Buy Cetirizine tablets po 10 mg No. 20 in pharmacies



Cetrizine is a prominent representative of the latest generation of antihistamines. Its action is characterized by a prolonged antiallergic effect[2].

Cetirizine is the active ingredient of the drug Cetrin®, which belongs to the group of effective second-generation histamine blockers. It is designed to effectively cope with many symptoms of allergic reactions (cough, itchy nose, rash and redness on the skin, lacrimation, photophobia, etc.)[1].

Cetirizine is synthesized as a crystalline white powder, easily soluble in water. Available in tablet form. The cardboard package contains 1 blister with 10 or 7 tablets, which contain 10 mg of active ingredient and a number of excipients (magnesium stearate, lactose monohydrate, titanium dioxide, colloidal silicon dioxide and others).

The drug helps relieve itching of the mucous membranes, reduce redness and lacrimation, cope with nasal congestion, and get rid of rhinorrhea and sneezing [1,2].

Composition and release form

The drug is available in the form of tablets and drops for oral administration.

The tablets have a special soluble coating. Packaged in paper packaging with attached instructions for use.

The drops are a light liquid. Sold in bottles of 10 or 20 ml.

The active ingredient is cetirizine dihydrochloride. Its content in tablets and drops is 10 mg.

Excipients: magnesium stearate, silicon dioxide, lactose in tablets. Also benzoic acid, glycerol, sodium acetate, propylene glycol and pure water in the form of drops.

pharmachologic effect

The medicine belongs to the pharmacological group of antiallergic drugs. The active components of the drug block H1 type histamine receptors, providing a pronounced antiexudative, antipruritic and decongestant effect.

There is a decrease in the permeability of the walls of blood vessels and capillaries, muscle spasms and skin reactions are stopped.

The drug does not exhibit sedative properties and almost does not cause anticholinergic effects.

The therapeutic effect is observed quickly, within an hour after application. Maximum after 4 hours and lasts throughout the day. After discontinuation of the drug, pharmacological activity is recorded for another 3 days. Addiction to Cetirizine does not develop.

Indications for use of cetirizine

Not all cetirizine-based drugs have the same indications for use. The maximum number of indications in Russia is registered for the drug Cetrin ®:

  • seasonal and year-round allergic rhinitis;
  • allergic conjunctivitis;
  • hay fever (hay fever);
  • urticaria (including chronic idiopathic);
  • itchy allergic dermatoses (atopic dermatitis, neurodermatitis);
  • angioedema (Quincke's edema) 2

Contraindications

Do not use an antihistamine in the following cases:

  1. The period of bearing a child.
  2. Breast-feeding.
  3. Children's age up to 6 years.
  4. Lactose intolerance and poor absorption.
  5. Kidney failure.
  6. Individual intolerance to drugs.
  7. Malalabsorption of glucose and galactose.

Cetirizine should be prescribed with caution to elderly people and those with serious kidney disease. Also for patients undergoing treatment with barbiturates, narcotic analgesics, and benzodiazepines.

Buy Cetirizine tablets po 10 mg No. 20 in pharmacies

Trade name:

Cetirizin-Teva

International nonproprietary name:

cetirizine

Dosage form:

film-coated tablets

Compound

1 tablet contains:

active substance

cetirizine dihydrochloride 10.00 mg;

Excipients:

microcrystalline cellulose (Avicel PH 102) 40.00 mg, lactose monohydrate 63.50 mg, colloidal silicon dioxide (colloidal silicon dioxide anhydrous) 0.50 mg, magnesium stearate 1.00 mg; shell Opadry OY-GM-28900 white: hypromellose (E464) 0.94 mg, polydextrose 0.94 mg, titanium dioxide (E171) 0.94 mg, macrogol-4000 (polyethylene glycol-4000) 0.18 mg.

Description

Biconvex oblong tablets, film-coated, white or almost white. On one side there is an engraving “C10”, on the other there is a dividing line. On a cross section, the core is white or almost white. The tablets must be free of cracks and chips.

Pharmacotherapeutic group:

antiallergic agent H1-histamine receptor blocker

Pharmacological properties

Pharmacodynamics

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

In addition to the antihistamine effect, cetirizine 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 with allergic reactions.

Clinical efficacy and safety. Studies in healthy volunteers have shown that cetirizine at doses of 5 or 10 mg significantly inhibits the rash and redness response to high concentrations of histamine in the skin, but the correlation with efficacy 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.

Taking cetirizine at the recommended dose showed an improvement in the quality of life of patients with year-round and seasonal allergic rhinitis.

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.

Pharmacokinetics

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

Absorption. The maximum concentration in blood plasma is reached after 1±0.5 hours and is 300 ng/ml.

