Bronchospasm is a phenomenon familiar to patients suffering from asthma. Against the background of obstructed bronchial passages, there is increased secretion sputum, the number of eosinophils increases. Symptoms of seasonal and year-round allergic rhinitis are swelling of the mucous membrane of the nasopharynx, lacrimation, headache, runny nose, itching, sneezing.
The American drug singular “turns off” cysteinyl leukotriene receptors in the epithelium of the patient’s respiratory organs, and also effectively relieves bronchospasms. Active substance The medicine contains montelukast.
The scope of application of the product includes the prevention of bronchospasms, treatment bronchial asthma in children and adults, as well as therapy for seasonal and regular allergic rhinitis. For children, the medication is approved from 6 years of age. Release form: tablets, chewable tablets.
The product is expensive, prices range from 1000–1300 rubles per package of 14 tablets. Cheap analogues Singular preparations contain the same active ingredient or have similar indications for use.
Russian-made analogues
Close substitutes for the singular Russian production are a high-quality replacement for the cheap medicine with montelukast. The table contains a list similar means with prices and brief characteristics.
| Name of the drug | average price in rubles | Characteristic |
| Moncasta | 750–840 | Chewable tablets with montelukast, causing bronchodilation within 2 hours after use. Used to relieve attacks of bronchial asthma and rhinitis of allergic origin. |
| Montelukast | 520–750 | The product has similar indications and contraindications to use as Singularia. |
| Ektalust | 440–520 | The cheapest synonym for singular from a domestic manufacturer. The composition of the drug includes montelukast. |
Ukrainian substitutes
Ukrainian-made medicines can be a worthy replacement for Singularia. Their cost is cheaper than the drug in question.
Medicines belong to pharmacological group medications for the treatment of obstructive diseases respiratory system, although not all products on the list contain montelukast.
- Montel. Inexpensive Ukrainian analogue with the same active ingredient. The drug is used to treat seasonal allergic rhinitis, bronchial asthma varying degrees gravity. Available in the form of regular pills and chewable ones. The average price is 450–490 rubles.
- Allergomax. Medicine in the form of syrup, nasal spray or tablets. The drug effectively eliminates symptoms allergic rhinitis– lacrimation, itching, swelling, headache. The average price is 56–90 rubles.
- Bronchomax. Fenspiride hydrochloride syrup or tablets. The medication is indicated for otitis media, sinusitis, rhinitis, including allergic rhinitis, and bronchitis. The drug is also used in the treatment of bronchial asthma. The average price is 95–140 rubles.
- Teopek. Anti-asthmatic drug based on theophylline. Pills are taken for bronchial asthma, emphysema, obstructive bronchitis.
Contraindications include childhood up to 14 years, pregnancy, period breastfeeding, convulsive states, acute heart attack myocardium, hyperfunction thyroid gland. The average price is 45–60 rubles.
Belarusian generics
The table brings together modern Belarusian generics of the singular. Antiasthmatic drugs are not its exact analogues, but are characterized by similar indications for use.
| Name of the drug | Average price in rubles | Characteristic |
| Eufillin | 15–35 | A bronchodilator that relaxes the muscles of the bronchi. The medicine effectively relieves bronchospasms. The indications for the medicine include bronchial asthma, obstructive bronchitis, Pickwick's syndrome, chronic cor pulmonale. |
| Beclomethasone | 330–380 | An antiasthmatic drug used in the treatment of bronchial asthma for adults and children over 6 years of age. Release form: aerosol for inhalation. |
| Seleflu | 330–400 | The aerosol is used in the therapeutic treatment of mild, moderate and severe asthma. Not intended to relieve acute symptoms asthma. |
Other foreign analogues
Imported synonyms for singular will help you choose what to replace singular with. The list is given below.
- Single. The best substitute for singular with the same principle of action and active ingredient. The product has similar indications for use. Country of origin: Hungary. The average price is 440–870 rubles.
- Montelar. The drug is produced in Switzerland, Turkey, Slovenia. The active ingredient is montelukast. The average price is 440–1050 rubles.
- Montclair. The release form of the medication is chewable tablets. Country of origin: Croatia. The average price is 240–440 rubles.
- Almont. Used for asthma and allergic rhinitis. The medicine is produced in Switzerland. The average price is 700–960 rubles.
- Montelast. A close substitute for singular with a similar active substance. Sold in tablets. The product is produced in Switzerland and Malta. The average price is 640–2600 rubles.
Singulair and its analogues are popular medicines in the treatment of diseases specified in the instructions.
Allergic rhinitis, like bronchial asthma, are serious diseases that, in extreme cases, can lead to conditions incompatible with life, so they cannot be ignored. Montelukast is an effective substance that can not only treat, but also prevent dangerous symptoms.
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pharmachologic effect
Leukotriene receptor antagonist. Montelukast selectively inhibits CysLT1 receptors of cysteinyl leukotrienes (LTC4, LTD4, LTE4) of the epithelium respiratory tract, and also prevents bronchospasm in patients with bronchial asthma caused by inhalation of cysteinyl leukotriene LTD 4. A dose of 5 mg is sufficient to relieve bronchospasm induced by LTD 4 . The use of montelukast in doses exceeding 10 mg 1 time / day does not increase the effectiveness of the drug.
Montelukast causes bronchodilation within 2 hours after oral administration and may complement bronchodilation caused by beta 2 -agonists.
Pharmacokinetics
Suction
After oral administration, montelukast is quickly and almost completely absorbed from the gastrointestinal tract. Eating normal food does not affect plasma Cmax and bioavailability of film-coated tablets, and chewable tablets. In adults, when taking film-coated tablets on an empty stomach at a dose of 10 mg, Cmax in blood plasma is achieved after 3 hours. Bioavailability when taken orally is 64%.
After oral administration on an empty stomach of the drug in the form of chewable tablets at a dose of 5 mg, Cmax in adults is achieved after 2 hours. Bioavailability is 73%.
Distribution
The binding of montelukast to plasma proteins is more than 99%. Vd averages 8-11 liters.
With a single dose of the drug in the form of film-coated tablets at a dose of 10 mg 1 time / day, moderate (about 14%) cumulation is observed active substance in plasma.
Metabolism
Montelukast is actively metabolized in the liver. When used in therapeutic doses, the concentration of montelukast metabolites in plasma at steady state in adults and children is not determined.
It is assumed that cytochrome P450 isoenzymes (3A4 and 2C9) are involved in the metabolism of montelukast, while at therapeutic concentrations montelukast does not inhibit cytochrome P450 isoenzymes: 3A4, 2C9, 1A2, 2A6, 2C19 and 2D6.
Removal
T1/2 of montelukast in young healthy adults ranges from 2.7 to 5.5 hours. The clearance of montelukast in healthy adults averages 45 ml/min. After oral administration of montelukast, 86% is excreted in feces within 5 days and less than 0.2% is excreted in urine, confirming that montelukast and its metabolites are excreted almost exclusively in bile.
