Glencet, pills 5mg, 14pcs

Composition

Active ingredient:  

levocetirizine dihydrochloride 5 mg

Auxiliary substances:  

Lactose monohydrate (Lactose 100)

microcrystalline cellulose (Avicel PH 112)

colloidal silicon dioxide (Aerosil 200)

opadrai white magnesium stearate

Pharmacological action

Levocetirizine, an enantiomer of cetirizine and a competitive histamine antagonist, blocks H1-histamine receptors, the affinity for which is 2 times higher than that of cetirizine. It affects the histamine-dependent stage of allergic reactions, reduces the migration of eosinophils, vascular permeability, and limits the release of inflammatory mediators. It prevents the development and eases the course of allergic reactions, has an anti-exudative, antipruritic effect, practically does not have an anticholinergic and antiserotonin effect. In therapeutic doses, the sedative effect is very weakly expressed. The action begins 12 minutes after taking a single dose in 50% of patients, after 1 hour – in 95% and continues for 24 hours. Pharmacokineticsparmakinetics are linear. It is rapidly absorbed when taken orally; food intake does not affect the completeness of absorption, but reduces its rate. Bioavailability – 100%. The time to reach the maximum concentration in the blood (Tmax) is 0.9 hours, the maximum concentration in the blood (Cmax) is 207 ng/ml. Volume of distribution -0.4 l / kg. Plasma protein binding is 90%. Less than 14% of the drug is metabolized in the liver by O-dealkylation to form a pharmacologically inactive metabolite. The elimination half-life (T 1/2) is 7-10 hours. The total clearance is 0.63 ml / min / kg. Completely eliminated from the body within 96 hours. It is excreted by the kidneys (85.4%). In patients with renal insufficiency (creatine clearance less than 40 ml / min), clearance decreases (in patients on hemodialysis – by 80%), T 1/2 – lengthens. Less than 10% is removed during hemodialysis. Penetrates into breast milk.

Indications

Symptomatic treatment of urticaria, including chronic idiopathic urticaria; angioedema; other allergic dermatoses accompanied by itching and rashes.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Contraindications

Hypersensitivity (including to piperazine derivatives), severe chronic renal failure (CRF, creatinine clearance less than 10 ml / min), pregnancy, lactation, children under 6 years of age. Galactose intolerance, lactase deficiency, and glucose-galactose malabsorption.

With caution

, chronic renal failure (dosage adjustment is required), elderly age (glomerular filtration rate may decrease).

Side effects

Possible side effects are listed below by body system and frequency: common (>1/10), uncommon (≥1/100, ≤1/10), rare (≥1/1000, ≤1/100), very rare (≥1/10000, ≤1/1000). From the central nervous systemsasto:  headache, fatigue, drowsiness. Rarely:  asthenia. Very rare:  aggression, agitation, hallucinations, depression, seizures. From the side of the senses: Very rare:  visual impairment. From the digestive system: Infrequently:  dryness of the oral mucosa. Rarely:  stomach pain. Very rare:  nausea, diarrhea, hepatitis. From the cardiovascular system: Very rare:  tachycardia. Respiratory system disorders: Very rare:  dyspnoea. From the musculoskeletal system: Very rare:  myalgia. From the side of metabolism: Very rare:  weight gain. Laboratory parameters: Very rare: changes in liver function tests. Allergic reactions: Very rare:  pruritus, rash, urticaria, angioedema, anaphylaxis.

Interaction

Theophylline (400 mg/day) reduces the total clearance of levocetirizine by 16%, while the kinetics of theophylline does not change.

Concomitant use with macrolides or ketoconazole did not cause significant ECG changes.

It can enhance the effect of drugs that depress the central nervous system and ethanol.

How to take, course of use and dosage

Inside, during a meal or on an empty stomach, with a small amount of water, without chewing.

The recommended dose for adults and children over 6 years of age, elderly patients (subject to normal renal function) – 5 mg (1 tablet) 1 time a day.

In patients with chronic renal failure, the dose is reduced 2-fold (1 tablet every other day) with creatinine clearance from 30 to 49 ml / min and 3-fold (1 tablet every 3 days) with creatinine clearance from 10 to 29 ml / min.

Patients with hepatic insufficiency do not need to adjust the dosage regimen.

The course of treatment for chronic diseases is up to 18 months.

Overdose

Symptoms:  drowsiness, in children – anxiety, irritability. Treatment:  gastric lavage, activated charcoal, symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective.

Special instructions

Caution is required when using alcohol concomitantly (see Interactions with other medications).

Influence on the ability to drive motor vehicles and manage mechanisms In an objective assessment, there was no significant effect of the drug on the ability to drive motor vehicles and manage mechanisms when taken at the recommended dose.

However, during the period of taking the drug, it is advisable to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Composition

Tablet Form of production

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 30 °C.

Shelf

life is 3 years.

Active ingredient

Levocetirizine

Dosage form

Tablets

Description

For adults and Children over 6 years of age

Indications

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