ΠΡΟΙΟΝΤΑ - SINGULAIR®
SINGULAIR® 10 mg Tablet
SINGULAIR® Paediatric 5 mg Chewable Tablet SINGULAIR® Paediatric 4 mg Chewable Tablet SINGULAIR® Paediatric 4 mg Granules (montelukast)
ABRIDGED PRESCRIBING INFORMATION
Refer to Summary of Product Characteristics (SPC) before prescribing
Adverse events should be reported. Reporting forms and information can be found at http://www.yellowcard.gov.uk Adver.se events should also be reported to Merck Sharp & Dohme Ltd (01992-467272).
PRESENTATIONS 'Singulair' 10 mg Tablets and Paediatric 5 mg and 4 mg chewable tablets containing montelukast sodium, equivalent to 10 mg, 5 mg and 4 mg montelukast. 'Singulair' Paediatric 4 mg granules containing montelukast sodium, equivalent to 4 mg montelukast.
USES All strengths (6 months and above) Treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma inadequately controlled on inhaled corticosteroids and in whom 'as needed' short-acting B2-agonists provide inadequate clinical control.
All strengths (2 years and above) Also tor the prophylaxis of asthma where the predominant component is exercise-induced bronchoconstriction.
Adult (15 years and above) 10 mg strength only: In those asthmatic patients where 'Singulair' is indicated in asthma, 'Singulair' can also provide symptomatic relief of seasonal allergic rhinitis.
Paediatric (2-14 years) 5 mg and 4 mg strengths: May also be an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.
DOSAGE AND ADMINISTRATION Adults 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis: one 'Singulair' 10 mg tablet daily in the evening with or without food. Paediatric patients 6-14 years of age: one 'Singulair' Paediatric 5 mg chewable tablet daily in the evening. Paediatric patients 2-5 years of age: one 'Singulair' Paediatric 4 mg chewable tablet daily in the evening. If taken with food 'Singulair' Paediatric tablets should be taken either one hour before, or two hours after food. Use of 'Singulair' Paediatric chewable tablets in children less than two years of age is not recommended. Paediatric patients 6 months - 5 years of age: one 'Singulair' Paediatric 4 mg granules sachet daily in the evening. The 'Singulair' Paediatric 4 mg granules formulation is not recommended below 6 months of age. 'Singulair' Paediatric granules can be administered either directly in the mouth, or mixed with a spoonful of soft food. 'Singulair' granules are not intended to be dissolved in liquid, although liquids may be taken subsequent to administration. All strengths: Patients should continue taking 'Singulair' even when asthma is under control as well as during periods of worsening asthma.
Therapy with 'Singulair' in relation to other treatments for asthma 'Singulair' can be added to a patient's existing treatment regimen, fa-agonist therapy: 'Singulair' can be added to the treatment regimen of patients who are not adequately controlled on 'as needed' short-acting B2-agonist. Adults 15 years of age and older: When treatment with 'Singulair' is used as add-on therapy to inhaled corticosteroids, 'Singulair' should not be substituted for inhaled corticosteroids. Paediatric patients 6 months - 14 years of age: When treatment with 'Singulair' is used as add-on therapy to inhaled corticosteroids, 'Singulair' should not be abruptly substituted for inhaled corticosteroids. Paediatric patients 2 - 14 years old: 'Singulair'can be used as an alternative treatment option to low-dose inhaled corticosteroids for mild persistent asthma. Mild persistent asthma defined as: asthma symptoms on average more than once a week but less than once a day, nocturnal symptoms on average more than twice a month but less than once a week, normal lung function between episodes. Montelukast is not recommended as monotherapy in patients with moderate persistent asthma. The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children with mild persistent asthma should only be considered for patients with no recent history of serious asthma attacks that required oral corticosteroid use and who have demonstrated they are not capable of using inhaled corticosteroids. If satisfactory control of asthma is not achieved at follow-up (usually within one month), the need for an additional or different anti-inflammatory therapy based on the step system for asthma therapy should be evaluated. Patients should be periodically evaluated for their asthma control. 'Singulair' as prophylaxis of asthma for 2 to 5 year old patients in whom the predominant component is exercise-induced bronchoconstriction: In these patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids. Patients should be evaluated after 2 to 4 weeks of treatment with montelukast. If a satisfactory response is not achieved, an additional or different therapy should be considered. 'Singulair' 10 mg tablets should not be used concomitantly with other products containing the same active ingredient, montelukast.
CONTRA-INDICATIONS Hypersensitivity to montelukast or any of the excipients.