Pharmacokinetics in special clinical situations
The pharmacokinetics of montelukast remains almost linear when administered orally in doses greater than 50 mg.
When taking montelukast in the morning and evening hours, no differences in pharmacokinetics were observed.
The pharmacokinetics of montelukast in women and men is similar.
When taking film-coated tablets orally at a dose of 10 mg 1 time / day, the pharmacokinetic profile and bioavailability are similar in elderly and young patients.
In patients with mild to moderate liver failure and clinical manifestations liver cirrhosis, a slowdown in the metabolism of montelukast was observed, accompanied by an increase in AUC by approximately 41% after a single dose of 10 mg. The elimination of montelukast in these patients is slightly increased compared to healthy subjects (T1/2 averages 7.4 hours). No dose adjustment of montelukast is required for patients with mild to moderate hepatic impairment. There are no data on the nature of the pharmacokinetics of montelukast in patients with severe liver failure (more than 9 points on the Child-Pugh scale).
Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast in patients with renal failure not evaluated. No dose adjustment is required in this category of patients.
There were no differences in clinically significant pharmacokinetic effects in patients depending on race.
Indications
Prevention and long-term treatment of bronchial asthma in adults and children aged 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 bronchospasm caused by physical activity.
Relief of daytime and nighttime symptoms of seasonal allergic rhinitis (in adults and children aged 6 years and older) and persistent allergic rhinitis (in adults and children aged 6 years and older).
Dosage regimen
The drug is taken orally 1 time/day, regardless of meals. For treatment of bronchial asthma Singulair ® should be taken in the evening. At treatment of allergic rhinitis the drug can be taken at any time of the day. With combined pathology ( bronchial asthma and allergic rhinitis) the drug should be taken in the evening.
Adults and teenagers aged 15 years and older the drug is prescribed at a dose of 10 mg (1 film-coated tablet)/day.
The therapeutic effect of the drug Singulair ® on indicators reflecting the course of bronchial asthma develops during the first day. The patient should continue to take Singulair ® both during the period of achieving control of bronchial asthma symptoms and during the period of exacerbation of the disease.
For elderly patients, patients with renal failure, patients with mild or moderate liver dysfunction, and depending on gender, special dose selection is not required.
Singulair ® can be added to treatment with bronchodilators and inhaled corticosteroids.
Side effect
Adults and children aged 15 years and older with asthma
In two similarly designed, 12-week placebo-controlled clinical trials, 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 more long-term treatment(for 2 years) the side effect profile did not change.
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 adverse effect assessed as drug-related that occurred in >1% of Singulair-treated patients and more frequently than in the placebo-treated group was headache. The difference in frequency between the two treatment groups was not statistically significant.
In studies assessing 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 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. Not reported in placebo-controlled clinical trials adverse reactions, which would be considered drug-related, would occur in ≥1% of patients treated with Singulair ® and more often than in the group of 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.
Children aged 2 to 14 years with seasonal allergic rhinitis
Patients took Singulair ® 1 time/day in the evening; in general, the drug was well tolerated. The safety profile of the drug was similar to that of placebo. In this clinical study, there were no adverse reactions that were considered drug-related and were observed in ≥1% of patients receiving Singulair ® or more frequently than in the placebo group.
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, no side effects were reported that were considered drug-related and were observed in ≥1% of patients treated with Singulair ® or more frequently than in patients treated with placebo. The incidence of drowsiness while taking the drug was the same as when taking placebo.
Generalized analysis of results clinical trials
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 9929 patients receiving Singulair ® and the 7780 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 receiving Singulair ® and 2.27% among patients receiving placebo; the odds ratio was 1.12 (95% confidence interval).
Side effects registered during post-marketing use of the drug
From the blood coagulation system: increased tendency to bleed.
From the outside immune system: hypersensitivity reactions, incl. anaphylaxis; very rarely (<1/10 000) - эозинофильная инфильтрация печени.
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) - судороги.
From the cardiovascular system: cardiopalmus.
From the respiratory system: nosebleeds.
From the digestive system: diarrhea, dyspepsia, nausea, vomiting, pancreatitis.
From the outsideliver and biliary tract: increased activity of ALT and AST in the blood; very rarely (<1/10 000) - гепатит (включая холестатические, гепатоцеллюлярные и смешанные поражения печени).
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.
In general, the drug Singulair ® is well tolerated by patients. Side effects are usually mild and, as a rule, do not require discontinuation of the drug. The overall frequency of side effects when treated with Singulair ® is comparable to their frequency when taking placebo.
Contraindications for use
- children under 6 years of age;
- hypersensitivity to the components of the drug.
Use during pregnancy and breastfeeding
Clinical studies of the drug Singulair ® have not been conducted in pregnant women. Singulair ® should be used during pregnancy and breastfeeding only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.
During post-registration use of the drug Singulair ®, the development of congenital limb defects was reported in newborns whose mothers took Singulair ® during pregnancy. Most of these women also took other medications to treat asthma during pregnancy. A cause-and-effect relationship between taking Singulair ® and the development of congenital limb defects has not been established.
It is not known whether montelukast is excreted in breast milk. Since many drugs are excreted in breast milk, this must be taken into account when prescribing Singulair ® to breastfeeding mothers.
Use in children
Contraindication: children under 6 years of age. Children aged 6 to 14 years prescribed at a dose of 5 mg (1 chewable tablet)/day. No dose adjustment is required for this age group.
Overdose
Symptoms overdoses were not identified during clinical studies of long-term (22 weeks) treatment with Singulair ® in adult patients with bronchial asthma in doses up to 200 mg/day, or during short (about 1 week) clinical studies when taking the drug in doses up to 900 mg/day .
There have been cases of acute overdose of Singulair ® (taking at least 1000 mg/day) in the post-registration period and during clinical trials in adults and children. Clinical and laboratory data indicated comparable safety profiles of Singulair ® in children, adults and elderly patients. The most common symptoms were thirst, drowsiness, vomiting, psychomotor agitation, headache and abdominal pain. These side effects are consistent with the safety profile of the drug Singulair ®.
Treatment: carrying out symptomatic therapy. There is no specific information on the treatment of overdose of Singulair ®. There are no data on the effectiveness of peritoneal dialysis or hemodialysis with montelukast.
Drug interactions
Singulair ® can be prescribed 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 did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
When co-administered with phenobarbital, the AUC value of montelukast is reduced by approximately 40 , but this does not require changes in the dosage regimen of the drug Singulair ®.
In vitro studies have shown that montelukast inhibits the CYP2C8 isoenzyme. However, in an in vivo study of drug interactions between montelukast and rosiglitazone (metabolized through the CYP2C8 isoenzyme), no confirmation of montelukast inhibition of the CYP2C8 isoenzyme was obtained. Therefore, in clinical practice, the effect of montelukast on the CYP2C8-mediated metabolism of a number of drugs, incl. paclitaxel, rosiglitazone, repaglinide.
