Cetirizine tablets p / o 10mg, No. 30 Vertex

Adults and children 6 years of age and older for relief:

• nasal and ocular symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis - itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;

• symptoms of chronic idiopathic urticaria.

Inside, regardless of the meal. The tablets should be swallowed whole with a little water.

The drug is used as directed by a doctor to avoid complications.

Adults and children over 12 years old - 1 tablet (10 mg of cetirizine) 1 time per day.

Children from 6 to 12 years old - 1 table (10 mg of cetirizine) 1 time per day or 1/2 table (5 mg of cetirizine) 2 times a day, morning and evening.

Film-coated tablets in 1 tablet:

Active substance:

cetirizine dihydrochloride - 10 mg

• Hypersensitivity to cetirizine, hydroxyzine or piperazine derivatives, as well as to other components of the drug;

• end stage renal failure (CC <10 ml / min);

• hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

• children under 6 years of age;

• pregnancy.

pharmachologic effect

Cetirizine is a metabolite of hydroxyzine, belongs to the group of competitive histamine antagonists, blocks histamine H1 receptors.

In addition to the antihistamine effect, cetirizine prevents the development and facilitates the course of allergic reactions: at a dose of 10 mg 1 or 2 times / day, it inhibits the late phase of eosinophil aggregation in the skin and conjunctiva of patients with allergic reactions.

Indications of the drug

Adults and children 6 years of age and older for relief:

• nasal and ocular symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis - itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;

• symptoms of chronic idiopathic urticaria.

Dosage regimen

Inside. It is recommended to take the tablets with a glass of water.

Adults

10 mg (1 tab.) 1 time / day.

Elderly patients

In elderly patients, there is no need to reduce the dose if renal function is not impaired.

Patients with renal impairment

Since cetirizine is excreted mainly by the kidneys, if alternative treatment is impossible in patients with renal insufficiency, the dosage regimen of the drug should be adjusted depending on the renal function (CC value).

Patients with impaired liver function

Patients with impaired liver function alone do not require dosage adjustment.

In patients with impaired liver function and renal function, correction of the dosage regimen is recommended (see table above).

Children

Children aged 6 to 12 years - 5 mg (1/2 tab.) 2 times / day.

Children over 12 years old - 10 mg (1 tab.) 1 time / day.

Sometimes an initial dose of 5 mg (1/2 tab.) May be sufficient if it allows satisfactory control of symptoms.

In children with renal insufficiency, the dose is adjusted taking into account the CC and body weight.

Side effect

The results of clinical studies have shown that the use of cetirizine in the recommended doses leads to the development of minor adverse effects from the central nervous system, including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical stimulation of the central nervous system was recorded.

Despite the fact that cetirizine is a selective blocker of peripheral H1 receptors and practically does not have an anticholinergic effect, isolated cases of difficulty urinating, disturbances of accommodation and dry mouth have been reported.

It has been reported about liver dysfunction, accompanied by an increase in the activity of hepatic enzymes and bilirubin. In most cases, adverse events resolved after discontinuation of cetirizine dihydrochloride.

List of undesirable side reactions

There is evidence from double-blind controlled clinical trials comparing cetirizine and placebo or other antihistamines used in recommended doses (10 mg 1 time / day for cetirizine) in more than 3200 patients, on the basis of which a reliable analysis can be performed safety data.

In a pooled analysis, placebo-controlled studies with cetirizine 10 mg showed the following adverse reactions with a frequency of 1% or higher:

Adverse reactions (WHO terminology) Cetirizine 10 mg (n = 3260) Placebo (n = 3061) General disorders and disorders at the injection site Fatigue 1.63% 0.95% From the nervous system Dizziness 1.10% 0.98% Headache 7.42% 8.07% From the digestive side systems Abdominal pain 0.98% 1.08% Dry mouth 2.09% 0.82% Nausea 1.07% 1.14% Mental disorders Drowsiness 9.63% 5% Respiratory system Pharyngitis 1.29% 1.34% Although the incidence of drowsiness in the cetirizine group was higher than that in the group placebo, in most cases this adverse event was mild to moderate in severity. In an objective assessment carried out in the framework of other studies, it was confirmed that the use of cetirizine at the recommended daily dose in healthy young volunteers does not affect their daily activity.

From the hematopoietic system: very rarely - thrombocytopenia.

From the immune system: rarely - hypersensitivity reactions; very rarely - anaphylactic shock.

Mental disorders: infrequently - agitation; rarely - aggression, confusion, depression, hallucinations, sleep disturbances; very rarely - tick; frequency unknown - suicidal ideation, sleep disturbances (including nightmares).

From the nervous system: infrequently - paresthesia; rarely - convulsions; very rarely - taste perversion, dyskinesia, dystonia, fainting, tremor; frequency unknown - memory impairment, incl. amnesia.

From the side of the organ of vision: very rarely - violation of accommodation, blurred vision, nystagmus.

