Singulair (montelukast). Composition, mechanism of action, release forms. Analogues. Indications, contraindications, instructions for use. Side effects, prices and reviews. Release form and packaging. Latin name of the substance Montelukast

1 coated tablet contains:

active ingredient: montelukast sodium 10.4 mg (equivalent to montelukast 10 mg); excipients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate.

Tablet film coating composition: hydroxypropyl cellulose,

methylhydroxypropylcellulose, titanium dioxide E 171, iron dyes red oxide and iron oxide yellow E 172, carnauba wax.

pharmachologic effect

Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent anti-inflammatory eicosanoids released from various cells, including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors (CysLT). CysLT type-1 (CysLT 1) receptors are found in the airways (including smooth muscle cells and respiratory tract macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs are associated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include bronchospasm, mucosal secretion, vascular permeability, and recruitment of eosinophils. In allergic rhinitis, CysLTs are released from the nasal mucosa after exposure to the allergen during the early and late phase of the reaction, and are also associated with symptoms of allergic rhinitis. An intranasal test with CysLTs demonstrated an increase in nasal airway resistance and symptoms of nasal congestion.

Montelukast is an active substance that, when administered orally, binds with high affinity and selectivity to CysLTi receptors. In clinical studies, montelukast inhibited bronchospasm induced by inhaled LTD4 at a dose of 5 mg. Bronchodilation occurred within 2 hours after oral administration. The bronchodilatory effect caused by β-agonists was complemented by the effect of montelukast. Treatment with montelukast inhibits both the early and late phases of bronchoconstriction due to antigenic stimulation. Montelukast, compared with placebo, reduces the level of eosinophils in the peripheral blood in adults and children. In a separate study, treatment with montelukast significantly reduced the number of eosinophils in the airways (determined by sputum analysis) and in peripheral blood, and improved clinical control of asthma.

In adult studies, montelukast 10 mg once daily, compared with placebo, showed a significant improvement in morning FEV1 (10.4% change from baseline compared to 2.7%), morning maximum expiratory volume flow ( MOV) (24.5 L/min change from baseline vs. 3.3 L/min) and a significant decrease in total β-agonist use (change from baseline: -26.1% vs. -4.6%) . Relief of daytime and nighttime asthma symptoms was reported by patients to be significantly better than placebo.

Studies in adults have demonstrated the ability of montelukast to complement the clinical effect of inhaled corticosteroids (% change from baseline for inhaled beclomethasone in combination with montelukast compared with beclomethasone, respectively, for FEV1: 5.43% vs. 1.04%; use P -agonists: -8.70% compared to 2.64%). Compared to inhaled beclomethasone (200 mcg twice daily, spacer device), montelukast showed a faster initial response, although during the 12-week study, beclomethasone resulted in a greater mean therapeutic effect (% change from baseline for montelukast compared to beclomethasone , respectively, for FEV1: 7.49% compared with 13.3%, the use of a P-agonist -28.28% compared with -43.89%). However, when compared with beclomethasone, more patients treated with montelukast achieved a similar clinical response (i.e., 50% of patients treated with beclomethasone achieved an improvement in FEV1 of approximately 11% or more compared to baseline, while while 42% of patients treated with montelukast achieved the same response).

A clinical study was conducted to evaluate the use of montelukast for the symptomatic treatment of seasonal allergic rhinitis in patients aged 15 years and older with asthma and concomitant seasonal allergic rhinitis. In this study, montelukast (10 mg tablets, once daily) demonstrated a statistically significant improvement in daily rhinitis symptom scores compared with placebo. The 24-hour rhinitis symptom score is the average of the daytime (mean values ​​for nasal congestion, rhinorrhea, sneezing, nasal itching) and nighttime (mean values ​​for nasal congestion on waking, difficulty falling asleep, nocturnal awakenings) rhinitis symptom scores. Patients' and physicians' overall assessments of drug efficacy in allergic rhinitis were statistically better than placebo. Evaluation of efficacy in asthma was not the primary goal of this study.

In an 8-week study in children aged 6 to 14 years, montelukast 5 mg once daily compared to placebo significantly improved respiratory function (FEV1 8.71% vs. 4.16% change from baseline). indicator; change from baseline in morning MORV of 27.9 l/min compared to 17.8 l/min) and a decrease in the frequency of use of β-agonists "on demand" (change from baseline: - 11.7% compared with + 8.2%.

A significant decrease in the score regarding exercise-related bronchospasm (EIB) was observed at week 12 of the study in adults (maximum decrease in FEV1 22.33% for montelukast compared with 32.40% for placebo; time to recovery within 5% from baseline FEV1 44.22 minutes compared to 60.64 minutes). This effect was consistent throughout the 12-week study period. A decrease in ERF has also been demonstrated in a short study in children aged 6 to 14 years (maximum decrease in FEV1 18.27% according to
compared to 26.11%; time to recovery within 5% of baseline FEV1 17.76 minutes compared to 27.98 minutes). The effect in both studies was demonstrated by the end of the drug dosing interval (1 time per day).

In patients with aspirin sensitivity treated with both inhaled and/or oral corticosteroids, treatment with montelukast resulted in a significant improvement in asthma control compared to placebo (change from baseline in FEV1 8.55% versus -1.74% and change from baseline in a decrease in total use (3-agonist -27.78% compared to 2.09%).

Pharmacokinetics

Suction

Montelukast is rapidly absorbed after oral administration. For film-coated tablets, 10 mg each, the average maximum plasma concentration (Cmax) was reached 3 hours (Tmax) after the drug was used by adults on an empty stomach. Oral bioavailability averages 64%. Regular food intake did not affect oral bioavailability and Cmax. Safety and efficacy have been confirmed in clinical studies with the use of film-coated tablets, 10 mg, regardless of the meal. For chewable tablets, 5 mg, Cmax was reached 2 hours after ingestion on an empty stomach in adults. Mean oral bioavailability was 73% and decreased to 63% when taken with a standard meal.

Distribution

Montelukast is more than 99% bound to plasma proteins. The volume of distribution of montelukast at steady state averages 8-11 liters. Studies in rats using radiolabeled montelukast indicate minimal distribution when penetrating the blood-brain barrier. In addition, radiolabeled concentrations 24 hours post-dose were minimal in all other tissues.

Metabolism

Montelukast is actively metabolized. In studies at therapeutic doses, plasma concentrations of montelukast metabolites are below the detection limit at steady state in adults and children.