In vitro studies have shown that montelukast is a substrate of CYP2C8, 2C9 and 3A4. Data from a clinical drug interaction study regarding montelukast and gemfibrozil (an inhibitor of both CYP2C8 and 2C9) demonstrate that gemfibrozil increases the effect of systemic exposure to montelukast by 4.4 times. Coadministration of itraconazole, a strong CYP3A4 inhibitor, 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 exposure of montelukast may not be considered clinically significant based on safety data when used at doses greater than the approved dose of 10 mg in adult patients (eg, 200 mg/day for adult patients for 22 weeks and up to 900 mg/day for no clinically significant adverse effects were observed in patients taking the drug for approximately one week). Thus, when co-administered with gemfibrozil, no dose adjustment of montelukast is required. Based on in vitro studies, no clinically significant drug interactions are expected with other known CYP2C8 inhibitors (for example, trimethoprim). In addition, coadministration of montelukast with itraconazole alone did not significantly increase 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. Once the therapeutic effect of treatment with Singulair ® is achieved, a gradual reduction in the dose of bronchodilators can begin.
Combined treatment with inhaled corticosteroids
Treatment with Singulair ® provides an additional therapeutic effect in patients using inhaled GCS. Once the condition has stabilized, you can begin a gradual reduction in the dose of GCS under the supervision of a physician. In some cases, complete abolition of inhaled corticosteroids is acceptable, but abrupt replacement of inhaled corticosteroids with Singulair ® is not recommended.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
List B. The drug should be stored out of the reach of children, protected from moisture and light at a temperature not exceeding 30°C. The shelf life of chewable tablets 5 mg is 2 years; film-coated tablets, 10 mg - 3 years.
Use for liver dysfunction
For patients with mild or moderate liver dysfunction, no special dose selection is required.
There are no data on the nature of the pharmacokinetics of montelukast in patients with severe liver failure (more than 9 points on the Child-Pugh scale).
Use for renal impairment
For patients with renal failure, no special dose selection is required.
Use in elderly patients
For elderly patients no special dose selection is required.
special instructions
The effectiveness of oral Singulair ® in the treatment of acute attacks of bronchial asthma 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 medications to relieve asthma attacks (short-acting inhaled beta 2 agonists).
You should not stop taking Singulair ® during an exacerbation of asthma and the need to use emergency medications (short-acting inhaled beta 2 agonists) to relieve attacks.
Patients with a confirmed allergy to acetylsalicylic acid and other 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 bronchoconstriction caused by NSAIDs.
The dose of inhaled corticosteroids used simultaneously with the drug Singulair ® can be gradually reduced under the supervision of a physician, however, an abrupt replacement of inhaled or oral corticosteroids with the drug Singulair ® cannot be carried out.
Neuropsychiatric disorders have been described in patients taking Singulair ® . Given that these symptoms could be caused by other factors, it is unknown whether they are related to taking Singulair ® . Physicians should discuss these side effects with patients and/or their parents/guardians. Patients and/or their caregivers should be advised that if such symptoms occur, they should notify their physician.
Reducing the dose of systemic corticosteroids in patients receiving anti-asthma drugs, including leukotriene receptor blockers, was accompanied in rare cases by the appearance of one or more of the following reactions: eosinophilia, rash, worsening of pulmonary symptoms, cardiac complications and/or neuropathy, sometimes diagnosed as Churg-Strauss syndrome, systemic eosinophilic vasculitis. Although the cause-and-effect relationship of these adverse reactions with therapy with leukotriene receptor antagonists has not been established, when reducing the dose of systemic corticosteroids in patients receiving Singulair ® , care must be taken and appropriate clinical monitoring should be carried out.
10 mg film-coated tablets contain lactose monohydrate. Patients with a rare form of hereditary galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption should not be prescribed Singulair ® in this dosage form.
Singulair ® 5 mg chewable tablets contain aspartame, a source of phenylalanine. Patients with phenylketonuria should be informed that each 5 mg chewable tablet contains aspartame equivalent to 0.842 mg of phenylalanine. Singulair ® 5 mg chewable tablets are not recommended for use in patients with phenylketonuria.
Impact on the ability to drive vehicles and operate machinery
There is no evidence that taking Singulair ® affects the ability to drive a car or drive machinery.
In the conditions of modern society and unfavorable environmental conditions, the number of allergy sufferers is constantly growing. The range of medications aimed at suppressing allergic reactions and eliminating signs of bronchial asthma is also increasing. Patients often argue whether Montelar or Singulair is better, but this question can only be answered individually. In fact, these antihistamines are analogues that have characteristic features and are distinguished by their selective action in the body.
Comparison of drugs
To determine an effective allergy treatment, the first step is to perform a blood test to determine the effective synthetic component against the allergen. A good drug, Singulair, in its pharmacological properties, is a leukotriene receptor blocker and has antibronchospastic and anti-inflammatory properties.
The drug Montelar is another antibronchoconstrictor drug, which is available in the form of chewable tablets, and helps with bronchial asthma, seasonal and allergic rhinitis, and progressive bronchospasm. The instructions for use tell you how to take the medicine correctly, and the practitioner individually determines the choice of medication.
Main differences
- The medicine Singulair is an analogue of Montelar, which is recommended for intolerance to the active ingredients of the first medication. There are other differences between these medications that determine the choice of intensive care regimen in a specific clinical picture. So:
- Montelar is better known as Montelukast, and in the body it supports bronchial hyperactivity, reduces the formation of secretions and prevents swelling. The second medication is more suitable for the treatment of rhinitis of allergic origin.
- Singulair has more side effects, some of which are associated with disturbances in emotional balance and increased excitability. The second medicine in this regard acts in the body in the so-called “gentle mode”.
- Montelar, being a Turkish drug, costs much less than Singulair from the Netherlands, although the therapeutic effect is no worse. Therefore, the patient has the opportunity to save some money on allergy treatment.
- Singulair can be prescribed to young patients aged 2 years and older, while the use of the antiallergic drug Montelar is allowed only from the age of six.
- It is much easier to find reviews about Turkish allergy medicine on medical forums, but notes about products from the Netherlands are very rare due to the high cost of the latter.
Reviews about Montelar
Since this Turkish drug is part of a complex treatment, it is difficult to judge its therapeutic effect. The medicine is reliable, does not cause outrage on the part of patients, and is recommended by the attending physician. Here's what allergy sufferers think about this pharmacological prescription:
- I took Montelar (Montelukast 5 mg) in full course for 2 weeks, and managed to suppress the frequent attacks of bronchial asthma. The disease cannot be completely cured in this way, but the period of remission has become longer.
- The medicine is effective, in my case it eliminates food allergic reactions. However, its effect gradually weakens, so it is better to alternate these types of medications.
