Almont, 10 mg 28 pcs.

Pharmacotherapeutic group: Anti-inflammatory antibronchoconstrictor agent – leukotriene receptor blocker

ATCode: R03DC03

Pharmacological properties.

Indications

Active ingredient

Composition

1 tablet contains:

Active substance

Montelukast (as montelukast sodium)

10.00 mg

(10.40 mg)

Auxiliary substances

kernel

Microcrystalline cellulose, type 102

89.30 mg

Hyprolose

4.00 mg

Sodium croscarmellose

6.00 mg

0.026 mg

0.003 mg

Total weight of the tablet

How to take, the dosage

To be taken by mouth once a day regardless of meals.

To treat bronchial asthma Almont should be taken in the evening. To treat allergic rhinitis, Almont can be taken at any time of the day. Patients with bronchial asthma and allergic rhinitis should take one tablet of Almont once a day in the evening.

Adults and children 15 years of age and older: one tablet 10 mg daily.

General recommendations

The therapeutic effect of montelukast on symptoms reflective of bronchial asthma develops within the first day. The patient should continue to take montelukast both during the period of achieving control of bronchial asthma symptoms and during periods of exacerbation of bronchial asthma.

In elderly patients, patients with renal impairment, and patients with mild to moderate impairment of liver function, as well as depending on gender, no special dose adjustment is required.

Prescribing montelukast concomitantly with other bronchial asthma treatment

Almont may be added to patient treatment with bronchodilators, inhaled glucocorticosteroids.

Interaction

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

The AUC value of montelukast is decreased by about 40% when phenobarbital is taken at the same time, but this does not require changes in the dosing regimen of Almont.

In in vitro studies, montelukast was found to inhibit the CYP2C8 isoenzyme of the cytochrome P450 system, but an in vivo drug interaction study of montelukast and rosiglitazone (metabolized with the CYP2C8 isoenzyme of the cytochrome P450 system) showed that montelukast did not inhibit the CYP2C8 isoenzyme. Thus, no effect of montelukast on the CYP2C8-mediated isoenzyme metabolism of drugs (e.g., paclitaxel, rosiglitazone, repaglinide) is expected.

In vitro studies have shown that montelukast is a substrate of the CYP2C8, 2C9 and WA4 isoenzymes. Data from a clinical study of drug interaction between montelukast and gemfibrozil (an inhibitor of both CYP2C8 and 2C9 isoenzymes) demonstrate that gemfibrozil increases the systemic effect of montelukast by 4.4-fold. Co-administration of itraconazole, a potent CYP3A4 isoenzyme inhibitor, together with gemfibrozil and montelukast did not result in an additional increase in the effect of systemic exposure to montelukast. The effect of gemfibrozil on the systemic effects of montelukast cannot be considered clinically significant based on safety data on the use of montelukast at doses higher than the approved dose of 10 mg for adult patients (no clinically significant adverse effects were observed when used at a dose of 200 mg/day for adult patients for 22 weeks and up to 900 mg/day for approximately one week). Thus, no dose adjustment of montelukast is required when coadministered with gemfibrozil. According to the results of in vitro studies, no clinically significant drug interactions with other known CYP2C8 isoenzyme inhibitors (e.g., trimethoprim) are expected. In addition, co-administration of montelukast with itraconazole alone did not significantly increase the systemic effect of montelukast.

Combined treatment with bronchodilators

Almont is a reasonable adjunct to bronchodilator monotherapy if bronchodilators do not adequately control bronchial asthma. Once treatment with Montelukast has achieved therapeutic benefit, a gradual reduction in the dose of bronchodilators may be initiated.

Combined treatment with inhaled glucocorticosteroids

The treatment with Almont provides additional therapeutic benefit to patients using inhaled glucocorticosteroids. Once stabilization has been achieved, a gradual reduction in the dose of the glucocorticosteroid under medical supervision may begin. Complete withdrawal of inhaled glucocorticosteroids is acceptable in some cases, but abrupt replacement of inhaled glucocorticosteroids with montelukast is not recommended.

Special Instructions

The oral efficacy of Almont in the treatment of acute attacks of bronchial asthma has not been established; therefore, Almont tablets are not recommended for the treatment of acute attacks of bronchial asthma. Patients should be instructed to always carry emergency medications for bronchial asthma attacks (short-acting inhaled beta2-agonists).

Almont should not be discontinued during an asthma exacerbation and when emergency medicine (short-acting inhaled beta2-agonists) should be used.

