ASMALAIR 5MG TAB; montelukast, respiratory tract agents .
ACTIVE-INGREDIENT OF ASMALAIR 5MG TAB
Each tablet contains: 5.2 montelukast sodium, which is equivalent to 5 mg montelukast.
INDICATION OF ASMALAIR 5MG TAB
Asmalair is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistant asthma who are inadequately controlled on inhaled corticosteroids and in whom ʺas-neededʺ short acting ß˗agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom Asmalair is indicated in asthma. Asmalair can also provide symptomatic relief of seasonal allergic rhinitis. Asmalair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
DOSAGE OF ASMALAIR 5MG TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Psology: 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 Asmalair on parameters of asthma control occurs within one day. Asmalair may be taken with or without food. Patients should be advised to continue taking Asmalair even if their asthma is under control, as well as during periods of worsening asthma. Asmalair 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 is no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients. Therapy with Asmalair in relation to other treatments for asthma: Asmalair can be added to a patient’s existing treatment regimen. Inhaled corticosteroids: Treatment with Asmalair can be used as add-on therapy in patients when inhaled corticosteroids plus ʺas neededʺ short acting ß˗agonists provide inadequate clinical control. Asmalair should not be abruptly substituated for inhaled corticosteroids. Paediatric population: Do not give Asmalair 10 mg tablets to children less than 15 years of age. The safety and efficacy of Asmalair 10 mg tablets in children less than 15 years has not been established. Method of administration: Oral use.
OVER-DOSAGE OF ASMALAIR 5MG TAB
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 occuring adverse experiences were consistent with the safety profile 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.
CONTRA-INDICATION OF ASMALAIR 5MG TAB
Hypersensitivity to the active substance or to any of the excipients.
STORAGE OF ASMALAIR 5MG TAB
Store in the original package in order to protect from light and moisture. Store in a dry place not exceeding 30 °C.
PACK OF ASMALAIR 5MG TAB
Carton box of 10,20,30 tablets in (obaque white PVC/Al foil) strips each strip containing 10 tablets packed with English/Arabic pamphlet.
ASMALAIR 5MG TAB MANUFACTURED BY
Hi Pharm for Manufacturing Pharmaceuticals and Chemicals.