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

Food intake does not affect the complete absorption of cetirizine, although its rate decreases. The bioavailability of various dosage forms of cetirizine (solution, capsules, tablets) is comparable.

Distribution.

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

Metabolism: Cetirizine does not undergo extensive primary metabolism.

Elimination: The half-life (T1/2) 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 in the urine.

Elderly patients. In 16 elderly individuals, with a single dose of 10 mg of the drug, 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.

Patients with renal failure. 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 (creatinine clearance <7 ml/min), when taking the drug orally at a dose of 10 mg, T1/2 is extended by 3 times, and the total clearance is reduced by 70% relative to healthy volunteers with normal renal function.

For patients with moderate or severe renal failure, an appropriate change in the dosage regimen is required. Cetirizine is practically not 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 insufficiency also has concomitant renal insufficiency.

Children. T1/2 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 for use

Cetirizine dihydrochloride is indicated for use in adults and children 6 years of age and older to relieve:

- 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 piperazine derivatives, as well as other components of the drug. — End-stage renal failure (creatinine clearance <10 ml/min). - Children under 6 years of age (for this dosage form). - Pregnancy. — Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Carefully

In patients:

— with chronic renal failure (with creatinine clearance > 10 ml per minute, dosage regimen adjustment is required); - elderly (with an age-related decrease in glomerular filtration); - with epilepsy and increased convulsive readiness; — with predisposing factors to urinary retention (see section “Special instructions”); - during breastfeeding.

Use during pregnancy and breastfeeding

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

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

Breastfeeding period

Cetirizine is excreted in breast milk in concentrations representing 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 doses

Inside. It is recommended to take the tablets with a glass of water without chewing, preferably in the evening.

For adults.

10 mg (1 tablet) once a day.

Elderly patients

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

Patients with kidney failure

Since Cetirizine-Teva is excreted from the body mainly by the kidneys (see subsection “Pharmacokinetics”), if alternative treatment is not possible, in patients with renal failure, the dosage regimen of the drug should be adjusted depending on renal function (creatinine clearance).

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

CC (ml/min) = [140 – age (years)] x body weight (kg)
72 x CKserum (mg/dL)

CC 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 CC (ml/min) Dosage regimen
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
End stage (patients on dialysis) < 10 taking the drug is contraindicated

Patients with liver dysfunction

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

In patients with impairment of both liver and kidney function, dosage adjustment is recommended (see table above)

Children

Children from 6 to 12 years old

5 mg (1/2 tablet) twice daily

Children over 12 years old

10 mg (1 tablet) once daily

Sometimes an initial dose of 5 mg (1/2 tablet) may be sufficient if satisfactory control of symptoms is achieved.

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

If there is no improvement after treatment or new symptoms appear, you should consult your doctor.

Use the drug only according to the method of use and in the doses indicated in the instructions.

Side effect

Data obtained from clinical studies

Review

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

Despite the fact that cetirizine is a selective blocker of peripheral H1 receptors and has virtually no anticholinergic effects, 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 dihydrochloride.

List of adverse 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 a frequency of 1.0% 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 %
Nervous system disorders
Dizziness 1,10 % 0,98 %
Headache 7,42 % 8,07 %
Gastrointestinal disorders
Abdominal pain 0,98 % 1,08 %
Dry mouth 2,09 % 0,82 %
Nausea 1,07 % 1,14 %
Mental disorders
Drowsiness 9,63 % 5,00 %
Disorders of the respiratory system, chest and mediastinal organs
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 greater in children aged 6 months to 12 years:

Adverse reactions (WHO terminology) Cetirizine ( n
=1656)
Placebo ( n
=1294)
Gastrointestinal disorders

Diarrhea

1,0 % 0,6 %
Mental disorders
Drowsiness 1,8 % 1,4 %
Respiratory, thoracic and mediastinal disorders

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 reactions are systematized in accordance with the World Health Organization (WHO) Classification: very common (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); frequency unknown (cannot be determined from available 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 - agitation; rarely - aggression, confusion, depression, hallucinations, sleep disturbance; very rarely - tic; 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, including amnesia, deafness.

From the organ of vision: very rarely - disturbance of accommodation, blurred vision, nystagmus; frequency unknown - vasculitis.

On the part of the hearing organs: frequency unknown - vertigo.

From the cardiovascular system: rarely - tachycardia.

From the digestive system: infrequently - diarrhea.

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

On the skin: infrequently - rash, itching; rarely - urticaria; very rarely - angioedema, persistent drug erythema; frequency unknown - acute generalized exanthematous pustulosis.

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

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

Research: rarely - weight gain.

Description of individual adverse reactions. Cases of itching (including intense itching) and/or urticaria have been reported following discontinuation of cetirizine use.

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.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms Symptoms observed with cetirizine overdose are mainly related to effects on the central nervous system or effects indicative of anticholinergic effects.

