Cetirizine Renewal oral drops 10mg/ml, 10ml

Composition

>

1 ml of drops for oral use contains:

Active ingredient:

cetirizine dihydrochloride 10 mg,

excipients:

benzoic acid-2 mg;

glycerol 85% – 125 mg;

propylene glycol-125 mg;

distilled water-763.6 µl;

sodium acetate trihydrate-15 mg

Pharmacological action

Pharmacodynamics :

Cetirizine has a pronounced anti-allergic effect. It has practically no sedative effect in pharmacologically active doses, belongs to the selective antagonists of H1-histamine receptors and practically does not have anticholinergic and antiserotonin effects, prevents the development and facilitates the course of allergic reactions. It has antipruritic and antiexudative effects.

It affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; inhibits the release of mediators involved in a late allergic reaction. Reduces capillary permeability, prevents the development of tissue edema, relieves smooth muscle spasm. Eliminates skin reactions to the introduction of histamine, specific allergens, as well as to cooling (with cold urticaria). Cetirizine significantly reduces the hyperreactivity of the bronchial tree, which occurs in response to histamine release in patients with bronchial asthma. The therapeutic effect of the drug is manifested on average in 60 minutes after use. Against the background of course admission, tolerance does not develop.

Pharmacokinetics:

Absorption: After oral use, cetirizine is rapidly and well absorbed from the gastrointestinal tract. The maximum concentration level is determined after about 40 to 60 minutes. Food intake does not significantly affect the amount of absorption, but in this case the rate of absorption is slightly reduced.

Distribution: Cetirizine binds to plasma proteins by approximately 93%. The volume of distribution (Vd) is low (0.5 l/kg), the drug does not penetrate the cell.

The drug does not cross the blood-brain barrier.

Metabolism: Cetirizine is poorly metabolized in the liver to form an inactive metabolite. With a 10-day application at a dose of 10 mg, no accumulation of the drug is observed.

Excretion: Approximately 70% occurs by the kidneys, mostly unchanged. The systemic clearance is approximately 54 ml/min.

After a single dose, the elimination half-life is approximately 10 hours. In children aged 2 to 12 years, the elimination half-life is reduced to 5-6 hours.

With impaired renal function (creatinine clearance below 11-31 ml / min) and in patients on hemodialysis (creatinine clearance less than 7 ml / min), the half-life increases by 3 times, and clearance decreases by 70%.

Against the background of chronic diseases and in elderly patients, there is an increase in the half-life by 50% and a decrease in clearance by 40%. Hemodialysis is ineffective.

Indications

• Year-round and seasonal allergic rhinitis (symptomatic therapy);
• urticaria, including chronic idiopathic;
• dermatoses that occur with pruritus (atopic dermatitis, neurodermatitis);
• allergic conjunctivitis.

Use during pregnancy and lactation

It is contraindicated during pregnancy and lactation.

Contraindications

• Hypersensitivity to cetirizine or other components of the drug;
• severe kidney disease.
• children under 1 year of age.
• pregnancy
• and lactation.

With caution: chronic pyelonephritis of moderate and severe severity (dosage adjustment is required), elderly age (glomerular filtration rate may decrease).

Side effects

From the digestive system: dry mouth, dyspepsia.

From the central nervous system: headache, drowsiness, fatigue, dizziness, agitation, migraine.

Allergic reactions: skin rash, angioedema, urticaria, pruritus.

The drug is usually well tolerated. Side effects are rare and transient.

Composition

No pharmacokinetic interactions were observed with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, and glipizide.

Co-use with theophylline (400 mg / day) resulted in a 16% decrease in the total clearance of cetirizine (theophylline kinetics did not change).

How to take, course of use and dosage

Inside, regardless of food intake.

Adults and adolescents over the age of 12 years are recommended to take 20 drops (10 mg) daily, preferably in the evening.

Children aged 6-12 years: 10 drops (5 mg) twice daily in the morning and evening, or 20 drops (10 mg) in the evening. Children aged 2-6 years: 10 drops (5 mg) in the evening or 5 drops (2.5 mg) in the morning and evening.

Children aged 1-2 years,5 drops (2.5 mg) twice a day.

In case of renal failure, the recommended dose should be reduced by 2 times.

If liver function is impaired, it is necessary to select the dose individually, especially carefully with simultaneous renal failure.

Elderly patients with normal renal function do not need to adjust the dose.

The duration of admission is determined individually, usually with seasonal allergic rhinitis, the duration of therapy is from 3 to 6 weeks, and with short-term exposure to pollen, one week is enough.

Overdose

Symptoms: possible drowsiness, lethargy, weakness, headache, tachycardia, increased irritability, urinary retention, fatigue (most often when taking 50 mg of cetirizine per day).

Treatment: perform symptomatic therapy. No specific antidote was identified. Hemodialysis is ineffective. Gastric lavage is performed, activated charcoal is prescribed.

Special instructions

With caution, cetirizine is prescribed to patients with CRF (moderate to severe severity – dosage adjustment is required), elderly patients (glomerular filtration rate may decrease).

Elderly patients with normal renal function do not need to adjust the dose.

Use in pediatrics

Caution should be exercised when prescribing cetirizine to children (there is insufficient experience of using it in children under 1 year of age).

Influence on the ability to drive motor vehicles and manage mechanisms

If the dose is exceeded 10 mg/day, the ability to react quickly may worsen. 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.

Active ingredient

Cetirizine

Dosage form

oral drops