ZODAC PILLS 10 MG

Description

Pharmachologic effect:

Zodac - antiallergic agent of the 2nd generation with a prolonged effect. The active ingredient of the drug is Cetirizine dihydrochloride, a selective blocker of peripheral H1 receptors. It has no significant antiserotoninovogo and anticholinergic actions. When used in therapeutic doses, Zodac does not cause a sedative effect, including drowsiness. The active ingredient of Zodac affects the histamine-dependent - the early phase of allergic reactions, as well as the late cellular phase. Under the action of cetirizine, histamine release from basophils and mast cells is inhibited, and migration of eosinophils and other cells is reduced. When receiving 5–60 mg of cetirizine, linear kinetics is observed. Total volume of distribution is 0.50 l / kg. The half-life of the active substance is 10 hours. Food intake does not affect the amount of absorption, however, the rate of absorption of cetirizine is reduced.

There was no cumulation effect when taking a dose of 10 mg every day for 10 days. The maximum concentration in the blood plasma after reaching the equilibrium concentration is 300 ng / ml, which is achieved after 60 ± 30 minutes. Associated with blood proteins 93 ± 0.3% cetirizine. It has no effect on the binding of Warfarin to plasma proteins.It does not undergo active metabolic transformation during the initial passage through the liver. Approximately 2/3 of cetirizine in unchanged form is excreted in the urine. A study on volunteers revealed no pharmacokinetic discrepancies for both AUC and maximum concentration values. There was no difference in pharmacokinetic parameters in adults of different races. The bioavailability of the active substance is the same for all dosage forms of the drug: syrup, drops and tablets.

Indications for use:

· Therapy for pruritus and urticaria of various origins, including urticaria, accompanied by fever (chronic idiopathic urticaria);

· Symptomatic therapy of allergic seasonal rhinitis and perennial allergic rhinitis;

· Symptomatic therapy of allergic conjunctivitis.

Contraindications:

Common to all dosage forms:

· Hypersensitivity to hydroxyzine or cetirizine in the history of life or to any other ingredients of Zodac;

· During pregnancy and breastfeeding;

· Renal failure with creatinine clearance less than 10 ml / min.

For pills - age up to 6 years.

For syrup - age up to 1 year.

Side effects:

Unlike previous generations of antihistamines, which belong to the group of H1 receptor antagonists, the active ingredient of Zodac penetrates the blood-brain barrier in small amounts, therefore the development of sedation is not expressed or expressed in a very slight degree.Although the effect of cetirizine is selective on peripheral H1 receptors, the anticholinergic effect is poorly expressed, however, there were reports of disturbed accommodation of the eyes, difficulty urinating, paradoxical stimulation of the central nervous system and a sense of dry mouth.

From the central and peripheral nervous system: fatigue, drowsiness, dizziness and headache; paradoxical stimulation of the nervous system - in isolated cases.

On the part of the hepatobiliary system: an increase in the content of bilirubin and the activity of liver enzymes (the indicated side effects are transient and disappeared after discontinuation of the drug).

Dosage and administration:

Zodak-pills

A pill is taken with a glass of water, regardless of the food. Do not chew! For adults and children from 12 years old - at 10 mg / day (1 tablet) in 1 reception.

In pediatrics: children from 6 to 12 years old - 5 mg / day (1/2 tablet) 2 p / day, 10 mg Zodac can be taken once daily.

Zodac drops

For adults and children from 12 years old - 10 mg (20 drops) 1 r / day. 1 ml of the preparation contains 20 drops.

In pediatrics: from the first days of life up to 2 years - 5 drops (2.5 mg) 2 p / day; from 2 to 6 years - 5 drops (2.5 mg cetirizine) 2 p / day, 10 drops (5 mg) are possible

1 p / day; from 6 to 12 years - 10 drops (5 mg) 2 p / day, 20 drops (10 mg) 1 p / day is possible.

Zodac syrup

For adults and children from 12 years old - 10 mg (2 measuring spoons) 1 p / day. 1 scoop contains 5 ml of Zodac syrup. The spoon is equipped with the divisions:? - corresponds to 1.25 ml of syrup and? - 2.5 ml.

In pediatrics: from 1 to 2 years - 2.5 mg (half a measuring spoon), 2 p / day; From 2 to 6 years old - 2.5 mg each (half a measuring spoon) 2 p / day, 5 mg (1 measuring spoon) 1 p / day is possible; From 6 to 12 years - 5 mg (1 measuring spoon) 2 p / day, 10 mg (2 measuring spoons) 1 p / day is possible.

Treatment of Elderly Patients

In the case of normally functioning kidneys, there is no need to reduce the dosage.

Treatment of patients with impaired renal function

In moderate or severe impaired renal functions, individual intervals should be established for Zodac intake, depending on the severity of renal failure: for minor violations (creatinine clearance 50–79 ml / min) - there is no need for dose adjustment and changing the interval between doses; for minor disorders (creatinine clearance 30–49 ml / min) - 5 mg / day as usual; for severe disorders (creatinine clearance? 30 ml / min) - 10 mg 1 time per day after 2 days; in the terminal stage, if there are contraindications to hemodialysis (creatinine clearance? 10 ml / min), Zodac is contraindicated.

The dose of cetirizine for children with renal insufficiency is calculated individually, based on body weight and the level of creatinine clearance.

Treatment of patients with impaired liver function

There is no need to reduce the dosage.

Overdose:

If the recommended dose of Zodac is exceeded, symptoms mainly associated with changes in the central nervous system develop, and anticholinergic actions of cetirizine are also likely.As a result of overdosing 5 times, the following symptoms of overdose are reported: diarrhea, anxiety, dizziness, nausea, fatigue, pupil dilation, headache, itching, sedation, nervousness, drowsiness, tachycardia, stupor, tremor and urinary retention.

The specific antidote is not revealed. In case of overdose, supportive and symptomatic therapy is used. Immediately after taking a large dose, gastric lavage is recommended. Hemodialysis is not effective because cetirizine is mostly bound to blood proteins.

Storage conditions:

At room temperature. Allowed for over-the-counter leave.