In vitro studies on human liver microsomes indicate that cytochromes P450 3A4, 2A6, 2C8 and 2C9 are involved in the metabolism of montelukast. According to the results of additional studies of human liver microsomes in vitro, therapeutic concentrations of montelukast in blood plasma do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19 or 2D6. The role of metabolites in the therapeutic effect of montelukast is minimal.

breeding

Plasma clearance of montelukast in healthy adults averages 45 ml/min. After oral administration of radiolabeled montelukast 86%

radioactivity is excreted within 5 days with feces and<0,2 % -с мочой. Учитывая биодоступность монтелукаста после перорального применения, это указывает на то, что монтелукаст и его метаболиты выводятся, практически полностью, с желчью.

Features of pharmacokinetics in different groups of patients

There is no need for dose adjustment in elderly patients or in mild to moderate hepatic impairment. No studies have been conducted in patients with impaired renal function. Since montelukast and its metabolites are excreted in the bile, it is not expected that there will be a need for dose adjustment of montelukast in patients with impaired renal function. There are no data on the pharmacokinetics of montelukast in patients with severe hepatic impairment (>9 on the Child-Pugh scale).

When using high doses of montelukast (20 and 60 times the recommended dose for adults), a decrease in theophylline concentration in blood plasma was observed. This effect was not observed when using the drug at the recommended dose of 10 mg 1 time per day.

Indications for use

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Pregnancy and lactation

Pregnancy. Animal studies do not demonstrate harmful effects in terms of effects on pregnancy or embryonic/fetal development. The limited information available from the pregnancy database does not indicate a causal relationship between the use of SINGULAIR and the occurrence of malformations (such as limb defects), which have rarely been reported in worldwide post-marketing experience.

SINGULAIR should only be used during pregnancy if absolutely necessary.

Lactation. In rat studies, montelukast has been shown to pass into milk.

It is not known whether montelukast passes into breast milk in women.

SINGULAIR may only be used during breastfeeding if absolutely necessary.

Dosage and administration

General recommendations. The therapeutic effect of the drug SINGULAIR with a change in the parameters of the course of bronchial asthma develops within 1 day. SINGULAIR can be taken with or without food. Patients should be advised that they need to take SINGULAIR even if their asthma is under control and during periods of worsening asthma. SINGULAIR should not be taken concomitantly with other medicines containing the same active ingredient, montelukast.

There is no need for dose adjustment for elderly patients, for patients with impaired renal function or with mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage for men and women is the same.

Treatment with SINGULAIR in relation to other asthma treatments SINGULAIR can be added to a patient's existing treatment. inhaled corticosteroids. Treatment with SINGULAIR can be used as add-on therapy in patients in whom the use of inhaled corticosteroids and, if necessary, short-acting β-agonists does not provide sufficient clinical control of asthma. SINGULAIR should not replace inhaled corticosteroids.

For children aged 6 to 14 years, chewable tablets are available at a dosage of 5 mg.

Side effect

Montelukast has been used in clinical trials:

Film-coated tablets (10 mg each) - in approximately 4,000 adult patients with asthma aged 15 years and older;

Film-coated tablets (10 mg each) - in approximately 400 patients with asthma and seasonal allergic rhinitis aged 15 years and older;

Chewable tablets (5 mg) - Approximately 1,750 children aged 6 to 14 years.

In clinical studies, the following adverse reactions were reported frequently (>1/100 to<1/10) у пациентов с астмой, получавших лечение монтелукастом, а также с большей частотой, чем у пациентов, получавших лечение плацебо.

Post-marketing experience with the drug

The following adverse reactions have been reported during post-marketing use; Reactions are listed according to organ system classes and specific adverse reaction terms. Frequency determined from relevant clinical studies.

Infections and invasions: very often - infections of the upper respiratory tract. Blood and lymphatic system disorders: rarely - increased bleeding tendency.

Immune system disorders: infrequently - hypersensitivity reactions, including anaphylaxis; very rarely - eosinophilic infiltration of the liver.

Mental disorders: infrequently - pathological dreams, including nightmares, insomnia, somnambulism, agitation, agitation, including aggressive behavior or hostility, depression, psychomotor hyperactivity (including irritability, anxiety and tremor); rarely - memory impairment, impaired attention; very rarely - hallucinations, disorientation, suicidal thoughts and behavior (suicidality).

Nervous system disorders: infrequently - dizziness, drowsiness, paresthesia / hypoesthesia, convulsions.

Cardiac disorders: rarely - palpitations.

Respiratory system, chest and mediastinal disorders: infrequently - epistaxis; very rarely - Churg-Strauss syndrome, pulmonary eosinophilia.

Gastrointestinal disorders: often - diarrhea, nausea, vomiting; infrequently - dry mouth, dyspepsia.

On the part of the hepatobiliary system: often - increased levels of transaminases (AJIT, ACT) in the blood serum; very rarely - hepatitis (including cholestatic, hepatocellular, and mixed liver damage).

Skin and subcutaneous tissue disorders: often - rash; infrequently - bruising, urticaria, itching; rarely - angioedema; very rarely - erythema nodosum, erythema multiforme.

Musculoskeletal and connective tissue disorders: infrequently - arthralgia, myalgia, including muscle spasms.

Violations of the general condition and associated with the way the drug is used: often - pyrexia; infrequently - asthenia / fatigue, malaise, edema.

Overdose

for 22 weeks, and in short studies - at doses up to 900 mg / day for about 1 week, which was not accompanied by clinically significant adverse reactions. There have been reports of acute overdose of montelukast during post-marketing use and clinical studies. These include reports of adults and children using doses of 1,000 mg (approximately 61 mg/kg in a 42-month-old child). The observed clinical and laboratory changes were comparable to the safety profile in adults and children. In most cases of overdose, adverse reactions did not occur. The most commonly reported adverse reactions were comparable to the safety profile of montelukast and included abdominal pain, drowsiness, thirst, headache, vomiting, and psychomotor hyperactivity.

It is not known whether montelukast is excreted from the body during peritoneal dialysis or hemodialysis.

Interaction with other drugs

Montelukast can be used with other drugs that are commonly used for the prevention and long-term treatment of asthma. In interaction studies with other drugs, the recommended clinical dose of montelukast did not have a clinically significant effect on the pharmacokinetics of drugs such as theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / norethindrone 35/1), terfenadine, digoxin and warfarin.

