How long should my child take singulair

Singulair Paediatric 5 mg Chewable Tablets - Summary of Product Characteristics (SmPC)

This information is intended for use by health professionals

Singulair® Paediatric 5 mg chewable Tablets

One chewable tablet contains montelukast sodium, which is equivalent to 5 mg montelukast.

: This medicine contains 1.5 mg aspartame (E 951) per tablet.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

For the full list of excipients, see section 6.1.

Chewable tablet.

Pink, round, biconvex, diameter 9.5 mm with SINGULAIR engraved on one side and MSD 275 on the other.

Singulair is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short-acting β-agonists provide inadequate clinical control of asthma.

Singulair may also be an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.2).

Singulair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.

Posology

The recommended dose for paediatric patients 6-14 years of age is one 5 mg chewable tablet daily to be taken in the evening. If taken in connection with food, Singulair should be taken 1 hour before or 2 hours after food. No dosage adjustment within this age group is necessary.

General recommendations

The therapeutic effect of Singulair on parameters of asthma control occurs within one day. Patients should be advised to continue taking Singulair even if their asthma is under control, as well as during periods of worsening asthma.

No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients.

Montelukast is not recommended as monotherapy in patients with moderate persistent asthma. The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children with mild persistent asthma should only be considered for patients who do not have a recent history of serious asthma attacks that required oral corticosteroid use and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4. 1). Mild persistent asthma is defined as asthma symptoms more than once a week but less than once a day, nocturnal symptoms more than twice a month but less than once a week, normal lung function between episodes. If satisfactory control of asthma is not achieved at follow-up (usually within one month), the need for an additional or different anti-inflammatory therapy based on the step system for asthma therapy should be evaluated. Patients should be periodically evaluated for their asthma control.

When treatment with Singulair is used as add-on therapy to inhaled corticosteroids, Singulair should not be abruptly substituted for inhaled corticosteroids (see section 4.4).

10 mg tablets are available for adults and adolescents 15 years of age and older.

Paediatric population

Do not give Singulair 5 mg chewable tablets to children less than 6 years of age. The safety and efficacy of Singulair 5 mg chewable tablets in children less than 6 years of age has not been established.

4 mg chewable tablets are available for paediatric patients 2 to 5 years of age.

4 mg granules are available for paediatric patients 6 months to 5 years of age.

Method of administration

Oral use.

The tablets are to be chewed before swallowing.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available. If an acute attack occurs, a short-acting inhaled β-agonist should be used. Patients should seek their doctors' advice as soon as possible if they need more inhalations of short-acting β-agonists than usual.

Montelukast should not be abruptly substituted for inhaled or oral corticosteroids.

There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.

In rare cases, patients on therapy with anti-asthma agents including montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a causal relationship with leukotriene receptor antagonism has not been established, physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. Patients who develop these symptoms should be reassessed and their treatment regimens evaluated.

Treatment with montelukast does not alter the need for patients with aspirin-sensitive asthma to avoid taking aspirin and other non-steroidal anti-inflammatory drugs.

Singulair contains aspartame, a source of phenylalanine. Patients with phenylketonuria should take into account that each 5 mg chewable tablet contains phenylalanine in an amount equivalent to 0.842 mg phenylalanine per dose.

Neuropsychiatric events have been reported in adults, adolescents, and children taking Singulair (see section 4.8). Patients and physicians should be alert for neuropsychiatric events. Patients and/or caregivers should be instructed to notify their physician if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Singulair if such events occur.

Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl oestradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.

The area under the plasma concentration curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital. Since montelukast is metabolised by CYP 3A4, 2C8, and 2C9, caution should be exercised, particularly in children, when montelukast is co-administered with inducers of CYP 3A4, 2C8, and 2C9, such as phenytoin, phenobarbital and rifampicin.

In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of medicinal products primarily metabolised by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo. Therefore, montelukast is not anticipated to markedly alter the metabolism of medicinal products metabolised by this enzyme (e.g., paclitaxel, rosiglitazone, and repaglinide).

In vitro studies have shown that montelukast is a substrate of CYP 2C8, and to a less significant extent, of 2C9, and 3A4. In a clinical drug-drug interaction study involving montelukast and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) gemfibrozil increased the systemic exposure of montelukast by 4.4-fold. No routine dosage adjustment of montelukast is required upon co-administration with gemfibrozil or other potent inhibitors of CYP 2C8, but the physician should be aware of the potential for an increase in adverse reactions.

Based on in vitro data, clinically important drug interactions with less potent inhibitors of CYP 2C8 (e.g., trimethoprim) are not anticipated. Co-administration of montelukast with itraconazole, a strong inhibitor of CYP 3A4, resulted in no significant increase in the systemic exposure of montelukast.

Pregnancy

Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/foetal development.

Available data from published prospective and retrospective cohort studies with montelukast use in pregnant women evaluating major birth defects have not established a drug-associated risk. Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups.

Singulair may be used during pregnancy only if it is considered to be clearly essential.

Breast-feeding

Studies in rats have shown that montelukast is excreted in milk (see section 5.3). It is unknown whether montelukast/metabolites are excreted in human milk.

Singulair may be used in breast-feeding mothers only if it is considered to be clearly essential.

Singulair has no or negligible influence on the ability to drive and use machines. However, individuals have reported drowsiness or dizziness.

Montelukast has been evaluated in clinical studies as follows:

• 10 mg film-coated tablets in approximately 4,000 adult and adolescent patients 15 years of age and older, and

• 5 mg chewable tablets in approximately 1,750 paediatric patients 6 to 14 years of age.

The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in patients treated with montelukast and at a greater incidence than in patients treated with placebo:

With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change.

Tabulated list of Adverse Reactions

Adverse reactions reported in post-marketing use are listed, by System Organ Class and specific Adverse Reactions, in the table below. Frequency Categories were estimated based on relevant clinical trials.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short-term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.

There have been reports of acute overdose in post-marketing experience and clinical studies with montelukast. These include reports in adults and children with a dose as high as 1,000 mg (approximately 61 mg/kg in a 42 month old child). The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients. There were no adverse experiences in the majority of overdose reports.

