Singular

Singular - an anti-inflammatory agent that affects the respiratory system.

Prevents the development of pathological mediators and spasm of the bronchi. It is prescribed for bronchial asthma and other severe allergic conditions. Used in emergency cases, refers to the prescription group of drugs.

The use of Singular in childhood is contraindicated up to 2 years. In this case, the smallest patients can be given only chewable tablets of 4 mg of the active ingredient. Chewable tablets of 5 mg are prescribed from the age of six, and tablets in the shell are allowed only from 15 years.

Clinical and pharmacological group

A leukotriene receptor antagonist. The drug for the treatment of bronchial asthma and allergic rhinitis.

Terms of sale from pharmacies

It is possible to buy under the prescription of the doctor.

Price

How much is Singular in pharmacies? The average price is at the level of1 200 rubles.

Composition and form of release

The preparation Singular is issued in the form of chewing tablets convex on both sides, pink. On one side of the tablet the name of the preparation is engraved with Latin letters. Tablets are packed in blisters of 7 pieces of 1-4 blisters in a cardboard box with the attached instructions.

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Each tablet contains 4 mg active ingredient montelukast sodium, as well as a number of auxiliary components, including aspartame and flavor "cherry".

pharmachologic effect

The Singular drug is a leukotriene receptor antagonist. The main component of the drug inhibits cysteinyl receptor leukotriene in the respiratory tract. In parallel, his ability to inhibit bronchospasm also manifests itself.

A dose of 5 mg is considered sufficient to stop this symptom. If montelukas is taken in a dose of 10 mg, the effect of the drug does not increase.

The active substance provokes bronchodilation in the course of 2 hours from the moment of application, and also shows the ability to supplement the bronchodilation, caused by beta2-adrenoblockers.

Indications for use

Taking into account the special mechanism of action of the preparation, the Singular is in demand:

with the allergic form of rhinitis in order to eliminate the daily symptoms of such a common cold and its nocturnal manifestations;
at a bronchial asthma for reduction of frequency of bronchospasm, including at an exercise stress and at night;
as a preventive agent that prevents allergic rhinitis and asthma attacks.

Some ENT doctors prescribe the Singular and adenoids, if the cause of an increase in tonsils is an allergic reaction.

Contraindications

Do not take this product with hypersensitivity to its components. Not suitable for children under 2 years.

Dosage and route of administration

As indicated in the instructions for use Singular is taken orally 1 time / day, regardless of food intake.

For treatment of bronchial asthma, the Singular preparation should be taken in the evening.
In the treatment of allergic rhinitis drug can be taken at any time of the day at the request of the patient.

Patients with bronchial asthma and allergic rhinitis should take 1 tablet of the preparation Singular 1 time per day.

Children aged 2 to 5 years:

With bronchial asthma and / or allergic rhinitis - 1 chewable tablet 4 mg per day.

General recommendations:

The therapeutic effect of the Singular preparation on the indicators reflecting the course of bronchial asthma develops during the first day. The patient should continue to take the Singular as in 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 insufficiency, as well as patients with mild or moderate violations of liver function, and also depending on sex, a special dose selection is not required.

Purpose of the preparation Singular at the same time as other types of treatment for bronchial asthma

The preparation Singular can be added to the treatment of the patient with bronchodilators and inhaled GCS.

Side effect

In general, the preparation of Singular is well tolerated by patients. Side effects are usually mild and, as a rule, do not require withdrawal of the drug. The overall incidence of side effects with Singular treatment is comparable to that of placebo.

Children aged 2 to 5 years with bronchial asthma:

In clinical studies of Singular, 573 patients aged 2-5 years took part. In a 12-week placebo-controlled clinical trial, the only adverse event (AE) evaluated as associated with admission of the drug observed in> 1% of patients taking the preparation of Singular, and more often than in the group of patients taking placebo, there was thirst. Differences in the frequency of this AE between the two treatment groups were statistically insignificant.

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

Children aged 2 to 14 years with seasonal allergic rhinitis:

In a 2-week placebo-controlled clinical trial using the Singular drug for the treatment of seasonal allergic rhinitis, 280 patients aged 2 to 14 years took part. Patients took Singular 1 time / day in the evening and were generally well tolerated. The safety profile of the drug in children was similar to the placebo safety profile. In this clinical study, AEs were not registered, which would be regarded as associated with taking the drug, would be observed in ≥1% of patients taking Singular, and more often than in the group of patients taking placebo.

Children aged 6 to 14 years with bronchial asthma:

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

In an 8-week, placebo-controlled clinical trial, a single AE, estimated as associated with drug intake, was observed > 1% of patients who took the Singular, and more often than in the group of patients taking placebo, had a headache. The frequency difference between the two treatment groups was statistically insignificant.

