Cetirizine: instructions for use and what it is needed for, price, reviews, analogues. Medicinal reference book geotar Can you drink alcohol after taking cetirizine?


Formula: C21H25ClN2O3, chemical name: -1-piperazinyl]ethoxy]acetic acid (and as hydrochloride).
Pharmacological group: intermediates/ histaminergic agents/ histaminolytics/ H1-antihistamines.
Pharmachologic effect: antiallergic, antihistamine.

Pharmacological properties

Cetirizine selectively blocks peripheral H1-histamine receptors, reduces the effect of histamine on blood vessels, reduces edema and hyperemia. Cetirizine effectively slows down the development of skin reactions (hyperemia and blister) to the introduction of specific allergens, histamine, and cooling (in patients with cold urticaria). The effect develops within 1–2 hours after taking cetirizine, the duration of blockade of H1 receptors is more than 1 day, in children under 2 years old - approximately 12 hours. Within 3 days, skin reactivity to histamine is restored. Cetirizine relieves the symptoms of allergic rhinitis (runny nose, sneezing, nasal congestion, watery eyes, itching). The drug dose-dependently reduces the narrowing of the bronchi, which is caused by histamine, in mild bronchial asthma. Slows down the development of the early phase of an allergic reaction mediated by histamine. Inhibits the migration of neutrophils, eosinophils and basophils, the secretion of mediators that take part in the late phase of the allergic reaction, in response to the introduction of an allergen. Cetirizine suppresses the action of other mediators and inducers of histamine secretion, such as substance P and platelet-activating factor, and reduces the expression of adhesion molecules (VCAM-1, ICAM-1). Cetirizine reduces the membrane fluidity of neutrophils, eosinophils and platelets, which were obtained from patients with seasonal allergic rhinitis and healthy volunteers.

The use of cetirizine for 1 week in doses that were 6 times the therapeutic daily dose was not accompanied by changes in the QT interval on the ECG and other signs of cardiotoxic effects. At doses of 20–25 mg/day, cetirizine does not affect the ability to concentrate and reaction time. In experimental studies, no effects on fertility or mutagenic effects were observed. When 20 mg/kg/day of the drug was administered to rats for 2 years, no carcinogenic effect was found. In mice that received 16 mg/kg/day of the drug (6 times the MRDC), cetirizine increased the incidence of benign liver tumors. Administration of the drug to mice during lactation was accompanied by a slowdown in body weight gain in the offspring.

When taken orally, cetirizine is absorbed by at least 70% and quickly. The maximum plasma concentration is 0.3 mcg/ml and is achieved within 1 hour when 10 mg of the drug is taken orally. Food does not affect the completeness of absorption, but can increase the time to reach maximum concentration by 1.7 hours and reduce it by 23%. The mean maximum concentration and AUC are proportional to the drug dose. Cetirizine is 93% bound to plasma proteins. The volume of distribution is 0.56 l/kg. 3 days after the start of administration, a stable plasma level is achieved. With repeated use, the content of cetirizine in the blood serum and skin is equivalent. The maximum concentration in the brain is no more than 10% of the maximum concentration in plasma. Cetirizine is excreted in breast milk. The half-life of cetirizine is 7-11 hours when using a single dose of 10 or 20 mg (in elderly people the half-life is prolonged, in children 2-12 years old it is shortened to 5-6 hours). In the liver, cetirizine is minimally metabolized to form an inactive metabolite and is excreted mainly by the kidneys unchanged. 60% of the dose taken during the day is excreted in the urine, 10% in feces. The clearance of cetirizine is 54 ml/min.

With daily use of 10 mg of the drug for 10 days, its accumulation in the body does not occur. According to the test of inhibition of the skin reaction (hyperemia and wheal) to intradermal administration of histamine, with prolonged use of the drug (up to 110 weeks), the development of tolerance is not observed. In cases of impaired renal function (with creatinine clearance less than 11–31 ml/min) and in patients on hemodialysis (with creatinine clearance below 7 ml/min), the half-life of cetirizine is extended by 3 times, its clearance is reduced by 70%. . In chronic liver diseases and in elderly patients, there is an increase in the half-life of cetirizine by 50% and a decrease in its clearance by 40%. The pharmacokinetic parameters of cetirizine do not depend on race and gender.

Indications

Year-round and seasonal allergic rhinitis; allergic conjunctivitis; hay fever; chronic idiopathic urticaria; angioedema; skin itching; complex treatment of chronic eczema, atopic dermatitis, atopic bronchial asthma.

Method of administration of cetirizine and dose

Cetirizine is taken orally (regardless of food intake), patients over 6 years old - 5 mg 2 times a day or 10 mg 1 time a day, patients 2–6 years old - 2.5 mg 2 times a day or 1 time a day 5 mg (depending on the response or severity of the condition), children 1-2 years old - 2 times a day, 2.5 mg, children 0.5 - 1 year old - 1 time a day 2.5 mg. For patients with renal failure, depending on creatinine clearance, the dose is reduced: with creatinine clearance 30–49 ml/min - 5 mg once a day, with 10–29 ml/min - 5 mg every other day.

