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Singulair 

Pharmacological effect of Singulair 

Leukotriene-receptor antagonist. Montelukast selectively inhibits receptors tsisteinilovyh CysLT1-leukotrienes (LTC4, LTD4, LTE4) airway epithelia, and prevents patients with bronchial asthma bronchoconstriction caused by inhalation of tsisteinilovogo leukotriene LTD4. 

Montelukast inhibits bronchospasm early and late phase by 75% and 57% respectively, and reduces the number of eosinophils in the peripheral blood by an average of 9-15%. 

The therapeutic effect of the drug Singulair ® with the change of the bronchial asthma develops during the day. 

Pharmacokinetics Singulair 

Suction 

After oral montelukast rapidly and almost completely absorbed. Receiving regular food does not affect the Cmax in plasma and bioavailability of chewable tablets. In children aged 2 to 5 years after receiving an empty stomach chewable tablets, 4 mg Cmax achieved in 2 hours 

Distribution 

Binding of montelukast to plasma proteins is over 99%. Vd average of 11.8 liters. 

Metabolism 

Montelukast is actively metabolized in the liver. When used in therapeutic doses, the concentration of metabolites of montelukast in plasma at steady state in adults and children is not determined. It is assumed that the metabolism of montelukast involve cytochrome P450 isoenzymes (3A4 and 2C9), with therapeutic concentrations of montelukast do not inhibit cytochrome P450 isoenzymes: 3A4, 2C9, 1A2, 2A6, 2S19, and 2D6. 

Breeding 

T1 / 2 of montelukast in young healthy adults is from 2.7 to 5.5 hours, clearance of montelukast in healthy adults an average of 45 ml / min. After oral administration of montelukast, 86% is excreted in the feces within 5 days and less than 0.2% - in the urine, confirming that montelukast and its metabolites are almost exclusively in bile. 

Pharmacokinetics in special clinical situations . When receiving montelukast in the morning and evening hours pharmacokinetic differences are not observed. 

In patients with hepatic insufficiency mild to moderate severity and clinical manifestations of liver cirrhosis observed slowing of metabolism of montelukast. Elimination of montelukast in these patients, a slight increase compared with healthy subjects (T1 / 2 on average 7.4 hours). Changing the dose of montelukast for patients with hepatic insufficiency mild to moderate severity is not required. Data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh) do not. 

Because montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast in patients with renal failure was not evaluated. Adjust dose in this patient is not required. 

Indications for use of the drug Singulair ® 

- Prevention and long-term treatment of bronchial asthma in children aged 2 years and older: in order to control daytime and nighttime symptoms; 

- Relief of symptoms of allergic rhinitis in children aged 2 years and older. 

Dosage Singulair 

The drug is taken orally 1 time per day regardless of meals. 

In bronchial asthma appoint 4 mg (1 tablet) at night. 

In bronchial asthma and allergic rhinitis appoint 4 mg (1 tablet) at night. 

With allergic rhinitis appoint 4 mg (1 tablet) / in an individual mode, depending on the time of the greatest exacerbation of symptoms. 

For children aged 2 to 5 years with asthma and / or allergic rhinitis dose is 4 mg (1 tablet) / 

For children, the elderly, patients with renal insufficiency and patients with mild / moderate hepatic dysfunction special dose adjustment is required. 

Side effects of Singulair 

Children aged 2 to 5 years with asthma 

Clinical studies of the drug Singulair ® in this age group were conducted with 573 children. According to the 12-week, placebo-controlled study in a group treatment with Singulair ® the only observed side effect, occurring with a frequency of more than 1% compared with placebo, was thirsty. The difference between the two treatment groups was not statistically significant. With longer follow-up (12 months or more) side effect profile has not changed. 

Children aged 2 to 14 years with seasonal allergic rhinitis 

Clinical studies of the drug Singulair ® in this age group were conducted with 280 children. The safety profile of the drug in children was generally similar to the safety profile in adults and safety profile comparable to placebo. According to the 2-week patsebo-controlled study in a group treatment with Singulair ® side effects, occurs with a frequency greater than 1%, compared with placebo, was not recorded. 

Side effects recorded during postmarketing use of the drug 

From the blood coagulation system: increased bleeding. 

Allergic reactions: anaphylaxis, angioedema, very rarely - eosinophilic infiltration of the liver. 

CNS and peripheral nervous system: drowsiness, paraesthesia / hypoesthesia, irritability, aggressive behavior, anxiety, unusual dreams, hallucinations, depression, insomnia, irritability, suicidal thoughts and behaviors, tremors, very rarely - seizures. 

With the cardiovascular system: heart rate. 

From the digestive system: diarrhea, dyspepsia, rarely - cholestatic hepatitis, hepatocyte damage, most often against a background of concomitant drug therapy, or existing liver disease (alcoholic hepatitis and other forms) are very rare - vomiting, pancreatitis. From the musculoskeletal system: arthralgia, myalgia, muscle cramps. Dermatological reactions: itching, hives, tendency to bruising, erythema nodosum. In general, Singulair ® was well tolerated. Side effects are usually mild and usually do not require discontinuation of treatment. The overall incidence of side effects reported with use of the drug Singulair ®, is comparable with that of placebo.  

