Solonex drops 10mg / ml, 20 ml

Hay fever,

allergic rhinitis,

conjunctivitis,

dermatitis,

hives,

Quincke's edema.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Adults and children over 12 years old - 10 mg / day in 1-2 doses. Children aged 2-6 years - 5 mg / day in 1-2 doses.

For patients with moderate or severe renal impairment, the dose should be halved.

for 1 ml

Active substance:

cetirizine dihydrochloride - 10 mg

Excipients:

propylene glycol - 350 mg, anhydrous glycerol - 250 mg, sodium saccharinate - 10 mg, sodium acetate trihydrate - 10 mg, methyl parahydroxybenzoate - 1.35 mg, propyl parahydroxybenzoate - 0.15 mg, glacial acetic acid - up to pH 4.0-6.0, water d / i - up to 1 ml.

Renal failure

pregnancy,

lactation period,

hypersensitivity to cetirizine,

children's age up to 6 months.

Trade name: Solonex

Description:

Drops for oral administration in the form of a clear, colorless or slightly colored liquid, with the smell of acetic acid.

Ingredients: 1 ml

Active substance:

cetirizine dihydrochloride - 10 mg

Excipients:

propylene glycol - 350 mg, anhydrous glycerol - 250 mg, sodium saccharinate - 10 mg, sodium acetate trihydrate - 10 mg, methyl parahydroxybenzoate - 1.35 mg, propyl parahydroxybenzoate - 0.15 mg, glacial acetic acid - up to pH 4.0-6.0, water d / i - up to 1 ml.

Clinical and pharmacological group: Histamine H1 receptor blocker. Antiallergic drug

Pharmaco-therapeutic group: Antiallergic agent - H1-histamine receptor blocker

pharmachologic effect

III generation histamine H1 receptor blocker. Influences the 'early' stage of an allergic reaction and reduces the migration of eosinophils; limits the release of mediators at the 'late' stage of the allergic reaction. Virtually no anticholinergic and antiserotonin action. In therapeutic doses, it does not cause sedation.

Pharmacokinetics

It is rapidly absorbed from the gastrointestinal tract, Cmax after oral administration is achieved after 1 hour. The bioavailability of cetirizine when taken in the form of tablets and syrup is the same. Food does not affect the completeness of absorption (AUC), but lengthens the time to reach Cmax by 1 hour and reduces the Cmax value by 23%. When taken in a dose of 10 mg 1 time / day for 10 days, Css in plasma is 310 ng / ml and is noted 0.5-1.5 hours after administration. Plasma protein binding is 93% and does not change at a cetirizine concentration in the range of 25-1000 ng / ml. Pharmacokinetic parameters of cetirizine change linearly when administered at a dose of 5-60 mg. Vd - 0.5 l / kg. In small amounts, it is metabolized in the liver by O-dealkylation to form a pharmacologically inactive metabolite (unlike other antagonists of H1-histamine receptors, which are metabolized in the liver by the cytochrome system).Does not cumulate. 2/3 of the dose is excreted unchanged by the kidneys and about 10% - with feces. Systemic clearance - 53 ml / min. T1 / 2 in adults - 7-10 hours, in children aged 6 to 12 years - 6 hours, from 2 to 6 years - 5 hours, from 6 months to 2 years - 3.1 hours. In elderly patients T1 / 2 increases by 50%, and systemic clearance decreases by 40% (decreased renal function). In patients with impaired renal function (CC <40 ml / min), the clearance of the drug decreases, and T1 / 2 is lengthened (for example, in patients on hemodialysis, the total clearance decreases by 70% and is 0.3 ml / min / kg, and T1 / 2 is extended 3 times), which requires a corresponding change in the dosage regimen. Practically not removed during hemodialysis. In patients with chronic liver diseases (hepatocellular,cholestatic or biliary cirrhosis) there is an increase in T1 / 2 by 50% and a decrease in total clearance by 40% (correction of the dosage regimen is required only with a concomitant decrease in the glomerular filtration rate). Penetrates into breast milk.

Indications:

Hay fever,

allergic rhinitis,

conjunctivitis,

dermatitis,

hives,

Quincke's edema.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Adults and children over 12 years old - 10 mg / day in 1-2 doses. Children aged 2-6 years - 5 mg / day in 1-2 doses.

For patients with moderate or severe renal impairment, the dose should be halved.

Side effect

Possibly: dry mouth, drowsiness, headache, fatigue.

Rarely: skin manifestations of allergic reactions, angioedema.

In some cases: dyspepsia, agitation.

Contraindications for use

Renal failure, pregnancy, lactation, hypersensitivity to cetirizine., Children up to 6 months of age.

Application during pregnancy and lactation

Contraindicated for use during pregnancy and lactation.

Application for impaired renal function

Contraindicated in renal failure.

Cetirizine is prescribed with caution in patients with chronic renal failure (moderate and severe - a dosage regimen adjustment is required).

Application in children

Cetirizine is prescribed with caution to children (experience in children under 1 year of age is insufficient).

Use in elderly patients

With caution, cetirizine is prescribed to elderly patients (a decrease in glomerular filtration is possible).

Elderly patients with normal renal function do not need dose adjustment.

special instructions

With caution, cetirizine is prescribed to patients with chronic renal failure (moderate and severe - correction of the dosage regimen is required), to elderly patients (a decrease in glomerular filtration is possible).

Elderly patients with normal renal function do not need dose adjustment.

Use in pediatrics

Cetirizine is prescribed with caution to children (experience with children under 1 year of age is insufficient).

Influence on the ability to drive vehicles and use mechanisms

If the dose is exceeded 10 mg / day, the ability to react quickly may deteriorate. During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Drug interactions

Pharmacokinetic interactions with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, diazepam and glipizide were not found.

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

Storage conditions

Keep out of the reach of children at a temperature not exceeding 25 ? C.

Expiration date: 3 years.

After opening the bottle - 6 months.

Do not take after the expiration date.