It is not recommended to use drugs that depress the central nervous system (including alcohol) with cetirizine. Use with caution while working for vehicle drivers and people whose professions involve increased concentration.

Contraindications for use

Hypersensitivity (including to hydroxyzine), breastfeeding, pregnancy, age up to 6 months.

Restrictions on use

Old age, moderate and severe chronic renal failure.

Use during pregnancy and breastfeeding

The use of cetirizine during pregnancy is contraindicated. During cetirizine therapy, breastfeeding should be stopped.

Side effects of cetirizine

Sense organs and nervous system: drowsiness, agitation, fatigue, headache, anxiety, dizziness, migraine, nervousness, impaired thinking and concentration, emotional lability, insomnia, euphoria, depression, confusion, depersonalization, amnesia, ataxia, tremor, impaired coordination of movements, hyperkinesis, paresthesia , calf muscle cramps, dysphonia, paralysis, myelitis, ptosis, blurred vision and accommodation, eye pain, xerophthalmia, glaucoma, hemorrhage in the eye, conjunctivitis, deafness, tinnitus, ototoxicity, impaired sense of smell;
digestive system: dry mouth, absence or change in taste perception, anorexia, increased appetite, stomatitis (including ulcerative), swelling and discoloration of the tongue, increased caries, increased salivation, thirst, dyspepsia, vomiting, gastritis, flatulence, abdominal pain, diarrhea, hemorrhoids, constipation, melena, impaired functional state of the liver, rectal bleeding;
circulatory system: very rarely - heart failure, hypertension, palpitations;
respiratory system: rhinitis, nasal polyp, nosebleeds, pharyngitis, sinusitis, cough, bronchitis, bronchospasm, increased bronchial secretion, upper respiratory tract infection, dyspnea, hyperventilation, pneumonia;
genitourinary system: swelling, urinary retention, polyuria, hematuria, dysuria, urinary tract infection, decreased libido, cystitis, dysmenorrhea, menorrhagia, intermenstrual bleeding, vaginitis;
support and movement system: arthralgia, arthrosis, arthritis, myalgia, muscle weakness, back pain;
skin: dry skin, blistering rashes, rash, itching, furunculosis, acne, dermatitis, hyperkeratosis, eczema, erythema, alopecia, increased sweating, angioedema, photosensitivity, hypertrichosis, seborrhea;
others: fever, malaise, chills, dehydration, hot flashes, breast pain, lymphadenopathy, weight gain, diabetes mellitus, allergic skin reactions, including urticaria.

Interaction of cetirizine with other substances

Theophylline reduces the clearance of cetirizine by 16%. Cetirizine is compatible with pseudoepinephrine, azithromycin, ketoconazole, diazepam, erythromycin and cimetidine.

Overdose

An overdose of cetirizine causes drowsiness and possible urinary retention, anxiety, tachycardia, tremor, rash, itching. Necessary: ​​gastric lavage, intake of activated carbon, symptomatic and supportive treatment; hemodialysis is ineffective.

Dosage form:  TO apli for oral administration. Compound:

Active substance: Cetirizine dihydrochloride - 10.00 mg.

Excipients: methyl parahydroxybenzoate - 1.35 mg, propyl parahydroxybenzoate - 0.15 mg, glycerol - 250.00 mg, propylene glycol - 350.00 mg, sodium saccharinate - 10.00 mg, sodium acetate trihydrate - 10.00 mg, glacial acetic acid - 0.53 mg, water - up to 1 ml.

Description: P a transparent, colorless or slightly brownish solution with a characteristic odor. Pharmacotherapeutic group:antiallergic agent - H1-histamine receptor blocker ATX:  

R.06.A.E.07 Cetirizine

Pharmacodynamics:

Cetirizine, the active substance of the drug, is a metabolite of hydroxyzine, belongs to the group of competitive histamine antagonists and blocks H1-histamine receptors. In addition to the antihistamine effect, it prevents the development and alleviates the course of allergic reactions: at a dose of 10 mg once or twice a day, it inhibits the late phase of eosinophil aggregation in the skin and conjunctiva of patients prone to atopy.

Clinical efficacy and safety

Studies in healthy volunteers have shown that ceti rizin at a dose of 5 and 10 mg significantly inhibits the reaction in the form of rash and redness to the introduction of high concentrations of histamine into the skin, but a correlation with effectiveness has not been established. A 6-week placebo-controlled study involving 186 patients with allergic rhinitis and concomitant mild to moderate asthma showed that cetirizine 10 mg once daily reduced rhinitis symptoms and did not affect pulmonary function.

The results of this study confirm the safety of cetirizine in patients suffering from allergies and mild to moderate bronchial asthma.

A placebo-controlled study showed that taking cetirizine at a dose of 60 mg per day for 7 days did not cause a clinically significant prolongation of the QT interval.

Children

In a 35-day study in patients aged 5-12 years, there was no evidence of resistance to the antihistamine effect of cetirizine. The normal skin reaction to histamine was restored within three days after discontinuation of the drug with repeated use.

