Singulair - 23 reviews, instructions for use

Singular

Children aged 2 to 5 years with bronchial asthma

Clinical studies of the drug Singulair® involved 573 patients aged 2 to 5 years. In a 12-week placebo-controlled clinical trial, the only adverse event (AE) assessed as drug-related occurring in >1% of Singulair-treated patients and more frequently than in placebo-treated patients was thirst. The differences in the incidence of this AE between the two treatment groups were not statistically significant.

In total, 426 patients aged 2 to 5 years were treated with Singulair® for at least 3 months, 230 were treated for 6 months or longer, and 63 patients were treated for 12 months or longer in the studies. With longer treatment, the AE profile did not change.

Children aged 2 to 14 years with seasonal allergic rhinitis

A 2-week, placebo-controlled clinical trial using Singulair® for the treatment of seasonal allergic rhinitis included 280 patients aged 2 to 14 years. Patients took Singulair® 1 time/day in the evening and was generally well tolerated. The safety profile of the drug in children was similar to that of placebo. In this clinical study, there were no AEs that were considered drug-related, occurred in ≥1% of patients taking Singulair®, and were more common than in the group of patients taking placebo.

Children aged 6 to 14 years with bronchial asthma

The safety profile of the drug in children was generally similar to the safety profile in adults and comparable to the safety profile of placebo.

In an 8-week placebo-controlled clinical trial, the only AE assessed as drug-related occurring in >1% of patients treated with Singulair and more frequently than in the placebo group was headache. The difference in frequency between the two treatment groups was not statistically significant.

In growth rate studies, the safety profile in patients in this age group was consistent with the previously described safety profile of Singulair®.

With longer treatment (more than 6 months), the AE profile did not change.

Adults and children aged 15 years and older with asthma

In two 12-week placebo-controlled clinical studies with a similar design, the only AEs assessed as drug-related occurring in ≥1% of patients treated with Singulair® and more frequently than in the placebo group were abdominal pain and headache. The differences in the incidence of these AEs between the two treatment groups were not statistically significant. With longer treatment (for 2 years), the AE profile did not change.

Adults and children aged 15 years and older with seasonal allergic rhinitis

Patients took Singulair® 1 time/day in the morning or evening, the drug was generally well tolerated, and the safety profile of the drug was similar to the safety profile of placebo. In placebo-controlled clinical trials, there were no AEs that were considered drug-related, occurring in ≥1% of patients treated with Singulair, or more frequently than in the placebo group. In the 4-week placebo-controlled clinical study, the safety profile of the drug was similar to that in the 2-week studies. The incidence of drowsiness when taking the drug in all studies was the same as when taking placebo.

Adults and children aged 15 years and older with year-round allergic rhinitis

Patients took Singulair® 1 time/day in the morning or evening; overall, the drug was well tolerated. The drug's safety profile was similar to that observed in patients with seasonal allergic rhinitis and placebo. In these clinical studies, there were no AEs that were considered drug-related, occurring in ≥1% of patients taking Singulair, or more frequently than in the placebo group. The incidence of drowsiness while taking the drug was the same as when taking placebo.

Generalized analysis of clinical trial results

Separately, a pooled analysis of 46 placebo-controlled clinical trials (35 studies in patients aged 15 years and older; 11 studies in patients aged 3 months to 14 years) was conducted to assess adverse behavioral effects. Among the 11,673 patients treated with Singulair® and 8,827 patients treated with placebo in these studies, the percentage of patients experiencing at least one adverse behavioral effect was 2.73% among patients receiving Singulair® and 2.27% among patients receiving placebo; the odds ratio was 1.12 (95% confidence interval [0.93, 1.36]).

AEs registered during post-registration use of the drug

Infectious and parasitic diseases: upper respiratory tract infections.

From the blood coagulation system: increased tendency to bleeding.

From the immune system: hypersensitivity reactions, incl. anaphylaxis; very rarely (<1/10,000) - eosinophilic infiltration of the liver.

From the psyche: agitation (including aggressive behavior or hostility), anxiety, depression, disorientation, impaired attention, pathological dreams, hallucinations, insomnia, memory impairment, psychomotor activity (including irritability, restlessness and tremor), somnambulism, suicidal thoughts thoughts and behavior (suicidality).

From the nervous system: dizziness, drowsiness, paresthesia/hypesthesia; very rarely (<1/10,000) - convulsions.