Symptoms of overdose

The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.

Management of overdose

No specific information is available on the treatment of overdose with montelukast. It is not known whether montelukast is dialysable by peritoneal- or haemo-dialysis.

Pharmacotherapeutic group: Leukotriene receptor antagonist

ATC-Code: R03D C03

Mechanism of action

The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors (CysLT) found in the human airway and cause airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment.

Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT₁ receptor. In clinical studies, montelukast inhibits bronchoconstriction due to inhaled LTD₄ at doses as low as 5 mg. Bronchodilation was observed within two hours of oral administration. The bronchodilation effect caused by a β-agonist was additive to that caused by montelukast. Treatment with montelukast inhibited both early- and late-phase bronchoconstriction due to antigen challenge. Montelukast, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients. In a separate study, treatment with montelukast significantly decreased eosinophils in the airways (as measured in sputum) and in peripheral blood while improving clinical asthma control.

Clinical efficacy and safety

In studies in adults, montelukast, 10 mg once daily, compared with placebo, demonstrated significant improvements in morning FEV₁ (10.4% vs 2.7% change from baseline), AM peak expiratory flow rate (PEFR) (24.5 L/min vs 3.3 L/min change from baseline), and significant decrease in total β-agonist use (-26.1% vs -4.6% change from baseline). Improvement in patient-reported daytime and night-time asthma symptoms scores was significantly better than placebo.

Studies in adults demonstrated the ability of montelukast to add to the clinical effect of inhaled corticosteroid (% change from baseline for inhaled beclomethasone plus montelukast vs beclomethasone, respectively for FEV₁ : 5.43% vs 1.04%; β-agonist use: -8.70% vs 2.64%). Compared with inhaled beclomethasone (200 μg twice daily with a spacer device), montelukast demonstrated a more rapid initial response, although over the 12-week study, beclomethasone provided a greater average treatment effect (% change from baseline for montelukast vs beclomethasone, respectively for FEV₁ : 7. 49% vs 13.3%; β-agonist use: -28.28% vs -43.89%). However, compared with beclomethasone, a high percentage of patients treated with montelukast achieved similar clinical responses (e.g., 50% of patients treated with beclomethasone achieved an improvement in FEV₁ of approximately 11% or more over baseline while approximately 42% of patients treated with montelukast achieved the same response).

In an 8-week study in paediatric patients 6 to 14 years of age, montelukast 5 mg once daily, compared with placebo, significantly improved respiratory function (FEV₁ 8.71% vs 4.16% change from baseline; AM PEFR 27.9 L/min vs 17.8 L/min change from baseline) and decreased “as-needed”  β-agonist use (-11.7% vs +8.2% change from baseline).

In a 12-month study comparing the efficacy of montelukast to inhaled fluticasone on asthma control in paediatric patients 6 to 14 years of age with mild persistent asthma, montelukast was non-inferior to fluticasone in increasing the percentage of asthma rescue-free days (RFDs), the primary endpoint. Averaged over the 12-month treatment period, the percentage of asthma RFDs increased from 61.6 to 84.0 in the montelukast group and from 60.9 to 86.7 in the fluticasone group. The between group difference in LS mean increase in the percentage of asthma RFDs was statistically significant (-2.8 with a 95% CI of -4.7, -0.9), but within the limit pre-defined to be clinically not inferior. Both montelukast and fluticasone also improved asthma control on secondary variables assessed over the 12 month treatment period:

FEV₁ increased from 1.83 L to 2.09 L in the montelukast group and from 1.85 L to 2.14 L in the fluticasone group. The between-group difference in LS mean increase in FEV₁ was -0.02 L with a 95% CI of -0.06, 0.02. The mean increase from baseline in % predicted FEV₁ was 0.6% in the montelukast treatment group, and 2.7% in the fluticasone treatment group. The difference in LS means for the change from baseline in the % predicted FEV₁ was significant: -2. 2% with a 95% CI of -3.6, -0.7.

The percentage of days with β-agonist use decreased from 38.0 to 15.4 in the montelukast group, and from 38.5 to 12.8 in the fluticasone group. The between group difference in LS means for the percentage of days with β-agonist use was significant: 2.7 with a 95% CI of 0.9, 4.5.

The percentage of patients with an asthma attack (an asthma attack being defined as a period of worsening asthma that required treatment with oral steroids, an unscheduled visit to the doctor's office, an emergency room visit, or hospitalisation) was 32.2 in the montelukast group and 25.6 in the fluticasone group; the odds ratio (95% CI) being significant: equal to 1.38 (1.04, 1.84).

The percentage of patients with systemic (mainly oral) corticosteroid use during the study period was 17.8% in the montelukast group and 10.5% in the fluticasone group. The between group difference in LS means was significant: 7. 3% with a 95% CI of 2.9; 11.7.

Significant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEV₁ 22.33% for montelukast vs 32.40% for placebo; time to recovery to within 5% of baseline FEV₁ 44.22 min vs 60.64 min). This effect was consistent throughout the 12-week study period. Reduction in EIB was also demonstrated in a short term study in paediatric patients (maximal fall in FEV₁ 18.27% vs 26.11%; time to recovery to within 5% of baseline FEV₁ 17.76 min vs 27.98 min). The effect in both studies was demonstrated at the end of the once-daily dosing interval.

In aspirin-sensitive asthmatic patients receiving concomitant inhaled and/or oral corticosteroids, treatment with montelukast, compared with placebo, resulted in significant improvement in asthma control (FEV₁ 8.55% vs -1.74% change from baseline and decrease in total β-agonist use -27. 78% vs 2.09% change from baseline).

Absorption

Montelukast is rapidly absorbed following oral administration. For the 10 mg film-coated tablet, the mean peak plasma concentration (C_max) is achieved three hours (T_max) after administration in adults in the fasted state. The mean oral bioavailability is 64%. The oral bioavailability and C_max are not influenced by a standard meal. Safety and efficacy were demonstrated in clinical trials where the 10 mg film-coated tablet was administered without regard to the timing of food ingestion.

