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What are the possible side effects of levocetirizine dihydrochloride (Montek-LC)?
Levocetirizine dihydrochloride (Montek-LC) has been associated with somnolence, fatigue, weakness and urinary retention.
Experience in clinical trials
The safety data described below reflect the exposure to levocetirizine dihydrochloride (Montek-LC) in 2708 patients with seasonal or perennial allergic rhinitis or chronic idiopathic urticaria in 14 controlled clinical trials of 1 week to 6 months duration.
Short-term (up to 6 weeks of exposure) safety data for adults and adolescents are based on eight clinical trials in which 1896 patients (825 males and 1071 females aged 12 years and older) were treated with levocetirizine dihydrochloride (Montek -LC) 2.5 , 5 or 10 mg once a day in the evening.
Short-term safety data in children and adolescents are based on two clinical studies in which 243 children with seasonal or perennial allergic rhinitis (162 boys and 81 girls, aged 6 to 12 years) were treated with levocetirizine dihydrochloride (Montek-LC). at a dose of 5 mg once daily for 4 to 6 weeks, a clinical trial in which 114 children (65 boys and 49 girls, 1 to 5 years of age) with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine dihydrochloride (Montek-LC ) 1.25 mg twice daily for 2 weeks, and a clinical trial in which 45 children (28 boys and 17 girls, aged 6 to 11 months) with symptoms of allergic rhinitis or chronic urticaria were treated with levocetirizine dihydrochloride (Montek-LC) at a dose of 1.25 mg once daily for 2 weeks.
Long-term safety data (4- or 6-month exposure) in adults and adolescents are based on two clinical trials in which 428 patients (190 males and 238 females) with allergic rhinitis were exposed to treatment with levocetirizine dihydrochloride (Montek- LC). 5 mg once daily. Long-term safety data are also available from an 18-month study in 255 patients aged 12 to 24 months treated with levocetirizine dihydrochloride (Montek-LC).
As clinical trials are conducted under very different conditions, the rates of adverse reactions seen in clinical trials for one drug cannot be directly compared to those seen in clinical trials for another drug and may not reflect the rates seen in practice.
Adults and adolescents 12 years and over
In studies of up to 6 weeks duration, the mean age of adult and adolescent patients was 32 years, 44% of patients were male and 56% female, and the vast majority (over 90%) were Caucasian.
In these studies, 43% and 42% of patients in the levocetirizine dihydrochloride (Montek-LC) 2.5 mg and 5 mg groups, respectively, experienced at least one adverse event compared to 43% in the placebo group.
In placebo-controlled trials of 1 to 6 weeks duration, the most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth and pharyngitis, most of which were mild to moderate in severity. Somnolence with levocetirizine dihydrochloride (Montek-LC) showed a dosing sequence among the 2.5, 5, and 10 mg doses tested and was the most common adverse reaction leading to treatment discontinuation (0.5%).
Table 1 lists the adverse reactions that were reported in at least 2% of patients 12 years of age and older exposed to levocetirizine dihydrochloride (Montek-LC) 2.5 mg or 5 mg in eight controlled clinical trials, placebo and were more common in levocetirizine dihydrochloride (Montek-LC) than placebo.
Additional medically significant adverse reactions observed at a higher incidence than placebo in adults and adolescents 12 years of age and older exposed to levocetirizine dihydrochloride (Montek-LC) are syncope (0.2%) and weight gain (0.2%). 5%).
Pediatric patients aged 6 to 12 years
A total of 243 pediatric patients aged 6 to 12 years received levocetirizine dihydrochloride (Montek-LC) 5 mg once daily in two short-term, double-blind, placebo-controlled studies. The mean age of the patients was 9.8 years, 79 (32%) were between 6 and 8 years old, and 50% were Caucasian. Table 2 lists the adverse reactions reported in at least 2% of patients aged 6 to 12 years exposed to levocetirizine dihydrochloride (Montek-LC) 5 mg in placebo-controlled clinical trials, and the most common adverse reactions associated with levocetirizine dihydrochloride (Montek-LC) are listed in Table 2. LC)-LC) than placebo.