The area under the plasma concentration curve (AUC) of montelukast decreased by approximately 40% in patients who used phenobarbital concomitantly. Because montelukast is metabolized by CYP 3A4, 2C8, and 2C9, montelukast should be administered with caution, especially to children, concomitantly with CYP 3A4, 2C8, and 2C9 inducers such as phenytoin, phenobarbital, and rifampicin.

In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8. However, data from clinical drug interaction studies investigating montelukast and rosiglitazone (a marker substrate representative of drugs metabolized predominantly by CYP 2C8) have demonstrated that montelukast does not inhibit CYP 2C8 in vivo. Therefore, montelukast is not expected to significantly affect the metabolism of drugs metabolized by this enzyme (eg, paclitaxel, rosiglitazone, and repaglinide).

In vitro studies have shown that montelukast is a substrate of CYP 2C8, 2C9 and 3A4. Data from clinical drug interaction studies that studied the use of montelukast and gemfibrozil (CYP 2C8 and 2C9 inhibitors) demonstrated that gemfibrozil increased the systemic exposure of montelukast by 4.4 times. With the combined use of gemfibrozole and other potential inhibitors of CYP 2C8, dose adjustment of montelukast is not required, but the possibility of an increase in adverse reactions should be taken into account.

Based on in vitro data, no clinically important interactions are expected with less potent inhibitors of CYP 2C8 (eg, trimethoprim). With the simultaneous use of montelukast with itraconazole (a potent inhibitor of CYP 3A4), there is no significant increase in the systemic exposure of montelukast.

Application features

EFFECT ON THE ABILITY TO DRIVE AND OTHER MECHANISMS

Montelukast is not expected to affect the patient's ability to drive or use machines. However, in rare cases, drowsiness or dizziness has been reported.

Precautionary measures

Montelukast should not abruptly replace inhaled or oral corticosteroids. There are no data to support that the dose of oral corticosteroids can be reduced while using montelukast.

In rare cases, patients treated with anti-asthma drugs, including montelukast, may experience systemic eosinophilia, sometimes with clinical manifestations of vasculitis characteristic of Churg-Strauss syndrome (a condition in which systemic corticosteroids are often treated). These cases have sometimes been associated with dose reduction or withdrawal of an oral corticosteroid. Although a causal relationship with the use of leukotriene receptor antagonists has not been established, clinicians should be aware of the possibility of patients developing eosinophilia, vascular rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy. Patients who develop these symptoms should be re-examined and their treatment regimen reviewed.

Patients who develop these symptoms should be re-examined and their treatment regimen reviewed.

In patients with aspirin-sensitive asthma, treatment with montelukast does not alter the need for aspirin or other non-steroidal anti-inflammatory drugs.

Patients with rare congenital diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use this drug.

Release form

7 or 14 coated tablets, 10 mg each, in a blister.

1 or 2 blisters in a carton box with instructions for use.

Storage conditions

Store in the original packaging at a temperature not exceeding 30 ° C in a place protected from moisture and light.

Keep out of the reach of children.

"Montelukast" - reviews of the drug can be easily found on thematic forums and sites dedicated to the problem of bronchial asthma - this is a classic leukotriene D4 receptor antagonist. The drug is widely used both in basic therapy and in order to prevent characteristic attacks of the disease. The balanced composition allows the drug to be used to treat patients of almost any age category.

Release form

There are a lot of reasons why Montelukast receives mostly positive reviews. However, the first thing that catches your eye is, of course, the range of tablets produced under this trade name.

At the moment, three technological matrices dominate. We are talking about standard film-coated pills (1 unit contains 10 mg of the active substance) and their chewable counterparts (4 mg and 5 mg of the reagent, respectively). The basic basis in both cases is sodium montelukast, but the composition of the auxiliary components is somewhat different - mannitol and aspartame are not present in samples intended for immediate ingestion when consumed.

In the comments, the question often pops up about fakes that now and then appear in pharmacy chains. You can protect yourself from counterfeit products if you pay attention to the appearance of the pharmacological product in a timely manner.

So, in particular, a chewable pill with 4 milligrams of the active ingredient has an oval shape and a pink tint (the description corresponds to tablets with a cherry flavor; differences are acceptable when using other flavors), as well as marking in the form of the number "4" on one of the sides. Analogues, in which the main active ingredient is 1 mg more, are round and marked with a “five”. Pills with a shell geometrically resemble a rectangle; they are beige and numbered "10".

Pharmacological affiliation

"Montelukast" (reviews describing situations where the reagent provoked complex allergies are extremely rare) is a typical representative of the group of anti-bronchoconstrictor drugs. The algorithm of its action allows us to speak of a “close relationship” with intermediates / prostaglandins and thromboxanes.

The main function of the drug is to block the cysteinyl leukotriene "sensors" of the respiratory system. It is these receptors that maintain the high activity of the bronchi during the development of asthma, and they also stimulate the synthesis of a secret, which then accumulates and complicates the work of the mucous membrane.

Regular intake leads to a significant decrease in the severity of symptoms against the background of a general decrease in the number of asthma attacks (as many patients note, positive changes are observed already on the first day of therapy).

Metabolic features

"Montelukast" (reviews of pharmacists indicate that the real choice of duplicates is limited by the pricing policy of manufacturers, that is, individual synonymous drugs, having identically structured molecules of the main component, cost several times more than the described drug), getting into the plasma blood, perfectly binds to its proteins. In the course of clinical studies, the result was recorded at the level of 99.37%. At the same time, its bioavailability is directly dependent on the technological form of release. For example, the ingredients of 5-milligram tablets are 73% absorbable, while the film-coated tablets, which contain 2 times more active substance, are only 64%.

A similar situation is with the half-life of the reagent: the components of chewable pills, having undergone metabolism, leave the body 2 hours after ingestion, and the constituent elements of conventional tablets after 180-200 minutes. At the same time, plasma clearance varies between 43-45 ml / minute. And, interestingly, only 0.2% of the dose is transported by the urinary tract. Intestines, for comparison, - more than 85%.

From the comments of authoritative experts it follows that the pharmacokinetic process proceeds equally smoothly in patients of both sexes, and that no serious adjustments for age and renal pathologies are required when calculating the daily dose of the drug. But malfunctions in the liver, especially when it comes to serious illnesses, deserve special attention when drawing up a therapeutic schedule.