For the 5 mg chewable tablet, the C_max is achieved in two hours after administration in adults in the fasted state. The mean oral bioavailability is 73% and is decreased to 63% by a standard meal.

Distribution

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

Biotransformation

Montelukast is extensively metabolised. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children.

Cytochrome P450 2C8 is the major enzyme in the metabolism of montelukast. Additionally CYP 3A4, and 2C9 may have a minor contribution, although itraconazole, an inhibitor of CYP 3A4, was shown not to change pharmacokinetic variables of montelukast in healthy subjects that received 10 mg montelukast daily. Based on in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6. The contribution of metabolites to the therapeutic effect of montelukast is minimal.

Elimination

The plasma clearance of montelukast averages 45 ml/min in healthy adults. Following an oral dose of radiolabelled montelukast, 86% of the radioactivity was recovered in 5-day faecal collections and <0.2% was recovered in urine. Coupled with estimates of montelukast oral bioavailability, this indicates that montelukast and its metabolites are excreted almost exclusively via the bile.

Characteristics in Patients

No dosage adjustment is necessary for the elderly or mild to moderate hepatic insufficiency. Studies in patients with renal impairment have not been undertaken. Because montelukast and its metabolites are eliminated by the biliary route, no dose adjustment is anticipated to be necessary in patients with renal impairment. There are no data on the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (Child-Pugh score >9).

With high doses of montelukast (20- and 60-fold the recommended adult dose), a decrease in plasma theophylline concentration was observed. This effect was not seen at the recommended dose of 10 mg once daily.

In animal toxicity studies, minor serum biochemical alterations in ALT, glucose, phosphorus and triglycerides were observed which were transient in nature. The signs of toxicity in animals were increased excretion of saliva, gastro-intestinal symptoms, loose stools and ion imbalance. These occurred at dosages which provided >17-fold the systemic exposure seen at the clinical dosage. In monkeys, the adverse effects appeared at doses from 150 mg/kg/day (>232-fold the systemic exposure seen at the clinical dose). In animal studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than 24-fold. A slight decrease in pup body weight was noted in the female fertility study in rats at 200 mg/kg/day (>69-fold the clinical systemic exposure). In studies in rabbits, a higher incidence of incomplete ossification, compared with concurrent control animals, was seen at systemic exposure >24-fold the clinical systemic exposure seen at the clinical dose. No abnormalities were seen in rats. Montelukast has been shown to cross the placental barrier and is excreted in breast milk of animals.

No deaths occurred following a single oral administration of montelukast sodium at doses up to 5,000 mg/kg in mice and rats (15,000 mg/m² and 30,000 mg/m² in mice and rats, respectively), the maximum dose tested. This dose is equivalent to 25,000 times the recommended daily adult human dose (based on an adult patient weight of 50 kg).

Montelukast was determined not to be phototoxic in mice for UVA, UVB or visible light spectra at doses up to 500 mg/kg/day (approximately >200-fold based on systemic exposure).

Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in rodent species.

Mannitol (E 421)

Microcrystalline cellulose

Hyprolose (E 463)

Red ferric oxide (E 172)

Croscarmellose sodium

Cherry flavour

Aspartame (E 951)

Magnesium stearate

Not applicable.

2 years.

Store in the original package in order to protect from light and moisture.

Packaged in polyamide/PVC/aluminium blister package in:

Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.

Blisters (unit doses), in packages of: 49x1, 50x1 and 56x1 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Organon Pharma (UK) Limited

The Hewett Building

14 Hewett Street

London EC2A 3NP

United Kingdom

PL 00025/0357

Date of first authorization: 15 January 1998

Date of latest renewal: 25 August 2007

23 September 2022

© 2022 Organon group of companies. All rights reserved.

SPC.SGA-5mg.22.UK.0122.IA-ORG-LDN.NoRCN

Montelukast is a medicine used to prevent asthma symptoms and seasonal allergies

1. About montelukast

Montelukast is used to prevent the symptoms of asthma. It's usually prescribed when asthma is mild and can stop it from getting worse.

It can also help people with asthma who have breathing difficulties when they exercise (exercise-induced asthma) and seasonal allergies, such as sneezing, itchiness and a blocked or runny nose (allergic rhinitis).

Montelukast is sometimes given to people without asthma to treat hives (urticaria) that last for a long time (more than 6 weeks).

Important: Important

Do not use montelukast to treat an asthma attack. Always use your reliever inhaler.

2. Key facts

• Montelukast helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks.
• Most people take montelukast once a day in the evening.
• If you take it for asthma, it's important to take it even when you have no symptoms.
• Montelukast is used alongside your inhalers or other asthma medicine.
• Some common side effects include headaches and feeling or being sick.

3. Who can and cannot take montelukast

Montelukast can be taken by adults and children from 6 months of age.

Montelukast is not suitable for people with certain health problems.

Check with your doctor before taking montelukast if:

• you have had an allergic reaction to montelukast or any other medicine in the past
• you have a rare hereditary problem of galactose intolerance (including Lapp lactase deficiency or glucose-galactose malabsorption)

4.

Always follow your doctor's instructions about how and when to take montelukast.

Dosage

Most people take montelukast once a day in the evening to prevent asthma or allergy symptoms. However, if exercise makes your asthma worse, your doctor might tell you to take montelukast 2 hours before you exercise. Never take more than 1 dose a day.

The usual dose for:

• adults and children aged 15 years and older – one 10mg tablet
• children aged 6 to 14 years – one 5mg chewable tablet
• children from 6 months old to 5 years – 4mg (this can be granules or as a chewable tablet)

How to take non-chewable tablets

You can take montelukast non-chewable tablets with or without food

Swallow tablets whole with water, juice or milk. Do not chew these tablets.

How to take chewable tablets

It's important to take chewable tablets at least 1 hour before food, or 2 hours after food. This is so the medicine is absorbed into your body properly.

