Composition
Tablets covered with a film-coated white or almost white color, biconvex oblong shape; on one side there is a dividing line, on the other – an engraving “C10”.
1 tablet contains:
Active ingredient
cetirizine dihydrochloride 10.00 mg;
excipients:
microcrystalline cellulose 40.00 mg,
lactose monohydrate 63.50 mg,
colloidal silicon dioxide 0.50 mg,
magnesium stearate 1.00 mg;
shell
Opadray OY-GM-28900 white: hypromellose (E 464) 0.94 mg, polydextrose 0.94 mg, titanium dioxide (E 171) 0.94 mg, macrogol-4000 0.18 mg.
Indications
Adults and children over 12 years of age
- Symptomatic treatment of seasonal and year-round allergic rhinitis with concomitant allergic conjunctivitis;
- chronic idiopathic urticaria. Children aged 6-12 years
- Symptomatic treatment of seasonal and year-round allergic rhinitis;
- chronic idiopathic urticaria.
Contraindications
Hypersensitivity to cetirizine, other components of the drug and piperazine derivatives; children under 6 years of age; pregnancy; breast-feeding; end-stage renal failure (creatinine clearance less than 10 ml / min); patients on hemodialysis; lactose intolerance, lactase deficiency; glucose-galactose malabsorption syndrome.
Use with caution
Moderate to severe chronic renal failure; age over 65 years; concomitant use with drugs that have a depressing effect on the central nervous system( CNS), such as barbiturates, opioid analgesics, ethanol, benzodiazepine derivatives, zolpidem, etc.
Side effects
the incidence of adverse reactions are classified according to the recommendations of the world health organization: very often – at least 10%; often – not less than 1% and less than 10%; infrequently – no more than 0.1% and less than 1%; rarely – not less than 0.01% and less than 0.1%; very rarely – less than 0.01%, including isolated cases.
Blood and lymphatic system disorders: Â very rarely – thrombocytopenia.
From the immune system: rarely – hypersensitivity reaction; very rarely-anaphylactic shock.
Nervous system disorders: infrequently-paresthesia, agitation; rarely-convulsions, movement disorders, aggression, confusion, depression, hallucinations, insomnia; very rarely-impaired taste sensation, fainting.
From the cardiovascular system: rarely-tachycardia, palpitation.
From the side of the visual organ: Â very rarely-accommodation disorders, blurred vision, oculohiric crisis.
From the gastrointestinal tract: infrequently – diarrhea.
Liver and biliary tract disorders: rarely-increased activity of “hepatic” transaminases, alkaline phosphatase, gamma-glutamyltransferase; very rarely-hepatitis.
Skin and subcutaneous tissue disorders: infrequently-pruritus, rash; rarely-urticaria; very rarely-angioedema, erythema multiforme.
From the side of the kidneys and urinary tract: Â very rarely – dysuria, urinary incontinence, difficulty urinating.
Other services: infrequently-asthenia, discomfort; rarely-edema, weight gain.
Composition
No pharmacokinetic interactions were observed with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, and glipizide.
Concomitant use with theophylline (400 mg / day) leads to a decrease in the total clearance of cetirizine (theophylline kinetics does not change).
Myelotoxic drugs increase the manifestations of cetirizine hematotoxicity.
The use of cetirizine should be stopped three days before the allergic tests are performed.
Caution is recommended when concomitantly using drugs that have a depressing effect on the central nervous system.
How to take, course of use and dosage
Inside. Tablets are swallowed completely, without chewing, washed down with a small amount of water, preferably in the evening. Adults, children over 12 years of age and weighing more than 30 kg
10 mg (1 tablet) 1 time a day.
Children 6-12 years old
With a body weight of more than 30 kg. Â 10 mg 1 time a day or 5 mg (1/2 tablet) 2 times a day (morning and evening). With a body weight of less than 30 kg. Â 5 mg (1/2 tablet) 1 time a day.
In patients with renal insufficiency, dose adjustment depends on the creatinine clearance value and is presented in the table:
Group Creatinine clearance (ml / min)
Dose and frequency of use
Mild CRF 50-7910 mg 1 time a day
Moderate CRF 30-495 mg per day
Severe CRF 11-305 mg 1 time every 2 days
End-stage CRF, patients on hemodialysis for Less than 10 years The drug is contraindicated
The duration of treatment is selected individually, depending on the symptoms of the disease.
If drowsiness occurs, the drug should be taken in the evening.
Overdose
Symptoms: drowsiness, restlessness, increased irritability, urinary retention, dry mouth, constipation, mydriasis, tachycardia.
Treatment: Â withdrawal of the drug, gastric lavage, taking activated charcoal, symptomatic therapy.
Special instructions
In some patients, long-term treatment with Cetirizine-Teva may increase the risk of tooth decay due to dry mouth. For this reason, careful oral hygiene is necessary during treatment with the drug.
The drug Cetirizine-Teva is used with caution in patients with moderate to severe chronic renal failure, in elderly patients (glomerular filtration rate may decrease).
The drug Cetirizine-Teva may increase the effects of alcohol, so it is recommended to refrain from drinking alcohol while using the drug. Cetirizine-Teva is contraindicated in patients with hereditary galactose intolerance, lactase deficiency, and impaired glucose-galactose absorption.
Active ingredient
Cetirizine
Dosage form
Tablets
Description
Children over 6 years old, For adults
Indications
Urticaria, Allergic Conjunctivitis, Quincke’s Edema, Pollinosis, Allergy, Pruritus, Eczema, Allergic Rhinitis
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Side effects of Cetirizine-Teva, pills 10mg 10pcs.
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