Indications for appointment

When the use of the Montelukast drug is justified, the reviews (the drug is recommended for children in chewable form; it is advisable to prescribe film-coated pills exclusively to adults and adolescents) left on the forums, of course, help to understand. However, being guided only by someone else's opinion is a big mistake, because without consulting a doctor, it is almost impossible to “identify” the type of asthma, and most importantly, find out the causes of its occurrence.

As for the official instructions, the circle of symptoms, ailments and other conditions is outlined as follows:

• bronchial spasms provoked by excessive physical activity;
• seasonal / chronic rhinitis of an allergic nature of origin;
• bronchial asthma;
• the need for preventive measures.

Optimal dosage

"Montelukast" (negative reviews are extremely difficult to find, since the active ingredient has long been successfully used as an integral part of many specialized drugs) is taken orally, once a day, without reference to the "breakfast - lunch - dinner" schedule.

For 4 mg and 5 mg chewable tablets, the following dosing rules apply:

• children aged 2 to 5 years: 1 unit of the drug (4 mg) per day, at bedtime, until control of symptoms is achieved, and with a mandatory prolongation of the course for 2-4 weeks to consolidate the effect obtained;
• patients from 6 to 14 years old: a similar regimen, but a single dose is 5 mg.

For film-coated pills, the following recommendations are relevant:

• adults and children over 15 years of age with bronchial asthma or chronic rhinitis: 1 unit (10 mg of the substance) / day, in the evening;
• in order to prevent spasms: the same dose for a time period of 14-28 days.

Side effect

"Montelukast" instructions (reviews confirm that even with full compliance with the provisions of the official guidelines, atypical reactions to the presence of ingredients cannot be completely ruled out) is positioned as a potentially safe medication, but with the proviso that an uncharacteristic "response" from the body in individual cases is still possible.

Valid scenarios:

• Gastrointestinal tract: diarrhea, dry mouth, pain in the abdomen, nausea;
• heart and blood lines: a very noticeable increase in heart rate;
• skin: rash, urticaria, local hematomas;
• respiratory system: rhinorrhea and severe cough;
• CNS: dizziness, fatigue, depressive moods, followed by excessive psychomotor agitation;
• musculoskeletal system: arthralgia and myalgia (including convulsions)
• other: symptoms characteristic of acute respiratory infections and influenza.

Restrictions and contraindications

"Montelukast" (instructions for use reviews finds the most positive, and the information contained in it, from the point of view of objectivity, there are practically no questions from members of the forum) is not prescribed if:

• hypersensitivity to the composition of the drug was found (the rule is relevant for all types of tablets);
• diagnosed with rare hereditary diseases, including those in which the body does not absorb galactose, or experiences a critical lactase deficiency (this restriction does not apply to chewable pills);
• the patient's condition is aggravated by phenylketonuria;
• the patient is not yet two years old (for tablets in the shell "age limit" - 15 years).

Overdose: symptoms and treatment

Studies have shown: "Montelukast" 4 mg (reviews about this trade form of the reagent, in fact, are identical to the comments that are addressed to chewable analogues containing 5 mg of the active substance), if the daily intake is exceeded, it has the same effect on the body as a 10 mg tablet . The most pronounced symptoms of overdose are seen in patients of the younger group. Adults, even when taking 200 mg / day for 5 months, did not notice any atypical reactions.

In single episodes, a sign of an increased concentration of the drug was:

• unquenchable thirst;
• drowsiness;
• pain in the abdomen;
• vomit;

Treatment is based on the observed clinical picture. There are no data on the effectiveness of hemodialysis.

Drug interactions and the most popular analogues

"Montelukast" 5 mg (reviews on chewable samples left by pediatricians boil down to the idea that the drug is undoubtedly worthy of the attention of young parents), like other forms of leukotriene receptor antagonist, when used in parallel with profile reagents, it helps to accelerate positive dynamics : the symptoms of bronchial asthma become less pronounced, the number of attacks decreases. However, abrupt cancellation of therapy based on inhaled corticosteroids is not recommended.

Significant fluctuations in pharmacokinetic processes involving theophylline and prednisol were not found. But absorption with the "union" with phenobarbital drops by as much as 40%.

Reagents that inhibit the synthesis of the CYP3A4 isoenzyme should only be used under medical supervision.

Structural analogues that are most often found on sale:

• "Moncasta".
• "Singlon".
• "Singular".
• "Ectalust".
• "Singulex".

"Singular" or "Montelukast": reviews of doctors and pharmacologists

According to experienced pharmacologists, disputes about which of the above drugs are safer and more effective are meaningless, since both Singulair and Montelukast have the same drug base. It's just that the first trade name has passed a patent registration, and the second one is international. Individual doctors and patients, however, have a different point of view, and consider the medicine distributed under the INN to be the only right decision.

Montelukast and its analogues is an active component of various means. The product looks like a dry white powder. It has good solubility. This component of drugs carries a bronchodilator action.

It works in conjunction with mediator receptors that are activated in diseases. lower respiratory tract including bronchioles and bronchi.

In contact with

Most often, a person, feeling unwell, goes to the pharmacy on his own and purchases various antiviral agents. In this case, the buyer is faced with the choice to buy this drug or purchase its analogue. The drug Montelukast, its analogues, use, and dosage instructions.

After entering the stomach, the drug is rapidly absorbed, acquiring the greatest effectiveness a few hours after ingestion. This drug is metabolized in the liver and excreted by the urinary system. Thanks to Montelukast, the following action occurs:

1. Reducing edema and spasms of smooth muscles.
2. The work of the vessels of the respiratory system (lower as well as upper sections) is normalized.
3. The transport of mucus is improved, due to a decrease in its production.

Montelukast may be presented in two forms. In the form of chewable tablets and coated pills for oral administration. The content of the components of Montelukast in one tablet may be different, so you should carefully read the instructions before buying the drug.

Montelukast tablets and its analogues

Instructions for use of the drug describes this remedy as a bronchodilator and anti-leukotriene antibiotic. It is produced in the form of chewable tablets, which contain 5 or 10 mg of active ingredients.

Montelukast: price and application rules

Montelukast tablets will cost 700 rubles. The price of the medicine will depend on how much of the drug you decide to purchase. So, 28 tablets of 5 grams can be bought at a cost of 900 rubles.

Before you start looking for similar drugs, you should find out the purpose of using this medicine. Montelukast is prescribed to people suffering from bronchial asthma for its treatment and prevention.

