Zodak Express tab n / 5mg film about 28 pc

$13.32

Zodak Express tab n / 5mg film about 28 pc

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Description

Composition
Active substance:
1 tablet contains: levocetirizine dihydrochloride – 5.00 mg.
Excipients:
Lactose monohydrate – 67.50 mg, Microcrystalline Cellulose – 25.00 mg sodium carboxymethylstarch – 1.00 mg colloidal silica – 0.50 mg magnesium stearate – 1.00 g; film coating: Hypromellose 2910/5 – 3.30 mg macrogol 6000 – 0.35 mg talc – 0.85 mg titanium dioxide E171 – 0.50 mg.
Description:
Oblong biconcave tablets, film-coated white or nearly white, marked “e” on one side.
Product form:
Tablets, film-coated, 5 mg. At 7 or 10 tablets in PVC / Aclar / PVC / Al or Al / Al blister. 1 or 4 blisters of 7 tablets; 2 blisters with 10 tablets together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to levocetirizine and other piperazine derivative or any of the auxiliary components of the preparation.
Terminal renal failure with CC less than 10 ml / min.
Pregnancy.
Children under 6 years (for a given dosage form).
Congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption (because of the content of lactose in the formulation).
Carefully
Care must be taken at the same time taking with alcohol (see. See “The interaction with other drugs”).
Chronic renal failure CS over 10 ml / min, but less than 50 ml / min (required correction mode).
Increasing age (perhaps decreased glomerular filtration).
Dosage
5 mg
Indications
– Treatment year symptoms (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia. – Hay fever (hay fever). – urticaria, including chronic idiopathic urticaria. – Angioedema (as adjuvant therapy). – Other allergic dermatoses, accompanied by itching and rashes.
Interaction with other drugs
Study of the interaction of levocetirizine with other drugs, including studies with isoenzyme inducers of CYP3A4, was conducted. In the study of drug interaction with racemic cetirizine pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam clinically significant adverse interactions not revealed. When concomitant administration with theophylline (400 mg / d) total clearance of cetirizine is reduced by 16% (theophylline kinetics does not change). In the study while receiving ritanovir (600 mg, 2 times daily) and cetirizine (10 mg daily) was shown that exposure of cetirizine increased by 40% and the exposure is varied slightly ritanovir (-11%). In sensitive patients the simultaneous reception of levocetirizine and alcohol or other substances that depress the central nervous system (CNS), may enhance the effect on the central nervous system, although it has been shown that the racemate cetirizine does not potentiate the effect of alcohol.
Overdose
Symptoms of overdose may include drowsiness in adults and excitement, and anxiety is replaced by drowsiness in children.
Treatment: No specific antidotes levocetirizine. In the case of overdose or symptomatic recommended maintenance treatment. If, after taking the drug did not take long, there should be gastric lavage. Levocetirizine hardly appear in hemodialysis.
pharmachologic effect
Pharmacological group:
Antiallergic agent – H1-histamine receptor blocker.
Pharmacodynamics:
Levocetirizine, (R) enantiomer of cetirizine, is an inhibitor of peripheral H1 histamine receptors, the affinity of which is 2 times higher than that of the cetirizine. After a single dose of levocetirizine observed binding of H1 histamine receptors by 90% after 4 hours and 57% after 24 hours. Levocetirizine okazyvaet influence on gistaminozavisimuyu step allergic reactions, reduces migration of eosinophils, reduces vascular permeability limits the release of inflammatory mediators, prevents the development and facilitates the allergic reactions has antiexudative, antipruritic effect, almost no anticholinergic and antiserotonin activities, virtually no therapeutic doses sedation. Action levocetirizine begins 12 minutes after receiving a single dose in 50% of patients after 1 hr in 95% of patients and is continued for 24 hours. Acceptance of levocetirizine has no effect on the QT interval on the electrocardiogram.
Pharmacokinetics:
The pharmacokinetics of levocetirizine is linear, not dose-dependent and time varies slightly in different patients. After oral administration, levocetirizine is rapidly and completely absorbed from the gastrointestinal tract. Food intake does not affect the completeness of absorption, although its speed is reduced. Maximum plasma concentration is reached after 0.9 hours (54 minutes) after dosing. The equilibrium concentration is set at 2 days. Maximum plasma concentration after a single dose of 5 mg of levocetirizine is 270 ng / ml, and after repeated administration at a dose of 5 mg – 308 ng / ml. Levocetirizine is 90% bound to plasma proteins. The volume of distribution of 0.4 l / kg. Data on the distribution of levocetirizine in the tissues and its penetration through the blood-brain barrier in humans. Levocetirizine is metabolized in the small amounts (