Chewable tablets can be chewed or sucked. You or your child can have a drink of water or squash afterwards.

How to give granules to a child

Montelukast granules come in a sachet with 4mg of granules inside (one dose). They can be put directly on your child's tongue. You can also mix the granules with a spoonful of cold, soft food, such as yoghurt or ice-cream.

Make sure your child takes the whole dose immediately (or within 15 minutes).

It's important to not dissolve the granules in a drink. You can give your child a drink afterwards.

What if I forget to take it?

If you or your child misses a dose of montelukast, skip the missed dose and take your next dose the following day at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you forget doses often, it may help to set an alarm to remind you. You could also ask a pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Urgent advice: Call 111 for advice if:

• you take too much montelukast

Go to 111.nhs.uk or call 111

If you need advice for a child under the age of 5 years, call 111.

If you need to go to hospital, do not drive yourself. Get someone else to drive you or call for an ambulance. Find your nearest A&E.

Take the montelukast packet or leaflet inside it plus any remaining medicine with you.

5. Side effects

Like all medicines, montelukast can cause side effects, although not everyone gets them.

Common side effects

These side effects can affect more than 1 in 100 people.

Talk to a pharmacist or doctor if these side effects bother you or do not go away:

• diarrhoea
• high temperature
• headaches
• stomach ache, feeling or being sick (nausea or vomiting)
• a mild rash

Serious side effects

Contact a doctor immediately if:

• you notice mood changes and you become depressed, aggressive or you're thinking of harming yourself
• you see things which are not there (hallucinations)
• you're finding it harder than usual to concentrate or remember things
• your speech changes or you start stuttering
• you have shaking or trembling in any part of your body
• you have an unusual or fast heartbeat
• you get yellow skin or the whites of your eyes become yellow – this could be a sign of liver problems

Serious allergic reaction

It is possible to have a serious allergic reaction (anaphylaxis) to montelukast.

Immediate action required: Call 999 or go to A&E if:

• you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
• you're wheezing
• you get tightness in the chest or throat
• you have trouble breathing or talking
• your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of montelukast. For a full list see the leaflet inside your medicines packet.

Information:

You can report any suspected side effect to the UK safety scheme.

6. How to cope with side effects

What to do about:

• diarrhoea – drink plenty of fluids, such as water or squash to prevent dehydration. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee. Do not take any medicines to treat diarrhoea without speaking to a pharmacist or doctor.
• high temperature – paracetamol will help to bring the temperature down. Drink plenty of fluids. See your doctor if it lasts for more than a few days.
• headaches – make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking montelukast. Talk to your doctor if headaches last longer than a week or are severe.
• stomach ache, feeling or being sick – stick to simple meals and do not eat rich or spicy food. If you're being sick, try having small, frequent sips of water or squash to avoid dehydration. Do not take any other medicines to treat vomiting without speaking to a pharmacist or doctor. Putting a heat pad or covered hot water bottle on your stomach may also help
• a mild rash – it may help to take an antihistamine, which you can buy from a pharmacy. Check with the pharmacist to see what type is right for you. If the rash gets worse, or does not get better after a week, speak to your doctor.

7. Pregnancy and breastfeeding

Montelukast and pregnancy

It's important for you and your baby to stay well when you're pregnant. If montelukast stops your asthma getting worse, you can keep taking it, even when you are pregnant.

The risks of having serious asthma attacks during pregnancy are much worse than the risks of using montelukast. Asthma attacks can prevent your unborn baby from getting enough oxygen.

Speak to your doctor if you become pregnant while you are taking montelukast.

Montelukast and breastfeeding

If your doctor or health visitor says your baby is healthy, you can take montelukast while you're breastfeeding.

Montelukast passes into breast milk in small amounts. The benefits of the medicine are greater than the small risk of side effects in your baby.

If you notice that your baby is not feeding as well as usual, seems unusually sleep, or if you have any other concerns about your baby, talk to a health visitor or doctor immediately.

Find out more about how montelukast can affect you and your baby during pregnancy on the Best Use of Medicines in Pregnancy (BUMPS) website.

Non-urgent advice: Tell a pharmacist or doctor if you're:

• trying to get pregnant
• pregnant
• breastfeeding

8. Cautions with other medicines

Tell your doctor if you are taking any of the following medicines:

• epilepsy medicines such as phenobarbital and phenytoin
• rifampicin (for tuberculosis)
• gemfibrozil (for high-cholesterol)

It's usually safe to take everyday painkillers with montelukast. However, do not take non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin or ibuprofen if they have ever made your asthma symptoms worse.

Mixing montelukast with herbal remedies and supplements

There's very little information about taking herbal medicines and supplements with montelukast. Ask a pharmacist for advice.

Important: Important

Tell your doctor or pharmacist if you're taking any other medicines, including herbal remedies, vitamins or supplements.

9. Common questions

Montelukast is from a group of medicines called leukotriene receptor antagonists (LTRAs). LTRAs work by stopping the chemicals in your body that narrow your airways. These chemicals are called leukotrienes.

Montelukast helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks.

Leukotrienes are also released in your body when you have an allergic reaction to something like dust or pollen and when you exercise. Montelukast helps to reduce the level of leukotrienes and stops you getting symptoms.

Montelukast starts to work immediately to reduce leukotriene levels in your body (which make your symptoms worse). However, it may take around a week before it reaches its full effect.

If you're taking montelukast to prevent exercise-induced asthma, take it 2 hours before you exercise. This will mean that the levels of medicine in your body is highest when you start exercising.

Take montelukast for as long as your doctor recommends it. It will only keep working while you are taking it.

Yes. There's no evidence to suggest that taking montelukast will cause any problems if taken for a long time.

Montelukast is one medicine used to prevent asthma symptoms.

Most people with asthma will be given an inhaler (such as beclomethasone or fluticasone). Montelukast may be given as an extra medicine if your doctor thinks you need it.

Other medicines which may help prevent asthma attacks are inhalers like salmeterol or sodium cromoglycate, or medicines like theophylline.