Also, pills used for rhinitis if it is allergic. The drug will perfectly cope with bronchospasm during increased physical exertion. Tablets are strictly prohibited for persons who are highly sensitive to this substance, as well as for children under 2 years of age and pregnant women.

If the use of tablets must be carried out during feeding, then lactation should be stopped. If the dosage is incorrectly selected or the instructions are not followed, the medicine can cause:

• indigestion and digestive system of the body;
• headache and dizziness;
• airway congestion and edema.

To all this, the tool is capable of cause CNS reactions, allergies, disruption of the circulatory and cardiac systems, as well as the flu-like condition of the patient.

How to take Montelukast

For more information about the rules for the use of the drug can be found in its instructions. For the treatment of bronchial asthma, usually take 10 mg of the drug per day (preferably at bedtime). For prophylactic purposes, the dose of the drug can reach up to 5 mg per day.

Montelukast should be taken in the treatment of allergic rhinitis 4 mg-10 mg medication per day(the dosage of the drug will depend on the degree of the disease and the estimated effectiveness of the drug).

The number of days during which the drug should be taken, determined by the attending physician taking into account all the features of the development of the disease. Montelukast tablets may be prescribed with corticosteroids and bronchodilators.

Montelukast - analogues

If the use of Montelukast is contraindicated for some reason, then you should choose analogues of this remedy together with your doctor.

Do not choose analogues on your own and do not give medicines to children without a pediatrician.

If the pharmacy does not have this drug, then you can look for its substitutes, similar in composition with original:

• Singular.
• Ectalust.
• Monler.
• Singlon.

Sometimes the reason a buyer chooses other manufacturers is to save money. Finding cheap substitutes for Montelukast tablets is not difficult. What drugs can save the consumer's money and produce the desired effect?

Singulair is the most popular analogue

This tool is also customary to produce in the form of chewable tablets. One tablet contains about 4, 5 or 10 mg of active ingredient. We can say that the Singulair analogue is not exactly cheap. So, 5 mg tablets in the amount of 14 pieces will have a price of 1200 rubles.

Unlike Montelukast, which is produced in Russia, Singulair originates in America. Such a drug can be used during pregnancy and even while breastfeeding. But the manufacturer warns that before using the drug, you should still consult a doctor.

Each tablet of the drug contains substance - aspartame therefore, patients with phenylketonuria should be warned about this in advance. You can not use this medicine to stop acute bronchial asthma.

Montelar is a good and inexpensive substitute

If your goal is to save on the purchase of a healing drug, then Montelar will definitely appeal to you. The dosage of the drug is the same as its predecessors.

The package contains 14 tablets weighing 5 mg and cost about 650 rubles. It will be twice cheaper than Singular. The manufacturer of the medicine is the country of Switzerland.

Tablets are categorically contraindicated for people with high intolerance to the components of the drug, as well as those suffering from phenylketonuria. And also, his should not be given to children less than six years of age.

According to the reviews of the medicine, you can see that it rarely causes side effects, in contrast to the previous means. Side effects can be manifested in the form of abdominal pain, allergies and a flu-like condition. The disadvantage of Montelar is its inability to replace inhaled drugs for use in emergency cases.

Ektalust - a cheap analogue

So, this tool is the most affordable of Montelukast's analogues. The package of Ectalust contains 14 tablets of 5 mg each, the drug costs about 500 rubles. The composition of the tablets includes the active substance - montelukast.

The drug is able to cure bronchial asthma, aspirin asthma, and can also prevent bronchospasm and shortness of breath during exercise. Ectalust tablets do an excellent job with nocturnal attacks of rhinitis.

Means prohibited for use children under the age of 2 years, as well as children under 6 years of age in the amount of 5 mg. For the treatment of bronchial asthma, Ectalust should be taken in the evening. If the patient has allergic rhinitis, then its use occurs one hour before meals or two after it. It is allowed to use the drug at any time of the day.

Monler tablets

Montelukast's analogues include Monler. The cost of Monler tablets will be about 700 rubles for 14 tablets weighing 5 mg. This is slightly more expensive than the cost of the initial medicine. This drug has no special properties and signs.

It should be noted that this drug good effect on the body of patients. So, practice has shown that the Monler remedy very rarely leads to the formation of side effects. Tablets quickly penetrate the body and the effect of treatment begins to appear after a few days of taking the medicine.

Other similar means

Other analogues of Montelukast may have other components in their composition, but at the same time have the same effect on the patient's body and treat bronchial asthma.

Funds bronchodilator type allow you to relax smooth muscles, relieve spasms of muscle tissue, facilitate breathing and expand the bronchi themselves.

These medicines can be used alone or in combination with other asthma medicines. In pharmacies, you can find the following analogue products:

1. Omnitus.
2. Pertussin and so on.

Substitutes for the original drug should be chosen drugs, while taking into account individual characteristics organism and stages of disease development.

Modern pharmacology is a mass of drugs used for different purposes. Ideally, if any complaints appear, a person should immediately contact a doctor. Only a doctor is able to conduct a thorough examination, make a correct diagnosis and determine the appropriate treatment regimen. But this is not always the case.

Often people, feeling unwell, go to the pharmacy, buy medicines on their own. At the same time, they face a choice: buy this drug or give preference to its analogue (generic). Today's article will introduce you to a drug called Montelukast. Analogues, synonyms and substitutes for the drug will be presented to your attention.

Substance characteristic

Montelukast, analogues of which will be presented to your attention today, is the active substance of several medicines. This compound is an optically active white powder. It is highly soluble in many liquids. The drug component (montelukast) has a bronchodilator effect. It works with mediator receptors that are activated in diseases of the lower respiratory tract, in particular bronchioles and bronchi.

After oral administration, montelukast is rapidly absorbed, reaching peak efficacy after 2-3 hours. It is metabolized in the liver and excreted in the bile. The use of a medicinal compound promises the following:

1. Reducing swelling and spasm of smooth muscles.
2. Normalization of the work of the vessels of the respiratory system (lower and upper sections).
3. Improving the transport of mucus by reducing its secretion.

From the presented component, two types of tablets are made: chewable and for oral administration, coated. The dosage of montelukast in one pill may vary. You should pay attention to this when buying a medication.