A 7-day placebo-controlled study of cetirizine in syrup dosage form involving 42 patients aged 6 to 2 months demonstrated the safety of its use. was prescribed at a dose of 0.25 mg/kg twice daily, which corresponds approximately to 4.5 mg per day (dose range was 3.4 to 6.2 mg per day).

Application in children from 6 to 12 months is possible only with a doctor's prescription and under strict medical supervision.

Pharmacokinetics:

The pharmacokinetic parameters of cetirizine when used in doses from 5 to 60 mg change linearly.

Suction

The maximum concentration (C m ax) in the blood plasma is reached after 1 ± 0.5 hours and is 300 ng/ml.

Various pharmacokinetic parameters, such as maximum plasma concentration and area under the concentration-time curve, are homogeneous.

Eating does not affect the complete absorption of cetirizine, although the rate will decrease. The bioavailability of various dosage forms of cetirizine (solution, capsules, tablets) is comparable.

Distribution

Cetirizine is 93 ± 0.3% bound to plasma proteins. The volume of distribution (Vd) is 0.5 l/kg. does not affect the binding of warfarin to proteins.

Metabolism

Cetirizine does not undergo extensive first-pass metabolism.

Removal

The half-life (T 1/2) is approximately 10 hours.

When taking the drug at a daily dose of 10 mg for 10 days, no accumulation of cetirizine was observed.

Approximately 2/3 of the dose taken is excreted unchanged by the kidneys.

Elderly patients

In 16 elderly individuals, with a single dose of cetirizine at a dose of 10 mg, T1/2 was 50% higher, and clearance was 40% lower compared to non-elderly individuals.

The decreased clearance of cetirizine in elderly patients is likely due to decreased renal function in this category of patients.

In patients with mild renal failure (creatinine clearance (CC) > 40 ml/min), pharmacokinetic parameters are similar to those in healthy volunteers with normal renal function.

In patients with moderate renal failure and in patients on hemodialysis (HD< 7 мл/мин), при приеме препарата внутрь в дозе 10 мг Т 1/2 удлиняется в 3 раза, а общий клиренс снижается на 70% относительно здоровых добровольцев с нормальной функцией почек.

For patients with moderate or severe renal impairment, appropriate changes to the dosage regimen are required (see section "Method of application and doses").

Cetirizine is poorly removed from the body during hemodialysis.

Patients with liver failure

In patients with chronic liver diseases (hepatocellular, cholestatic and biliary cirrhosis), with a single dose of 10 or 20 mg, T1/2 increases by approximately 50%, and clearance decreases by 40% compared to healthy subjects. Dose adjustment is only necessary if the patient with hepatic impairment also has concomitant renal impairment. failure.

Children

T 1/2 in children from 6 to 12 years is 6 hours, from 2 to 6 years - 5 hours, from 6 months to 2 years - reduced to 3.1 hours.

Indications:

Cetirizine dihydrochloride, oral drops 10 mg/ml, is indicated in adults and children 6 months and older for the relief of:

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.

Contraindications:

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

End-stage renal disease (creatinine clearance< 10 мл/мин);

Children under 6 months of age (due to limited data on the effectiveness and safety of the drug);

Pregnancy.

Carefully:

Chronic renal failure (with creatinine clearance >10 ml/min, dosage regimen adjustment is required);

Elderly patients (with an age-related decrease in glomerular filtration);

Epilepsy and patients with increased seizure activity;

Patients with predisposing factors to urinary retention (see section "Special instructions");

Children under 1 year of age;

Breastfeeding period.

Pregnancy and lactation:

Pregnancy

An analysis of prospective data from more than 700 cases of pregnancy outcomes revealed no cases of malformations, embryonic or neonatal toxicity with a clear cause-and-effect relationship.

Experimental studies in animals have not revealed any direct or indirect adverse effects of cetirizine on the developing fetus (including in the postnatal period), pregnancy and postnatal development.

Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy have not been conducted, therefore the drug should not be used during pregnancy.

Breast-feeding

Cetirizine is excreted in breast milk in concentrations ranging from 25% to 90% of the drug concentration in the blood plasma, depending on the time after administration. During breastfeeding, it is used after consultation with a doctor, if the expected benefit to the mother outweighs the potential risk to the child.

Fertility

Available data on the effects on human fertility are limited, but no adverse effects on fertility have been identified.

Directions for use and dosage:

Inside, drop into a spoon or dissolve in water.

The amount of water to dissolve the drug should correspond to the amount of liquid that the patient (especially a child) is able to swallow.

The solution should be taken immediately after preparation.

For adults

10 mg (20 drops) 1 time per day.

Sometimes an initial dose of 5 mg (10 drops) may be sufficient if satisfactory control of symptoms is achieved.

Elderly patients

There is no need to reduce the dosage in elderly patients unless renal function is impaired.