With a single dose of 50 mg, the following symptoms were 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 induction of vomiting. It is recommended to take activated carbon and carry out symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective.

Interaction with other drugs

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

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

The level of absorption of cetirizine is not reduced by food intake, but the rate of absorption is reduced.

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

If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Cetirizine-Teva.

special instructions

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

In patients with renal failure, the dosage regimen of the drug should be adjusted (see section "Dosage and Administration").

Due to a possible decrease in renal function in elderly patients, the dosage regimen of the drug should be adjusted (see section "Dosage and Administration").

Caution is recommended when using cetirizine concomitantly with alcohol, as cetirizine may cause increased drowsiness.

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 H1-histamine receptor blockers inhibit the development of skin allergic reactions.

Cetirizine 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 occur, even if these symptoms were absent at the beginning of treatment. In some cases, symptoms may be severe and require resumption of cetirizine. Symptoms disappear when cetirizine is resumed.

Children.

Cetirizine film-coated tablets are contraindicated in children under 6 years of age, since this dosage form does not allow the use of an appropriate dosage for this age group.

Impact on the ability to drive vehicles and machinery

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 a car, engaging in potentially hazardous activities, or operating machinery that requires increased concentration and speed of psychomotor reactions.

Release form

Film-coated tablets, 10 mg.

10 tablets in blisters made of PVC/PVDC/aluminum foil. 1, 2 or 3 blisters along with instructions for use are placed in a cardboard box, on which protective stickers can additionally be applied.

Storage conditions

Store at a temperature not exceeding 25 °C in the original packaging to protect from light.

Keep out of the reach of children!

Best before date

3 years.

Do not use after the expiration date.

Vacation conditions

Available without a prescription.

Side effects

Taking an antihistamine may be accompanied by side effects. More common:

  1. Stool disorder.
  2. Excitement, nervousness.
  3. Asthenia.
  4. Skin rashes, itching, swelling.
  5. Parasthesia.
  6. The following side effects occur less frequently:
  7. Quincke's edema, urticaria.
  8. Urinary dysfunction.
  9. Increased body weight.
  10. Movement disorders.
  11. Drowsiness or insomnia.
  12. Loss of consciousness.
  13. Depression, aggression.
  14. Increased heart rate.
  15. Signs of hepatitis.

Instructions for use

The dosage and duration of the course of Cetirizine depends on the age of the patient, diagnosis and dosage form of the drug.

The product in the form of drops is used according to the following scheme:

  • Children 1-2 years old - 5 drops 2 times a day.
  • Children 3-6 years old - 10 drops before bedtime.
  • Patients 6-12 years old - no more than 20 drops in the evening.
  • Children over 12 years of age and adults - 20 drops once.

For elderly people, the dosage is not changed. In case of kidney disease, dosage adjustment is important. For long-term allergic reactions, the course is 3-6 weeks. In case of short-term effects of allergens on the body, the medicine is used for no more than a week.

Cetirizine tablets are taken orally and should not be chewed. It is recommended to drink before bedtime. Children from 6 to 12 years old are prescribed 10 mg once a day if their weight is more than 30 kg and 5 mg per day if their body weight is up to 30 kg. For patients over 12 years of age, 10 mg per day is indicated.

special instructions

After taking the medicine, you should not drive a vehicle.

Interaction with Diazepam, Cimetidine and Azithromycin has not been established. Use with Theophylline leads to a decrease in drug clearance. Particular caution should be taken in parallel with medications that have a depressant effect on the central nervous system.

The product enhances the effect of alcohol, so you should avoid taking it. The medication must be taken 3 days before allergy testing.

You can buy it at a pharmacy without a doctor's prescription.

Store at room temperature. Shelf life – 36 months from the date of release.

How many days should you take Cetirizine?

The duration of antihistamine therapy directly depends on the diagnosis. On average, the medicine is prescribed for 1 week. The maximum duration is a month.

According to external factors and the patient’s well-being, course correction is possible.

Can I take it during pregnancy?

There have been no clinical trials on the use of the drug during pregnancy. Therefore, bearing a child is an absolute contraindication to the use of the drug.

Use during pregnancy

The instructions for the drug say that Cetirizine should not be taken while pregnant. This is due to the fact that no studies have been conducted on pregnant women. Animal studies have not shown any adverse reactions to the fetus. There is also no information on the effects of the drug during lactation, so you should avoid taking it during breastfeeding.

A few studies indicate that taking the drug in the 1st trimester has no effect on the number of congenital defects, the frequency of miscarriages and the premature birth of a baby. The weight of the newborn also did not differ from normal values.

If a pregnant woman experiences allergic reactions, then, taking into account the possible risks, it is better to give preference to Fencarol, cetirizine, which should be avoided in the first trimester.

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