About Montelukast

Instructions for use (price, analogues will be presented for you later) characterizes this medicine as a bronchodilator and antileukotriene medication. It is produced in the form of chewable tablets containing 5 or 10 mg of the active ingredient. The cost of the drug depends on which form you prefer. For example, 28 tablets with a dosage of 5 mg can be purchased for 900 rubles, and 10 mg pills in the amount of 30 pieces will cost you about 700 rubles.

Before looking for substitutes for Montelukast tablets (analogues), you need to find out the purpose of the medication. This medicine is prescribed for the treatment of bronchial asthma and for the purpose of its prevention. Tablets help with rhinitis caused by seasonal allergies. The effectiveness of the drug "Montelukast" has been proven in patients with strong physical exertion (prevents bronchospasm). It is important to know that the drug is contraindicated in case of high sensitivity to the active substance, children under 2 years of age and pregnant women. If the need to use tablets occurs during breastfeeding, then lactation should be stopped. If used incorrectly, it can provoke side reactions:

• digestive disorder;
• dizziness and headaches;
• swelling of the nasal mucosa, congestion.

Less commonly, the drug causes CNS reactions, allergies, disruption of the circulatory and cardiac systems, and a flu-like condition.

Instructions for use

The dosage of the drug "Montelukast" is described in detail in the instructions. For the treatment of bronchial asthma, 10 mg of the drug per day (before bedtime) is used. For the purpose of prevention, the dose can be halved: up to 5 mg of the active substance. During allergic rhinitis, 4 to 10 mg of the drug is used (depending on the severity of the disease and the estimated effectiveness of the drug). The duration of the therapeutic course is determined by the doctor, taking into account all the features of the course of the pathology. Montelukast may be given in combination with corticosteroids and bronchodilators.

When does a drug need to be changed?

If for some reason you cannot take Montelukast, the instructions for use recommend choosing analogues together with your doctor. Do not take substitutes yourself, do not give medicines to children without a pediatrician's prescription. In the absence of the drug "Montelukast" in pharmacies, you can replace it with drugs similar in composition:

• "Singular".
• "Ectalust".
• Montelar.
• "Monler".
• "Singlon" and so on.

Sometimes the consumer's goal is to save money. Finding such substitutes for Montelukast tablets (analogues are cheaper) is not so difficult. Let us consider in more detail the means that can satisfy the needs of the buyer and give an effect similar to that of the claimed medicine.

"Singular": a popular substitute

This tool, like its predecessor, is available in the form of chewable tablets. One pill contains 4, 5 or 10 mg of active ingredient. We can say that "Singular", "Montelukast" are structural analogues. If we compare the cost of the drug, we can call it expensive. Tablets of 5 mg in the amount of 14 pieces will cost you 1200 rubles.

Unlike the Russian drug "Montelukast", "Singular" is produced in America. This medication can be used during pregnancy and lactation. The manufacturer says that before doing this, you should definitely consult a doctor. Each tablet of the drug "Singulair" - says the abstract - contains aspartame. Patients with phenylketonuria should be warned about this. You should not take this medicine to relieve an exacerbation of bronchial asthma.

"Montelar": cheaper analogue

If you want to use economical substitutes for Montelukast (analogues), you will like the price of this medicine. The drug is produced in the same dosages as its predecessors. It costs 14 pills of 5 mg, about 650 rubles. This is almost two times cheaper than the price of the previous analogue. The drug "Montelar" is produced in Switzerland.

The drug is not prescribed to persons who are hypersensitive to the components, as well as to patients with phenylketonuria. It is contraindicated to use Montelar for children under 6 years of age. From the reviews of this remedy, you can find out that the tablets are less likely to provoke adverse reactions than their predecessor ("Montelukast" 10 mg). A remedy similar in action can provoke headaches and abdominal discomfort, allergies and a flu-like condition. The drug "Montelar" is not able to replace inhaled medicines for emergency use.

"Ektalust": an inexpensive drug

They have tablets "Montelukast" analogues even more affordable. This was the drug "Ectalust". A package containing 14 tablets of 5 mg each costs about 500 rubles. The composition contains all the same active substance - montelukast. This medication is used for the treatment and prevention of bronchial asthma, with aspirin asthma, in order to prevent bronchospasm and shortness of breath during physical exertion. Nocturnal attacks of allergic rhinitis can be successfully removed with Ektalust tablets.

Treatment with the declared analogue of children under 2 years is contraindicated, and at a dose of 5 mg, the drug should not be given to children under 6 years of age. In order to treat bronchial asthma, tablets should be taken in the evening. With allergic rhinitis, the medication is prescribed one hour before a meal or two after it (at a convenient time of day).

Tablets "Monler"

You already know what are the cheaper substitutes for the drug "Montelukast" (analogues). The price of Monler tablets is about 700 rubles for 14 5 mg pills. This is more expensive than the cost of the original drug. This medication does not have any special differences from the Russian predecessor. It should be noted that this drug is better tolerated by consumers. Practice shows that Monler tablets very rarely provoke adverse reactions. Moreover, they are such that there is no need to cancel treatment.

Other drugs

Used to treat bronchial asthma "Montelukast". Analogues of the drug may have a different composition, but at the same time have a similar effect on the patient's body. Bronchodilators relax smooth muscles, relieve spasm of muscle tissue, facilitate breathing and promote bronchial expansion. These medicines can be used alone or in combination with others to treat asthma. In free sale, you can find the following substitute drugs for Montelukast:

• "Omnitus".
• Erespal.
• "Ascoril".
• "Pertussin" and so on.

An alternative to the original medication should be chosen taking into account the individual characteristics of the organism and the course of the disease.

REGISTRATION NUMBER: LSR-005945/09-270115
TRADE NAME: SINGULAIR®
INTERNATIONAL NON-PROPRIETARY NAME: montelukast
PHARMACEUTICAL FORM: chewable tablets

COMPOUND
1 chewable tablet contains:
Active substance: montelukast sodium 4.16 mg (equivalent to 4.0 mg free acid).
Excipients: mannitol 161.08 mg, microcrystalline cellulose 52.8 mg, hyprolose (hydroxypropyl cellulose) 7.2 mg, iron oxide red 0.36 mg, croscarmellose sodium 7.2 mg,
cherry flavor 3.6 mg, aspartame 1.2 mg, magnesium stearate 2.4 mg.

DESCRIPTION:
Pink, oval, biconvex tablets, debossed with "SINGULAIR" on one side and "MSD 711" on the other side.

PHARMACOTHERAPEUTIC GROUP:
Anti-inflammatory antibronchospasmic agent, leukotriene receptor blocker.