Patients with kidney failure

Since it is excreted from the body mainly by the kidneys (see subsection "Pharmacokinetics"), If alternative treatment is not possible for patients with renal failure, the dosage regimen of the drug should be adjusted depending on renal function (creatinine clearance - creatinine clearance).

Creatinine clearance for men can be calculated from the serum creatinine concentration using the following formula:

CK (ml/min) = /72 x serum CK (mg/dl)

Creatinine clearance for women can be calculated by multiplying the resulting value by a factor of 0.85.

Dosing in Adult Patients with Renal Impairment

Kidney failure

Creatinine clearance, ml/min

Dose and frequency of administration

5 mg every other day

End stage - hemodialysis patients

taking the drug is contraindicated

Patients with liver dysfunction

In patients with impaired liver function alone, no dosage adjustment is required.

In patients with impaired liver function and renal function, dosage adjustment is recommended (see table above).

Children

Use in children from 6 to 12 months is possible only as prescribed by a doctor and under strict medical supervision.

Children from 6 to 12 months

2.5 mg (5 drops) 1 time per day

Children from 1 year to 6 years

2.5 mg (5 drops) 2 times a day

Children from 6 to 12 years old

5 mg (10 drops) 2 times a day

Children over 12 years old

10 mg (20 drops) 1 time per day

Sometimes an initial dose of 5 mg (10 drops) may be sufficient exactly if uh T o allows achieve satisfactory symptom control.

For children with renal failure the dose is adjusted taking into account CC and body weight.

Side effects:

Data , obtained in clinical studies

Review

The results of clinical studies have demonstrated that the use of cetirizine in recommended doses leads to the development of minor adverse effects on the central nervous system (CNS), including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical stimulation of the central nervous system has been reported.

Despite the fact that it is a selective blocker of peripheral H1 receptors and has virtually no anticholinergic effect, isolated cases of difficulty urinating, disturbances of accommodation and dry mouth have been reported.

Liver dysfunction has been reported, accompanied by increased levels of liver enzymes and bilirubin. In most cases, adverse events resolved after discontinuation of cetirizine.

List of unwanted side reactions

Data from double-blind, controlled clinical trials comparing cetirizine with placebo or other antihistamines given at recommended doses (10 mg once daily for cetirizine) in more than 3200 patients are available on which to conduct a reliable analysis safety data.

According to the results of the pooled analysis, in placebo-controlled studies with the use of cetirizine at a dose of 10 mg, the following adverse reactions were identified with an incidence of 1.0% or higher

Adverse reactions (WHO terminology)

Cetirizine 10 mg (n = 3260)

Placebo (n = 3061)

Fatigue

1,63%

0,95%

Nervous system disorders

Dizziness

1,10%

0,98%

Headache

7,42 %

8,07%

Violations by gastrointestinal tract

Abdominal pain

0,98 %

1,08%

Dry mouth

2,09 %

0,82%

Nausea

1,07%

1,14%

Mental disorder

Drowsiness

9,63 %

5,00 %

Respiratory, thoracic and mediastinal disorders

Pharyngitis

1,29%

1,34%

Although the incidence of somnolence in the cetirizine group was higher than that in the placebo group, most cases were mild or moderate in severity. When objectively assessed in other studies, it was confirmed that the use of cetirizine at the recommended daily dose in healthy young volunteers does not affect their daily activities.

Children

In placebo-controlled studies, the following adverse reactions were observed with an incidence of 1% or higher in children aged 6 months to 12 years:

Adverse reactions (terminology WHO)

Cetirizine (n =1656)

Placebo (n =1294)

Gastrointestinal disorders

Diarrhea

1,0%

0,6%

Mental disorder

Drowsiness

1,8%

1,4%

Respiratory system disorders, organs of the chest and mediastinum

Rhinitis

1,4%

1,1%

General disorders and disorders at the injection site

Fatigue

1 , 0%

0,3%

Post-registration experience

In addition to the adverse events identified during clinical trials and described above, the following adverse reactions were observed during post-registration use of the drug.

Adverse events are presented below by MedDRA organ system class and incidence, based on data from post-marketing use of the drug. The incidence of adverse events was determined as follows: very often (≥1/10); often (≥1/100,<1/10); нечасто (≥1/1000, <1/100); редко (≥1/10000, <1/1000); очень редко (<1 /10000), frequency unknown(due to insufficient data).

From the blood and lymphatic system : very rarely - thrombocytopenia.

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

Metabolic and eating disorders : frequency unknown - increased appetite.

Mental disorders : infrequently- excitement; rarely - aggression, confusion, depression, hallucinations, sleep disturbance; very rarely - tic; frequency unknown- suicidal ideas.

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

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

From the hearing organs : frequency unknown - vertigo.

From the digestive system : infrequently - diarrhea.

From the cardiovascular system : rarely - tachycardia.

Hepatobiliary disorders : rarely - changes in functional liver tests (increased activity of transaminases, alkaline phosphatase, gamma-glutamyltransferase and bilirubin).

From the skin : infrequently- rash, itching; rarely - urticaria; very rarely - angioedema, persistent drug erythema.

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

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

Research : rarely- increase in body weight.