Reviews about Singulair
It is more difficult to find notes about such a medication, since Singulair (Singlon) is an imported, expensive drug. Doctors are confident that if you take such pills in full, the therapeutic effect will be almost immediate. Skin rashes disappear, bronchial asthma attacks do not bother you, and inner peace appears. There is not a single review on thematic forums, and all of them are positive:
- Singulair is expensive, but the resulting effect is worth it. For chronic allergy sufferers, this is an ideal remedy because it quickly relieves signs of inflammation and makes the skin smooth and even.
- The drug does not cause side effects, acts quickly, and is not addictive. The only drawback is the high price, but the main thing is to feel the desired result.
What's better?
It is advisable to buy an effective drug that will help cure an allergic disease, even a chronic one. The effectiveness of Singulair is beyond doubt, but buying such a medicine in a pharmacy is very problematic. In addition, it is recommended to correctly select other medications in one treatment regimen, and then an integrated approach to the problem will ensure a sustainable hypoallergenic effect. In this matter, you need to individually contact a specialist.
What is more effective?
In fact, these are complete analogues, only Singulair is expensive, Montelar is a cheaper medical drug. Patients came to the general conclusion that the therapeutic effect does not depend on the price, so it is better not to overpay. The Turkish medicine is more effective in its pharmacological properties, since more patients were personally convinced of its therapeutic effect and even cured bronchial asthma. Opinions about Singulair are more restrained, and doctors do not recommend experimenting with your own health again.
It only remains to add that both medications effectively suppress bronchospasm and provide a long period of remission. However, the final choice of medication still remains with the attending physician.
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In people suffering from allergic rhinitis or asthma, leukotriene-mediated effects are responsible for triggering the bronchospasm mechanism. At the same time, active secretion of sputum begins, and bronchial patency decreases. The number of eosinophils increases.
This condition cannot be left unattended. It is necessary to block cysteinyl leukotriene receptors located in the respiratory organs. Drugs containing the active ingredient montelukast are able to bind to special substances and inhibit the process of bronchoconstriction that occurs in people suffering from asthma.
The most famous drug with the specified active ingredient is Singulair. The instructions (reviews about the product only confirm this) indicate that it is capable of suppressing bronchospasm at any stage. Moreover, the effect appears even when taking low doses of the drug. After taking the drug, the process of expanding the lumen of the bronchi begins.
The specified Italian drug is produced in the form of chewable tablets or coated tablets, on one side of which there should be the inscription MSD 275 or MSD 117, and on the other - SINGULAIR. In the first tablets, the dosage of montelukast sodium is 5.2 mg, in the second - 10.4 mg.
Singulair tablets are classified as anti-asthma drugs. They prevent bronchospasm that can develop when inhaling cysteinyl leukotriene LTD4.
Singulair is prescribed as a preventive or therapeutic agent. The drug is used to prevent the development or long-term treatment of bronchial asthma, including for:
Preventing the occurrence of night or daytime symptoms of the disease;
Preventing the development of bronchospasm during physical activity;
Treatment of patients with revealed sensitivity to acetylsalicylic acid.
The therapeutic effect is achieved already on the first day of taking Singulair. The drug can be taken both during the period of exacerbation of asthma and during the period of reduction of its manifestations. It can be used simultaneously with other bronchodilators and inhaled glucosteroids.
Despite the high effectiveness of the drug and its indispensability for certain people, many doubt and wonder whether it is worth buying it. The reason for such fluctuations is the cost of Singular. The price of a package containing 14 tablets is about 1000 rubles. In this case, the prescribed dosage does not affect the cost. The price of tablets containing 4, 5 or 10 mg of montelukast is practically the same. In some pharmacies you can find them for 864, but there are those where they cost 1045 rubles.
Having learned about the cost of this drug, many begin to look for analogues of Singular. There are now several types of products on sale in which the active ingredient is montelukast. Moreover, some of them are noticeably cheaper than the main drug, although their composition does not differ significantly.
Possible substitutes include such products as “Singlon”, “Montelast”, “Ektalust”, “Montelar”.
All analogues of Singular are identical products. After all, the main component in all tablets is montelukast. Regardless of the trade name of the product, the active substance found in it is quickly absorbed from the gastrointestinal tract.
At the same time, the instructions for the drug “Singulair” indicate that eating regular food does not in any way affect the effectiveness of the medication. When 5 mg chewable tablets are taken on an empty stomach in adults, the maximum concentration of the drug in the blood plasma occurs after 2 hours. And for film-coated tablets at a dosage of 10 mg, this period is 3 hours.
Montelukast is metabolized in the liver. It is completely excreted from the body in feces within 5 days. This confirms that this drug is excreted in the bile.
This product is available in the form of chewable tablets. The concentration of the active substance can be 4.16 or 5.2 mg. The tablets are lenticular in shape, pale yellow in color, with a distinct cherry odor. These tablets are produced by Gedeon Richter Poland.
Many people want to figure out what to buy - “Singlon” or “Singular”? What's better? It's difficult to choose. After all, these drugs contain the same active ingredient. They differ only in the concentration of the dye and the substance mannitol. The dosage of the main active and other auxiliary components in these drugs is absolutely the same.
As with taking the drug “Singulair”, when using the drug “Singlon”, a day is enough for the therapeutic effect to occur. But it is recommended to take the drug both during remission and during exacerbation of asthma.
According to the instructions for the Singulair product, the tablets must be taken once a day, without focusing on food intake. The only thing that matters is the time of use of the drug. For example, if you need to treat asthma, doctors recommend taking it at night. And to get rid of allergic rhinitis, you can drink it at any convenient time. If the patient suffers from both asthma and a runny nose, then it is better to move the appointment time to the evening hours.
Children aged 2 to 5 years are prescribed this drug or analogues of Singulair at a dosage of 4 mg/day. No special dose selection is required. From 6 to 14 years of age, you need to take a 5 mg tablet every day. But adolescents over 15 years of age and adult patients should take a different form of the drug. They need film-coated tablets. The concentration of the active substance in them is 10 mg.
By the way, the instructions for the drug “Singlon” indicate that you need to drink it on an empty stomach. This should be done 1 hour before meals or 2 hours after meals. The same is indicated in the instructions for Montelast tablets.
All drugs in which the main active ingredient is montelukast prevent the development of bronchospasm. Often doctors do not prescribe a specific drug. They say that it is necessary to use medications that contain montelukast. Patients themselves can choose whether to buy “Singlon” or “Singular”. Which is better, you will have to find out on your own. The patient can also buy other analogues - Montelast, Ektalust, Montelar.
These medications are produced by different manufacturers. This is one of the reasons for such a significant difference in cost. One of the most expensive is Singular. The price for a package of 14 tablets is about 1000 rubles. A more affordable product is “Singlon”. A package of 28 tablets costs about 760 rubles. The price of the drug Montelast is approximately the same. But you can also find packs of 98 pieces on sale. The price of such a box is about 2150 rubles. for tablets with a dosage of 4 mg, and about 2500 rubles. – for a dosage of 10 mg.
