Composition:
Utilisé dans le traitement:
Examiné médicalement par Kovalenko Svetlana Olegovna, Pharmacie Dernière mise à jour le 26.06.2023
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Montene 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. In those asthmatic patients in whom Montene is indicated in asthma, Montene can also provide symptomatic relief of seasonal allergic rhinitis.
Montene is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
Posology
The recommended dose for adults and adolescents 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis, is one 10 mg tablet daily to be taken in the evening.General recommendations
The therapeutic effect of Montene on parameters of asthma control occurs within one day. Montene may be taken with or without food. Patients should be advised to continue taking Montene even if their asthma is under control, as well as during periods of worsening asthma. Montene should not be used concomitantly with other products containing the same active ingredient, montelukast.
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 Montene in relation to other treatments for asthma
Montene can be added to a patient's existing treatment regimen.
Inhaled corticosteroids: Treatment with Montene can be used as add-on therapy in patients when inhaled corticosteroids plus “as needed†short acting β-agonists provide inadequate clinical control. Montene should not be abruptly substituted for inhaled corticosteroids.
Paediatric population
Do not give Montene 10 mg film-coated tablets to children less than 15 years of age. The safety and efficacy of Montene 10 mg film-coated tablets in children less than 15 years has not been established.
5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.
4 mg chewable tablets are available for paediatric patients 2 to 5 years of age.
4 mg granules are available for paediatric patients 6 months to 5 years of age.
Method of administration
Oral use.
Les patients doivent être avisés de ne jamais utiliser de montélukast oral pour traiter les crises d'asthme aiguë et de garder leurs médicaments de sauvetage appropriés habituels à cette fin facilement disponibles. En cas d'attaque aiguë, un agoniste de l'β inhalé à courte durée d'action doit être utilisé. Les patients doivent demander conseil à leur médecin dès que possible s'ils ont besoin de plus d'inhalations d'agonistes de l'β à courte durée d'action que d'habitude.
Le montélukast ne doit pas être remplacé brusquement par des corticostéroïdes inhalés ou oraux.
Il n'y a pas de données démontrant que les corticostéroïdes oraux peuvent être réduits lorsque le montélukast est administré en concomitance.
Dans de rares cas, les patients sous traitement avec des agents anti-asthmatiques, y compris le montélukast, peuvent présenter une éosinophilie systémique, présentant parfois des caractéristiques cliniques de vascularite compatibles avec le syndrome de Churg-Strauss, une affection qui est souvent traitée avec une corticothérapie systémique. Ces cas ont parfois été associés à la réduction ou au retrait de la corticothérapie orale. Bien qu'une relation causale avec l'antagonisme des récepteurs du leucotriène n'ait pas été établie, les médecins doivent être attentifs à l'éosinophilie, à une éruption vasculaire, à une aggravation des symptômes pulmonaires, à des complications cardiaques et / ou à une neuropathie se présentant chez leurs patients. Les patients qui développent ces symptômes doivent être réévalués et leurs schémas thérapeutiques évalués.
Le traitement par le montélukast ne modifie pas le besoin de patients souffrant d'asthme sensible à l'aspirine pour éviter de prendre de l'aspirine et d'autres anti-inflammatoires non stéroïdiens.
Les patients présentant des problèmes héréditaires rares d'intolérance au galactose, de déficit en lactase de Lapp ou de malabsorption du glucose-galactose ne doivent pas prendre ce médicament.
Montene has no or negligible influence on the ability to drive and use machines. However, individuals have reported drowsiness or dizziness.
Montelukast has been evaluated in clinical studies as follows:
- 10 mg film-coated tablets in approximately 4,000 adult and adolescent asthmatic patients 15 years of age and older.
- 10 mg film-coated tablets in approximately 400 adult and adolescent asthmatic patients with seasonal allergic rhinitis 15 years of age and older.
- 5 mg chewable tablets in approximately 1,750 paediatric asthmatic patients 6 to 14 years of age.
The following drug-related adverse reactions in clinical studies were reported commonly (>1/100 to <1/10) in asthmatic patients treated with montelukast and at a greater incidence than in patients treated with placebo:
| Body System Class | Adult and Adolescent Patients 15 years and older (two 12-week studies; n=795) | Paediatric Patients 6 to 14 years old (one 8-week study; n=201) (two 56-week studies; n=615) |
| Nervous system disorders | headache | headache |
| Gastro-intestinal disorders | abdominal pain |
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.
Tabulated list of Adverse Reactions
Adverse reactions reported in post-marketing use are listed, by System Organ Class and specific Adverse Reactions, in the table below. Frequency Categories were estimated based on relevant clinical trials.
| System Organ Class | Adverse Reactions | Frequency Category* |
| Infections and infestations | upper respiratory infection†| Very Common |
| Blood and lymphatic system disorders | increased bleeding tendency | Rare |
| Immune system disorders | hypersensitivity reactions including anaphylaxis | Uncommon |
| hepatic eosinophilic infiltration | Very Rare | |
| Psychiatric disorders | dream abnormalities including nightmares, insomnia, somnambulism, anxiety, agitation including aggressive behaviour or hostility, depression, psychomotor hyperactivity (including irritability, restlessness, tremor§) | Uncommon |
| disturbance in attention, memory impairment | Rare | |
| hallucinations, disorientation, suicidal thinking and behaviour (suicidality) | Very Rare | |
| Nervous system disorders | dizziness, drowsiness, paraesthesia/hypoesthesia, seizure | Uncommon |
| Cardiac disorders | palpitations | Rare |
| Respiratory, thoracic and mediastinal disorders | epistaxis | Uncommon |
| Churg-Strauss Syndrome (CSS) | Very Rare | |
| pulmonary eosinophilia | Very Rare | |
| Gastrointestinal disorders | diarrhoea‡, nausea‡, vomiting‡ | Common |
| dry mouth, dyspepsia | Uncommon | |
| Hepatobiliary disorders | elevated levels of serum transaminases (ALT, AST) | Common |
| hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury). | Very Rare | |
| Skin and subcutaneous tissue disorders | rash‡ | Common |
| bruising, urticaria, pruritus | Uncommon | |
| angiooedema | Rare | |
| erythema nodosum, erythema multiforme | Very Rare | |
| Musculoskeletal and connective tissue disorders | arthralgia, myalgia including muscle cramps | Uncommon |
| General disorders and administration site conditions | pyrexia‡ | Common |
| asthenia/fatigue, malaise, oedema | Uncommon | |
| * Frequency Category: Defined for each Adverse Reaction by the incidence reported in the clinical trials data base: Very Common (>1/10), Common (>1/100 to <1/10), Uncommon (>1/1,000 to <1/100), Rare (>1/10,000 to <1/1,000), Very Rare (<1/10,000). †This adverse experience, reported as Very Common in the patients who received montelukast, was also reported as Very Common in the patients who received placebo in clinical trials. ‡ This adverse experience, reported as Common in the patients who received montelukast, was also reported as Common in the patients who received placebo in clinical trials. § Frequency Category: Rare | ||
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
In chronic asthma studies, montelukast 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 overdose in post-marketing experience and clinical studies with montelukast. These include reports in adults and children with a dose as high as 1,000 mg (approximately 61 mg/kg in a 42 month old child). The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients. There were no adverse experiences in the majority of overdose reports.
Symptoms of overdose
The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.
Management of overdose
No specific information is available on the treatment of overdose with montelukast. It is not known whether montelukast is dialysable by peritoneal- or haemodialysis.
