Levocetirizine-Teva tablets coated. 5 mg 14 pcs. (Levocetirizine)

Release form

Tablets.

Pharmacological action

Levocetirizine - the active substance of the drug Levocetirizine-Teva - is the R-enantiomer of cetirizine, which belongs to the group of competitive histamine antagonists and blocks H1-histamine receptors.

Levocetirizine affects the histamine-dependent stage of allergic reactions, and also reduces the migration of eosinophils, reduces vascular permeability, and limits the release of inflammatory mediators. Levocetirizine prevents the development and facilitates the course of allergic reactions, has antiexudative, antipruritic effect, practically does not have anticholinergic and antiserotonin effects. In therapeutic doses, it has almost no sedative effect.

Indications

- treatment of symptoms of perennial (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis, such as pruritus, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia, sore throat, acute sore throat, other accompanied by itching and rashes.

Caution: - in chronic renal failure (dosage adjustment is necessary)

- in elderly patients (with an age-related decrease in glomerular filtration)

- in patients with spinal cord injury, prostatic hyperplasia, as well as in the presence of other predisposing factors for urinary retention, since levocetirizine may increase the risk of urinary retention

- when taken concomitantly with alcohol (see “Interaction with other medicines”)

- when given to pregnant women and in period of breastfeeding.

Contraindications

Hypersensitivity (including to piperazine derivatives), severe CRF (CC less than 10 ml / min), pregnancy, lactation, children's age (up to 6 years).

Caution. CRF, advanced age (possibly a decrease in glomerular filtration).

Special instructions

During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions, as well as from the use of ethanol.

Composition

1 tablet contains:

Active ingredient: levocetirizine dihydrochloride 5.00 mg

Excipients: microcrystalline cellulose 30.00 mg, lactose monohydrate 63.50 mg, silicon dioxide colloid 0, 50 mg, magnesium stearate 1.00 mg shell Opadry Y1-7000N white: macrogol-400 0.1875 mg, titanium dioxide (E171) 0.9375 mg, hypromellose-2910 (E464) 1.875 mg.

Dosage and administration

Film-coated tablets are taken orally, swallowed whole, with food or on an empty stomach, washed down with a little water.

Adults and children 6 years of age and older: The daily dose is 5 mg (1 tablet) once.

Since levocetirizine is excreted by the kidneys, when using the drug in patients with renal failure and elderly patients, the dose should be adjusted depending on the degree of renal failure.

Patients with mild renal impairment (creatinine clearance 50-79 ml / min) dose adjustment is not required.

In patients with moderate renal failure (creatinine clearance from 30 to 49 ml / min), the recommended dose is 5 mg every other day.

In patients with severe renal failure (creatinine clearance less than 30 ml / min), the recommended dose is 5 mg once every 3 days.

In patients with renal and hepatic insufficiency, dosing is carried out according to the above scheme.

Patients with impaired hepatic function alone do not require a dosage adjustment.

Side effects

Headache, drowsiness, dryness of the oral mucosa, fatigue, rarely - migraine, dizziness, dyspepsia, allergic reactions (angioedema, rash, urticaria, pruritus).

Drug interaction

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

Joint use with macrolides or ketoconazole did not cause significant changes on the ECG.

Overdose

Symptoms: drowsiness, in children - anxiety, irritability.

Treatment: gastric lavage, activated charcoal, symptomatic therapy. There is no specific antidote. Hemodialysis is not effective.

active substance

Levocetirizine

lekarstvennaja form

tablets

Prescribing

For adults, Children over 6 years old

Teva Pharmaceutical Enterprises Co., Ltd., Israel



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