Pediatric patients aged 1 to 5 years
A total of 114 pediatric patients aged 1 to 5 years received levocetirizine dihydrochloride (Montek-LC) 1.25 mg twice daily in a two-week, double-blind, placebo-controlled safety study. The mean age of patients was 3.8 years, 32% were between 1 and 2 years of age, 71% were Caucasian, and 18% were Black. Table 3 lists the adverse reactions that were reported in at least 2% of patients 1 to 5 years of age exposed to levocetirizine dihydrochloride (Montek-LC) 1.25 mg twice daily in a placebo-controlled safety study and which occurred more frequently with levocetirizine dihydrochloride (Montek-LC) than with placebo.
Pediatric patients aged 6 to 11 months
A total of 45 pediatric patients aged 6 to 11 months received levocetirizine dihydrochloride (Montek-LC) 1.25 mg once daily in a two-week, double-blind, placebo-controlled safety study. The mean age of the patients was 9 months, 51% were Caucasian and 31% were Black. Adverse reactions that were reported in more than 1 subject (i.e. more than or equal to 3% of patients) aged 6 to 11 months exposed to levocetirizine dihydrochloride 1.25 mg once daily in a placebo-controlled safety study and which occurred more frequently for levocetirizine dihydrochloride than placebo included diarrhea and constipation, which were reported in 6 (13%) and 1 (4%) and 3 (7%) and 1 (4%) children in the levocetirizine dihydrochloride (Montek-LC) and placebo groups appropriately.
Experience in long-term clinical trials
In two controlled clinical trials, 428 patients (190 males and 238 females) aged 12 years and older were treated with levocetirizine dihydrochloride (Montek-LC) 5 mg once daily for 4 or 6 months. Patient characteristics and safety profile were similar to those observed in short-term studies. Ten (2.3%) patients treated with levocetirizine dihydrochloride (Montek-LC) discontinued treatment due to somnolence, fatigue or weakness compared to 2 (<1%) in the placebo group.
There are no long-term clinical studies in children under 12 years of age with allergic rhinitis or chronic idiopathic urticaria.
Abnormalities in laboratory tests
Increased bilirubin and blood transaminases have been reported in <1% of patients in clinical trials. The increases were transient and did not lead to treatment discontinuation in any patient.
post-marketing experience
In addition to the adverse reactions reported in clinical trials and listed above, adverse events have also been observed with the post-marketing use of levocetirizine dihydrochloride (Montek-LC). Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions in the form of hypersensitivity and anaphylaxis, increased appetite, angioedema, persistent drug eruption, pruritus, rash and urticaria, convulsions, paraesthesia, dizziness, tremor, dysgeusia, vertigo, movement disorders (including dystonia and ocular crisis), aggression and agitation, hallucinations, depression, insomnia, suicidal thoughts, visual disturbances, blurred vision, palpitations, tachycardia, shortness of breath, nausea, vomiting, hepatitis, dysuria, urinary retention, myalgia and oedema.
In addition to these events reported during treatment with levocetirizine dihydrochloride (Montek-LC), other potentially serious adverse reactions have been reported in post-marketing experience with cetirizine. Since levocetirizine dihydrochloride (Montek-LC) is the main pharmacologically active ingredient of cetirizine, it should be taken into account that the following adverse reactions may occur during treatment with levocetirizine dihydrochloride (Montek-LC): orofacial dyskinesia, severe hypotension, cholestasis, glomerulonephritis, stillbirth, tics, myoclonus and extrapyramidal symptoms.
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What are the possible side effects of Montelukast (Montek-LC)?