The drug "Ektalust" is produced in the form of chewable tablets of 14 pieces. packaged. It costs from 350 rubles. But the price of Montelar exceeds 900 rubles. for 14 tablets, it is almost the same as for the drug “Singulair”.
Asthma does not allow the patient to be particularly picky. To prevent attacks, many patients are forced to choose the most suitable drug and take it both during periods of deterioration and during periods of remission.
Products based on montelukast can reduce the manifestations of bronchial asthma and prevent attacks. This is evidenced by the instructions supplied with the drug “Singulair”. Reviews for children who were given the drug indicate that taking it helps prevent the transition of any cold to bronchitis. Including the obstructive form. Doctors often advise drinking it in courses of 2-3 months. But many choose a different regimen for taking the drug. They drink it for 2-4 weeks. Courses can be repeated as needed.
Other analogues of Singular can be used in the same way. They are prescribed not only to asthmatics, but also to people suffering from allergies, which manifest themselves as a runny nose or bronchospasm. Timely use of montelukast can prevent the development of asthma.
It also works to restore brain cells.
In general, it works with age-related excessive activation of the immune system, which for some reason attacks the brain, forming chronic foci of inflammation.
They tested it on rats, the essence of the experiment is harsh. The rat is thrown into the water in a pool, where at some depth there is a small platform on which to sit. The rats begin to swim chaotically until they come across this platform. After some time (I don’t know for sure a week or a month), the rats are thrown into the water again. Young rats, without question, immediately swim in a straight line to this platform, and the old ones begin to swim chaotically, because they have forgotten the topic.
So, after the singular course, brain functionality was restored and the rats, just like the young ones, swam to the platform in a straight line.
SINGULAR®
Trade name: SINGULAIR® / SINGULAIR®
International nonproprietary name: montelukast
Dosage form: film-coated tablets / chewable tablets
1 film-coated tablet contains:
Active substance: montelukast - 10 mg;
Excipients: microcrystalline cellulose, lactose, croscarmellose sodium, hyprolose, magnesium stearate.
The composition of the coating covering the tablet: hyprolose, hypromellose, titanium dioxide, dyes iron oxide red and iron oxide yellow and carnauba wax.
1 chewable tablet contains:
Active substance: montelukast - 5 mg;
Excipients: mannitol, microcrystalline cellulose, hyprolose, red iron oxide dye, croscarmellose sodium, cherry flavor, aspartame and magnesium stearate.
Description:
10 mg film-coated tablets: light cream, square, round-edged, film-coated tablets debossed with "MSD 117" on one side and "SINGULAIR" on the other side.
5 mg chewable tablets: pink, round, biconvex tablets embossed with "MSD 275" on one side and "SINGULAIR" on the other side.
Pharmacotherapeutic group: Leukotriene receptor blocker.
ATX code: R03DC03
Pharmacological properties:
Pharmacodynamics
Montelukast inhibits cysteinyl leukotriene receptors of the airway epithelium, thereby simultaneously having the ability to inhibit bronchospasm caused by inhaled cysteinyl leukotriene LTD4 in patients with bronchial asthma. A dose of 5 mg is sufficient to relieve bronchospasm induced by LTD4. The use of montelukast in doses exceeding 10 mg per day, taken once, does not increase the effectiveness of the drug.
Montelukast causes bronchodilation within 2 hours after oral administration; and may complement bronchodilation caused by β2-adrenergic agonists.
Pharmacokinetics
Suction
Montelukast is rapidly and almost completely absorbed after oral administration. Eating normal food does not affect the bioavailability and maximum plasma concentration (Cmax) of film-coated tablets and chewable tablets. In adults, when taking 10 mg film-coated tablets on an empty stomach, Cmax is achieved after 3 hours. Bioavailability when taken orally is 64%.
When taking 5 mg chewable tablets on an empty stomach, Cmax in adults is achieved after 2 hours. Bioavailability is 73%.
Distribution
Montelukast is more than 99% bound to plasma proteins. The volume of distribution of montelukast averages 8-11 liters.
Metabolism
Montelukast is actively metabolized in the liver. When using therapeutic doses, the concentration of montelukast metabolites in plasma at steady state in adults and children is not determined.
It is assumed that the cytochrome P450 CYP isoenzymes (3A4 and 2C9) are involved in the metabolism of montelukast, while at therapeutic concentrations montelukast does not inhibit the cytochrome P450 CYP isoenzymes: 3A4, 2C9, 1A2, 2A6, 2C19 and 2D6.
Removal
The clearance of montelukast averages 45 ml/min in healthy adults. After oral administration of montelukast, 86% of its amount is excreted in the feces within 5 days and less than 0.2% in the urine, confirming that montelukast and its metabolites are excreted almost exclusively in bile.
The half-life of montelukast in young healthy adults ranges from 2.7 to 5.5 hours. The pharmacokinetics of montelukast remains almost linear when administered orally at doses above 50 mg. When taking montelukast in the morning and evening hours, no differences in pharmacokinetics were observed. When taking 10 mg film-coated tablets once a day, a moderate (about 14%) cumulation of the active substance in plasma is observed.
Features of pharmacokinetics in different groups of patients
The pharmacokinetics of montelukast are similar in women and men.
Elderly patients
When taken orally once daily, 10 mg film-coated tablets have a similar pharmacokinetic profile and bioavailability in elderly and young patients.
Liver failure
In patients with mild to moderate hepatic impairment and clinical manifestations of cirrhosis, a slowdown in the metabolism of montelukast was observed, accompanied by an increase in the area under the concentration-time pharmacokinetic curve (AUC) by approximately 41% after a single dose of 10 mg. The elimination of montelukast in these patients is slightly increased compared to healthy subjects (average half-life of 7.4 hours). No dose adjustment of montelukast is required for patients with mild to moderate hepatic impairment. There are no data on the nature of the pharmacokinetics of montelukast in patients with severe liver failure (more than 9 points on the Child-Pugh scale).
There were no differences in clinically significant pharmacokinetic effects in patients of different races.
Kidney failure
Because montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast in patients with renal impairment have not been evaluated. No dose adjustment is required for this group of patients.
Indications for use:
Prevention and long-term treatment of bronchial asthma in adults and children from 6 years of age, including prevention of daytime and nighttime symptoms of the disease, treatment of aspirin-sensitive patients with bronchial asthma and prevention of exercise-induced bronchospasm.
Relief of daytime and nighttime symptoms of seasonal allergic rhinitis (in adults and children over 6 years of age) and persistent allergic rhinitis (in adults and children over 6 years of age)
Contraindications:
Hypersensitivity to any of the components of the drug.
Children's age up to 6 years.
Use during pregnancy and lactation:
SINGULAR should be used during pregnancy and lactation only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Directions for use and dosage:
Orally 1 time per day, regardless of meals. To treat bronchial asthma, Singulair should be taken in the evening. When treating allergic rhinitis, the dose can be taken at any time of the day at the request of the patient. Patients suffering from bronchial asthma and allergic rhinitis should take one Singulair tablet once a day in the evening.
