Allerwei pills 5mg, 10pcs

Composition

Each film-coated tablet contains: Active ingredient: levocetirizine dihydrochloride 5.00 mg; excipients: lactose monohydrate 88.00 mg; microcrystalline cellulose 34.10 mg; colloidal silicon dioxide 1.60 mg; magnesium stearate 1.30 mg; film coating: Opadray white OY 58900 (hypromellose (5 cP) 62.5%; titanium dioxide (E 171) 31.25%; macrogol-400 6.25%) 3.25 mg

Pharmacological action

Pharmacotherapy group: anti-allergic agent – H1-histamine receptor blocker. ATX code: R06AE09 Pharmacological Propertiespharmacodynamicalevocetirizine (R), the enantiomer of cetirizine, is an inhibitor of peripheral H1-histamine receptors. Levocetirizine has a pronounced antihistamine and anti-allergic effect. It affects the histamine-dependent phase of an allergic reaction, reduces the migration of eosinophils, reduces the permeability of the vascular wall, and limits the release of inflammatory mediators. Levocetirizine prevents the development and eases the course of allergic reactions, has an antipruritic and anti-exudative effect. Practically does not affect cholinergic and serotonin receptors, in therapeutic doses it does not have a sedative effect. Pharmacokineticthe pharmacokinetics of levocetirizine vary linearly. Absorption After oral use, the drug is rapidly and completely absorbed from the gastrointestinal tract. Food intake does not affect the completeness of absorption, although its rate decreases. In adults, after a single dose of the drug in a therapeutic dose (5 mg), the maximum concentration (Cmax) in blood plasma is 270 ng / ml and is reached in 0.9 hours, after repeated use at a dose of 5 mg – 308 ng / ml. Equilibrium plasma concentration (Css) is reached after 2 days. Distribution Levocetirizine is 90% bound to plasma proteins. The volume of distribution (Vd) is 0.4 l/kg. Bioavailability reaches 100%. Metabolism Less than 14% of the drug is metabolized in the body by N – and O-dealkylation (unlike other H1-histamine receptor antagonists, which are metabolized in the liver by the cytochrome system) to form a pharmacologically inactive metabolite. Due to the limited metabolism and lack of metabolic inhibitory activity, the interaction of levocetirizine at the metabolic level with other substances is unlikely. Elimination In adults, the half-life (T1 / 2) is 7.9±1.9 hours, the total clearance is 0.63 ml / min/kg. About 85.4% of the drug dose is excreted unchanged by the kidneys through glomerular filtration and tubular secretion; about 12.9% – through the intestine. Features of pharmacokinetics in individual patients Patients with impaired renal function In patients with renal insufficiency (creatinine clearance (CC)) In patients undergoing hemodialysis, total clearance is reduced by 80%, which requires a change in the dosage regimen. Less than 10% of levocetirizine is removed during a standard 4-hour hemodialysis procedure.

Indications

Allervay, film-coated tablets,5 mg is indicated in adults and children from 6 years of age and older when:

• treatment of symptoms of allergic rhinitis, including year-round (persistent) and seasonal (intermittent) allergic rhinitis, and allergic conjunctivitis, such as itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;
• pollinosis (hay fever);
• urticaria;
• other allergic dermatoses accompanied by itching and rashes.

Contraindications

• Hypersensitivity to the Active ingredient, cetirizine, hydroxyzine, any piperazine derivative or to any excipient of the drug.
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
• End-stage renal failure (CC 
• Children under 6 years of age (due to limited safety and efficacy data).

With caution

• In case of chronic renal failure (correction of the dosage regimen is necessary).
• In elderly patients (with an age-related decrease in glomerular filtration).
• In patients with spinal cord injury, prostatic hyperplasia, or other predisposing factors to urinary retention, levocetirizine may increase the risk of urinary retention.
• When used concomitantly with alcohol (see the section “Interaction with other medicinal products”).
• When prescribed to pregnant women and during breastfeeding.

Side effects

Clinical trials

During clinical trials, men and women aged 12-71 years with a frequency of 1% or more (often ≥ 1/100, < 1/10) experienced the following side effects: headache, drowsiness, dry mouth, fatigue, infrequently (≥ 1/1000,

During clinical trials in children aged 6 to 12 years with a frequency of 1% or more (often ≥ 1/100,

Post-registration studies:

• The frequency of side effects is not known (cannot be estimated from the available data).
• Immune system disorders
• Hypersensitivity reactions, including anaphylaxis.
• Metabolic disorders and eating disorders
• Increased appetite.
• Mental disorders
• Anxiety, aggression, agitation, depression, hallucinations, insomnia, suicidal thoughts.
• Nervous system disorders
• Seizures, dura mater sinus thrombosis, paresthesia, dizziness, fainting, tremor, dysgeusia.
• Hearing disorders and labyrinth disorders
• Vertigo 
• Visual disturbances
• Visual impairment, blurred vision, inflammatory manifestations.
• Disorders of the cardiovascular system
• Angina pectoris, tachycardia, palpitation, jugular vein thrombosis.
• Respiratory system disorders
• Shortness of breath, increased symptoms of rhinitis.
• Disorders of the gastrointestinal tract
• Nausea, vomiting, diarrhea.
• Liver and biliary tract disorders 
• Hepatitis, changes in liver function tests.
• Disorders of the kidneys and urinary system
• Dysuria, urinary retention.
• Skin and subcutaneous tissue disorders
• Angioedema, persistent drug-induced erythema, rash, pruritus, urticaria, hypotrichosis, cracks, photosensitization.
• Musculoskeletal and connective tissue disorders
• Muscle pain, arthralgia.

General violations:  

• Peripheral edema, weight gain.
• Cross-reactivity.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

The interaction of levocetirizine with other drugs has not been studied. When studying the drug interaction of cetirizine racemate with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole, pseudoephedrine and phenazone, no clinically significant adverse interactions were detected. When co-administered with theophylline (400 mg/day), the total clearance of cetirizine decreases by 16% (theophylline kinetics does not change). In a study with simultaneous use of ritanovir (600 mg twice daily) and cetirizine (10 mg daily), it was shown that cetirizine exposure increased by 40%, while ritonavir exposure changed slightly (-11%). In some cases, concomitant use of levocetirizine with alcohol or drugs that have an overwhelming effect on the central nervous system (CNS) can cause lethargy and deterioration of performance.

How to take, course of use and dosage

The tablet should be taken orally, without chewing and washed down with liquid, regardless of food intake. Adults and children over 6 years of age The daily dose is 5 mg (1 tablet) once. Duration of taking the drug In the treatment of seasonal (intermittent) rhinitis (the presence of symptoms less than 4 days a week or their total duration is less than 4 weeks), the duration of treatment depends on the duration of symptoms; treatment can be discontinued when symptoms disappear and resumed when symptoms appear. In the treatment of year-round (persistent) allergic rhinitis (the presence of symptoms more than 4 days a week and their total duration is more than 4 weeks), treatment can continue for the entire period of exposure to allergens. The course of treatment for pollinosis is set by the doctor. There is clinical experience with continuous use of levocetirizine in adult patients lasting up to 6 months. If you miss an appointment, do not take a double dose, but take the next dose at the usual time. Special patient groups Patients with impaired renal function Since levocetirizine is eliminated from the body by the kidneys, when using the drug, the dose should be adjusted depending on the degree of renal failure. With a creatinine clearance of 50-79 ml / min, no dose adjustment is required, with a creatinine clearance of 30 to 49 ml / min, the recommended dose is 5 mg (1 tablet) every other day (1 time in 2 days), in patients with severe renal insufficiency (creatinine clearance of less than 30 ml/min), the recommended dose is 5 mg (1 tablet) 1 time in 3 days. In patients with end-stage renal insufficiency (creatinine clearance less than 10 ml / min), the drug is contraindicated. Patients with renal and hepatic insufficiency Dosing is carried out according to the above scheme. Patients with impaired liver function No dose adjustment is required for isolated hepatic impairment. Elderly patients without impaired renal function No dose adjustment is required.

Overdose

Symptoms:

• drowsiness (in adults),
• agitation and restlessness, followed by drowsiness (in children).

Treatment: it is necessary to flush the stomach or take activated charcoal if little time has passed since taking the drug. Symptomatic and supportive care is recommended. There is no specific antidote. Hemodialysis is not effective.

Description

Oval biconvex tablets, film-coated in white or almost white color, smooth on one side, engraved “R 5″on the other side. On a cross-section, the core is white to almost white in color.

Special instructions

The intervals between doses should be selected individually, depending on renal function. Caution is recommended when used concomitantly with alcohol. Caution should be exercised if patients have predisposing factors to urinary retention (for example, spinal cord injury, prostatic hyperplasia), as levocetirizine may increase the risk of urinary retention. Effects on the ability to drive vehicles and mechanismsmilevocetirizine can lead to increased drowsiness, therefore, the drug may affect the ability to drive a car or work with machinery. During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Film-coated tablets.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children!

Shelf

life is 2 years.

Active ingredient

Levocetirizine

Dosage form

Tablets

Purpose

Children over 6 years old, For adults

Indications

Pollinosis, Diathesis, Urticaria, Allergic Conjunctivitis, Allergy, Allergic Rhinitis, Dermatosis, Neurodermatitis