Montelukast (Montek-LC) (Montek-LC) is generally well tolerated. Side effects, which are usually mild, usually do not require discontinuation of therapy. The overall incidence of side effects reported with Montelukast (Montek-LC) (Montek-LC) was comparable to placebo.
Adults 15 years and older with asthma:Montelukast (Montek-LC) (Montek-LC) has been studied in approximately 2,600 adult patients 15 years of age and older in clinical trials. In two similarly designed 12-week placebo-controlled clinical trials, the only adverse reactions reported as drug-related in ≥ 1% of patients treated with Montelukast (Montek-LC) and occurring at a higher incidence than patients treated with placebo were abdominal pain and abdominal pain. headache. The incidence of these events was not significantly different between the two treatment groups.
A total of 544 patients were treated with Montelukast (Montek-LC) for at least 6 months, 253 for 1 year and 21 for 2 years in clinical trials. During prolonged treatment, the profile of adverse reactions did not change.
Pediatric patients 6 to 14 years of age with asthma:Montelukast (Montek-LC) (Montek-LC) has been evaluated in approximately 475 pediatric patients aged 6 to 14 years. The safety profile in children and adolescents is generally similar to the safety profile in adults and placebo.
In an 8-week placebo-controlled clinical trial, the only adverse reaction reported in > 1% of patients treated with Montelukast (Montek-LC) (Montek-LC) was drug-related and occurred at a higher incidence than placebo-treated patients was headache. The incidence of headache was not significantly different between the two treatment groups.
In growth rate studies, the safety profile in these pediatric patients was consistent with the previously described safety profile of Montelukast (Montek-LC) (Montekast (Montek-LC)).
A total of 263 pediatric patients aged 6 to 14 years were treated with Montelukast (Montek-LC) (Montek-LC) for at least 3 months and 164 for 6 months or more. During prolonged treatment, the profile of adverse reactions did not change.
Pediatric patients 2 to 5 years of age with asthma:Montelukast (Montek-LC) (Montek-LC) was evaluated in 573 pediatric patients aged 2 to 5 years. In a 12-week placebo-controlled clinical trial, the only adverse reaction reported as drug-related occurred in > 1% of patients treated with Montelukast (Montek-LC) (Montek-LC) and had a higher incidence than placebo-treated patients was thirst. The frequency of thirst was not significantly different between the two treatment groups.
A total of 426 pediatric patients 2 to 5 years of age were treated with Montelukast (Montek-LC) (Montek-LC) for at least 3 months, 230 for 6 months or more, and 63 patients for 12 months or more. During prolonged treatment, the profile of adverse reactions did not change.
Children and adolescents aged 6 months to 2 years with asthma:Montelukast (Montek-LC) (Montek-LC) was evaluated in 175 pediatric patients aged 6 months to 2 years. In a 6-week placebo-controlled clinical trial, adverse reactions reported as drug-related in > 1% of patients treated with Montelukast (Montek-LC) (Montek-LC) and at a higher incidence than placebo-treated patients were diarrhoea, hyperkinesia, asthma, eczematous skin and rash.
The incidence of these adverse reactions was not significantly different between the two treatment groups.
Adults 15 years of age and older with seasonal allergic rhinitis:Montelukast (Montek-LC) (Montelucast (Montek-LC)) has been studied in clinical trials in 2,199 adult patients 15 years of age and older for the treatment of seasonal allergic rhinitis. Montelukast (Montek-LC) (Montek-LC) administered once daily in the morning or evening was generally well tolerated, with a safety profile similar to placebo. In placebo-controlled clinical trials, no drug-related adverse reactions were observed in 1% of patients treated with Montelukast (Montek-LC) (Montek-LC) and the incidence was higher than in patients treated with placebo. In the 4-week placebo-controlled clinical trial, the safety profile was consistent with that observed in the 2-week studies. In all studies, the incidence of somnolence was similar to placebo.