From the cardiovascular system: rapid heartbeat.

From the respiratory system: nosebleeds, pulmonary eosinophilia.

From the digestive system: diarrhea, dyspepsia, nausea, vomiting, pancreatitis.

From the liver and biliary tract: increased activity of ALT and AST in the blood; very rarely (<1/10,000) - hepatitis (including cholestatic, hepatocellular and mixed liver lesions).

From the skin and subcutaneous tissues: tendency to form hematomas, erythema nodosum, erythema multiforme, itching, rash.

Allergic reactions: angioedema, urticaria.

From the musculoskeletal system: arthralgia, myalgia, including muscle cramps.

From the urinary system: enuresis in children.

General reactions: asthenia (weakness)/fatigue, edema, pyrexia.

In general, Singulair® is well tolerated by patients. Side effects are usually mild and, as a rule, do not require discontinuation of the drug. The overall incidence of side effects when treated with Singulair® is comparable to their frequency when taking placebo.

Singulair®

Children aged 2 to 5 years with bronchial asthma

Clinical studies of the drug Singulair® involved 573 patients aged 2 to 5 years. In a 12-week placebo-controlled study in the Singulair treatment group, the only observed adverse effect assessed as drug-related in >1% of patients compared with placebo was thirst. The differences in the frequency of this side effect were not statistically significant.

Children aged 2 to 14 years with seasonal allergic rhinitis

A 2-week, placebo-controlled clinical trial using Singulair® for the treatment of seasonal allergic rhinitis included 280 patients aged 2 to 14 years. Patients took Singulair® 1 time/day in the evening and was generally well tolerated. The safety profile of the drug in children was similar to that of placebo. In this clinical study, there were no adverse reactions considered to be related to the drug that were observed in ≥1% of patients taking Singulair® and more often than in the group of patients taking placebo.

Side effects reported during post-marketing use of the drug

Infectious and parasitic diseases:

upper respiratory tract infections.

From the blood coagulation system:

increased tendency to bleed.

From the immune system:

hypersensitivity reactions, incl. anaphylaxis; very rarely (<1/10,000) - eosinophilic infiltration of the liver.

From the mental side:

agitation (including aggressive behavior or hostility), anxiety, depression, disorientation, impaired attention, pathological dreams, hallucinations, insomnia, memory impairment, psychomotor activity (including irritability, restlessness and tremors), somnambulism, suicidal thoughts and behavior ( suicidality).

From the nervous system:

dizziness, drowsiness, paresthesia/hypesthesia; very rarely (<1/10,000) - convulsions.

From the cardiovascular system:

cardiopalmus.

From the respiratory system:

nosebleeds.

From the digestive system:

diarrhea, dyspepsia, nausea, vomiting, pancreatitis.

From
the liver and biliary tract:
increased activity of ALT and AST in the blood; very rarely (<1/10,000) - hepatitis (including cholestatic, hepatocellular and mixed liver lesions).

For the skin and subcutaneous tissues:

tendency to form hematomas, erythema nodosum, erythema multiforme, itching, rash.

Allergic reactions:

angioedema, urticaria.

From the musculoskeletal system:

arthralgia, myalgia, including muscle cramps.

General reactions:

asthenia (weakness)/fatigue, edema, pyrexia.

Singulair tablets 5 mg No. 28

Side effects

In general, Singulair is well tolerated by patients. Side effects are usually mild and, as a rule, do not require discontinuation of the drug. The overall incidence of side effects when treated with Singulair is comparable to their frequency when taking placebo.

Children aged 2 to 5 years with bronchial asthma

Clinical studies of the drug Singulair involved 573 patients aged 2 to 5 years. In a 12-week placebo-controlled clinical trial, the only adverse event (AE) assessed as drug-related that occurred in >1% of Singulair-treated patients and more frequently than placebo-treated patients was thirst. The differences in the incidence of this AE between the two treatment groups were not statistically significant. A total of 426 patients aged 2 to 5 years were treated with Singulair for at least 3 months, 230 for 6 months or longer, and 63 patients for 12 months or longer. With longer treatment, the AE profile did not change.

Children aged 2 to 14 years with seasonal allergic rhinitis

A 2-week, placebo-controlled clinical trial using Singulair for the treatment of seasonal allergic rhinitis included 280 patients aged 2 to 14 years. Patients took Singulair 1 time/day in the evening and was generally well tolerated. The safety profile of the drug in children was similar to that of placebo. In this clinical study, there were no AEs that were considered drug-related, occurred in ≥1% of patients treated with Singulair, or occurred more frequently than in patients treated with placebo.