Adverse Reaction Alert

A system for reporting suspected adverse reactions after registration of a medicinal product is of great importance.

This allows continuous monitoring of the benefit/risk ratio of the drug.

Overdose:

Symptoms

With a single dose of 50 mg, the following symptoms may be observed: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, itching, anxiety, weakness, sedation, drowsiness, stupor, tachycardia, tremor, urinary retention.

Treatment: immediately after taking the drug - gastric lavage or inducing vomiting. It is recommended to take activated carbon and carry out symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective.

Interaction:

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

There were no significant interactions observed with pseudoephedrine or theophylline (at a dose of 400 mg per day) in specific drug interaction studies.

The simultaneous use of cetirizine with alcohol and other drugs that depress the central nervous system may further reduce concentration and reaction speed, although it does not enhance the effect of alcohol (at a blood concentration of 0.5 g/l).

Special instructions:

Due to the potential for central nervous system depressant effects, caution should be exercised when prescribing the drug to children under 1 year of age who have the following risk factors for sudden infant death syndrome, such as (but not limited to):

Sleep apnea syndrome or sudden infant death syndrome in a sibling;

Maternal drug abuse or smoking during pregnancy;

Young maternal age (19 years and younger);

Smoking abuse by a nanny caring for a child (one pack of cigarettes a day or more);

Children who regularly fall asleep face down and are not placed on their back;

Premature (gestational age less than 37 weeks) or low birth weight (below 10th percentile of gestational age) infants;

When taking drugs together that have a depressant effect on the central nervous system.

The drug contains excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions, including delayed ones.

In patients with spinal cord injury, prostatic hyperplasia, or other factors predisposing to urinary retention, caution is required as it may increase the risk of urinary retention.

Caution is recommended when using cetirizine concomitantly with alcohol, although no clinically significant interaction with alcohol was observed at therapeutic doses (at a blood alcohol concentration of 0.5 g/l).

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

Before prescribing allergy tests, a three-day “washing out” period is recommended due to the fact that H 1 -histamine receptor blockers inhibit the development of skin allergic reactions.

Impact on the ability to drive vehicles. Wed and fur.:

An objective assessment of the ability to drive vehicles and operate machinery did not reliably reveal any adverse events when taking the drug at the recommended dose. However, for patients with symptoms of drowsiness while taking the drug, it is advisable to refrain from driving. classes potentially dangerous activities or control of mechanisms that require increased concentration and speed of psychomotor reactions.

Release form/dosage:

Drops for oral administration, 10 mg/ml.

Package:

10 ml or 20 ml of solution in an orange glass bottle, or a polymer bottle, or a polyethylene terephthalate bottle for medicines, equipped with a dropper stopper, sealed with a polymer screw cap with first opening control.

A label based on self-adhesive film or a label made from label paper is glued onto the bottle.

One bottle along with instructions for use is placed in a cardboard package (pack) made of cardboard for consumer packaging.

Storage conditions:

At a temperature not higher than 25 °C.

Keep out of the reach of children.

Best before date:

Do not use after the expiration date.

Conditions for dispensing from pharmacies: Over the counter Registration number: LP-003955 Registration date: 10.11.2016 Expiration date: 10.11.2021 Owner of the Registration Certificate: ATOLL, LLC Russia Manufacturer:   Representative office:   OZONE LLC Russia Information update date:   11.12.2016 Illustrated instructions"Salutas Pharma GmbH" subsidiary of the company "Hexal AG", Germany

Active ingredient: Cetirizine Hexal

Cetirizine

Release forms of Cetirizine Hexal

Film-coated tablets, 10 mg No. 7, No. 20

Who is Cetirizine Hexal indicated for?

For the symptomatic treatment of allergic diseases:
  • chronic (year-round) allergic rhinitis;
  • seasonal allergic rhinitis;
  • allergic conjunctivitis;
  • chronic idiopathic urticaria;
  • allergic dermatitis.

How to use Cetirizine Hexal

Method of administration and dose.

Adolescents over 12 years of age and adults: 1 tablet per day, preferably in the evening.

In children aged 6 to 12 years, dosage depends on their body weight: for body weight less than 30 kg: ½ film-coated tablet per day, in the evening (the tablet has a notch on one side, which makes it possible to divide it in half); for body weight over 30 kg: 1 film-coated tablet per day, divided into 2 doses (1/2 tablet in the morning and 1/2 in the evening), if this is possible in a particular case.

Cetirizine Hexal can be taken with or without food. The film-coated tablet should be swallowed without chewing and washed down with liquid.

In patients with hepatic insufficiency, the appropriate dose should be adjusted individually, especially in cases of concomitant renal insufficiency. Elderly patients may exhibit greater sensitivity to the drug, which requires dose adjustment.

The duration of treatment depends on the nature, duration and dynamics of symptoms, and is determined by the doctor.

Features of application.

Warning for diabetic patients: 1 tablet contains less than 0.01 carbohydrate exchange units.