Patients with confirmed allergies to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs) should not take these medications during treatment with Almont because Almont, while improving respiratory function in allergic bronchial asthma patients, cannot completely prevent NSAID-induced bronchoconstriction. The dose of inhaled glucocorticosteroids used concomitantly with Almont can be gradually reduced under medical supervision, but abrupt replacement of inhaled or oral glucocorticosteroids with Almont should not be performed. Neuropsychiatric disorders have been described in patients who have taken montelukast. Given that these symptoms may have been caused by other factors, it is unknown whether they are related to taking Almont. The physician needs to discuss these NNIs with patients and/or their parents/guardians. Patients and/or their parents/guardians should be advised that if such symptoms occur, it is important to inform the treating physician. In rare cases, patients receiving anti-asthmatic drugs, including leukotriene receptor antagonists, have experienced one or more of the following: eosinophilia, skin rash, worsening of pulmonary symptoms, cardiac complications and/or neuropathy, sometimes diagnosed as Churg-Strauss syndrome, systemic eosinophilic vasculitis. These cases have sometimes been associated with dose reductions or withdrawal of oral glucocorticosteroid therapy. Although a causal relationship between these NIs and therapy with leukotriene receptor antagonists has not been established, caution should be exercised in patients taking Almonte and appropriate clinical monitoring should be performed in these patients.

Almont contains lactose monohydrate. Patients with a rare form of hereditary galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption should not take Almont.

Application in elderly patients

There are no differences in the age-related efficacy and safety profiles of montelukast.

Influence on ability to drive and operate machinery

Montelukast administration is not expected to affect the ability to drive and operate machinery. However, individual reactions to the drug may vary. Some side effects (such as dizziness and somnolence), which have been reported to occur very rarely with montelukast, may affect the ability of some patients to drive vehicles and operate machinery. If these adverse events occur, you should refrain from performing these activities.

Synopsis

Contraindications

Side effects

In general, montelukast is well tolerated. Side effects are usually mild and usually do not require withdrawal of the drug. The overall incidence of side effects during treatment with the drug is comparable to their incidence when taking placebo.

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 adverse events (AEs) evaluated as related to taking the drug observed in >1% of patients taking montelukast and more frequently than in the placebo group were abdominal pain and headache. Differences in the frequency of these NIHs between the two treatment groups were statistically insignificant. The NIH profile did not change with longer treatment (for 2 years).

Adults and children 15 years and older with seasonal allergic rhinitis

Montelukast was taken by patients once daily in the morning or evening and was generally well tolerated; 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 drug-related, observed in >1% of patients taking montelukast and more frequently than in the placebo-treated group of patients. 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 and older with year-round allergic rhinitis

Montelukast was taken by patients once daily and was generally 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 drug administration, observed in > 1% of patients taking montelukast and more frequently than in the group of patients taking placebo. The incidence of drowsiness when taking the drug was the same as when taking placebo.

Cumulative analysis of clinical trial results

A generalized analysis of 41 placebo-controlled clinical trials (35 studies involving patients aged 15 years and older) using validated suicide assessment methods was conducted. Among the 9929 patients taking montelukast and the 7780 patients taking placebo in these studies, one patient with suicidal tendencies was identified in the patient group taking montelukast. There were no suicides, suicide attempts or other preparations indicating 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 and 11 studies involving patients aged 3 months to 14 years) was conducted to assess adverse behavioral effects (ABEs). Among the 11673 patients who took montelukast in these studies and the 8827 patients who took 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; 1.361]).

The most common adverse events associated with drug use were headache and abdominal pain (frequent).

The incidence of adverse events is rated according to the following: very frequently (≥1/10), frequently (≥1/100 to < 1/10), infrequently (≥1/1000 to < 1/100), rarely (≥1/10000 to < 1/1000), very rarely (< 1/10000), unknown (cannot be estimated from available data).

The following adverse reactions have been reported during post-registration use of montelukast:

Infectious and parasitic diseases:

Very common: Upper respiratory tract infections.

Disorders of the blood and lymphatic system:

Rarely: increased tendency to bleeding.

Very rare: thrombocytopenia.

Immune system disorders:

Infrequent: hypersensitivity reactions, including anaphylaxis.

Very rare: eosinophilic infiltration of the liver.

Mental disorders:

Infrequent: sleep disturbances, including nightmares, insomnia, somnambulism, irritability, restlessness, agitation, including aggressive behavior or hostility, depression.

Very rare: Hallucinations, disorientation, suicidal thinking and behavior (suicidality), dysphemia.

Nervous system disorders:

Infrequent: dizziness, somnolence, paresthesia/hypesthesia, seizures.

Cardiac disorders:

Rarely: palpitations.

Disorders of the respiratory system, thorax and mediastinum:

Not common: nose bleeding.

Very rare: pulmonary eosinophilia.

Gastrointestinal tract disorders:

Often: diarrhea, nausea, vomiting.

Infrequent: dry mouth, dyspepsia.

Liver and biliary tract disorders:

Often: increased alanine aminotransferase and aspartate aminotransferase activity.

Very rare: hepatitis (including cholestatic, hepatocellular and mixed liver lesions).

Skin and subcutaneous tissue disorders:

Often: rash.

Infrequent: susceptibility to bruising, urticaria, itching.

Rare: angioedema.

very rarely: erythema nodosum, erythema multiforme.

Muscular and connective tissue disorders:

Infrequent: arthralgia, myalgia, including muscle cramps.

Renal and urinary tract disorders:

Not common: enuresis in children.

General disorders and disorders at the site of administration:

Often: pyrexia.

Not frequent: asthenia/fatigue, edema.

Overdose

Pregnancy use

Similarities