Cetirizine Sandoz pills 10mg, 10pcs

Composition

1 coated tablet contains: Active ingredient: cetirizine dihydrochloride 10 mg, excipients: lactose monohydrate-80 mg; MCC-23.8 mg; colloidal silicon dioxide-0.6 mg; magnesium stearate-0.6 mg shell: white dye Opadry — 5 mg (contains lactose monohydrate-1.8 mg; titanium dioxide-1.3 mg; hypromellose-1.4 mg; macrogol 4000 (polyethylene oxide 4000-0.5 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.

Contraindications

• Hypersensitivity to cetirizine or other components of the drug;
• severe kidney disease.
• children under 6 years 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.

Interaction

No clinically significant interactions of cetirizine with other drugs have been established.

Concomitant use with theophylline (400 mg / day) leads to a decrease in the total clearance of cetirizine (theophylline kinetics does not change).

How to take, course of use and dosage

Inside, regardless of food intake, without chewing and drinking enough liquid, preferably in the evening.

Children aged 6-12 years:

• if the body weight is less than 30 kg: ½ tablet, coated, in the evening
• if the body weight is more than 30 kg: 1 tablet, coated, in the evening.

It is possible to take 2 times a day (morning and evening) for ½ tablet. Adults and adolescents over the age of 12 years are recommended to take 1 tablet of cetirizine, preferably in the evening.

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.

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

The duration of therapy for children over the age of 6 years is from 2 to 4 weeks, and with short-term exposure to the allergen,1 week is sufficient.

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

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.

Simultaneous use of drugs that depress the central nervous system and alcohol is not recommended.

Instructions for patients with diabetes mellitus: 1 tablet corresponds to less than 0.01 bread units.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Cetirizine

Dosage form

Tablets

Description

For adults and Children over 6 years of age

Indications

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