In studies to assess the rate of growth, the safety profile in patients of this age group was consistent with the previously described safety profile of the Singular preparation.

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

Adults and children aged 15 years and older with bronchial asthma:

In two 12-week, placebo-controlled clinical trials with a similar design, the only AEs evaluated as drug-related, observed in ≥1% of patients taking Singular, and more often than in the group of patients taking placebo, had abdominal pain and headache. Differences in the frequency of AE data between the two treatment groups were statistically insignificant. With longer treatment (within 2 years), the profile of AE did not change.

Adults and children aged 15 years and over with seasonal allergic rhinitis:

Patients took the Singular 1 time / day in the morning or evening, the overall tolerability of the drug was good, the drug safety profile was similar to the placebo safety profile. In placebo-controlled clinical trials, AEs were not recorded, which would be regarded as associated with admission of the drug would have been observed in ≥1% of patients taking the Singular and more often than in the placebo group. In a 4-week, placebo-controlled clinical study, the drug safety profile was similar to that in the 2-week study. The incidence of drowsiness when taking the drug in all studies was the same as when taking a placebo.

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

Patients took the Singular 1 time / day in the morning or evening, overall the tolerance of the drug was good. The drug safety profile was similar to the safety profile observed in the treatment of patients with seasonal allergic rhinitis and with placebo. In these clinical trials, AEs have not been reported that would be regarded as associated with taking the drug, would be observed in ≥1% of patients taking Singular, and more often than in the group of patients taking placebo. The incidence of drowsiness when taking the drug was the same as when taking a placebo.

Generalized analysis of the results of clinical trials:

A generalized analysis of 41 placebo-controlled clinical trials was conducted (35 studies involving patients aged 15 years and older, 6 studies involving patients aged 6 to 14 years) using approved methods of assessing suicidality. Among 9929 patients receiving the Singular and 7780 patients who received placebo in these studies, 1 patient was identified with a suicidal mood in the group of patients receiving the Singular. In none of the treatment groups were there any suicides, suicidal attempts or other preparatory actions that indicated suicidal behavior.

Separately, a generalized analysis of 46 placebo-controlled clinical trials (35 studies involving patients aged 15 years and older; 11 studies involving patients aged 3 months to 14 years) to assess adverse behavioral effects. Among the 1, 73 patients who took the Singular drug in these studies, and 8827 patients taking placebo, the percentage of patients with at least one adverse behavioral effect, was 2.73% among the patients receiving the Singular, and 2.27% among the patients receiving the placebo; the odds ratio was 1.12 (95% is the confidence interval [0.93, 1.36]).

AEs registered during the post-marketing use of the drug:

Infectious and parasitic diseases: upper respiratory tract infections.
From the side of the blood coagulation system: increased tendency to bleeding.
From the skin and subcutaneous tissues: a tendency to form hematomas, erythema nodosum, erythema multiforme, itching, rash.
Allergic reactions: angioedema, hives.
From the musculoskeletal system: arthralgia, myalgia, including muscle cramps.
From the urinary system: enuresis in children.
From the side of the immune system: hypersensitivity reactions, incl. anaphylaxis; very rarely (<1/10 000) - eosinophilic liver infiltration.
From the nervous system: dizziness, drowsiness, paresthesia / hypoesthesia; very rarely (<1/10 000) - convulsions.
From the cardiovascular system: heart palpitations.
From the respiratory system: nasal bleeding, pulmonary eosinophilia.
On the part of the digestive system: diarrhea, dyspepsia, nausea, vomiting, pancreatitis.
From the side of the psyche: agitation (including aggressive behavior or hostility), anxiety, depression, disorientation, attention impairment, pathological dreams, hallucinations, insomnia, memory disorders, psychomotor activity (including irritability, anxiety and tremor), somnambulism, suicidal thoughts and behavior (suicidal).
From the liver and biliary tract: increased activity of ALT and ACT in the blood; Very rarely (<1/10 000) - hepatitis (including cholestatic, hepatocellular and mixed liver damage).
Common reactions: asthenia (weakness) / fatigue, swelling, pyrexia.

Overdose

During the studies it was found that only very significant doses of montelukast (over 1000 mg per day) cause negative symptoms. With such a severe overdose, the patient develops drowsiness, headache, thirst, a fit of vomiting, or abdominal pain. Symptoms are used to treat this condition.

special instructions

The effectiveness of the drug for the treatment of acute attacks of bronchial asthma is not established, and therefore it is not recommended for use in such situations. Patients should always have emergency medication to relieve asthma attacks (short-acting inhaled β2-agonists).

