Singular,10 mg 28 pcs

Bronchial Asthma, BronchospasmProphylaxis and long-term treatment of bronchial asthma in adults and children 6 years and older, including:

• Prevention of daytime and nighttime symptoms of the disease;
• Treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid;
• Prevention of exercise-induced bronchospasm.

Cure daytime and nighttime symptoms of seasonal and/or year-round allergic rhinitis (in adults and children aged 6 years and older).

Active ingredient

Composition

1 tablet contains:

The main substance:

Montelukast sodium 10.4 mg (which corresponds to the content of montelukast 10 mg).

Auxiliary substances:

Hyprolose (hydroxypropyl cellulose) – 4 mg;

Microcrystalline cellulose – 89.3 mg;

Lactose monohydrate – 89.3 mg;

Sodium croscarmellose – 6 mg;

Magnesium stearate – 1 mg.

The composition of the shell:

Hyprolose (hydroxypropyl cellulose) – 1.73 mg;

Hypromellose (methylhydroxypropylcellulose) – 1.73 mg;

Titanium dioxide (E171) – 1.5 mg;

Red iron oxide (E172) – 0.004 mg;

Iron oxide yellow (E172) – 0.036 mg;

Carnauba wax – 0.006 mg.

How to take, the dosage

Interaction

Singulair may be administered together with other drugs traditionally used for the prevention and long-term treatment of bronchial asthma and/or treatment of allergic rhinitis. Montelukast at the recommended therapeutic dose had no clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinylestradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.

The AUC of Montelukast is decreased by about 40% when concomitantly taking phenobarbital, but this does not require changes in the dosing regimen of Singulair.

In in vitro studies, montelukast was found to inhibit the CYP2C8 isoenzyme. However, in in vivo drug interaction studies of montelukast and rosiglitazone (metabolized with the participation of CYP2C8 isoenzyme) have not been confirmed inhibition of CYP2C8 isoenzyme by montelukast. Therefore, in clinical practice the effect of montelukast on CYP2C8-mediated metabolism of several drugs, including paclitaxel, rosiglitazone, repaglinide is not expected.

In vitro studies have shown that montelukast is a substrate of CYP2C8, 2C9 and 3A4. Data from a clinical study of drug interaction between montelukast and gemfibrozil (an inhibitor of both CYP2C8 and 2C9) demonstrate that gemfibrozil increases the systemic effect of montelukast 4.4-fold. Co-administration of itraconazole, a potent CYP3A4 inhibitor, together with gemfibrozil and montelukast did not result in an additional increase in the systemic effect of montelukast. The effect of gemfibrozil on the systemic effects of montelukast cannot be considered clinically significant based on safety data when used at doses greater than the approved dose of 10 mg for adult patients (e.g., 200 mg/day for adult patients for 22 weeks and up to 900 mg/day for patients taking the drug for approximately one week, no clinically significant adverse effects were observed).

Hence, no dose adjustment of montelukast is required when co-administered with gemfibrozil. According to the results of in vitro studies, no clinically significant drug interactions with other known CYP2C8 inhibitors (e.g., with trimethoprim) are expected. In addition, co-administration of montelukast with itraconazole alone did not lead to a significant increase in the effect of systemic effects of montelukast.

Combined treatment with bronchodilators

Singulair is a reasonable adjunct to monotherapy with bronchodilators if the latter do not adequately control bronchial asthma. Once therapeutic benefit from treatment with Singulair has been achieved, a gradual reduction in the dose of bronchodilators may begin.

Combined treatment with inhaled GCS

The treatment with Singulair provides additional therapeutic benefit in patients using inhaled GCS. Once the condition has been stabilized, a gradual reduction in the dose of GCS under medical supervision may be started. Complete abolition of inhaled GCS is acceptable in some cases, but abrupt replacement of inhaled corticosteroids by Singulair is not recommended.

Directions for use

Special Instructions

Contraindications

Side effects

In general, Singulair is well tolerated by patients. Side effects are usually mild and usually do not require withdrawal. The overall incidence of side effects when treated with Singular is comparable to that of placebo.

Children aged 2 to 5 years with bronchial asthma

The clinical trials of Singulair enrolled 573 patients aged 2 to 5 years. In a 12-week placebo-controlled clinical trial, the only adverse event (AE) evaluated as drug-related was thirst, observed in >1% of patients taking Singulair and more frequently than in the placebo group. Differences in the frequency of this NIH between the two treatment groups were statistically insignificant.
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. There was no change in the NJ profile with longer treatment.

Children aged 2 to 14 years with seasonal allergic rhinitis

A 280 patients aged 2 to 14 years participated in a 2-week placebo-controlled clinical trial using Singulair for the treatment of seasonal allergic rhinitis. Patients took Singulair once daily in the evening and were generally well tolerated. The safety profile of the drug in children was similar to that of placebo. In this clinical trial, there were no reported NTs that were considered to be drug-related, observed in ≥1% of patients taking Singulair and more frequently 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 that of placebo.
In an 8-week placebo-controlled clinical trial, the only NIH assessed as related to drug ingestion observed in >1% of patients taking Singulair and more frequently than in the placebo-treated group was headache. The difference in frequency between the two treatment groups was statistically insignificant.
In growth rate studies, the safety profile of patients in this age group was consistent with the previously described safety profile of Singulair.There was no change in the NOH profile with longer treatment (>6 months).

Adults and children 15 years of age and older with bronchial asthma

. In two 12-week placebo-controlled clinical trials with a similar design, the only side effects evaluated as related to taking the drug observed in ≥1% of patients taking Singulair and more frequently than in the placebo group were abdominal pain and headache. Differences in the frequency of these side effects between the two treatment groups were statistically insignificant. The profile of side effects did not change with longer treatment (for 2 years).

Adults and children 15 years of age and older with seasonal allergic rhinitis

Patients took Singulair once daily in the morning or evening and generally tolerated the drug well. The safety profile of the drug was similar to that of placebo. In placebo-controlled clinical trials, there were no reported NTs that were considered to be related to taking the drug, observed in ≥1% of patients receiving Singulair and more frequently than in the group of patients taking placebo. In a 4-week placebo-controlled clinical trial, the safety profile of the drug was similar to that in 2-week trials. The incidence of somnolence when taking the drug was similar to that of placebo in all studies.

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

Patients took Singulair once daily in the evening and overall, the drug was well tolerated. The safety profile of the drug was similar to the safety profile observed in patients with seasonal allergic rhinitis and when taking placebo. In these clinical trials, there were no reported NTs that were considered to be related to the drug administration, observed in ≥1% of patients receiving Singulair® and more frequently than in the group of patients receiving placebo. The incidence of drowsiness when taking the drug was the same as when receiving placebo.

Summary analysis of clinical trial results

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

NOs reported during post-registration use of the drug

Overdose

Pregnancy use

Similarities