Yes, you can drink alcohol while taking montelukast.

You do not need to avoid any food or drink while taking montelukast.

Montelukast does not affect any type of contraception including the combined pill and emergency contraception.

Read more about what to do if you're taking the pill and you're being sick or have diarrhoea.

There is no firm evidence to suggest that taking montelukast will reduce fertility in either men or women

Montelukast does not usually cause any problems with driving or riding a bike.

Do not drive a car or ride a bike if montelukast makes you see things which are not there (hallucinate), if you get shaking or tremors in any part of your body or you're unable to concentrate or make decisions.

It's your responsibility to decide if it's safe to drive. If you're in any doubt, do not drive.

Related conditions

• Asthma
• Asthma attacks
• Allergic rhinitis

Useful resources

• HealthUnlocked: montelukast forum
• Asthma UK: charity

Page last reviewed: 25 February 2020
Next review due: 25 February 2023

Singulair instructions for use: indications, contraindications, side effects - description Singulair tab.

📜 Instructions for use Singular ® 💊 Composition of the drug Singulair ® ✅ Application of Singular ® 📅 Storage conditions Singular ® ⏳ Singular Shell Save Search for analogues Interaction Product description Singular ® (Singulair ® ) Based on the official instructions for use of the drug, approved by the manufacturer and prepared for the electronic edition of the Vidal Handbook 2021 year, update date: 2021. 01.13 Marketing authorization holder: MERCK SHARP & DOHME, B.V. (Netherlands) Manufactured: MERCK SHARP & DOHME, Ltd. (UK) Packaging and release quality control: MERCK SHARP & DOHME, B.V. (Netherlands) or Chemical-pharmaceutical plant AKRIKHIN, JSC (Russia) Contacts for inquiries: MSD Pharmaceuticals LLC (Russia) ATX code: R03DC03 (Montelukast) Active substance: montelukast (montelukast) Rec. INN WHO registered Dosage form Singular ® Tab. chewable 5 mg: 7, 14, 28 or 56 pcs. reg. No.: P N016104/02 dated 30.03.10 - Indefinitely Re-registration date: 08/03/18 Release form, packaging and composition ® Chewable tablets pink, round, biconvex, debossed with "SINGULAIR" on one side and "MSD 275" on the other side. 1 tab. Mandelukast sodium 5.2 mg, What corresponds to the content of the Montelukast 5 mg Auxiliary substances - 201.35 mg, Polullose Microcrystallic, Hydroloprosa, Hydroloprosa ( mg, red iron oxide - 0.45 mg, croscarmellose sodium - 9 mg, cherry flavor - 4.5 mg, aspartame - 1.5 mg, magnesium stearate - 3 mg. 7 pcs. - blisters (1) - packs of cardboard. 7 pcs. - blisters (2) - packs of cardboard. 7 pcs. - blisters (4) - packs of cardboard. 14 pcs. - blisters (1) - packs of cardboard. 14 pcs. - blisters (2) - packs of cardboard. 14 pcs. - blisters (4) - packs of cardboard. Clinical and pharmacological group: Leukotriene receptor antagonist. Drug for the treatment of bronchial asthma and allergic rhinitis Pharmacotherapeutic group: Leukotriene receptor blocker Pharmacological action Cysteinyl leukotrienes (LTC 4 , LTD 4 , LTE 4 ) are strong inflammatory mediators - eicosanoids, which are secreted by various cells, incl. mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors. Cysteinyl leukotriene type I receptors (CysLT 1 receptors) are present in the human airways (including bronchial smooth muscle cells, macrophages) and other proinflammatory 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 nasal obstruction. Montelukast is a highly potent oral drug that significantly improves inflammation in asthma. According to biochemical and pharmacological analysis, montelukast binds with high affinity and selectivity to CysLT 1 receptors, without interacting with other pharmacologically important receptors in the respiratory tract (such as prostaglandin receptors, cholino- or β-adrenergic receptors). Montelukast inhibits the physiological action of cysteinyl leukotrienes LTC 4 , LTD 4 , LTE 4 by binding to CysLT 1 receptors without stimulating these receptors. Montelukast inhibits CysLT receptors in the respiratory tract, as evidenced by the ability to block the development of bronchospasm in response to inhalation LTD 4 in patients with bronchial asthma. Doses of 5 mg are sufficient to relieve bronchospasm induced by LTD 4 . Montelukast causes bronchodilation within 2 hours of ingestion and may supplement beta 9 induced bronchodilation0132 2 - adrenomimetics. Pharmacokinetics Absorption Montelukast is rapidly and almost completely absorbed after oral administration. When taken on an empty stomach chewable tablets 5 mg C max in adults is achieved after 2 hours. The average oral bioavailability is 73%. Food intake does not have a clinically significant effect with long-term use. Distribution Plasma protein binding of montelukast is more than 99%. V d montelukast in a state of equilibrium concentration averages 8-11 liters. Studies with radiolabeled montelukast in rats indicate minimal BBB penetration. In addition, the concentrations of the labeled drug 24 hours after administration were minimal in all other tissues. Metabolism Montelukast is extensively metabolized. In the study of therapeutic doses in adults and children, the concentration of montelukast metabolites in the equilibrium state in plasma is not determined. In vitro studies using human liver microsomes have shown that cytochrome P450 isoenzymes 3A4, 2C8 and 2C9 are involved in the metabolism of montelukast. According to the results of studies conducted in vitro in human liver microsomes, montelukast at a therapeutic concentration in blood plasma does not inhibit cytochrome P450 isoenzymes: 3A4,2C9, 1A2, 2A6, 2C19 and 2D6. Elimination Plasma clearance of montelukast in healthy adults averages 45 ml/min. After ingestion of radioactively labeled 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. T 1/2 montelukast in young healthy adults is from 2.7 to 5.5 hours. The pharmacokinetics of montelukast retains an almost linear character when administered at doses above 50 mg. When taking montelukast in the morning and evening, no differences in pharmacokinetics are observed. When taking montelukast at a dose of 10 mg 1 time / day, a moderate (about 14%) accumulation of the active substance in plasma is observed. Pharmacokinetics in special clinical situations 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. T 1/2 montelukast from plasma 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 depending on race. 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 AUC of 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 T 1/2 - 7.4 hours). Dose modification of montelukast is not required in patients with mild to moderate hepatic impairment. 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 in this category of patients is not required. Indications of the drug Singulair ® prevention and long-term treatment of bronchial asthma in children aged 6 to 14 years, including prevention of daytime and nighttime symptoms of the disease, treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid and prevention of exercise-induced bronchospasm; management of daytime and nighttime symptoms of seasonal and/or perennial allergic rhinitis in children aged 6 to 14 years. Open list of ICD-10 codes J30. 