Use in children. Due to the lack of relevant data, the use of Cetirizine Hexal in infants and children under 2 years of age is not recommended. The drug in tablet form is used from 6 years of age. The drug must be discontinued several days before the planned skin tests with allergens.

Pregnancy and lactation.

Although animal studies have not found any teratogenic effect, Cetirizine Hexal should not be used during pregnancy, since there are no relevant data on the effect of the drug on the fetus. Since experimental studies have shown that the active ingredient cetirizine is excreted in human milk and excretion into breast milk has not been studied in humans, women who are breastfeeding should not take Cetirizine Hexal.

Impact on the ability to drive a car and use machinery.

Comparative clinical studies found no evidence of impairment in attention, reaction time or driving ability after taking cetirizine hydrochloride at recommended doses. However, we recommend that patients who drive, work in hazardous conditions or use machinery do not exceed the prescribed dose and take into account the possibility of individual reactions (dizziness, drowsiness) to the drug.

Alcohol. Although studies have found that the effects of alcohol (blood alcohol concentration 80 ml) are not enhanced by Cetirizine Hexal tablets, taking them together is not recommended.

Side effects of Cetirizine Hexal

In isolated cases, transient side effects are possible, in particular headache, dizziness, agitation, weakness, xerostomia, manifestations of allergic skin reactions, increased fatigue, laryngitis, abdominal pain, cough, diarrhea, nosebleeds, bronchospasm, nausea, vomiting, angioedema .

In some patients, hypersensitivity reactions and manifestations of liver dysfunction (hepatitis, increased transaminase levels) were observed.

Who is Cetirizine Hexal contraindicated for?

  • Hypersensitivity to the active ingredient, or to any of the inactive ingredients;
  • severe forms of nephropathy;
  • period of pregnancy and lactation;
  • infants and children under 2 years of age.

Interaction of Cetirizine Hexal

Co-administration of cetirizine dihydrochloride 20 mg and cimetidine 400 mg does not affect the manifestations of the skin reaction caused by the injection of histamine, in comparison with a similar reaction when taking cetirizine dihydrochloride itself.

Despite the lack of direct evidence of interaction of cimetidine with drugs that depress the central nervous system, caution should be exercised when prescribing them together.

Concomitant use of cetirizine with drugs that exhibit ototoxic effects, such as gentamicin, may mask symptoms of ototoxicity such as tinnitus and dizziness.

There was a decrease in the elimination of cetirizine from the body when it was used simultaneously with theophylline at a dose of 400 mg.

Overdose of Cetirizine Hexal

With a significant overdose (50 mg of cetirizine dihydrochloride once), drowsiness and increased side effects may occur.

In cases of significant overdose, standard measures should be taken to remove the drug and prevent its subsequent absorption, in particular gastric lavage. The patient's subsequent condition should be monitored.

A specific antidote is unknown. Cetirizine dihydrochloride is not dialysable. Therapy is symptomatic.

Not all medications can be safely mixed with alcoholic beverages. Antibiotics and antiviral drugs should not be taken in parallel with alcohol. The ban on combining it with alcohol also applies to antihistamines designed to relieve allergy symptoms. This group of medications includes Cetrin.

Features of the medicine

Cetrin is one of the popular antihistamines, available in the form of tablets or syrup for internal use. The solid form is ideal for adult patients, while the liquid medicine is the best option for children over two years of age. Before this age, the drug is not prescribed.

Cetrin is a modern medicine that, by its mechanism of action, is a histamine receptor blocker. The active component of tablets or liquid syrup is cetirizine. It is due to this chemical substance that the therapeutic effect is achieved.

Cetrin is a second generation antihistamine. This means that the medicine works quite effectively, but also has some side effects. All of them are weaker compared to those of the first generation drugs, such as Suprastin and Tavegil. However, now you can buy more modern medicines in pharmacies. These are the so-called third generation antihistamines - Claritin, Telfast. They differ from Cetrin in their maximum selectivity of action, therefore they have almost no effect on the nervous system.

Cetrin quickly and efficiently copes with allergy symptoms, but after taking these tablets or syrup, the patient may develop unwanted side effects:

  • drowsiness;
  • weakness;
  • headache;
  • dizziness;
  • migraine;
  • dry mouth;
  • stomach ache.

At the same time, all side effects when used correctly are extremely rare. Most often, patients note only a slight depression of central nervous system functions, which manifests itself as weakness and drowsiness.

Intended area of ​​the drug


Cetrin is a proven antihistamine, which allows it to be prescribed for various manifestations of allergies in humans. Tablets or syrup help quickly eliminate such unpleasant symptoms as:

  • swelling;
  • burning;
  • redness;
  • peeling of the skin.

Experts explain that the product works by reducing the permeability of capillaries, through which blood nourishes soft tissues. Consequently, excess fluid is removed from them.

Another effect of Cetrin syrup and tablets is to relieve spasms of smooth muscles. This helps stop a coughing or choking attack, relieve swelling from the larynx and trachea and restore proper breathing.