Pregnancy and breast-feeding
Use of the drug during pregnancy is contraindicated. Levocetirizine is excreted in breast milk, so if you need to use the drug during lactation should stop breastfeeding.
Conditions of supply of pharmacies
Without a prescription.
side effects
Side effects of levocetirizine separated by systemic organ classes according to the classification of the Medical dictionary for regulatory activities (MedDRA) indicating the frequency of occurrence: often (> 1/100 and 1/10); uncommon (> 1/1000 and
Violations by the immune system
Very rare: hypersensitivity reactions, including anaphylactic reactions.
Disorders of the nervous system
Common: headache.
Uncommon: somnolence.
Very rare: aggression, agitation, hallucinations, depression, convulsions.
Violations by the organ of vision
Very rare: visual disturbances.
Violations of the heart
Very rare: palpitations, tachycardia.
Violations of the respiratory system, organs, thoracic and mediastinal disorders
Very rare: shortness of breath.
Disorders of the gastrointestinal tract
Frequently: dryness of the oral mucosa.
Uncommon: abdominal pain.
Very rare: nausea, diarrhea.
Disorders of the liver and biliary tract
Very rare: hepatitis.
Violations of the skin and subcutaneous tissue
Very rare: angioneurotic edema, pruritus, rash, including drug rash, urticaria.
Violations by musculoskeletal and connective tissue
Very rare: myalgia.
General disorders
Common: fatigue.
Uncommon: asthenia.
Violations by the laboratory and instrumental data
Very rare: impaired liver function, weight gain.
special instructions
During treatment is not recommended to take ethanol
Impact on the ability to drive or engage in other potentially hazardous activities
Levocetirizine by its reception at the recommended doses has no adverse effect on the attention and psychomotor speed of reaction and the ability to operate vehicles. Nevertheless, during the period of ingestion it is advisable to refrain from activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
Store at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
The tablet should be taken orally without chewing, and with some liquid, regardless of the meal. It is recommended to take the daily dose in one step. Adults, adolescents and children over 6 years recommended daily dose is 5 mg (1 tablet).
Elderly: in elderly patients with moderate to severe renal insufficiency recommended dosage adjustment (see ‘Patients with impaired renal function, “below.).
Patients with impaired renal function: the interval between doses of the drug is determined individually depending on renal function. a dose adjustment, see below. To use it must be calculated creatinine clearance (CC) in a patient in ml / min based on the concentration of creatinine in serum (mg / dl) using the following formula:
CC = [(140 – age (years)) x weight (kg) / (72 x serum creatinine (mg / dl)] × 0.85 for women
dose adjustment for patients with impaired renal function: Creatinine clearance (ml / min) over 80 dose is 5 mg once a day; Creatinine clearance (ml / min) 50-79-dose is 5 mg once a day; Creatinine clearance (ml / min) 30-49-dose is 5 mg once every 2 days; Creatinine clearance (ml / min) than 10-medication contraindicated creatinine clearance (ml / min) less than 30, the dose is 5 mg once every 3 days;
Children with impaired renal function the dose is adjusted individually for creatinine clearance and body weight. Separate data for use in children with impaired renal function is not
Patients with hepatic impairment: in isolated abnormal liver function dose adjustment is required. In patients with hepato-renal insufficiency recommended dosage adjustment (see. “Patients with impaired renal function” above).
Duration of treatment: treatment of allergic rhinitis was conducted in accordance with the course of the disease; the drug can be stopped with the disappearance of the symptoms and to resume at relapse. In the case of chronic allergic rhinitis can be written in the long-term treatment of allergens period. Currently, clinical experience with levocetirizine in the form of tablets, film-coated, 5 mg, limited 6th months.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Zodak

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