1 Pollen allergic rhinitis J30.3 Other allergic rhinitis (perennial allergic rhinitis) J45 Asthma Dosing mode The drug is taken orally 1 time / day, regardless of food intake. For asthma treatment, Singulair ® should be taken in the evening. When treatment of allergic rhinitis the drug 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 1 tablet of the drug Singulair ® 1 time / day in the evening. For children aged 6 to 14 years, is prescribed at a dose of 5 mg (1 chewable tablet) / day. No dose adjustment is required for this age group. General recommendations The therapeutic effect of Singulair ® on parameters reflecting the course of bronchial asthma develops within the first day. The patient should continue to take Singulair ® both during the period of achieving control of the symptoms of bronchial asthma, and during periods of exacerbation of bronchial asthma. For elderly patients, patients with renal insufficiency, and patients with mild to moderate hepatic impairment , and also, depending on the sex, a special dose selection is not required. Prescribing Singulair ® concomitantly with other treatments for bronchial asthma Singulair ® may be added to the patient's treatment with bronchodilators and inhaled corticosteroids (see section "Drug Interactions"). Side effects In general, Singulair ® is well tolerated by patients. Side effects are usually mild and usually do not require discontinuation of the drug. Overall frequency of side effects during treatment with Singulair ® is comparable to their frequency when taking placebo. Children aged 2 to 5 years with bronchial asthma Clinical trials of Singulair ® included 573 patients aged 2 to 5 years. In a 12-week placebo-controlled clinical trial, the only adverse event (AE) assessed as drug-related occurring in >1% of patients treated with Singulair ® and more frequently than in the placebo group was thirst . Differences in the incidence of this AE between the two treatment groups were not statistically significant. A total of 426 patients aged 2 to 5 years were treated with Singulair ® for at least 3 months, 230 for 6 months or more, and 63 patients for 12 months or more. With longer treatment, the AE profile did not change. Children aged 2 to 14 years with seasonal allergic rhinitis In a 2-week placebo-controlled clinical trial with Singulair ® for the treatment of seasonal allergic rhinitis involved 280 patients aged 2 to 14 years. Patients took Singulair ® once a day in the evening, the drug was generally well tolerated. The safety profile of the drug in children was similar to that of placebo. In this clinical study, there were no AEs that would be regarded as drug-related, observed in ≥1% of patients taking Singulair ® , and more often than in the placebo group. Children aged 6 to 14 years with bronchial asthma The safety profile of the drug in children was generally similar to that in adults and comparable to that of placebo. In an 8-week placebo-controlled clinical trial, the only AE assessed as drug-related occurring in >1% of patients treated with Singulair ® , and more frequently than in the placebo group, 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 ® . Longer treatment (more than 6 months) did not change the AE profile. Adults and children 15 years of age and older with asthma Singular ® , and more often than in the placebo group, there were abdominal pain and headache. The differences in the frequency of these side effects between the two treatment groups were not statistically significant. With longer treatment (within 2 years), the side effect profile did not change. Adults and children aged 15 years and older with seasonal allergic rhinitis Patients took Singulair ® 1 time per 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, no AEs that would be regarded as drug-related were observed in ≥1% of patients treated with Singulair ® , and more often than in the placebo group. In a 4-week placebo-controlled clinical study, the safety profile of the drug was similar to that in 2-week studies. The incidence of drowsiness when taking the drug in all studies was the same as when taking placebo. Adults and children aged 15 years and older with perennial allergic rhinitis Patients took Singular ® 1 time per day in the evening, in general, the drug was well tolerated. The safety profile of the drug was similar to the safety profile observed in the treatment of patients with seasonal allergic rhinitis and placebo. In these clinical studies, no AEs that would be regarded as drug-related were observed in ≥1% of patients treated with Singulair ® and more frequently than in the placebo group. The incidence of drowsiness when taking the drug was the same as when taking placebo. Pooled analysis of clinical trial results A pooled analysis of 41 placebo-controlled clinical trials (35 studies in patients aged 15 years and older, 6 studies in patients aged 6 to 14 years) was performed using approved methods for assessing suicidality. Among 9Of the 929 patients who received Singulair ® and 7780 patients who received placebo in these studies, 1 patient with suicidal ideation was identified in the group of patients who received Singulair ® . None of the treatment groups experienced any suicide, suicide attempt, or other preparatory actions indicative of suicidal behavior. Separately, a pooled analysis of 46 placebo-controlled clinical trials (35 trials in patients aged 15 years and older; 11 trials in patients aged 3 months to 14 years) was performed to evaluate adverse behavioral effects (ABE). Among 11673 patients treated in these studies, Singulair ® and 8827 placebo patients, the percentage of patients with at least one adverse behavioral effect was 2.73% among patients treated with Singular ® , and 2.27% among patients treated with placebo; the odds ratio was 1.12 (95% confidence interval [0.93; 1.36]). Adverse events reported during post-marketing use of the drug are listed in the table below according to system organ classes and specific adverse events. Frequency categories were evaluated based on relevant clinical studies. 9000 9000 904 9000 9000 9000 9000 9000 9000 9008 and lymphatic system 9000 9000 9000 9000 9000 , edema Unwanted phenomena Category Category 1 INCOUNTIONS AND PARAZIAN Diseases increased bleeding tendency rare thrombocytopenia very rarely From the side of the immune system hypersensitivity reactions, incl. Anaphilaxia It is infrequently Eosinophilic liver infiltration Very rarely Mental disorders Sleep disturbances, including nightmares, insomnia, somnambulism, anxiety, excitement, excitement, i.e. aggressive behavior or hostility, depression, psychomotor hyperactivity (including irritability, restlessness, tremor 3 ) Infrequently Violation of attention, memory violation, TIK rarely hallucinations, disruption, dysfemia (stuttering), suicidal thoughts and behavior (suicidality), obsessive-compulsive symptoms are very rare From the side of the nervous system dizziness, drowsiness, paresthesia / hypesthesia, convulsions infrequently from the heart Far heartbeat rarely from the respiratory system NOSIS BELISE BELISE CRIDS Special instructions"), pulmonary eosinophilia very rarely From the gastrointestinal tract diarrhea 4 , nausea 4 , vomiting 4 often Dry mucous membrane of the oral cavity, dyspepsia It is infrequently from the liver and biliary tract often hepatitis (including cholestatic, hepatocellular and mixed liver disease) very rarely From the skin and subcutaneous tissues rash 4 Often The tendency to generate hematomas, urticaria, itching infrequently Angion -European swelling , erythematical From the musculoskeletal system arthralgia, myalgia, including muscle cramps infrequently from the urinary system Enures in children It is infrequently General disorders and violations at the introduction of common 1 Frequency category: defined for each adverse reaction based on the frequency reported in the clinical trial database: very common (≥1/10), common (≥1/100 to < 1/10), infrequently (from ≥1/1000 to <1/100), rarely (from ≥1/10000 to <1/1000), very rarely (<1/10000). 2 This adverse event, which was categorized as "very common" in patients treated with montelukast, was also categorized as "very common" in patients treated with placebo in clinical trials. 