Children aged 6 to 14 years with bronchial asthma

The safety profile of the drug in children was generally similar to the safety profile in adults and comparable to the safety profile of placebo. In an 8-week placebo-controlled clinical trial, the only AE assessed as drug-related occurring in >1% of Singulair-treated patients and more frequently than in placebo-treated patients was headache. The difference in frequency between the two treatment groups was not statistically significant. In studies assessing the growth rate, the safety profile in patients of this age group corresponded to the previously described safety profile of the drug Singulair. With longer treatment (more than 6 months), the AE profile did not change.

Adults and children aged 15 years and older with asthma

In two 12-week placebo-controlled clinical trials with a similar design, the only side effects assessed as drug-related that occurred in ≥1% of patients taking Singulair and more frequently than in the placebo group were abdominal pain and headache. The differences in the incidence of these side effects between the two treatment groups were not statistically significant. With longer treatment (2 years), the side effect profile did not change.

Adults and children aged 15 years and older with seasonal allergic rhinitis

Patients took Singulair 1 time/day in the morning or evening; in general, the drug was well tolerated. The safety profile of the drug was similar to that of placebo. In placebo-controlled clinical trials, there were no AEs considered to be drug-related that occurred in ≥1% of patients treated with Singulair or more frequently than in patients treated with placebo. In the 4-week placebo-controlled clinical study, the safety profile of the drug was similar to that in the 2-week studies. The incidence of drowsiness with the drug in all studies was the same as with placebo.

Adults and children aged 15 years and older with year-round allergic rhinitis

Patients took Singulair 1 time/day in the evening; in general, the drug was well tolerated. The drug's safety profile was similar to that observed in patients with seasonal allergic rhinitis and placebo. In these clinical studies, there were no AEs that were considered drug-related, occurring in ≥1% of patients treated with Singulair, or more frequently than in patients receiving placebo. The incidence of drowsiness while taking the drug was the same as when taking placebo.

Generalized analysis of clinical trial results

A pooled analysis was conducted of 41 placebo-controlled clinical trials (35 studies involving patients aged 15 years or older, 6 studies involving patients aged 6 to 14 years) using validated methods for assessing suicidality. Among the 9,929 patients receiving Singulair and the 7,780 patients receiving placebo in these studies, 1 patient was identified as suicidal in the Singulair group. There were no suicides, suicide attempts, or other preparatory acts indicative of suicidal behavior in any of the treatment groups. Separately, a pooled analysis of 46 placebo-controlled clinical trials (35 studies in patients aged 15 years and older; 11 studies in patients aged 3 months to 14 years) was conducted to assess adverse behavioral effects. Among the 11,673 patients treated with Singulair in these studies and the 8,827 patients treated with placebo, the percentage of patients experiencing at least one adverse behavioral effect was 2.73% among patients treated with Singulair® and 2.27% among patients treated with placebo; the odds ratio was 1.12 (95% confidence interval [0.93, 1.36]).

AEs registered during post-registration use of the drug

Infectious and parasitic diseases: upper respiratory tract infections.
From the blood coagulation system: increased tendency to bleeding.
From the immune system: hypersensitivity reactions, incl. anaphylaxis; very rarely (
From the psyche: agitation (including aggressive behavior or hostility), anxiety, depression, disorientation, impaired attention, pathological dreams, hallucinations, insomnia, memory impairment, psychomotor activity (including irritability, restlessness and tremor), somnambulism, suicidal thoughts thoughts and behavior (suicidality).
From the nervous system: dizziness, drowsiness, paresthesia/hypesthesia; very rarely (
From the cardiovascular system: rapid heartbeat.
From the respiratory system: nosebleeds, pulmonary eosinophilia.
From the digestive system: diarrhea, dyspepsia, nausea, vomiting, pancreatitis.
From the liver and biliary tract: increased activity of ALT and AST in the blood; very rarely (
From the skin and subcutaneous tissues: tendency to form hematomas, erythema nodosum, erythema multiforme, itching, rash.
Allergic reactions: angioedema, urticaria.
From the musculoskeletal system: arthralgia, myalgia, including muscle cramps.
From the urinary system: enuresis in children.
General reactions: asthenia (weakness)/fatigue, edema, pyrexia.