There are reports of the occurrence of psychoneurological disorders in patients taking the drug. Considering that other factors can serve the development of these symptoms, their connection with taking the medication has not been proved. About these side effects and the need to report their occurrence, the doctor should be warned by patients and their parents / guardians.

Reception Singuljara do not stop in the period of an exacerbation of a bronchial asthma and at purpose or appointment of preparations of the emergency help for oppression of attacks (inhalation β2-agonists of short action).

With a confirmed allergy to ASA and other NSAIDs (non-steroidal anti-inflammatory drugs), these drugs should not be taken during the Singular therapy. Since it can not completely prevent the resulting NSAID bronchoconstriction, despite the improvement of respiratory function in allergic bronchial asthma.

With the simultaneous use of inhaled glucocorticosteroids, you should gradually reduce their dose under the supervision of a doctor, a sharp replacement for the Singular can not be done.

Reducing the dose of systemic GCS in patients taking antiasthmatics (including leukotriene receptor blockers) is rarely accompanied by the onset of one or more reactions: systemic eosinophilic vasculitis, cardiac complications and / or neuropathy, sometimes diagnosed as Chardz-Strauss syndrome, worsening of pulmonary symptoms, rash, eosinophilia. Despite the fact that the causal relationship of these side effects with the administration of leukotriene receptor antagonists is not established, with a decrease doses of systemic SCS in patients receiving the Singular should be careful and conduct appropriate clinical monitoring.

Interaction with other drugs

The singular is used with other medicines to treat bronchial asthma or allergic rhinitis.

With simultaneous administration with phenobarbital, Singular's effectiveness is reduced by 40%, which, however, does not require a change in the regimen of the drug.

The singular is a component of therapy of bronchial asthma, used in parallel with bronchodilators. When the patient's condition stabilizes, you can start to gradually reduce the dosage of the latter. The same applies to inhaled glucocorticosteroids.

Reviews

We offer you to get acquainted with the opinions of people who used the drug Singular:

Marina. Good afternoon. At the child (6) allergic rhinitis and predisposition to a bronchial asthma (since there is a cough a dry rare). According to the analysis, a minimal allergy to pollen and dust mites. The allergist has appointed or nominated Singuljar 5 mg - have spent on drink it or him 4 months, tussis only now has passed or has taken place also snot too.
Elena. The drug did not give any result, either in Russia a fake, or such a drug. Diagnosis in the child bronchial asthma. Attacks were less in the combination of Alvesco and Montelar. And the price of the Singular is very high with the fact that it should be taken at least 3 months.
Anna. Have registered to mum after he has started it to drink, terrible side effects have begun - insomnia, tremor of arms or hand, extremely depressive condition, palpitations, a strong decrease in art pressure, numbness of the extremities. It was very scary. I did not understand what was wrong with her. She asked that she drink, as it turned out only a singular. I read the side effects and was horrified. We refused these pills. Be careful with this medication. As a rule, doctors prescribe medications and they are sent to a pharmacy. Do not hesitate and do not warn about side effects.

The doctors' testimonies testify that this remedy is often prescribed for various respiratory diseases. Specialists and patients believe that the high price of the drug is absolutely justified.

Analogues

Instead of the Singular, it is possible to take the following analogues:

Almonte is a complete analogue of the preparation Singular. It is produced in chewable tablets, which are 4, 5 and 10 mg. In a suitable dosage, the drug can be taken in children from 2 years of age. With care, tablets are allowed to chew pregnant women.
Ektalust - domestic medicine, which as an active ingredient contains montelukast. On sale it is in chewable tablets for children from 2 years old and in ordinary tablets of 10 mg for patients over 15 years. The drug is acceptable for strict indications during pregnancy and lactation.
Singlon refers to the complete analogues of the Singular medicine. This is a high-quality drug, produced in chewable tablets of 4 mg (used in children 2-6 years) and 5 mg (developed for patients 6-14 years), as well as in regular tablets of 10 mg, which can be administered to patients older than 15 years, including women in the position and breastfeeding.
Montelar is a complete analog of the Singular. Produced in the form of chewable tablets for children who are 2 years old and in tablets, coated with a shell for people over 15 years.

Before buying an analogue, consult your doctor.

Singlon or Singular - which is better?

Singlon is one of the most popular analogues of the Singular. The latter drug for many has too high a price, so they try to look for substitutes for it. Questions "Singlon or Singular - which is better?" Can often be found on forums. Those who tried both means write that they did not notice the difference. At the same time, Singlon is twice cheaper.

Doctors report that there is a difference in efficiency and in most cases it is better to take the Singular, but if it is necessary to replace it, it is advisable to begin taking Singlon.

Shelf life and storage conditions

The drug should be kept out of the reach of children in a dark, cool place. The expiry date is indicated on the package, after which the medicine should be disposed of.