis. 5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties:
ATO Code: RO3D CO3
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 receptors (CysLT) found in the human airway and cause airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment. 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. Bronchodilation was observed within 2 hours of oral administration. The bronchodilation effect caused by a β-agonist was additive to that caused by montelukast. Treatment with SINGULAIR inhibited both early- and late-phase bronchoconstriction due to antigen challenge. SINGULAIR, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients. In a separate study, treatment with SINGULAIR significantly decreased eosinophils in the airways (as measured in sputum) and in peripheral blood while improving clinical asthma control. In studies in adults SINGULAIR, 10 mg once daily, compared with placebo, demonstrated significant improvements in morning FEV1, (10.40% vs 2.7% change from baseline), AM peak expiratory flow rate (PEFR) (24.5 L/min vs 3.3 L/min change from baseline), and significant decrease in total β-agonist use (-26.1% vs -4.6% change from baseline). Improvement in patient-reported daytime and night-time asthma symptom scores was significantly better than placebo. Studies in adults demonstrated the ability of SINGULAIR to add to the clinical effect of inhaled corticosteroid (% change from baseline for inhaled beclomethasone plus montelukast vs beclomethasone, respectively for FEV1: 5.43% vs 1.04%; β-agonist use: -8.70% vs 2.64%). Compared with inhaled beclomethasone (200 ug twice daily with a spacer device), SINGULAIR demonstrated a more rapid initial response, although over the 12-week study, beclomethasone provided a greater average treatment effect (% change from baseline for montelukast vs beclomethasone, respectively for FEV1: 7.49% vs 13.3%; β-agonist use: -28.28% vs -43.89%). However, compared with beclomethasone, a high percentage of patients treated with SINGULAIR achieved similar clinical responses (e.g. 50% of patients treated with beclomethasone achieved an improvement in FEV1 of approximately 1l% or more over baseline while approximately 42% of patients treated with SINGULAIR achieved the same response). In an 8-week study in paediatric patients, SINGULAIR 5 mg, once daily, compared with placebo, significantly improved respiratory function (FEV1 8.71% vs 4.16% change from baseline; AM PEFR 27.9 L/min vs 17.8 L/min change from baseline) and decreased 'as needed' β-agonist use (-11.7% vs +8.2% change from baseline). Significant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEV1 22.33% for montelukast vs 32.40% for placebo; time to recovery to within 5% of baseline FEV1 44.22 min vs 60.64 mm). This effect was consistent throughout the 12-week study period. Reduction in EIB was also demonstrated in a short term study in paediatric patients (maximal fall in FEV1, 18.27% vs 26.11%; time to recovery to within 5% of baseline FEV1 17.76 mm vs 27.98 min). The effect in both studies was demonstrated at the end of the once-daily dosing interval. In aspirin-sensitive asthmatic patients receiving concomitant inhaled and/or oral corticosteroids, treatment with montelukast, compared with placebo, resulted in significant improvement in asthma control (FEV1 8.55% vs -l.74% change from baseline and decrease in total β-agonist use -27.78% vs 2.09% change from baseline). 5.2 Pharmacokinetic properties:
Absorption: Montelukast is rapidly absorbed following oral administration. For the 10 mg film-coated tablet, the mean peak plasma concentration (Cmax) is achieved 3 hours (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 trials where the 10 mg film-coated tablet was administered without regard to the timing of food ingestion. For the 5 mg chewable tablet, the Cmax is achieved in 2 hours after administration in adults in the fasted state. The mean oral bioavailability is 73% and is decreased to 63% by a standard meal. Distribution: Montelukast is more than 99% bound to plasma proteins. The steadystate volume of distribution of montelukast averages 8-11 litres. Studies in rats with radiolabelled montelukast indicate minimal distribution across the blood-brain barrier. In addition, concentrations of radiolabelled material at 24 hours post-dose were minimal in all other tissues. Biotransformation: Montelukast is extensively metabolised. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children. In vitro studies using human liver microsomes indicate that cytochromes P450 3A4, 2A6 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. The contribution of metabolites to the therapeutic effect of montelukast is minimal. Elimination: The plasma clearance of montelukast averages 45 ml/mm in healthy adults. Following an oral dose of radiolabelled montelukast, 86% of the radioactivity was recovered in 5-day faecal collections and <0.2% was recovered in urine. 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. There are no data on the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (Child-Pugh score >9). With high doses of montelukast (20- and 60-fold the recommended adult dose), a decrease in plasma theophylline concentration was observed. This effect was not seen at the recommended dose of 10 mg once daily. 5.3 Preclinical safety data:
In animal toxicity studies, minor serum biochemical alterations in ALT, glucose, phosphorus and triglycerides were observed which were transient in nature. The signs of toxicity in animals were increased excretion of saliva, gastro-intestinal symptoms, loose stools and ion imbalance. These occurred at dosages which provided >17-fold the systemic exposure seen at the clinical dosage. In monkeys, the adverse effects appeared at doses from 150 mg/kg/day (>232-fold the systemic exposure seen at the clinical dose). In animal studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than 24-fold. A slight decrease in pup body weight was noted in the female fertility study in rats at 200 mg/kg/day (>69-fold the clinical systemic exposure). In studies in rabbits, a higher incidence of incomplete ossification, compared with concurrent control animals, was seen at systemic exposure >24-fold the clinical systemic exposure seen at the clinical dose. No abnormalities were seen in rats. Montelukast was determined not to be phototoxic in mice for UVA, UVB or visible light spectra at doses up to 500 mg/kg/day (approximately >200-fold based on systemic exposure). Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in in vivo tests in rodent species. 6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients:
5 mg chewable tablet: Mannitol (E421), microcrystalline cellulose (E460), hydroxypropyl cellulose, red ferric oxide (E172) (colouring agent), croscarmellose sodium, cherry flavour, aspartame (E951) and magnesium stearate (E572). 10 mg film-coated tablet: Microcrystalline cellulose (E460), lactose monohydrate (89.3 mg), croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate (E572). Film coating: hypromellose, hydroxypropyl cellulose, titanium dioxide (E171) (colouring agent), red and yellow ferric oxide (E172) (colouring agent) and carnauba, wax. 6.2 Incompatibilities:
6.3 Shelf life:
5 mg chewable tablet: 2 years. 10 mg film-coated tablet: 2 years. 6.4 Special precautions for storage:
Store below 30oC, protected from moisture and light. 6.5 Nature and contents of container:
Polyamide/PVC/aluminium blister pack enclosed in a cardboard carton containing 28 tablets. 6.6 Instructions for use and handling:
7. MARKETING AUTHORISATION HOLDER
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK 8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
10. DATE OF (PARTIAL) REVISION OF TEXT

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