Properties
What is it?
Levomont Composition: Active substance: Each tablet contains 5mg Levocetirizine Dihydrochloride and 10mg Montelukast. Excipients: Povidone, Microcrystalline Cellulose, Lactose, Corn Starch, Magnesium Stearate, Purified Talc, Sodium Starch Glycolate, Anhydrous Colloidal Silicon Dioxide, Tartrazine Supra color. Pharmacotherapeutic group: Drugs for the treatment of obstructive airway diseases, combined anti-allergic and antiasthmatic agent, other agents for systemic use for the treatment of obstructive diseases. Pharmacological properties: Montelukast is a cysteinyl leukotriene receptor antagonist. It blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on cysteinyl leukotriene receptors (CysLT1) located in the lungs and bronchi, reducing bronchoconstriction and inflammation caused by leukotrienes. Levocetirizine (the optical isomer of cetirizine) is a selective and potent antagonist of peripheral H1 receptors. Levocetirizine inhibits the early phase of histamine-induced allergic reaction and reduces the migration of some inflammatory cells and the release of various mediators associated with the late-phase allergic reaction. Pharmacokinetics: Montelukast is rapidly absorbed after oral administration. In adults, the maximum concentration in the blood is reached within 3 hours after taking a 10mg dose on an empty stomach. Bioavailability is 64%; bioavailability and Cmax are not dependent on food intake. 99% of montelukast binds to plasma proteins. The volume of distribution is 8-11L. Montelukast is extensively metabolized. The therapeutic effect of metabolites is minimal. In healthy individuals, plasma clearance is 45 ml/min. Montelukast and its metabolites are primarily excreted via bile; only 0.2% is excreted in urine. Levocetirizine is rapidly and completely absorbed after oral administration. Maximum concentration in the blood is reached approximately 1 hour after administration, and steady-state concentration is reached in 2 days. The peak concentration after a single daily dose of 5mg is 270 ng/mL, and 308 ng/mL after multiple doses. The degree of absorption depends on the dose, but maximum plasma concentration is reached with a delay when taken with food. 90% of levocetirizine binds to plasma proteins. The volume of distribution is 0.4 L/kg. 14% of the administered dose is metabolized in the body. Due to the low degree of metabolism and low potential for metabolic inhibition, interactions between levocetirizine and other drugs are less likely. In adults, the half-life is 7.9±1.9 hours. The average total clearance is 0.63 mL/min/kg. Levocetirizine and its metabolites are primarily excreted in urine, with a small portion in feces. Indications: Allergic rhinitis (perennial and seasonal), chronic bronchial asthma, chronic urticaria, atopic dermatitis. Dosage and administration: Adults: 1 tablet once daily, in the evening. Children aged 6-15 years: 1/2 tablet once daily, in the evening. Side effects: Gastrointestinal system: abdominal pain, dry mouth, nausea, sometimes diarrhea. Hepatobiliary system: rare liver function abnormalities. Respiratory system: pharyngitis. CNS: drowsiness or sometimes agitation; dizziness, headache; rarely, impaired consciousness, depression, hallucinations, insomnia, seizures, movement disorders; very rarely, taste disturbance, tremor, dystonia, dyskinesia. Sensory organs: very rarely, accommodation disorder, visual impairment, eye movement disorders. Cardiovascular system: rarely, tachycardia. Urinary system: very rarely, enuresis, dysuria. Immune system: rarely, hypersensitivity; very rarely, anaphylactic shock. Skin and subcutaneous tissue: sometimes itching, rash; rarely, urticaria, very rarely, angioedema. Blood and lymphatic system: very rarely, thrombocytopenia. General disorders: fatigue, weakness, rarely, edema. Contraindications: Hypersensitivity to levocetirizine and montelukast or piperazine derivatives; patients with severe renal failure; rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; children under 6 years of age. Overdose: Data on overdose of the active substances in the preparation are available: Montelukast - symptoms of overdose include abdominal pain, drowsiness, thirst, headache, vomiting, and psychomotor hyperactivity. Symptomatic and supportive therapy is recommended in case of overdose. Levocetirizine - symptoms of overdose in adults include increased drowsiness, and in children, initial agitation and restlessness followed by drowsiness. There is no specific antidote. In case of overdose, symptomatic treatment is recommended - discontinuation of the drug and gastric lavage. Special instructions: Due to the lack of relevant studies, this preparation is not prescribed for pregnant women. Levocetirizine is excreted in breast milk, so this combination is not used during lactation. During montelukast treatment, some patients experience symptoms of eosinophilia, clinically manifested as vasculitis, sometimes diagnosed as Churg-Strauss syndrome. The dose of the drug cannot be doubled to compensate for a missed dose. Due to the side effects of the preparation (drowsiness, fatigue, asthenia), particular caution is required when driving or operating machinery. Dosage form: Tablets №20. Shelf life: 2 years. Dispensing regime: Pharmaceutical product group - II, dispensed with prescription form N3. Manufacturer: CORONA Remedies Pvt. LTD, India