On the part of the organ of hearing: the frequency is unknown - vertigo, deafness.

From the side of the cardiovascular system: rarely - tachycardia; frequency unknown - vasculitis.

From the digestive system: infrequently - diarrhea; rarely - liver failure with changes in liver function tests (increased activity of transaminases, alkaline phosphatase, GGT and bilirubin); frequency unknown - increased appetite.

On the part of the skin and subcutaneous tissues: infrequently - rash, itching; rarely - urticaria; very rarely - angioedema, persistent drug erythema.

From the urinary system: very rarely - dysuria, enuresis; frequency unknown - urinary retention.

From the musculoskeletal system: the frequency is unknown - arthralgia.

General disorders: infrequently - asthenia, malaise; rarely - peripheral edema, weight gain.

Contraindications for use

• hypersensitivity to cetirizine, hydroxyzine or piperazine derivatives, as well as to other components of the drug;

• end stage renal failure (CC <10 ml / min);

• hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

• children under 6 years of age;

• pregnancy.

Carefully

chronic renal failure (with CC> 10 ml / min, correction of the dosage regimen is required); elderly patients (possibly a decrease in GFR); epilepsy and patients with increased convulsive readiness; patients with predisposing factors for urinary retention (spinal cord lesions, prostatic hyperplasia); period of breastfeeding.

Application during pregnancy and lactation

Pregnancy

When analyzing prospective data from more than 700 cases of pregnancy outcomes, there were no cases of the formation of malformations, embryonic and neonatal toxicity with a clear causal relationship.

Experimental studies on animals have not revealed any direct or indirect adverse effects of cetirizine on the developing fetus (including in the postnatal period), during pregnancy and childbirth. Adequate and strictly controlled clinical studies on the safety of using the drug during pregnancy have not been carried out, therefore ZodakЃ should not be used during pregnancy.

Breast-feeding

Cetirizine is excreted in breast milk at a concentration of 25% to 90% of the drug concentration in blood plasma, depending on the time after administration. During breastfeeding, ZodakЃ is used after consulting a doctor if the intended benefit to the mother outweighs the potential risk to the child.

Fertility

The available data on the effects on human fertility are limited, but no negative effects on fertility have been identified.

Application for impaired liver function Patients with impaired liver function alone do not require correction of the dosage regimen.

In patients with impaired liver function and renal function, correction of the dosage regimen is recommended.

Application for impaired renal function The use of the drug is contraindicated in patients with end-stage renal failure (CC <10 ml / min).

The drug should be prescribed with caution in chronic renal failure (with CC> 10 ml / min, a correction of the dosage regimen is required).

Application in children

The drug is contraindicated for use in children under 6 years of age.

Use in elderly patients

The drug should be prescribed with caution in elderly patients (possibly a decrease in GFR).

special instructions

It is recommended to be careful when using cetirizine concomitantly with alcohol.

In patients with spinal cord injury, prostatic hyperplasia, and other predisposing factors for urinary retention, caution is required because cetirizine may increase the risk of urinary retention.

Caution should be observed in patients with epilepsy and increased convulsive readiness.

Before the appointment of allergy tests, a three-day 'wash-off' period is recommended due to the fact that blockers of histamine H1 receptors inhibit the development of allergic skin reactions.

Cetirizine in the form of film-coated tablets should not be prescribed to patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

After stopping the use of cetirizine, itching and / or urticaria may appear, even if these symptoms were absent at the beginning of treatment. In some cases, symptoms may be intense and require resuming cetirizine. Symptoms disappear when cetirizine is resumed.

Influence on the ability to drive vehicles and mechanisms

An objective assessment of the ability to drive vehicles and work with mechanisms did not reliably reveal any undesirable effects when using the drug in recommended doses. However, for patients with manifestations of drowsiness while taking the drug during the period of treatment, it is advisable to refrain from driving, engaging in potentially hazardous activities or controlling mechanisms that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms: after a single dose of cetirizine at a dose of 50 mg, the following clinical picture was observed - confusion, dizziness, drowsiness, stupor, weakness, anxiety, sedation, increased fatigue, malaise, headache, mydriasis, itching, tachycardia, tremor, diarrhea, delay urine.

Treatment: immediately after taking the drug, it is necessary to wash the stomach or stimulate vomiting. The appointment of activated carbon, symptomatic and supportive therapy is recommended. The specific antidote is unknown. Hemodialysis is ineffective.

Drug interactions

Based on the analysis of pharmacodynamics, pharmacokinetics of cetirizine, interaction with other drugs is unlikely.

There was no significant interaction with pseudoephedrine and theophylline (400 mg / day) in specific drug interaction studies.

The simultaneous use of cetirizine with ethanol and drugs that depress the central nervous system may contribute to a further decrease in concentration and speed of reactions, although cetirizine does not enhance the effect of ethanol (when its concentration in the blood is 0.5 g / l).