Active substance:Levocetirizine dihydrochloride; 1 film coated tablet contains Levocetirizine hydrochloride 5 mg.
Excipients: Microcystalline cellulose, Croscarmellose natrium, Colloidal silicon dioxide anhydrous, Magnesium stearate, coating – Opadry II 85G 51300 green*.
Conditions of supply. Without prescription.
Pharmaceutical Form. Film coated tablets.
Round biconvex tablets coated with green coating.
Antihistaminic medications for system use. Code ATC: R06A Å09.
Levocetirizine is H1-histamine receptors blocker, Cetirizine enantiomer and competitive antagonist of Histamine. Levocetirizine influences on a histamine dependent stage of allergic reactions, reduces the vessels penetrability and eosinophil migration, limits the release of inflammatory mediators and in this way prevents the allergic reactions development and significantly relieves their course, removes the exudation and itch. Levocetirizine has almost no anticholinergic and antiserotonin action. It does not pass through hematoencephalic barrier.
Levocetirizine has almost no sedative effect if therapeutic doses used. After oral administration of single dose the medication effect begins after 15 minutes and continues for 24 hours.
Levocetirizine is rapidly absorbed in internal administration; the simultaneous use of meal decreases the absorption rate but does not influence over its completeness. Levocetirizine bioavailability is 100%. Peak concentration is 207 ng/ml, TCmax – 0.9 hours, distribution volume – 0.4 l/kg. The binding with plasma proteins is 90%. The period of half-life is 7–10 hours. More than 85% of the medicine is eliminated via kidneys. Levocetirizine is secreted in the breast milk.
Indications for use.
Symptomatic treatment of seasonal allergic rhinitis (hay fever) and chronic allergic rhinitis caused by pets, dust, cool, etc.; allergic conjunctivitis, allergic dermatitis, urticaria, including the chronic idiopathic urticaria.
Hypersensitivity to Levocetirizine or other drug components. High stages of chronic renal insufficiency (creatinine clearance – less 10 ml/min). Pregnancy and lactation. Children age less than 6 years old.
Safety measures in use.
Do not exceed the recommended dose.
Because of the medicine mainly elimination via kidneys it is necessary to administrate L-CET® carefully for patients with renal pathology. In patients with the renal insufficiency (creatinine clearance < 40 ml/min) the Levocetirizine elimination is reduced (up to 80% in hemodialysis patients). In renal insufficiency the therapeutic dose depends on creatinine clearance (CC). If CC is 50–80 ml/min and more the administration is 1 tablet per a day, if CC is 30–49 ml/min – 1 tablet every other day, if CC is 30 ml/min – 1 tablet every other three days. In hepatic insufficiency the therapeutic dose is not corrected.
Administration in pregnancy and lactation.
There is no data indicating the safety of the medicine while pregnancy that’s why the administration in pregnant women is contraindicated. Levocetirizine is secreted in the breast milk. If there is a need the usage of the medicine while breast feeding should be stopped.
Influence on alertness while driving and operating other machines.
Taking into consideration the possibility of side effects development (drowse, fatigability, asthenia) ability to drive and operate other machines must conduct a doctor after studying an individual patient’s reaction to the medicine.
The medicine does not use in children under 6 years old.
Administration and Dosage.
The medicine is taken internally, without chewing, following with some water. The medicine effect is more rapid in usage on an empty stomach. The recommended dose for adults and children above 6 years old is 5 mg (1 tablet 1 time per day). The course of the treatment of hay fever (pollinosis) is from 1 to 6 weeks. In chronic allergic diseases the course of treatment can continue up to 12 months.
Symptoms: drowse, headache, dry mouth, nausea and gastric pain. Treatment. Removing the medicine from gastro-intestinal tract via gastric lavage and administration of sorbents with further symptomatic therapy. Less than 10% of Levocetirizine is excreted via hemodialysis. There is no specific antidote. Hemodyalisis is ineffective.
Headache, dry mouth, migraine, dizziness, dyspepsia, fatiguability, drowse and allergic reactions (angioneurotic edema, skin rash, urticaria and skin itch) may occur.
The synchronous usage of the medicine with teophylline reduces the total Levocetirizine clearance. In trials of the concomitant usage of Levocetirizine with Ketoconazole and macrolides there were not any valid changes of cardiac function in electrocardiograms. In a case of the synchronous usage of Levocetirizine with central nervous system depressive medicines (tranquilizers, tricyclic antidepressants, MAO inhibitors) and alcohol it may occur drowse.
Shelf-life. 2 years.
Store at a temperature not more than 25C° in dry place, protected from light. Keep it out of reach of children.
Package. 10 tablets are in a blister, 1 or 3 blisters are in a carton pack.
Manufacturer name. KUSUM HEALTHCARE PVT LTD.
Information given on this site should not be used for self-diagnosis and treatment and can't be a replacement of doctor's advice.