Contraindications to the use of the drug Singulair ® 

- Children up to age 2 years;

- Hypersensitivity to the drug. 

Use of the drug Singulair ® during pregnancy and breastfeeding 

Singulair ® should be used during pregnancy and lactation only when the expected benefit to the mother justifies the potential risk to the fetus or child.  

Use in hepatic dysfunction Singulair 

For patients with mild to moderate liver dysfunction a special dose adjustment is required. 

Data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh) do not. 

Use in renal impairment Singulair  

For patients with renal insufficiency special dose adjustment is required. 

Special instructions Singulair 

Singulair ® is not recommended for treatment of acute asthma attacks. In acute bronchial asthma patients should be prescribed drugs for therapy, relieves and prevents attacks of the disease. 

Patients with asthma should always carry emergency medications (inhaled short-agonists, β-blockers). 

For relief of acute bronchial asthma after exercise to use the drug for relief of an attack, ie short-agonists, inhaled β-adrenergic receptors. Treatment with Singulair ® does not guarantee absolute prevention of exacerbations. 

During the period of exacerbation of asthma and the need to apply for cupping drugs emergency (short-inhaled β-adrenergic agonists), stop taking the drug Singulair ® should not be. 

Dose used in conjunction with inhaled corticosteroids Singulairom can gradually reduce under medical supervision. Should not be abruptly replaced by therapy with inhaled or oral corticosteroids drug Singulair. 

Patients with confirmed allergy to aspirin and other NSAIDs should be for a period of treatment with Singulair ® to avoid contact with these drugs, as Singulair ®, improving respiratory function in patients with allergic asthma, however, does not prevent the bronchoconstriction caused by the action of NSAIDs. 

Reducing the dose corticosteroids for systemic use in patients receiving anti-asthma product, including leukotriene-receptor antagonist, was accompanied in rare cases, the appearance of one or more of the following effects: eosinophilia, purpura, aggravation of symptoms of the lung, cardiac complications and / or neuropathy sometimes diagnosed as a syndrome Chargoi-Straus (systemic eosinophilic vasculitis). Although the causal relationship of these adverse events with therapy leukotriene-receptor antagonist has not been established at lower doses of systemic corticosteroids in patients taking Singulair ®, please be careful and conduct appropriate clinical supervision. 

Patients with phenylketonuria should be informed that, in a chewing tablet contains no less than 1.2 mg of aspartame.  

Singulair Overdose  

Symptoms of overdose Singulair ® in patients with chronic bronchial asthma when used in a dose exceeding 200 mg / d, for 22 weeks and a dose of 900 mg / - for 1 week, were not identified. 

There have been reports of acute overdose of montelukast (when receiving at least 1 g /) in the postmarketing period, and in clinical studies in adults and children. Clinical and laboratory data at this show under the security profile of the drug Singulair ® in children, adults and elderly patients. The most common symptoms are thirst, drowsiness, vomiting, psychomotor agitation, headache and abdominal pain. 

Treatment: symptomatic therapy of conduct. 

Data on the possibility of removing montelukast by peritoneal dialysis or hemodialysis are absent. 

Singulair Drug Interactions 

Singulair ® can be prescribed with other drugs, traditionally used for prevention and long-term treatment of bronchial asthma and / or treatment of allergic rhinitis. Montelukast in the recommended therapeutic dose has no clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / norethindrone 35 / 1), terfenadine, digoxin and warfarin. 

Patients simultaneously receiving phenobarbital, AUC of montelukast decreased by approximately 40%. Selection of dose Singulair ® for this patient is not required. 

With the ineffectiveness of bronchodilators as a single agent asthma treatment can be added Singulair ®. Upon reaching the therapeutic effect (usually after the first dose) during therapy with Singulair ® dose bronchodilator can be gradually reduced. 

Treatment with Singulair ® provides an additional therapeutic effect in patients receiving inhaled corticosteroids. Upon reaching the stabilization of the patient may decrease the dose of corticosteroids. Dose of corticosteroids should be reduced gradually under medical supervision. In some cases, permitted complete elimination of inhaled corticosteroids. Not recommended sharp replacement therapy with inhaled corticosteroids on Singulair ®. 

In in vitro studies found that montelukast inhibits the isoenzyme CYP2C8. However, the study of drug interactions in vivo montelukast and rosiglitazone (metabolized with the participation of isoenzyme CYP2C8) is not received confirmation of inhibition of montelukast isoenzyme CYP2C8. Thus, in clinical practice is not expected to effect of montelukast on CYP2C8-mediated metabolism of certain drugs, including paclitaxel, rosiglitazone, repaglinide.  

Conditions and terms of Singulair 

The drug should be kept away from children, dry, dark place at a temperature of 15 ° to 30 ° C. Shelf life - 2 years.