Adults aged 15 years and older
The dose for adults and children over 15 years of age is one 10 mg film-coated tablet per day.
Children aged 6 to 14 years
The dosage for children 6-14 years old is one chewable tablet 5 mg per day. No dosage adjustment is required for this age group.
The therapeutic effect of SINGULAR on indicators reflecting the course of bronchial asthma develops during the first day. The patient should continue to take SINGULAR both during the period of achieving control over the symptoms of bronchial asthma, and during periods of exacerbation of bronchial asthma.
For elderly patients, patients with renal failure, as well as patients with mild or moderate liver dysfunction, as well as depending on gender, no special dose selection is required.
Prescribing SINGULAR simultaneously with other types of treatment for bronchial asthma
SINGULAR can be added to the patient's treatment with bronchodilators and inhaled glucocorticosteroids (See Section "Interaction with other drugs").
Side effect:
In general, SINGULAR is well tolerated. Side effects are usually mild and usually do not require discontinuation of treatment. The overall incidence of side effects reported with SINGULAR is comparable to that for placebo:
hypersensitivity reactions (including anaphylaxis, angioedema, rash, itching, urticaria and very rarely eosinophilic liver infiltrates); erythema nodosum, unusual vivid dreams; hallucinations; drowsiness; irritability; agitation, including aggressive behavior; fatigue; suicidal thoughts and suicidal behavior (suicidality); insomnia; paresthesia/hypesthesia and very rarely – seizures; nausea, vomiting, diarrhea, abdominal pain; headache; arthralgia; myalgia; muscle cramps; tendency to increased bleeding, the formation of subcutaneous hemorrhages; heartbeat; swelling.
Overdose:
There are no data on overdose symptoms when taking SINGULAR in patients with bronchial asthma at a dose exceeding 200 mg/day for 22 weeks and at a dose of 900 mg/day for 1 week.
There are reports of acute overdose of montelukast in children (taking at least 150 mg of the drug per day). Clinical and laboratory data indicate that the safety profile of SINGULAR in children corresponds to the safety profile in adults and elderly patients. The most common adverse events were thirst, drowsiness, mydriasis, hyperkinesis and abdominal pain.
Treatment is symptomatic.
There are no data on the possibility of removing montelukast by peritoneal dialysis or hemodialysis.
Interaction with other drugs:
SINGULAR can be prescribed together with other drugs traditionally used for the prevention and long-term treatment of bronchial asthma. The recommended clinical dose of montelukast did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
The AUC is reduced in individuals concomitantly receiving phenobarbital (by approximately 40%), however, no adjustment of the SINGULAR dosage regimen is required in such patients.
Treatment with bronchodilators: SINGULAR can be added to the treatment of patients whose asthma is not controlled by bronchodilators alone. When a therapeutic effect is achieved (usually after the first dose) during therapy with SINGULAR, the dose of bronchodilators can be gradually reduced.
Inhaled glucocorticosteroids: Treatment with SINGULAR provides an additional therapeutic effect to patients receiving treatment with inhaled glucocorticosteroids. Once the patient's condition has stabilized, the dose of glucocorticosteroids may be reduced. The dose of glucocorticosteroids should be reduced gradually, under the supervision of a physician. In some patients, inhaled glucocorticosteroids may be completely discontinued. An abrupt replacement of inhaled glucocorticosteroid therapy with SINGULAR is not recommended.
Special instructions:
SINGULAR tablets are not recommended for the treatment of acute attacks of bronchial asthma. In acute cases of bronchial asthma, patients should be prescribed medications to relieve and prevent asthma attacks.
The dose of inhaled glucocorticosteroids used simultaneously with SINGULAR can be gradually reduced under the supervision of a physician. SINGULAR cannot be used as a substitute for inhaled or oral glucocorticosteroids.
Reducing the systemic dose of corticosteroids in patients receiving antiasthmatic drugs, including leukotriene receptor blockers, was accompanied in rare cases by the appearance of one or more of the following phenomena: eosinophilia, vascular rash, worsening of pulmonary symptoms, cardiac complications and/or neuropathy, sometimes diagnosed as Charg syndrome - Ostrich – systemic eosinophilic vasculitis. Although a causal relationship between these adverse events and leukotriene receptor antagonist therapy has not been established, caution and appropriate clinical monitoring should be used when reducing the systemic dose of glucocorticosteroids in patients taking SINGULAR.
Use in elderly patients
There were no age-related differences in the efficacy and safety profiles of SINGULAR.
Impact on the ability to drive a car or move machinery.
There is no evidence that taking SINGULAR affects the ability to drive a car or drive machinery.
Release form:
Chewable tablets 5 mg or film-coated tablets 10 mg.
7 chewable tablets of 5 mg or 7 film-coated tablets of 10 mg are placed in a blister.
1, 2 or 4 blisters along with instructions for use are placed in a cardboard box.
Storage conditions:
List B.
At a temperature not exceeding 30°C, protected from moisture and light and out of the reach of children.
Best before date:
The shelf life for 5 mg chewable tablets is 2 years.
The shelf life for 10 mg film-coated tablets is 3 years.
Do not use after the expiration date indicated on the package.
Preparations containing leukotriene receptor blockers (ATC R03DC):
| Frequent release forms of Montelukast (Montelukast, ATC code R03DC03) | |||
|---|---|---|---|
| Name, manufacturer | Release form | Pack, pcs. | Price, r |
| Singulair, Netherlands, Merck Sharp Dome | table chewing 4mg | 14 | 680-1860 |
| 28 | 1.300- 2.200 | ||
| table chewing 5mg | 7 | 1070-1370 | |
| 14 | 870-1.940 | ||
| 28 | 1.290-2.300 | ||
| table 10mg | 14 | 950-1.800 | |
| 28 | 1.490-2.380 | ||
| Almont, Malta, Actavis |
table chewing 4mg | 28 | 600-1.310 |
| 98 | 1.820-2.950 | ||
| table chewing 5mg | 28 | 760-1.480 | |
| 98 | 1.820-3.370 | ||
| table 10mg | 28 | 840-1.650 | |
| 98 | 1.820-3.800 | ||
| Montelar, Türkiye, Sandoz | table chewing 4mg | 14 | 420-1.080 |
| 28 | 680-1.380 | ||
| table chewing 5mg | 14 | 380-950 | |
| 28 | 720-1.500 | ||
| table 10mg | 14 | 380-980 | |
| 28 | 680-1.500 | ||
| Singlon, Poland, Gedeon Richter | table 4mg | 28 | 730-1.600 |
| table 5mg | 14 | 400-540 | |
| 28 | 670-1.400 | ||
| table 10mg | 28 | 750-1.520 | |
| Montelukast (Montelukast, Russia, Vertex) | table chewing 5mg | 10 | 420-530 |
| 28 | 580-1.000 | ||
| tablet 10mg | 30 | 505-930 | |
| Rare forms of release of Montelukast (Montelukast, ATC code R03DC03) | |||
| Name, manufacturer | Release form | Pack, pcs. | Price, r |
| Glemont, India, Glenmark | table chewing 4mg | 28 | 580-800 |
| table chewing 5mg | 28 | 550-770 | |
| Ektalust, Russia, Kanonpharma | table chewing 4mg | 14 | No |
| table chewing 5mg | 14 | 440-550 | |
| table 10mg | 14 | 490-680 | |
| Discontinued release forms of Zafirlukast (Zafirlukast, ATC code R03DC01) | |||
| Accolate, England, Astra Zeneca | table 20mg | 28 | No |
Commercial names abroad (abroad) - for Montelukast - Airlukast, Asthator, Asthmatin, Emlucast, Lukotas, Monkasta, Montair, Montecad, Montek, Montelo-10, Monteflo, Monti, Odimont, Singulair; for Zafirlukast - Accolate, Accoleit, Aeronix, Azimax, Olmoran, Resma, Vanticon, Zuvair.
