In general, the preparation of Moncasta® is well tolerated. Side effects are usually mild and, as a rule, do not require withdrawal of the drug. The overall incidence of side effects with Moncast® is comparable to that of placebo.
Children aged 2 to 5 years with bronchial asthma
In clinical studies of Montelukast, 573 patients aged 2 to 5 years took part. In a 12-week, placebo-controlled clinical trial, the only adverse event (AE) estimated to be associated with taking the drug was observed in> 1% of patients taking montelukast, and more often than in the group of patients taking placebo, there was a thirst. Differences in the frequency of this AE between the two treatment groups were statistically insignificant.
A total of 426 patients aged 2 to 5 years were treated with Montelukast for at least 3 months, 230 patients for 6 months or longer, and 63 patients for 12 months or longer. With longer treatment, the profile of AE did not change.
Children aged 2 to 14 years with seasonal allergic rhinitis
In a 2-week, placebo-controlled clinical trial using montelukast for the treatment of seasonal allergic rhinitis, 280 patients aged 2 to 14 years took part. Montelukast was taken by patients once a day in the evening and was generally well tolerated, the safety profile of Montelukast was similar to the placebo safety profile. In this clinical trial, AEs that were considered to be drug-related were not recorded would be observed in ≥1% of patients taking montelukast, and more often than in the group of patients taking placebo.
Children aged 6 to 14 years with bronchial asthma
The safety profile of Montelukast in children was generally similar to that of adults and was comparable to the placebo safety profile.
In an 8-week, placebo-controlled clinical trial, a single AE, estimated to be associated with drug intake, was observed in> 1% of patients taking montelukast, and more often than in the group of patients taking placebo, there was a headache. The frequency difference between the two treatment groups was statistically insignificant.
In studies to assess the rate of growth, the safety profile of patients of this age group was consistent with the previously described safety profile of montelukast.
With longer treatment (more than 6 months), the profile of AE did not change.
Adults and children aged 15 years and older with bronchial asthma
In two 12-week, placebo-controlled clinical trials with a similar design, the only AEs evaluated as drug-related, observed in ≥1% of patients taking montelukast, and more often than in the group of patients taking placebo, there were abdominal pain and headache. Differences in the frequency of AE data between the two treatment groups were statistically insignificant. With longer treatment (within 2 years), the profile of AE did not change.
Adults and children aged 15 years and older with seasonal allergic rhinitis
Montelukast was taken by patients once or twice a day in the morning or in the evening and was generally well tolerated, the drug safety profile was similar to the placebo safety profile. In placebo-controlled clinical trials, AEs that were considered to be drug-related were not reported would be observed in ≥1% of patients taking montelukast, and more often than in the group of patients taking placebo. In a 4-week, placebo-controlled clinical trial, the safety profile of Montelukast was similar to that in a 2-week study. The incidence of drowsiness with montelukast in all studies was the same as with placebo.
Adults and children aged 15 years and older with year-round allergic rhinitis
Montelukast was taken by patients 1 time per day and was generally well tolerated. The drug safety profile was similar to the safety profile observed in the treatment of patients with seasonal allergic rhinitis and with placebo. In these clinical trials, AEs were not registered,which would be regarded as associated with taking the drug, would be observed in ≥1% of patients taking montelukast, and more often than in the group of patients taking placebo. The incidence of drowsiness with montelukast was the same as with placebo.
Generalized analysis of the results of clinical trials
A generalized analysis of 41 placebo-controlled clinical trials was conducted (35 trials involving patients aged 15 years and older, 6 trials involving patients aged 6 to 14 years) using approved methods for assessing suicidality. Among 9929 patients who took montelukast, and 7780 patients taking placebo in these studies, one patient was identified with suicidal tendencies in the group of patients taking montelukast. In none of the treatment groups were there any suicides, suicidal attempts or other preparatory actions that indicated suicidal behavior.
Separately, a generalized analysis of 46 placebo-controlled clinical trials (35 trials involving patients aged 15 years and older, 11 studies involving patients aged 3 months to 14 years) was conducted to evaluate adverse behavioral effects (NPEs).Among the 11673 patients taking in these studies montelukast, and 8827 patients taking placebo, the percentage of patients with at least one NPE was 2.73% among those taking montelukast, and 2.27% among those taking placebo, the odds ratio was 1.12 (95% confidence interval [0.93, 1.36]).
During the post-marketing application of Montelukast, the following identified AEs were reported:
Infectious and parasitic diseases: infections of the upper respiratory tract.
Violations from the blood and lymphatic system: increased tendency to bleeding.
Immune system disorders: hypersensitivity reactions, including anaphylaxis, very rarely (<1/10000) eosinophilic liver infiltration.
Disorders of the psyche: agitation, including aggressive behavior or hostility, anxiety, depression, disorientation, attention impairment, pathological dreams, hallucinations, insomnia, memory disorders, psychomotor activity (including irritability, anxiety and tremor), somnambulism, suicidal thoughts and behavior (suicidal).
Impaired nervous system: dizziness, drowsiness, paresthesia / hypoesthesia, very rarely (<1/10000) convulsions.
Heart Disease: cardiopalmus.
Disorders from the respiratory system, the thoracic and mediastinal organs: nosebleeds, pulmonary eosinophilia.
Disorders from the digestive system: diarrhea, dyspepsia, nausea, vomiting, pancreatitis.
Disorders from the liver and bile ducts: an increase in the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (ACT) in the blood, very rarely (<1/10000) hepatitis (including cholestatic, hepatocellular and mixed liver damage).
Disturbances from the skin and subcutaneous tissues: angioedema, tendency to form hematomas, erythema nodosum, erythema multiforme, itchy skin, rashes, urticaria.
Disturbances from the musculoskeletal and connective tissue: arthralgia, myalgia, including muscle cramps.
Disorders from the kidneys and urinary tract: enuresis in children.
General disorders and disorders at the site of administration: asthenia (weakness) / fatigue, swelling, pyrexia.