Cetrin is an effective medicine that is prescribed for the following conditions:

  • hay fever;
  • allergic conjunctivitis;
  • eczema;
  • asthma;
  • Quincke's edema;
  • dermatitis;
  • hives;
  • seasonal runny nose.

Cetrin will help with all of the above conditions. It is only important to strictly adhere to the dosage and duration of treatment. In addition, you must adhere to all other doctor’s recommendations. In particular, experts prohibit taking Cetrin and its analogues in parallel with alcoholic beverages.

Possible increased side effects

As already mentioned, cetrin is a second generation antihistamine. These are relatively safe drugs that block only certain histamine receptors. However, it is still not possible to completely avoid side effects. As a rule, the vast majority of patients experience drowsiness and dizziness. These symptoms are associated with partial depression of the human central nervous system.

Alcohol also affects the nervous system. Moreover, if when taking small doses its inhibition is observed, which repeats the effect of antihistamines, then with an increase in the volume drunk, the opposite effect occurs.

Alcohol excites the patient's central nervous system, which leads to even more severe side effects. Instead of the usual dizziness, there is a severe headache, similar to a migraine attack. Weakness increases, and is accompanied by nausea, confusion, or even hallucinations.

Effect on various organ systems

Cetrine and alcohol are a dangerous combination, not only because of the possible increase in side effects. Experts are convinced that such a combination of substances has a detrimental effect on many organs of the human body:


After completing the course of treatment, it is important to give the body a period to recover. After 1-2 weeks, you will be able to safely drink a small dose of alcohol - a glass of red wine or 50 mg of cognac.

Increased allergic reaction

By taking an antihistamine, a person seeks to get rid of the unpleasant manifestations of allergies - swelling, itching, redness of the skin or watery eyes, but sometimes the opposite effect is observed. This happens quite rarely, and such a reaction is usually provoked by errors in treatment.

If the doctor strictly prohibits combining Cetrin with any type of alcohol, then you need to follow his recommendations. Violating them can lead to an increase in allergies after drinking even a minimal dose of alcohol. A person’s skin instantly becomes covered with red spots, which itch very much and subsequently begin to peel off. It is also possible to develop laryngeal edema, which causes breathing difficulties.

When these symptoms disappear, no specialist will answer. It is possible that the situation may worsen, even to the point of loss of consciousness and coma. For this reason, it is best to immediately call an ambulance. Doctors will quickly relieve all unpleasant manifestations of allergies using powerful hormonal drugs.

Experts are convinced that second-generation antihistamines, such as Cetrin, are ideal assistants in getting rid of allergies. They work quickly and effectively, while having an adequate cost and a minimum of side effects. The latter can be avoided if you carefully listen to the recommendations of your doctor and follow them. In particular, you cannot combine Cetrin with alcoholic beverages. This will allow you to quickly get rid of allergies without causing additional harm to your health.

Cetirizine is an antihistamine, a histamine H1 receptor blocker. The second generation remedy helps alleviate the symptoms characteristic of an allergic reaction and prevent its development. There is a list of contraindications for use.

  1. Pills. They have an oblong shape and are white in color.
  2. Drops for oral administration. They are odorless and colorless.
  3. Syrup (the most preferred form for children). Transparent composition with banana flavor.

The optimal dosage form is determined by the attending physician in a particular case for a particular patient.

Description and composition

One tablet of the drug contains 10 mg of cetirizine dihydrochloride. Auxiliary components are:

  • lactose monohydrate;
  • microcrystalline cellulose;
  • titanium dioxide;
  • colloidal silicon dioxide;
  • magnesium stearate.

The drug in the form of drops contains 10 mg of cetirizine dihydrochloride per 1 ml of composition. The list of auxiliary components includes the following compounds:

  • sodium acetate trihydrate;
  • benzoic acid;
  • propylene glycol;
  • glycerol;
  • distilled water.

The syrup for oral administration contains 1 mg of cetirizine dihydrochloride per 1 ml of the medicinal composition. Additional components are the following compounds:

  • glycerol;
  • sodium saccharin;
  • banana flavoring;
  • sorbitol;
  • acetic acid;
  • sodium acetate;
  • propylene glycol.

Pharmacological group

Cetirizine can be classified as a histamine H1 receptor blocker. the drug has a pronounced antihistamine effect on the human body. When taken in acceptable dosages, the active substance does not have a sedative, antiserotonic, or anticholinergic effect. The drug is used to eliminate the symptoms of an allergic reaction and prevent its manifestation. The product has an antiexudative effect: it eliminates nasal discharge, prevents tearing, and also has an antipruritic effect. Effective in the fight against contact allergies.

At the early stage of allergy development, the active substance allows you to reduce the rate of migration of inflamed cells, at a later stage it allows you to stop the rate of release of mediators. According to the instructions for use, the drug begins to act 1 - 1.5 times after oral administration.

