Description
Release form
film-coated tablets
Pharmacological action
The drug has an antipruritic, antiexudative effect. It does not have antiserotonin and anticholinergic effects. It prevents the development and greatly facilitates the course of various allergic reactions.
Admission at the indicated therapeutic doses does not cause a sedative effect. Does not affect the performance of the electrocardiogram.
The active substance, levocetirizine, is a representative of the group of competitive histamine antagonists. Completely blocks histamine H1 receptors and shows a high level of selectivity for H1-GR. It affects the allergic reaction in a histamine-dependent stage.
By inhibiting eotaxins, which stimulate transendothelial migration of eosinophils, completely blocking the expression of the vascular cell adhesion molecule 1, significantly reduces vascular permeability, migration of eosinophils and limits the release of inflammatory mediators.
Indications
Symptomatic treatment:
year-round allergic rhinitis
seasonal allergic rhinitis
chronic idiopathic urticaria.
Contraindications
– end-stage renal failure (patients undergoing hemodialysis)
– women during pregnancy and breastfeeding (lactation)
– hypersensitivity to the components that are part of the drug
– glucose intolerance
– lactase deficiency
– children under 6 years.
Use during pregnancy and lactation
There is insufficient clinical data on the use of levocetirizine in pregnant women, so the drug Levocetirizine-Teva should not be used during pregnancy.
Levocetirizine is excreted in breast milk. If it is necessary to use the drug Levocetirizine-Teva, breastfeeding should be discontinued.
Special instructions
Never exceed the daily dose!
Drinking drinks containing alcohol is not recommended during the course of therapy.
Influence on the ability to drive cars. At recommended dosages, the drug does not affect the ability to drive vehicles. However, it is necessary to take into account the development of adverse reactions (dizziness, drowsiness) and exercise extreme caution during classes of particularly dangerous activities that require a person to have increased concentration of attention and speed of psychomotor reactions.
Composition of
1 tablet contains: active substance:
levocetirizine dihydrochloride 5.00 mg
excipients:
microcrystalline cellulose 30.00 mg,
lactose monohydrate 63.50 mg, srdlkld 0.5 mg silica stearate 1.00 mg
shell: Opadry Y1-7000H white: macrogol-400 0.1875 mg, titanium dioxide (E171) 0.9375 mg, hypromellose-2910 (E464) 1.875 mg.
Dosage and administration
The drug is taken orally, chewed and washed down with a small amount of water, regardless of food intake. Dosage Levocetirizine-Teva:
Adults and children over 6 years of age: 5 mg daily once a day. The duration of administration depends on the severity of the manifestations of an allergic reaction and averages 3-6 weeks. In case of exposure to an allergen, the course may last for 1 week. The treatment of diseases in the chronic stage can be 6 months.
Elderly patients: dose adjustment not required. Patients with impaired renal function: the dosage of the drug is selected taking into account QC:
– more than 80 ml / min (normal) – 5 mg per day
– 50-79 ml / min (mild) – 5 mg per day
– 30-49 ml / min (medium) – 5 mg once a 2 days
– less than 30 ml / min (severe) – 5 mg once every 3 days
– less than 10 ml / min (terminal stage) – administration is contraindicated. Patients with impaired liver function: dose adjustment is not required.
Side effects
The frequency of side effects is classified according to the recommendations of the World Health Organization: very often – at least 10% often – at least 1%, but less than 10% infrequently – at least 0.1%, but less than 1% rarely – not less than 0.01%, but less than 0.1% very rarely – less than 0.01%, including isolated cases.
From the nervous system: often – headache, drowsiness, aggression, agitation, cramps rarely – migraine, dizziness.
From the side of the organ of vision: often – visual impairment.
From the cardiovascular system: very rarely – tachycardia.
From the respiratory system: very rarely – dyspnea.
From the digestive system: often – dryness of the oral mucosa infrequently – abdominal pain is very rare – nausea, dyspepsia, diarrhea, changes in liver function tests, hepatitis.
From the musculoskeletal system: rarely – myalgia.
From the side of metabolism: rarely – weight gain.
Allergic reactions: very rarely – itching, skin rash, urticaria, angioedema, anaphylaxis.
Other: often – fatigue, fatigue infrequently – asthenia.
Drug Interactions
When studying the drug interaction of levocetirizine with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam, no clinically significant undesirable interaction was detected. Concomitant use with macrolides or ketoconazole did not cause significant changes on the ECG.
With simultaneous use with theophylline (400 mg / day), the total clearance of cetirizine is reduced by 16%, the pharmacokinetic parameters of theophylline do not change.
In some cases, with the simultaneous use of levocetirizine with ethanol or drugs that have a depressing effect on the central nervous system (CNS), it is possible to enhance their effect on the central nervous system, although it has been proven that levocetirizine does not enhance the effect of ethanol.
Overdose
Symptoms: drowsiness (in adults), excitement and anxiety, followed by drowsiness (in children).
Symptomatic treatment: immediately after taking the drug, wash the stomach or induce artificial vomiting. The use of activated carbon, symptomatic and supportive therapy is recommended. There is no specific antidote. Hemodialysis is ineffective.
Storage conditions
It is recommended to store in places out of the reach of children. The storage temperature should not exceed 25C.
Term hodnosty
3 years
active substance
levocetirizine
Conditions of release from drugstores
Without prescription
lekarstvennaja tablet form
Prescribing
For children over 6 years old, For adults
Indications
Indications
allergy, allergic rhinitis, Angioedema, allergic conjunctivitis, atopic dermatitis, urticaria, dermatitis, hay fever
Teva Pharmaceutical Enterprises Co., Ltd., Israel