3 Frequency category: Rare. 4 This adverse event, which was categorized as common in patients treated with montelukast, was also categorized as common in patients treated with placebo in clinical trials. Contraindications for use hypersensitivity to any of the components of the drug; children under 6 years of age; phenylketonuria. Use in Pregnancy and Lactation Singulair ® should be used during pregnancy and lactation only if the expected benefit to the mother outweighs the potential risk to the fetus or baby. Based on the available published data from prospective and retrospective cohort studies of the use of montelukast in women during pregnancy, whose children were evaluated for severe congenital malformations, no risks associated with taking the drug have been identified. The available studies have methodological limitations, including small sample sizes, retrospective data collection in some cases, and disparate comparison groups. It is not known if Singulair ® is excreted in breast milk. Since many drugs are excreted in breast milk, this should be taken into account when prescribing Singulair ® during breastfeeding. Use in hepatic impairment For patients with mild or moderate hepatic impairment, no special dose adjustment is required. Data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9Child-Pugh scores) no. Use in impaired renal function No special dose adjustment is required for patients with renal insufficiency. Use in children Contraindication: children under 6 years of age. Use in the Elderly Elderly patients do not require special dose adjustments. Precautions The efficacy of oral Singulair ® in the treatment of acute asthma attacks has not been established. So Singular ® tablets are not recommended for the treatment of acute attacks of bronchial asthma. Patients should be instructed to always carry emergency asthma medications (inhaled beta 2 short-acting agonists) with them at all times. Do not stop taking Singulair ® during an asthma exacerbation and the use of rescue drugs (inhaled beta 2 short-acting agonists). Patients with confirmed allergy to acetylsalicylic acid and other NSAIDs should not take these drugs during treatment with Singulair ® , because Singular ® , while improving respiratory function in patients with allergic bronchial asthma, however, cannot completely prevent the caused they have NSAIDs bronchoconstriction. Dose of inhaled corticosteroids used simultaneously with Singulair ® can be gradually reduced under the supervision of a physician, however, a sharp replacement of inhaled or oral GCS with Singulair ® should not be carried out. Psychoneurological disorders have been described in patients treated with Singulair ® (see section "Side Effects"). Given that these symptoms may have been caused by other factors, it is not known if they are related to the use of Singulair ® . The physician should discuss these AEs 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. In rare cases, patients treated with anti-asthma drugs, including leukotriene receptor antagonists, experienced one or more of the following AEs: eosinophilia, rash, worsening 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 corticosteroid therapy. Although a causal relationship of these AEs with leukotriene receptor antagonist therapy has not been established, patients taking Singulair ® , care must be taken; in such patients, appropriate clinical monitoring should be carried out. Singulair ® chewable tablets 5 mg contains aspartame, a source of phenylalanine. Patients with phenylketonuria should be informed that each 5 mg chewable tablet contains aspartame in an amount equivalent to 0.842 mg phenylalanine. Singulair ® 5 mg chewable tablets are not recommended for use in patients with phenylketonuria. Use in elderly patients No age-related differences in the efficacy and safety profiles of Singulair ® have been identified. Effects on ability to drive and use machines Singulair ® 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) that have been reported to be very rare with Singulair ® may affect the ability of some patients to drive and use machines. Overdose Symptoms No symptoms of overdose were observed during clinical studies of long-term (22 weeks) treatment of adult patients with bronchial asthma with daily doses of Singulair ® up to 200 mg, or during short (about 1 week) clinical trials. studies with daily doses up to 900 mg. There have been cases of acute overdose (taking the drug at least 1000 mg / day) with Singulair ® in the post-registration period and during clinical trials in adults and children. Clinical and laboratory data indicated comparability of the safety profiles of the drug Singulair ® in children, adults and elderly patients. The most common side effects were thirst, drowsiness, vomiting, psychomotor agitation, headache, and abdominal pain. These side effects are consistent with the safety profile of Singulair 9.0006® . Treatment There is no specific information on the treatment of overdose with Singulair ® . Treatment in case of acute overdose is symptomatic. There are no data on the effectiveness of peritoneal dialysis or hemodialysis of montelukast. Drug Interactions Singulair ® may be administered with other medicinal products conventionally used for the prevention and long-term treatment of 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. 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 shown that montelukast inhibits the CYP2C8 isoenzyme of the cytochrome P450 system, however, in an in vivo drug interaction study of montelukast and rosiglitazone (metabolized with the participation of the CYP2C8 isoenzyme of the cytochrome P450 system), it was shown that montelukast did not inhibit the CYP2C8 isoenzyme. Thus, no effect of montelukast on the CYP2C8-mediated metabolism of a number of drugs is expected, 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 between 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. Co-administration of itraconazole, a potent inhibitor of CYP3A4, 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 at doses greater than the approved dose of 10 mg in adults (e.g., 200 mg/day in adults 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 with other known inhibitors of CYP2C8 (eg, trimethoprim) are expected. 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 bronchodilator monotherapy if the latter do not provide adequate control of bronchial asthma. Once treatment with Singulair ® has achieved therapeutic effect, a gradual reduction in the dose of bronchodilators can be started. Combination treatment with inhaled corticosteroids Treatment with Singulair ® provides an additional therapeutic effect in patients using inhaled corticosteroids. Upon reaching stabilization of the condition, you can begin a gradual reduction in the dose of corticosteroids under the supervision of a physician. In some cases, the complete abolition of inhaled corticosteroids is acceptable, however, an abrupt replacement of inhaled corticosteroids with Singulair ® is not recommended. Before prescribing any drug mentioned in this material, please read the full instructions for use provided by the manufacturer. MSD does not recommend the use of MSD products in ways other than those described in the prescribing information. Storage conditions of the drug Singulair ® The drug should be stored out of the reach of children, protected from moisture and light at a temperature of 15°C to 30°C. Shelf life of Singulair ® Shelf life - 2 years. Do not use after the expiry date stated on the packaging. Terms of sale The drug is dispensed by prescription. EN-SNG-00187; 11-2020 Contacts for inquiries 119021 Moscow, st. Timura Frunze, 11, building 1, Business Center "Demidov" Tel.: +7 (495) 916-71-00 Fax: +7 (495) 916-70-94 www.msd.ru Keep