Singulair (Montelukast) in tablets 5 and 10 mg - instructions for use.
Clinical and pharmacological group:
Leukotriene receptor antagonist. A drug for the treatment of bronchial asthma and allergic rhinitis.
pharmachologic effect
Leukotriene receptor antagonist. Montelukast selectively inhibits CysLT1 receptors of cysteinyl leukotrienes (LTC4, LTD4, LTE4) of the respiratory tract epithelium, and also prevents bronchospasm in patients with bronchial asthma caused by inhalation of cysteinyl leukotriene LTD4. A dose of 5 mg is sufficient to relieve bronchospasm induced by LTD4. The use of montelukast in doses exceeding 10 mg once a day does not increase the effectiveness of the drug.
Montelukast causes bronchodilation within 2 hours after oral administration and may be additive to the bronchodilation caused by beta2-agonists.
Pharmacokinetics
Suction
After oral administration, montelukast is quickly and almost completely absorbed from the gastrointestinal tract. Eating normal food does not affect plasma Cmax or the bioavailability of film-coated tablets and chewable tablets. In adults, when taking film-coated tablets on an empty stomach at a dose of 10 mg, Cmax in blood plasma is achieved after 3 hours. Bioavailability when taken orally is 64%.
After oral administration on an empty stomach of the drug in the form of chewable tablets at a dose of 5 mg, Cmax in adults is achieved after 2 hours. Bioavailability is 73%.
Distribution
The binding of montelukast to plasma proteins is more than 99%. Vd averages 8-11 liters.
With a single dose of the drug in the form of film-coated tablets at a dose of 10 mg 1 time per day, a moderate (about 14%) cumulation of the active substance in plasma is observed.
Metabolism
Montelukast is actively metabolized in the liver. When used in therapeutic doses, the concentration of montelukast metabolites in plasma at steady state in adults and children is not determined.
It is assumed that cytochrome P450 isoenzymes (3A4 and 2C9) are involved in the metabolism of montelukast, while at therapeutic concentrations montelukast does not inhibit cytochrome P450 isoenzymes: 3A4, 2C9, 1A2, 2A6, 2C19 and 2D6.
Removal
T1/2 of montelukast in young healthy adults ranges from 2.7 to 5.5 hours. The clearance of montelukast in healthy adults averages 45 ml/min. After oral administration of montelukast, 86% is excreted in feces within 5 days and less than 0.2% is excreted in urine, confirming that montelukast and its metabolites are excreted almost exclusively in bile.
Indications for use of the drug SINGULAR®
Prevention and long-term treatment of bronchial asthma in adults and children aged 6 years and older, including:
- prevention of day and night symptoms of the disease;
- treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid;
- prevention of bronchospasm caused by physical activity.
Relief of daytime and nighttime symptoms of seasonal allergic rhinitis (in adults and children aged 6 years and older) and persistent allergic rhinitis (in adults and children aged 6 years and older).
Directions for use and dosage
The drug is taken orally 1 time per day, regardless of meals. For the treatment of bronchial asthma, Singulair® should be taken in the evening. When treating allergic rhinitis, the drug can be taken at any time of the day. In case of combined pathology (bronchial asthma and allergic rhinitis), the drug should be taken in the evening.
For adults and adolescents aged 15 years and older, the drug is prescribed at a dose of 10 mg (1 film-coated tablet) per day.
Children aged 6 to 14 years are prescribed a dose of 5 mg (1 chewable tablet) per day. No dose adjustment is required for this age group.
The therapeutic effect of the drug Singulair® on indicators reflecting the course of bronchial asthma develops during the first day. The patient should continue to take Singulair® both during the period of achieving control of bronchial asthma symptoms and during the period of exacerbation of the disease.
For elderly patients, patients with renal failure, patients with mild or moderate liver dysfunction, and also depending on gender, no special dose adjustment is required.
Singulair® can be added to treatment with bronchodilators and inhaled corticosteroids.
Side effect
In general, Singulair® was well tolerated. 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.
Adults and children aged 15 years and older with bronchial asthma
In two similarly designed, 12-week placebo-controlled clinical trials, the only side effects assessed as drug-related that occurred in >1% of patients treated with Singulair® and more frequently than in patients treated with placebo 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.
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 adverse effect assessed as drug-related that occurred 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 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 side effect profile did not change.
Adults and children aged 15 years and older with seasonal allergic rhinitis
Patients took Singulair® once a 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 adverse reactions 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.
Children aged 2 to 14 years with seasonal allergic rhinitis
Patients took Singulair® once a day in the evening; in general, the drug was well tolerated. The safety profile of the drug 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 receiving Singulair®, and more often than in the group of patients receiving placebo.
Adults and children aged 15 years and older with year-round allergic rhinitis
Patients took Singulair® once a 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 side effects considered to be related to the drug that were observed in >1% of patients receiving Singulair®, and more often than in the group of 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 9929 patients receiving Singulair® and the 7780 patients receiving placebo in these studies, 1 patient was identified as suicidal in the group of patients receiving Singulair®. 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® and the 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).
Side effects reported during post-marketing use of the drug
From the blood coagulation system: increased tendency to bleeding.
From the immune system: hypersensitivity reactions, incl. anaphylaxis; very rarely (<1/10 000) - эозинофильная инфильтрация печени.
From the psyche: agitation (including aggressive behavior or hostility), anxiety, depression, disorientation, pathological dreams, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thoughts and behavior (suicidality), tremor.
From the nervous system: dizziness, drowsiness, paresthesia/hypesthesia; very rarely (<1/10 000) - судороги.
From the cardiovascular system: rapid heartbeat.
From the respiratory system, chest and mediastinal organs: 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) - гепатит (включая холестатические, гепатоцеллюлярные и смешанные поражения печени).
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.
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.
