Zodak - instructions for use, dose, side effects, contraindications

Cetirizine belongs to the group of competitive antagonists of histamine, blocks H₁-gistamine receptors, practically does not have anticholinergic and antiserotonin action. Has a pronounced anti-allergic effect, prevents development and facilitates the course of allergic reactions. Has antipruritic and anti-exsudative effect. Affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; oppresses the selection of mediators involved in a late allergic reaction. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasm of smooth muscles. Eliminates the skin reaction to the administration of histamine, specific allergens, and also to cooling (with cold urticaria). In therapeutic doses, it practically does not have a sedative effect. Against the background of the course, tolerance does not develop.

The effect of the drug begins in 20 minutes (in 50% of patients), after 1 hour (in 95% of patients), and persists for 24 hours.

Pharmacokinetics:

Suction: after oral administration cetirizine quickly and well absorbed from the gastrointestinal tract. The maximum level of concentration is determined after about 30 -60 minutes.

Eating does not have a significant effect on the amount of absorption, but in this case, the rate of absorption is slightly reduced.

Distribution: Cetirizine binds to blood plasma proteins by about 93%. The volume of the distribution (V_d) is low (0.5 l / kg), the preparation does not penetrate into the cell.

The drug does not penetrate the blood-brain barrier.

Metabolism: Cetirizine is poorly metabolized in the liver with the formation of an inactive metabolite.

At 10-day application in a dose of 10 mg accumulation of the drug is not observed.

Excretion: approximately 70% of the kidneys are mostly unchanged.

The system clearance is about 54 ml / min.

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

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

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

Hemodialysis is ineffective.

Indications:

- Seasonal and all-the-year-round allergic rhinitis and conjunctivitis;

- Itching allergic dermatoses;

- Pollinosis (hay fever);

- Hives (including chronic idiopathic);

- Edema Quincke.

Contraindications:

- Hypersensitivity to the components of the drug.

- Terminal stage of renal failure (creatinine clearance <10 ml / min).

- Hereditary intolerance to galactose, deficiency of lactase or syndrome of glucose-galactose malabsorption.

- Children under 6 years.

- Pregnancy, lactation.

Carefully:Care should be taken in patients with impaired liver and / or kidney function and elderly people.

Dosing and Administration:

Zodak® is used as directed by a doctor to avoid complications.

Inside, regardless of food intake.

Adults and children over the age of 12 years

Zodak® is usually prescribed 1 tablet coated with a coat (= 10 mg cetirizine) once a day.

Children aged 6 to 12 years

Zodak® is usually prescribed 1 tablet coated with a coat (= 10 mg cetirizine), once a day or 1/2 of the tablet covered with a coating (= 5 mg cetirizine), twice a day, morning and evening.

Patients with renal insufficiency, the dose decreases depending on the clearance of creatinine (CC): with QC 30-49 ml / min -5 mg once a day; at 10-29 ml / min -5 mg every other day.

When the drug is prescribed for patients with renal failure and elderly patients, the dose should be adjusted depending on the magnitude of the SC.

The creatinine clearance for men can be calculated based on the serum creatinine concentration, according to the following formula:

CK (ml / min) = [140 - age (years)] x body weight (kg) / 72 x KK_serum (mg / dL)

QC for women can be calculated by multiplying the obtained value by a factor of 0.85.

Renal failure	QC (ml / min)	Mode dosing
Norm	≥ 80	10 mg / day
Lightweight	50-79	10 mg / day
Average	30-49	5 mg / day
Heavy	10-29	5 mg every other day
Terminal stage - patients on hemodialysis	< 10	Reception preparation contraindicated

Patients with a dysfunction only liver function correction dosage is not required.

If you miss the time of taking the drug accidentally, the next dose should be taken as soon as possible. In the event that the time of the next intake of the drug is approaching, the next dose should be taken on schedule, without increasing the total dose.

The drug Zodak® can be taken regardless of the time of eating. Tablets, coated with a shell, should be swallowed whole, washed down with a small amount of water.

Side effects:

The drug is usually well tolerated. Adverse events occur rarely and have a transient nature.

Possible side effects are given below for body systems and frequency of occurrence: very often (≥ 1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥ 1/10000, <1/1000), very rarely (<1/10000), the frequency is unknown (according to available data, it is not possible to determine the frequency of occurrence of a side effect).

Violations of the blood and lymphatic system

Very rarely: thrombocytopenia.

Immune system disorders

Rarely: hypersensitivity reactions.

Very rarely: anaphylactic shock

Disturbances from the nervous system

Often: headache, drowsiness, fatigue, dizziness.

Infrequently: paresthesia.

Rarely: convulsions, impaired motor function.

Very rarely: perversion of taste, dyskinesia, dystonia, fainting, tremor, tick.

The frequency is unknown: memory impairment, including amnesia.

Disorders of the psyche

Infrequently: arousal.

Rarely: aggression, confusion, depression, hallucinations, sleep disturbance. The frequency is unknown: suicidal ideation.

Disturbances on the part of the organ of sight

Very rarely: disorders of accommodation, blurred vision, nystagmus.

Hearing disorders and labyrinthine disorders Frequency unknown: vertigo.

Disorders from the digestive system

Often: dry mouth, nausea.

Infrequently: diarrhea, abdominal pain.

Heart Disease

Rarely: tachycardia.

Disturbances from the respiratory system, chest and mediastinal organs

Often: rhinitis, pharyngitis.

Disorders from the metabolism and nutrition

Rarely: weight gain.

Disorders from the kidneys and urinary tract

Very rarely: dysuria, enuresis.

Frequency unknown: retention of urine.

Laboratory and instrumental data

Rarely: changes in functional liver samples (increased activity of "liver" transaminases, alkaline phosphatase, gamma-glutamyltransferase and bilirubin concentrations).

Very rarely: thrombocytopenia.

Disturbances from the skin and subcutaneous tissues

Infrequent: rash, itching.

Rarely: urticaria.

Very rarely: angioedema, persistent erythema.

General disorders

Infrequently: asthenia, malaise.

Rarely: peripheral edema.

Frequency unknown: increased appetite.

Overdose:

Symptoms

Possible confusion, dizziness, drowsiness, blocking, stupor, weakness, anxiety, increased irritability, sedation, fatigue, headache, mydriasis, itching, tachycardia, tremor, urinary retention, dry mouth, diarrhea, constipation (most often with admission per day 50 mg cetirizine), malaise.

Treatment

Conduct symptomatic therapy.

A specific antidote has not been identified. Hemodialysis is ineffective. The stomach is washed, Activated carbon.

Interaction:

Clinically significant interactions of cetirizine with other drugs have not been established.

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

Special instructions:It is not recommended simultaneous use of drugs that depress the central nervous system, alcohol.

Effect on the ability to drive transp. cf. and fur:During the treatment period it is necessary to refrain from engaging in potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets, film-coated, 10 mg.

Packaging:For 7 or 10 tablets in a PVC / PVDC / A1 blister. Each blister is 7 tablets; 1, 3, 6, 9 or 10 blisters of 10 tablets together with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature of 10-25 ° C in a dry place.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N013867 / 01

Date of registration:09.12.2011

Expiration Date:Unlimited

The owner of the registration certificate:Zentiva c.s.Zentiva c.s. Czech Republic

Manufacturer: & nbsp

ZENTIVA, k.s. Czech Republic

Representation: & nbspZENTIVA PHARMA, LLCZENTIVA PHARMA, LLC

Information update date: & nbsp15.10.2017

Illustrated instructions

Instructions

Zodak® (Zodac)