relief of allergy and asthma symptoms - Pro-Pharma leaflet

Prescription drugs

Singulair 5mg

1 chewable tablet contains montelukast sodium 5.2 mg (equivalent to montelukast 5 mg)

The use of montelukast helps to reduce the body's response to allergic antigens and block bronchospasm at any stage in patients with bronchial asthma.

Singular is also used for the prevention of asthma and the relief of symptoms of allergic rhinitis of any origin.

Information

Indications for use (instruction): Singulair 5 mg

As an additional treatment for bronchial asthma in patients with mild to moderate persistent asthma that is not adequately controlled by inhaled corticosteroids, as well as insufficient clinical control of asthma with β-agonists short-acting adrenergic receptors, which are used if necessary.

As an alternative treatment to low-dose inhaled corticosteroids for patients with mild persistent asthma who have not had a recent severe asthma attack that requires oral corticosteroids and cannot use inhaled corticosteroids.

Prevention of asthma, the dominant component of which is exercise-induced bronchospasm.

Relief of symptoms of seasonal and perennial allergic rhinitis.

Directions for use

Patients with asthma and allergic rhinitis (seasonal and year-round) should take 1 chewable tablet 5 mg once a day. To alleviate the symptoms of allergic rhinitis, the time of admission is selected individually.

For the treatment of asthma, the dose for children aged 6 to 14 years is 1 chewable tablet (5 mg) per day, in the evening. Singular® should be taken one hour before meals or 2 hours after meals. There is no need for dose adjustment for this age group.

General advice . The therapeutic effect of the drug Singular® on asthma control occurs within 1 day. Patients should be advised to continue taking Singular® even if asthma is controlled and also during periods of asthma exacerbation.

No dose adjustment is necessary in patients with mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage for boys and girls is the same.

As an alternative treatment to low-dose inhaled corticosteroids for mild persistent asthma. Montelukast is not recommended as monotherapy in patients with moderate persistent asthma. The use of montelukast as an alternative to low-dose inhaled corticosteroids in children with mild persistent asthma should only be considered in patients who have not had a recent severe asthma attack requiring oral corticosteroids and who cannot use inhaled corticosteroids. Mild persistent asthma is defined as the occurrence of asthma symptoms more than once a week but less than once a day, the occurrence of nocturnal symptoms more than twice a month but less than once a week, normal lung function in the periods between episodes. If sufficient asthma control is not achieved in the future (usually within 1 month), the need for additional or other anti-inflammatory therapy should be determined, based on a sequential asthma management system. Patients should be periodically assessed for asthma control.

Treatment with Singular® in conjunction with other asthma treatment. When Singulair® treatment is used as adjunctive therapy to inhaled corticosteroids, Singulair® should not drastically change inhaled corticosteroids.

Contraindications

Hypersensitivity to drug components.

Patients should be warned that Singulair® Oral is never used to treat acute asthma attacks and that they should carry the appropriate rescue medication with them at all times. In an acute attack, short-acting inhaled β-agonists should be used. Patients should consult their physician as soon as possible if they require more short-acting β-agonist than usual.

Do not abruptly replace montelukast therapy with inhaled or oral corticosteroids.

There is no evidence that the dose of oral corticosteroids can be reduced while using montelukast.

Psychoneurological events have been reported in patients taking Singular®. Since these events may be influenced by other factors, it is not known whether these events are associated with the use of the drug Singulair®. Physicians should discuss these adverse events with their patients and/or their caregivers. Patients and/or caregivers should be instructed to report these changes to their physician.

In rare cases, patients receiving anti-asthma drugs, including montelukast, may experience systemic eosinophilia, sometimes along with clinical manifestations of vasculitis, the so-called Churg-Strauss syndrome, which is treated with systemic corticosteroid therapy. Such cases were usually (but not always) associated with dose reduction or withdrawal of the GCS drug. The possibility that leukotriene receptor antagonists may be associated with Churg-Strauss syndrome cannot be refuted or confirmed.

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