ATX CODE: R03DC03

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics
Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are strong inflammatory mediators - eicosanoids, which are secreted by various cells, including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors. Cysteinyl leukotriene type 1 receptors (CysLT1 receptors) are present in the human airways (including bronchial smooth muscle cells, macrophages) and other pro-inflammatory cells (including eosinophils and some myeloid stem cells). Cysteinyl leukotrienes correlate with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include bronchospasm, increased mucus secretion, increased vascular permeability, and increased eosinophil counts. In allergic rhinitis, after exposure to an allergen, cysteinyl leukotrienes are released from pro-inflammatory cells of the nasal mucosa during the early and late phases of the allergic reaction, which is manifested by symptoms of allergic rhinitis. An intranasal test with cysteinyl leukotrienes demonstrated an increase in airway resistance and symptoms of initial obstruction.
Montelukast is a highly potent oral drug that significantly improves inflammation in asthma. According to biochemical and pharmacological analysis, the drug binds with high selectivity and chemical affinity to CysLT1 receptors (instead of other pharmacologically important airway receptors such as prostaglandin, cholinergic or β-adrenergic receptors). Montelukast inhibits the physiological action of the cysteinyl leukotrienes LTC4, LTD4 and LTE4 by binding to CysLT1 receptors without stimulating these receptors.
Montelukast inhibits CysLT receptors in the epithelium of the respiratory tract, thus simultaneously possessing the ability to inhibit bronchospasm caused by inhalation of LTD4 in patients with bronchial asthma. Doses of 5 mg are sufficient to relieve bronchospasm induced by LTD4.
Montelukast causes bronchodilation within 2 hours of oral administration and may supplement bronchodilation induced by β2-agonists.
The use of montelukast in doses exceeding 10 mg per day, taken once, does not increase the effectiveness of the drug.
Pharmacokinetics
Suction
Montelukast is rapidly and almost completely absorbed after oral administration. In adults, when taking 10 mg coated tablets on an empty stomach, the maximum concentration (Cmax) is reached after 3 hours (Tmax). The average oral bioavailability is 64%. Eating does not affect Cmax in blood plasma and the bioavailability of the drug.
When taken on an empty stomach, 5 mg chewable tablets Cmax in adults is achieved after 2 hours. The average oral bioavailability is 73%.
In children aged 2 to 5 years, Cmax is reached 2 hours after taking 4 mg chewable tablets on an empty stomach.
Distribution
Montelukast binds to plasma proteins by more than 99%. The volume of distribution of montelukast at steady state is 8-11 liters on average. Studies conducted on rats with radiolabeled montelukast indicate minimal penetration through the blood-brain barrier. In addition, the concentrations of the labeled drug 24 hours after administration were minimal in all other tissues.
Metabolism
Montelukast is actively metabolized. In the study of therapeutic doses at steady state plasma concentration in adults and children, the concentration of montelukast metabolites is not determined. In vitro studies using human liver microsomes have shown that cytochromes P450, 3A4, 2C8 and 2C9 are involved in the metabolism of montelukast. According to further results of studies conducted in vitro in human liver microsomes, the therapeutic concentration of montelukast in blood plasma does not inhibit cytochrome P450 CYP isoenzymes: 3A4, 2C9, 1A2, 2A6, 2C19 and 2D6.
breeding
Plasma clearance of montelukast in healthy adults averages 45 ml/min. After ingestion of radiolabeled montelukast, 86% of its amount is excreted in the feces within 5 days and less than 0.2% in the urine, which confirms that montelukast and its metabolites are excreted almost exclusively in the bile.
The half-life of montelukast in young healthy adults is 2.7 to 5.5 hours. The pharmacokinetics of montelukast remains almost linear at oral doses of more than 50 mg. When taking montelukast in the morning and evening, no differences in pharmacokinetics are observed. When taking 10 mg of montelukast 1 time per day, a moderate (about 14%) accumulation of the active substance in plasma is observed.
Features of pharmacokinetics in different groups of patients

The pharmacokinetics of montelukast in women and men is similar.

With a single oral dose of 10 mg of montelukast, the pharmacokinetic profile and bioavailability are similar in elderly and young patients. The plasma half-life of montelukast is slightly longer in the elderly. Dose adjustment in the elderly is not required.

There were no differences in clinically significant pharmacokinetic effects in patients of different races.

In patients with mild to moderate hepatic insufficiency and clinical manifestations of liver cirrhosis, a slowdown in the metabolism of montelukast was noted, accompanied by an increase in the area under the concentration-time pharmacokinetic curve (AUC) by approximately 41% after a single dose of the drug at a dose of 10 mg. The excretion of montelukast in these patients is slightly increased compared to healthy subjects (mean elimination half-life -7.4 hours). Changes in the dose of montelukast for patients with mild to moderate hepatic insufficiency are not required. There are no data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale).

Because montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast have not been evaluated in patients with renal insufficiency. Dose adjustment for this group of patients is not required.

INDICATIONS FOR USE:

Prevention and long-term treatment of bronchial asthma in children from 2 years of age, control of day and night symptoms of the disease.
Relief of symptoms of allergic rhinitis (seasonal and year-round) in children from 2 years of age.

CONTRAINDICATIONS

Hypersensitivity to any of the components of the drug
Phenylketonuria

USE IN PREGNANCY AND DURING BREASTFEEDING

Clinical studies of the drug SINGULAIR® with the participation of pregnant women have not been conducted. SINGULAIR® should be used during pregnancy and lactation only if the expected benefit to the mother outweighs the potential risk to the fetus or child. During the post-registration use of the drug SINGULAIR®, the development of congenital limb defects in newborns whose mothers took the drug SINGULAIR® during pregnancy was reported. Most of these women also took other drugs for the treatment of bronchial asthma during pregnancy. A causal relationship between taking the drug SINGULAIR® and the development of congenital limb defects has not been established.
It is not known if SINGULAIR® is excreted in breast milk. Because many drugs are excreted in breast milk, this should be taken into account when prescribing SINGULAIR® to breastfeeding mothers.

