Singulair 5mg 28 chewable tablets — Made in Great Britain — Free Delivery
(Singulair )
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Description Singulair 5mg 28 chewable tablets — Made in Great Britain — Free Delivery
Product description
Singular® chewable tablets are used for the following indications:
- as an additional treatment for bronchial asthma in patients with persistent mild to moderate asthma, which is insufficiently controlled by inhaled corticosteroids, as well as in case of insufficient clinical control of asthma using short-acting β-adrenergic receptor agonists, which are used if necessary;
- as an alternative method of treatment instead of low doses of inhaled corticosteroids for patients with persistent mild asthma who have not recently experienced serious attacks of bronchial asthma requiring the use of oral corticosteroids, and who are unable to use inhaled corticosteroids;
- prevention of asthma, the dominant component of which is exercise-induced bronchospasm;
- relief of symptoms of seasonal and perennial allergic rhinitis.
Compound
The active ingredient is montelukast (one chewable tablet contains montelukast sodium 5.2 mg (equivalent to montelukast 5 mg)).
Excipients: mannitol (E 421), microcrystalline cellulose, hydroxypropyl cellulose, red iron oxide (E172), croscarmellose sodium, cherry flavor, aspartame (E 951), magnesium stearate.
Contraindications
Hypersensitivity to any component of the preparation.
Mode of application
Chew the tablets before swallowing.
Patients with asthma and allergic rhinitis (seasonal and year-round) should take one 5 mg chewable tablet once a day. To relieve the symptoms of allergic rhinitis, the time of admission is selected individually.
For the treatment of asthma, the dose for children aged 6 to 14 years is one chewable tablet (5 mg) per day, in the evening. Singular® should be taken 1 hour before meals or 2 hours after meals. No dose adjustment is necessary for this age group.
General recommendations
The therapeutic effect of the preparation "Singular®" on the parameters of asthma control occurs within one day. Patients should be advised to continue taking Singulair® even if asthma control is achieved, as well as during periods of asthma exacerbation.
There is no need for dose adjustment for patients with impaired renal function or with mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage for boys and girls is the same.
As an alternative treatment for low-dose inhaled corticosteroids for persistent mild asthma
Montelukast is not recommended as monotherapy in patients with moderate persistent asthma. The use of montelukast as an alternative to low-dose inhaled corticosteroids in children with persistent mild asthma should only be considered in patients who have not had a recent severe asthma attack requiring oral corticosteroids and who cannot use inhaled corticosteroids. Mild persistent asthma is defined as the occurrence of asthma symptoms more than once a week but less than once a day, the occurrence of nocturnal symptoms more than twice a month but less than once a week, and normal lung function between episodes. If sufficient asthma control is not achieved further (usually within one month), the need for additional or other anti-inflammatory therapy should be determined based on a consistent asthma management system. Patients should be periodically assessed for asthma control.
Application of the preparation "Singular®" depending on other asthma treatment
When Singular® is used as an adjunct therapy to inhaled corticosteroids, Singular® should not suddenly replace inhaled corticosteroids.
Application features
Pregnant
Animal studies have shown no deleterious effects on pregnancy or embryonic / fetal development. The available data from published prospective and retrospective cohort studies using montelukast in pregnant women who assess significant birth defects in children have not established the risk associated with the use of the preparation. The available studies have methodological limitations, including small sample sizes, in some cases retrospective data collection, and incompatible comparison groups.
Studies in rats have shown that montelukast passes into milk. It is not known whether montelukast is excreted in breast milk in women. This medication should only be used during breastfeeding if it is considered absolutely necessary.
Children
Applied to children aged 6 to 14 years.
Drivers
It is not expected that montelukast will affect the patient's ability to drive vehicles or other machinery. However, drowsiness or dizziness has been reported very rarely.
Overdose
There is no special information on the treatment of an overdose with the preparation "Singular®". In studies of chronic asthma, montelukast was prescribed in doses up to 200 mg / day to adult patients for 22 weeks, and in short-term studies - up to 900 mg / day for about one week, while clinically important adverse reactions did not occur. In post-marketing use and in clinical trials, there have been reports of acute overdose of the preparation "Singular®". These included the administration of the preparation in adults and children in doses exceeding 1000 mg (approximately 61 mg / kg in a child aged 42 months). The obtained clinical and laboratory data were consistent with the safety profile in adult patients and children. In most cases of overdose, no adverse reactions were reported. The most common adverse reactions were observed, which corresponded to the safety profile of the preparation "Singular" and included: abdominal pain, drowsiness, thirst, headache, vomiting and psychomotor hyperactivity.
It is not known whether montelukast is excreted by peritoneal dialysis or hemodialysis.
Side effects
Montelukast has been evaluated in clinical trials: chewable tablets 5 mg were used by approximately 1,750 children aged 6 to 14 years.
In clinical studies, the following adverse reactions were observed frequently (from ≥ 1/100 to <1/10) in patients treated with montelukast, and also with a greater frequency than in patients treated with placebo.
Nervous system disorders: headache.
Storage conditions
Store in its original packaging at a temperature not exceeding 30 ° C, out of the reach of children.
Shelf life is 2 years.
Tags: Singulair
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