Children and adolescents aged 2 to 14 years with seasonal allergic rhinitis:Montelukast (Montek-LC) (Montek-LC) was evaluated in 280 pediatric patients aged 2 to 14 years for the treatment of seasonal allergic rhinitis in a 2-week placebo-controlled clinical trial. Montelukast (Montek-LC) (Montek-LC) administered once daily in the evening was generally well tolerated and had a safety profile similar to placebo. In this study, no drug-related adverse reactions were observed in 1% of patients treated with Montelukast (Montek-LC) and the incidence was higher than in patients receiving placebo.
Adults 15 years of age and older with perennial allergic rhinitis:Montelukast (Montek-LC) (Montek-LC) was evaluated in 3,235 adults and adolescents aged 15 years and older with perennial allergic rhinitis in two 6-week placebo-controlled clinical trials.
Montelukast (Montek-LC) once daily was generally well tolerated and the safety profile was consistent with that observed in patients with seasonal allergic rhinitis and similar to placebo. In these two studies, no drug-related adverse reactions were observed in 1% of patients treated with Montelukast (Montek-LC) (Montek-LC) and more than in patients treated with placebo. The incidence of somnolence was similar to placebo.
Pooled analyzes from experience in clinical trials:A pooled analysis of 41 placebo-controlled clinical trials (35 trials in patients 15 years of age and older; 6 trials in children and adolescents 6 to 14 years of age) was performed using a validated method of suicide assessment. Among the 9,929 patients who received Montelukast (Montek-LC) (Montek-LC) and the 7,780 patients who received placebo in these studies, there was one suicidal patient in the Montelukast (Montek-LC) (Montek-LC) group (Montek-LC) LC). LC) group LC)). There were no completed suicides, suicide attempts, or acts of preparatory suicidal behavior in any of the treatment groups.
A separate pooled analysis of 46 placebo-controlled clinical trials (35 studies in patients aged 15 years and older; 11 studies in children aged 3 months to 14 years) evaluating behavioral adverse reactions (BRAE) was performed. Among the 11,673 patients who received Montelukast (Montek-LC) (Montek-LC) and the 8,827 patients who received placebo in these studies, the incidence of at least one BRAE was 2.73% in patients who received Montelukast (Montek-LC) ) LC ) (Montelukast (Montek-LC)) and 2.27% in patients receiving placebo; the odds ratio was 1.12 [CI 95% (0.93, 1.36)].
The clinical trials included in these pooled analyzes were not specifically designed to study suicide or BRAE.
Post-Marketing Experience:The following side effects have been reported in post-marketing experience:Infections and Infestations:Upper respiratory tract infection.
Blood and lymphatic system disorders:Increased bleeding tendency.
Immune system disorders:Hypersensitivity reactions including anaphylaxis, very rarely eosinophilic infiltrates in the liver.
Mental disorders:Agitation, including aggressive behavior or hostility, anxiety, depression, confusion, disturbance in attention, sleep disorders, hallucinations, insomnia, memory impairment, attention deficit hyperactivity disorder (including irritability, restlessness and tremors), sleepwalking, suicidal thoughts and behavior (suicide).
Nervous system disorders:Dizziness, somnolence, paraesthesia/hypoaesthesia, very rarely convulsions.
Cardiac disorders:Palpitations.
Respiratory, thoracic and mediastinal disorders:epistaxis.
Gastrointestinal problems:Diarrhoea, indigestion, nausea, vomiting; pulmonary eosinophilia.
Hepatobiliary disorders:Increased ALT and AST, very rare hepatitis (including cholestatic, hepatocellular and mixed hepatic changes).
Skin and subcutaneous tissue disorders:Angioedema, hematoma, erythema multiforme, erythema nodosum, pruritus, rash, urticaria.
Musculoskeletal and connective tissue disorders:Joint pain, muscle pain including muscle spasms.
Renal and urinary disorders:Enuresis in children.
General disorders and conditions at the administration site:Weakness/fatigue, swelling, fever.