Contraindications to the use of SINGULAR®
- children under 6 years of age;
- hypersensitivity to the components of the drug.
Use of SINGULAR® during pregnancy and breastfeeding
Clinical studies of the drug Singulair® have not been conducted in pregnant women. Singulair® should be used during pregnancy and breastfeeding only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.
During post-registration use of the drug Singulair®, the development of congenital limb defects was reported in newborns whose mothers took Singulair® during pregnancy. Most of these women also took other medications to treat asthma during pregnancy. A cause-and-effect relationship between taking Singulair® and the development of congenital limb defects has not been established.
It is not known whether montelukast is excreted in breast milk. Since many drugs are excreted in breast milk, this must be taken into account when prescribing Singulair® to breastfeeding mothers.
Use for liver dysfunction
For patients with mild or moderate liver dysfunction, no special dose selection is required.
There are no data on the nature of the pharmacokinetics of montelukast in patients with severe liver failure (more than 9 points on the Child-Pugh scale).
Use for renal impairment
For patients with renal failure, no special dose selection is required.
Use in elderly patients
For elderly patients, no special dose selection is required.
Use in children
Contraindication: children under 6 years of age. Children aged 6 to 14 years are prescribed a dose of 5 mg (1 chewable tablet) per day. No dose adjustment is required for this age group.
special instructions
The effectiveness of oral Singulair® in the treatment of acute attacks of bronchial asthma 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 medications to relieve asthma attacks (short-acting inhaled beta2-agonists).
You should not stop taking Singulair® during an exacerbation of asthma and the need to use emergency medications (short-acting inhaled beta2-agonists) to relieve attacks.
Patients with a confirmed allergy to acetylsalicylic acid and other 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 bronchoconstriction caused by NSAIDs.
The dose of inhaled corticosteroids used simultaneously with the drug Singulair® can be gradually reduced under the supervision of a physician, however, an abrupt replacement of inhaled or oral corticosteroids with the drug Singulair® cannot be carried out.
Neuropsychiatric disorders have been described in patients taking Singulair®. Given that these symptoms could be caused by other factors, it is unknown whether they are related to taking Singulair®. Physicians should discuss these side effects with patients and/or their parents/guardians. Patients and/or their caregivers should be advised that if such symptoms occur, they should notify their physician.
Reducing the dose of systemic corticosteroids in patients receiving anti-asthma drugs, including leukotriene receptor blockers, was accompanied in rare cases by the appearance of one or more of the following reactions: eosinophilia, rash, worsening of pulmonary symptoms, cardiac complications and/or neuropathy, sometimes diagnosed as Churg-Strauss syndrome, systemic eosinophilic vasculitis. Although the cause-and-effect relationship of these adverse reactions with therapy with leukotriene receptor antagonists has not been established, when reducing the dose of systemic corticosteroids in patients receiving Singulair®, caution and appropriate clinical monitoring must be performed.
10 mg film-coated tablets contain lactose monohydrate. Patients with a rare form of hereditary galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption should not be prescribed Singulair® in this dosage form.
Singulair® chewable tablets 5 mg contain aspartame, a source of phenylalanine. Patients with phenylketonuria should be informed that each 5 mg chewable tablet contains aspartame equivalent to 0.842 mg of phenylalanine. Singulair® chewable tablets 5 mg are not recommended for use in patients with phenylketonuria.
Impact on the ability to drive vehicles and operate machinery
There is no evidence that taking Singulair® affects the ability to drive a car or drive machinery.
Overdose
Symptoms of overdose were not identified during clinical studies of long-term (22 weeks) treatment with Singulair® in adult patients with bronchial asthma in doses up to 200 mg per day, or during short (about 1 week) clinical studies when taking the drug in doses up to 900 mg per day. day.
There have been cases of acute overdose of Singulair® (taking at least 1000 mg per day) in the post-registration period and during clinical trials in adults and children. Clinical and laboratory data indicated comparable safety profiles of Singulair® in children, adults and elderly patients. The most common symptoms were thirst, drowsiness, vomiting, psychomotor agitation, headache and abdominal pain. These side effects are consistent with the safety profile of Singulair®.
Treatment: symptomatic therapy. There is no specific information on the treatment of overdose of Singulair®. There are no data on the effectiveness of peritoneal dialysis or hemodialysis with montelukast.
Drug interactions
Singulair® can be prescribed together with other drugs that are usually used for the prevention and long-term treatment of bronchial asthma and/or the treatment of allergic rhinitis. Montelukast at the recommended therapeutic dose did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
When used concomitantly with phenobarbital, the AUC of montelukast decreased by approximately 40%, and no adjustment of the dosage regimen of Singulair is required.
In vitro studies have established that montelukast inhibits the CYP2C8 isoenzyme, however, an in vivo drug interaction study between montelukast and rosiglitazone (metabolized by the CYP2C8 isoenzyme) did not confirm that montelukast inhibits the CYP2C8 isoenzyme. Therefore, in clinical practice, the effect of montelukast on CYP2C8-mediated metabolism of a number of drugs, incl. paclitaxel, rosiglitazone, repaglinide.
Combination treatment with bronchodilators: Singulair® is a reasonable addition to bronchodilator monotherapy if the latter do not provide adequate control of bronchial asthma. Once the therapeutic effect of treatment with Singulair® is achieved, a gradual reduction in the dose of bronchodilators can begin.
Combined treatment with inhaled GCS: treatment with Singulair® provides an additional therapeutic effect in patients receiving inhaled GCS. Once the condition has stabilized, you can begin a gradual reduction in the dose of GCS under the supervision of a physician. In some cases, complete abolition of inhaled corticosteroids is acceptable, but abrupt replacement of inhaled corticosteroids with Singulair® is not recommended.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
List B. The drug should be stored out of the reach of children, protected from moisture and light at a temperature not exceeding 30°C. The shelf life of chewable tablets 5 mg is 2 years; film-coated tablets, 10 mg - 3 years.
The instructions are quoted from the Vidal pharmaceutical website.
Singulair (Montelukast) 4 mg chewable tablets - indications and dosage
Indications for use of the drug SINGULAR® chewable tablets 4 mg
- prevention and long-term treatment of bronchial asthma in children aged 2 years and older: to control daytime and nighttime symptoms of the disease;
- relief of symptoms of allergic rhinitis in children aged 2 years and older.
Dosage
The drug is taken orally 1 time per day, regardless of meals.
For bronchial asthma, 4 mg (1 tablet) is prescribed at night.
For bronchial asthma and allergic rhinitis, 4 mg (1 tablet) is prescribed at night.
For allergic rhinitis, 4 mg (1 tablet) per day is prescribed individually, depending on the time of greatest exacerbation of symptoms.
For children aged 2 to 5 years with bronchial asthma and/or allergic rhinitis, the dose is 4 mg (1 tablet) per day.
For children, elderly patients, patients with renal failure and patients with mild/moderate liver dysfunction, no special dose selection is required.