METHOD OF APPLICATION AND DOSES:

The drug is taken orally once a day, regardless of the meal.
For bronchial asthma: 1 tablet of SINGULAIR at night.
For bronchial asthma and allergic rhinitis: 1 tablet of SINGULAIR at night.
In allergic rhinitis: 1 tablet of SINGULAIR per day on an individual basis, depending on the time of the greatest exacerbation of symptoms.
Children aged 2 to 5 years with asthma and/or allergic rhinitis
The dosage for children 2-5 years of age is one 4 mg chewable tablet per day.
The therapeutic effect of SINGULAIR with a change in the course of bronchial asthma develops within a day. The chewable tablets can be taken with or without food.
Children, the elderly, patients with renal insufficiency and patients with mild / moderate liver dysfunction do not require a special dose selection.

SIDE EFFECT

OVERDOSE:

Symptoms of overdose after long-term (22 weeks) treatment of patients with bronchial asthma with daily doses of SINGULAIR over 200 mg per day, or after treatment with daily doses of 900 mg for 1 week, were not observed.
There have been cases of acute overdose (taking at least 1000 mg of the drug per day) of montelukast in the post-marketing period and in clinical studies in adults and children. Clinical and laboratory data indicated comparability of the safety profiles of SINGULAIR in pediatric, adult and elderly patients. The most common side effects were thirst, drowsiness, vomiting, psychomotor agitation, headache, and abdominal pain.
Treatment in case of acute overdose is symptomatic.
There are no data on the effectiveness of peritoneal dialysis or hemodialysis of montelukast.

INTERACTIONS WITH OTHER DRUGS

SINGULAIR may be administered with other medicinal products commonly used for the prevention and long-term treatment of asthma and/or the treatment of allergic rhinitis. The recommended therapeutic dose of montelukast did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / norethisterone 35/1), terfenadine, digoxin and warfarin.
The AUC value of montelukast is reduced by about 40% while taking phenobarbital, but this does not require changes in the dosing regimen of the drug SINGULAIR.
In vitro studies have established that montelukast inhibits the CYP 2С3 isoenzyme of the cytochrome P450 system, however, in the study of in vivo drug interactions of montelukast and rosiglitazone (metabolized with the participation of the CYP 2С8 isoenzyme of the cytochrome system), no confirmation of inhibition of the CYP 2С8 isoenzyme by montelukast was obtained. Therefore, in clinical practice, no effect of montelukast on CYP 2C8-mediated metabolism of a number of drugs, including paclitaxel, rosiglitazone, repaglinide, etc., is expected. In vitro studies have shown that montelukast is a substrate of CYP 2C8, 2C9 and 3A4. Data from a clinical drug interaction study between montelukast and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) demonstrate that gemfibrozil increases the effect of systemic exposure to montelukast by 4.4 times. Co-administration of itraconazole, a potent inhibitor of CYP 3A4, with gemfibrozil and montelukast did not lead to an additional increase in the effect of systemic exposure to montelukast. The effect of gemfibrozil on the systemic exposure of montelukast cannot be considered clinically relevant 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). Thus, when co-administered with gemfibrozil, dose adjustment of montelukast is not required. Based on the results of in vitro studies, no clinically significant drug interactions are expected with other known inhibitors of CYP 2C8 (for example, with trimethoprim). In addition, the co-administration of montelukast with itraconazole alone did not lead to a significant increase in the effect of systemic exposure to montelukast.
Combination treatment with bronchodilators
SINGULAIR is a reasonable addition to monotherapy with bronchodilators if the latter do not provide adequate control of bronchial asthma. Upon reaching the therapeutic effect of treatment with SINGULAIR, you can start a gradual reduction in the dose of bronchodilators.
Combined treatment with inhaled glucocorticosteroids
Treatment with SINGULAIR provides an additional therapeutic effect to patients using inhaled glucocorticosteroids. Upon reaching stabilization of the condition, you can start a gradual reduction in the dose of glucocorticosteroid under the supervision of a physician. In some cases, the complete abolition of inhaled glucocorticosteroids is acceptable, but an abrupt replacement of inhaled corticosteroids with SINGULAIR is not recommended.

SPECIAL INSTRUCTIONS

The efficacy of oral SINGULAIR® in the treatment of acute asthma attacks has not been established. Therefore, SINGULAIR® tablets are not recommended for the treatment of acute attacks of bronchial asthma. Patients should be instructed to always carry emergency asthma medications (short-acting inhaled beta2-agonists) with them at all times.
Do not stop taking SINGULAIR® during an asthma exacerbation and the need to use emergency drugs (short-acting inhaled beta 2-agonists) to stop attacks.
Patients with confirmed allergy to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) should not take these drugs during treatment with SINGULAIR®, since SINGULAIR®, while improving respiratory function in patients with allergic bronchial asthma, however, cannot completely prevent the caused they have NSAID bronchoconstriction.
The dose of inhaled glucocorticosteroids used concomitantly with SINGULAIR® can be gradually reduced under the supervision of a physician, but abrupt replacement of inhaled or oral glucocorticosteroids with SINGULAIR® should not be carried out.
Psychoneurological disorders have been described in patients taking SINGULAIR® (see the section "Side effects"). Given that these symptoms may have been caused by other factors, it is not known whether they are related to the use of SINGULAIR®. The physician should discuss these adverse events with patients and/or their parents/guardians. Patients and/or their caregivers should be advised that if these symptoms occur, the attending physician should be informed.
Rarely, patients treated with anti-asthma drugs, including leukotriene receptor antagonists, have experienced one or more of the following adverse events: eosinophilia, 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 reduction or discontinuation of oral glucocorticosteroid therapy. Although a causal relationship of these adverse events with leukotriene receptor antagonist therapy has not been established, caution should be exercised in patients taking SINGULAIR® and appropriate clinical monitoring should be carried out.
SINGULAIR® 4 mg chewable tablets contain aspartame, a source of phenylalanine. Patients with phenylketonuria should be informed that each 4 mg chewable tablet contains aspartame equivalent to 0.674 mg phenylalanine and that SINGULAIR® 4 mg chewable tablets are not recommended for use in patients with phenylketonuria.

EFFECT ON ABILITY TO DRIVE A VEHICLE OR MOVING MECHANISMS

This section does not apply to Singular® 4 mg chewable tablets as it is intended for use in children 2 to 5 years of age. Thus, the information provided below refers to the active substance of the drug montelukast.
Singular® is not expected to affect the ability to drive and use machines. However, individual reactions to the drug may be different. Some side effects (such as dizziness and drowsiness), which have been reported to occur very rarely with the use of the drug Singulair®, may affect the ability of some patients to drive a car and move machinery.