Indications for use

The drug is prescribed to patients for the relief and prevention of symptomatic manifestations of an allergic reaction. The product can be used to eliminate the symptoms of an allergic reaction caused by food intake or contact with an external irritant.

for adults

The drug can be prescribed to patients with the following conditions:

  • allergic rhinitis provoked by external irritants;
  • allergic, accompanied by swelling of the eyelids and lacrimation;
  • allergic;
  • allergic reaction to sunlight;
  • cold dermatitis;
  • active mucus formation in the oral cavity;
  • generalized skin itching;
  • reaction to an insect bite.

The drug can be used to prevent an allergic reaction in a patient while taking antibacterial agents.

for children

Cetirizine tablets are prescribed to children over 12 years of age with the following contraindications:

  • allergic rhinitis;
  • the appearance of rashes on areas of the skin and mucous membranes;
  • allergic swelling of the mucous membranes.

Dosage for children under 12 years of age is determined privately.

Children over 1 year of age are prescribed the drug in the form of drops to combat various symptoms of an allergic reaction. The product in syrup form can be used to relieve attacks of allergic reactions in children over 2 years of age.

Clinical trials and studies on the effects of cetirizine on the fetus during fetal development have not been conducted. Since the safety of the drug has not been proven in clinical studies, the drug is not prescribed to pregnant women.

The active component of the antiallergic drug has the ability to penetrate into breast milk, therefore, the drug should not be used during breastfeeding. If it is necessary to use a medicinal composition, the issue of the possibility of stopping breastfeeding should be decided.

Contraindications

The drug Cetirizine, regardless of the release form, can be used orally after carefully studying the instructions for use, which regulate the recommended dosages and exclude the possibility of a reaction in the body.

The list of contraindications for taking the composition includes:

  • disturbances in the functioning of the kidneys, accompanied by severe organ dysfunction;
  • children under 6 years of age;
  • period of pregnancy and lactation;
  • the particular sensitivity of the patient’s body to the components of the drug;
  • lactose intolerance;
  • liver failure;
  • disturbances in the functioning of the central nervous system;
  • advanced age of the patient - more than 65 years;
  • heart rhythm disturbances.

The drug is prescribed with caution to patients suffering from chronic.

Applications and dosages

The dosage of the drug is determined individually depending on the age of the patient and the form of release of the composition used.

for adults

Adults are prescribed the drug Cetirizine in tablet form. The drug has a prolonged action. therefore, the permissible daily dose is 1 tablet. The drug in syrup form is prescribed to adults and children over 12 years of age at 10 ml per day. Cetirizine in the form of drops for oral administration - 20 drops per day. For patients suffering from renal failure, adjustment of the permissible dose is indicated.

The duration of treatment for seasonal allergies is from 3 to 6 weeks.

for children

The daily dose of Cetirizine syrup for children aged 2 to 12 years weighing less than 30 kg is no more than 5 ml per day. If the child's weight is over 30 kg, the dose should be increased to 10 ml.

Children under two years of age are recommended to take oral drops. The permissible dose is 5 drops per day. For children aged 2 to 6 years, the dose is 10 drops. For the age group from 6 to 12 years, the dose is 20 drops per day.

for pregnant women and during lactation

The composition is not used during pregnancy and breastfeeding.

Side effects

Adverse reactions from the functioning of various body systems appear extremely rarely and with low intensity.

The following symptoms may be observed in the digestive tract:

  • feeling of heaviness in the stomach;
  • dry mouth;
  • decreased appetite;
  • nausea;
  • digestive disorders.

The following symptoms may appear from the nervous system:

  • constant drowsiness;
  • prostration;
  • lethargy and apathy;
  • headache;
  • increased irritability.

Cardiovascular system disorders:

  • heart rhythm disturbances;
  • pain in the chest area;
  • decreased blood pressure;
  • shortness of breath.

The manifestation of these symptoms is a reason for an unscheduled visit to a specialist. The doctor will adjust the dose or select a drug with better tolerance.

Interaction with other drugs

Cetirizine should not be used in combination with Theophylline. The latter has the ability to reduce the intensity of the purification process of biological fluids and tissues in the human body.

It is not recommended to use Cetirizine in combination with sorbents, because their consumption may reduce the effectiveness of the antihistamine. It is important to remember that Cetirizine has the ability to enhance the effectiveness of sedatives and antidepressants.

special instructions

The list of special instructions is as follows:

  1. The antiallergic drug is prescribed with caution to elderly patients.
  2. You should not combine taking the drug with drinking alcohol.
  3. The drug in tablet form is not prescribed to children under 12 years of age.
  4. Cetirizine affects the patient’s reaction rate, therefore, during the period of consuming the drug composition, one should refrain from working with complex mechanisms and driving a vehicle.

Overdose

With an overdose of Cetirizine, the intensity of side effects increases. To eliminate the symptoms, you should stop taking the drug, rinse the patient’s stomach and prescribe an enterosorbent. If the patient's condition is critical, an emergency team should be called. is a substitute for Cetirizine in the therapeutic group. The drug is available in syrup and tablets. An antihistamine can be prescribed to children older than 6 months. It is not recommended for patients who are expecting a baby or are breastfeeding.

The cost of the medicine is on average 103 rubles. Prices range from 43 to 254 rubles.