PRECAUTIONS The diagnosis of persistent asthma in very young children (6 months - 2 years) should be established by a paediatrician or pulmonologist. 'Singulair' should never be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available. If an attack occurs, a short-acting inhaled 82 agonist should be used. Adults 15 years of age and older: 'Singulair' should not be substituted for inhaled or oral corticosteroids. Paediatric patients 6 months -14 years of age: 'Singulair' should not be abruptly substituted for inhaled or oral corticosteroids. The possibility that leukotriene receptor antagonists may be associated with the emergence of Churg-Strauss syndrome can neither be excluded nor established. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or neuropathy presenting in their patients. Patients with aspirin-sensitive asthma must continue to avoid taking aspirin and other non-steroidal anti-inflammatory drugs. 'Singulair' 10 mg tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 'Singulair' Paediatric chewable tablets contain aspartame which is a source of phenylalanine (0.674 mg phenylalanine per 4 mg tablet and 0.842 mg phenylalanine per 5 mg tablet). Interactions: Use with caution, especially in children, when given with CYP 3A4 inducers (such as phenytoin, phenobarbital and rifampicin). In vitro studies have shown montelukast is a potent inhibitor of CYP 2C8. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of medicinal products primarily metabolised by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo. Therefore, montelukast is not anticipated to alter the metabolism of medicinal products metabolised by this enzyme (e.g. paclitaxel, rosiglitazone, and repaglinide.) Use in pregnancy and lactation: Animal studies do not indicate harmful effects on pregnancy or embryonal/foetal development. Limited data from pregnancy databases do not suggest causal relationship between 'Singulair' and limb defect malformations that have been rarely reported in worldwide post-marketing experience. Studies in rats have shown that montelukast is excreted in milk. It is not known if montelukast is excreted in human milk. 'Singulair' may be used during pregnancy and in breast-feeding only if considered to be clearly essential.
SIDE EFFECTS Refer to SPC for complete information on side effects. Side effects, usually mild, generally did not require discontinuation of therapy. 'Singulair' 10 mg tablets 'Singulair' 10 mg tablets have been evaluated in approximately 4,000 asthmatic patients and 400 asthmatic patients with seasonal allergic rhinitis aged 15 years and older. In two similarly designed trials, only abdominal pain and headache were commonly reported as drug-related. 'Singulair' Paediatric 5 mg chewable tablets 'Singulair' Paediatric 5 mg chewable tablets have been evaluated in approximately 1,750 paediatric patients 6 to 14 years of age. In two 56-week and one eight-week, placebo-controlled clinical trial, the only adverse experience commonly reported as drug-related in patients treated with montelukast was headache. 'Singulair' Paediatric 4 mg chewable tablets 'Singulair' Paediatric 4 mg chewable tablets have been evaluated in approximately 851 paediatric patients 2 to 5 years of age. In a 48-week and a 12-week, placebo-controlled clinical study, the only adverse experiences commonly reported as drug-related in patients treated with montelukast were abdominal pain and thirst. 'Singulair' Paediatric 4 mg granules 'Singulair' Paediatric 4 mg granules have been evaluated in approximately 175 paediatric patients 6 months to 2 years of age. In a 6-week, placebo-controlled clinical study, the adverse experiences commonly reported were hyperkinesia, asthma, diarrhoea, eczematous dermatitis and rash. With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change. Cumulatively, 502 paediatric patients 2 to 5 years of age were treated with montelukast for at least 3 months, 338 for 6 months or longer, and 534 patients for 12 months or longer. With prolonged treatment, the safety profile did not change in these patients either. The following adverse reactions have been reported in post-marketing use:
Blood and lymphatic system disorders: increased bleeding tendency Immune system disorders: hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration
Psychiatric disorders: dream abnormalities including nightmares, hallucinations, insomnia, irritability, anxiety, restlessness, agitation including aggressive behaviour, tremor, depression, suicidal thinking and behaviour (suicidality) in very rare cases
Nervous system disorders: dizziness, drowsiness, paraesthesia/hypoesthesia, seizure
Cardiac disorders: palpitations Respiratory, thoracic and mediastinal disorders: epistaxis
Gastro-intestinal disorders: diarrhoea, dry mouth, dyspepsia, nausea, vomiting
Hepato-biliary disorders: elevated levels of serum transaminases (ALT, AST) cholestatic hepatitis
Skin and subcutaneous tissue disorders: angiooedema, bruising, urticaria, pruritus, rash, erythema nodosum
Musculoskeletal disorders: arthralgia, myalgia including muscle cramps General disorders and administration site conditions: asthenia/fatigue, malaise, oedema, pyrexia. Very rare cases of Churg-Strauss Syndrome (CSS) have been reported during treatment*^ asthmatic patients.
PACKAGE QUANTITIES AND BASIC NHS COST
'Singulair' 10 mg tablets: £26.97 for 28 tablets
'Singulair' Paediatric 5 mg chewable tablets: £25.69 for 28 tablets
'Singulair' Paediatric 4 mg chewable tablets: £25.69 for 28 tablets
'Singulair' Paediatric 4 mg granules: £25.69 for 28 sachets
Marketing Authorisation Holder: Merck Sharp & Dohme Limited. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK.
| POM | Date of review of prescribing information: August 2009
® denotes registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. © Merck Sharp & Dohme Limited