Singular, 5 mg 14 pcs

How to take, the dosage

Orally once a day regardless of meals. For treatment of bronchial asthma Singulair should be taken in the evening. In treatment of allergic rhinitis, the dose may be taken at any time of the day at the request of the patient. Patients with bronchial asthma and allergic rhinitis should take one tablet of Singular once a day in the evening.

Adults aged 15 years and older
The dose for adults and children over 15 years is one coated tablet of 10 mg per day.

Children aged 6 to 14 years
The dosage for children 6-14 years is one 5 mg chewable tablet per day. No dosage adjustment is required for this age group.

General Recommendations
The therapeutic effect of SINGULAR on indicators reflective of bronchial asthma develops during the first day. The patient should continue to take SINGULAR both during the period of achieving bronchial asthma symptom control and during periods of bronchial asthma exacerbation.
For elderly patients, patients with renal insufficiency, and patients with mild to moderate hepatic dysfunction, as well as depending on gender, no special dose adjustment is required.

Administration of SINGULAR simultaneously with other bronchial asthma treatment
SINGULAR may be added to the patient’s treatment with bronchodilators and inhaled glucocorticosteroids (See Section “Interaction with other medicinal products”).

Interaction

SINGULAR may be administered together with other drugs traditionally used for the prevention and long-term treatment of bronchial asthma. The recommended clinical dose of montelukast had no clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinylestradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.

The AUC decreases in persons receiving phenobarbital concomitantly (approximately 40%), but dosing regimen adjustment is not required in these patients.

Treatment with bronchodilators: SINGULAR may be added to the treatment of patients in whom bronchial asthma is not controlled with bronchodilators alone. When a therapeutic effect is achieved (usually after the first dose) with SINGULAR therapy, the dose of bronchodilators can be gradually reduced.

Inhaled glucocorticosteroids: Treatment with SINGULAR provides additional therapeutic effect in patients treated with inhaled glucocorticosteroids. A reduction in the dose of glucocorticosteroids is possible when the patient’s condition reaches stabilization. The dose of glucocorticosteroids should be reduced gradually, under medical supervision. In some patients, inhaled glucocorticosteroids may be discontinued completely. Abrupt replacement of inhaled glucocorticosteroid therapy by prescription of SINGULAR is not recommended.

Special Instructions

SINGULAR tablets are not recommended for the treatment of acute attacks of bronchial asthma. In the acute course of bronchial asthma patients should be prescribed medication for asthma relief and asthma attack prevention.

The dose of inhaled glucocorticosteroids used concomitantly with SINGULAR may be gradually reduced under medical supervision. Inhaled or oral glucocorticosteroids should not be abruptly replaced with SINGULAR.

Decreasing the systemic dose of glucocorticosteroids in patients receiving anti-asthmatic agents, including leukotriene receptor blockers, has been accompanied in rare cases by the occurrence of one or more of the following phenomena eosinophilia, vascular rash, worsening of pulmonary symptoms, cardiac complications, and/or neuropathy, sometimes diagnosed as Churg-Strauss syndrome-systemic eosinophilic vasculitis.

While a causal relationship between these adverse events and therapy with leukotriene receptor antagonists has not been established, caution and appropriate clinical monitoring should be exercised when reducing the systemic dose of glucocorticosteroids in patients taking SINGULAR.

Application in elderly patients

There are no age-related differences in the efficacy and safety profiles of SINGULAR.

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Contraindications

Hypersensitivity to any of the ingredients of the drug Singular, children under 6 years of age.

Side effects

In general, SINGULAR is well tolerated. Side effects are usually mild and usually do not require treatment withdrawal.

The overall incidence of side effects reported with SINGULAR is comparable to that of placebo:

• Hypersensitivity reactions (including anaphylaxis, angioedema, rash, pruritus, urticaria, and very rarely eosinophilic liver infiltrates);

• Heuritis nodosa, unusual vivid dreams;

• Hallucinations; drowsiness;

• Irritability;

• Agitation, including aggressive behavior;

• Fatigue;

• Suicidal thoughts and suicidal behavior (suicidality);

• Insomnia;

• Paresthesia/hypoesthesia and very rarely seizures;

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• Nausea, vomiting, diarrhea, abdominal pain;

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• Headache;

• Arthralgia;

• Myalgia;

• Muscular cramps;

• Tendency to increase bleeding, formation of subcutaneous hemorrhages;

• Heart palpitations;

• Swelling.

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Overdose

There have been no reports of overdose symptoms in patients with bronchial asthma taking SINGULAR at a dose greater than 200 mg/day for 22 weeks and at a dose of 900 mg/day for 1 week.

There have been reports of acute overdose of montelukast in children (taking at least 150 mg of the drug per day). Clinical and laboratory data suggest that the safety profile of SINGULAR in children is consistent with the safety profile in adult and elderly patients. The most frequent adverse events were thirst, somnolence, mydriasis, hyperkinesias and abdominal pain.

The treatment is symptomatic.

There are no data on the possibility of excretion of montelukast by peritoneal dialysis or hemodialysis.

Pregnancy use

SINGULAR should be used during pregnancy and lactation only if the expected benefit to the mother outweighs the potential risk to the fetus or child.

Similarities

Singular, Montelar, Montelukast, Singlon, Montelukast, Almont, Glémont