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.
Cetirinax
Active substance:
Cetirizine*
Pharmgroup:
H1.antihistamines
Analogs for the active substance:Alerza Allertek Zintset Zyrtec Zodak Letizen Parlazin Cetirizine Cetirizine HEXAL Cetirizine DS Cetirizine dihydrochloride Tsetrin | Application area:Allergic rhinopathy Allergic rhinosinusopathy Allergic eye diseases Allergic diseases of the upper respiratory tract Allergic respiratory diseases Allergic skin diseases Allergic skin diseases of non-infectious etiology Allergic skin diseases of non-microbial etiology Allergic skin diseases Allergic conjunctivitis Allergic skin lesions Allergic manifestations on the skin Allergic dermatitis Allergic dermatosis Allergic diathesis Allergic pruritic dermatosis Allergic conjunctivitis Allergic conjunctivitis caused by chemical and physical factors Allergic runny nose Allergic edema Allergic rhinitis Allergic rhinitis seasonal Allergic rhinoconjunctivitis Allergic eye inflammation Allergic skin disease Allergic skin irritation Vasomotor rhinitis Spring Qatar Spring keratitis Spring conjunctivitis Restoration of the mucous membrane after surgical interventions in the paranasal sinuses Allergic dermatitis Atopic dermatitis Allergic dermatosis Exudative diathesis Long-term allergic rhinitis Disease of the nose and paranasal sinuses Itchy atopic eczema Pruritic allergic dermatosis Idiopathic urticaria Idiopathic chronic urticaria Insect urticaria Skin allergic disease Skin allergic reaction to drugs and chemicals Skin reaction to medications Skin allergic disease Allergic conjunctivitis Newborn urticaria Year-round allergic rhinitis Year-round allergic conjunctivitis Year-round allergic rhinitis Year-round or seasonal allergic rhinitis Year-round rhinitis of allergic nature Laryngeal exacerbation with angioedema Runny nose, vasomotor allergic Exacerbation of hay fever in the form of rhinoconjunctival syndrome Exacerbation of hay fever in the form of rhinoconjunctival syndrome Acute eczema Acute allergic keratoconjunctivitis Acute allergic conjunctivitis Acute allergic rhinitis Quincke's edema Swelling of the nasal mucosa Swelling of the nasal mucosa Swelling of the nasal mucosa Swelling of the nasal mucosa Swelling of the nasal mucosa Superficial bacterial eye infection Hay fever Persistent allergic rhinitis Common neurodermatitis Recurrent angioedema Recurrent angioedema Rhinoconjunctivitis Rhinoconjunctivitis Rhinosinusitis Rhinosinusopathy Seasonal allergic rhinitis Seasonal allergic conjunctivitis Seasonal allergic rhinitis Seasonal conjunctivitis Sennoz Hay rhinitis Chronic idiopathic urticaria Chronic urticaria Chronic allergic keratoconjunctivitis Chronic allergic conjunctivitis Chronic allergic rhinitis Chronic atopic dermatitis Sneezing Exudative diathesis |
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.
Pharmacological properties
According to the instructions for use, Cetirizine is an antihistamine (antiallergic) drug. While taking the drug, the course of undesirable reactions is significantly alleviated: itching disappears, spasms of smooth muscles are relieved. The medicine is intended not only to get rid of allergy symptoms, but also to prevent its development.
Cetirizine drops and tablets also have anti-inflammatory and anti-exudative effects, preventing the occurrence of swelling in the tissues.
According to the instructions, the active component prevents the development of the pathological process even at the late stage of the allergy. What is important is that it does not cause a sedative effect when taking therapeutic doses.
The active substance begins to act within 20 minutes after entering the body. After taking a single dose, the effect lasts for 24 hours. During long-term treatment, tolerance to the active ingredient does not develop. After completing the course, the effect can last up to 72 hours.
Contraindications
Do not use an antihistamine in the following cases:
- The period of bearing a child.
- Breast-feeding.
- Children's age up to 6 years.
- Lactose intolerance and poor absorption.
- Kidney failure.
- Individual intolerance to drugs.
- 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.
special instructions
Treatment of patients suffering from epilepsy and patients with a predisposition to the development of seizures must be carried out under special supervision.
In patients with chronic renal failure of severe or moderate severity, the dosage is changed.
Taking the drug in recommended doses does not enhance the effect of ethanol (at a concentration of no more than 0.5 g/l). It is recommended to refrain from drinking ethanol during treatment with Cetirinax, as well as from taking the drug together with drugs that depress the central nervous system.
If the daily dose of 10 mg is exceeded, the speed of reaction may deteriorate.
Side effects
Taking an antihistamine may be accompanied by side effects. More common:
- Stool disorder.
- Excitement, nervousness.
- Asthenia.
- Skin rashes, itching, swelling.
- Parasthesia.
- The following side effects occur less frequently:
- Quincke's edema, urticaria.
- Urinary dysfunction.
- Increased body weight.
- Movement disorders.
- Drowsiness or insomnia.
- Loss of consciousness.
- Depression, aggression.
- Increased heart rate.
- Signs of hepatitis.
Side effects
When monotherapy with the drug, the following side effects may develop:
- drowsiness;
- paradoxical stimulation of the central nervous system;
- headache;
- feeling tired;
- dizziness;
- thrombocytopenia;
- allergic reactions: skin rash, angioedema, itching, urticaria;
- agitation;
- convulsions;
- syncope;
- oculogyric crisis;
- tachycardia;
- gastrointestinal discomfort and upset;
- changes in laboratory parameters of liver function;
- hepatitis;
- dry mouth;
- weight gain.
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.
Cetirizine
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 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 effect, isolated cases of difficulty urinating, disturbances of accommodation and dry mouth have been reported.
Liver dysfunction has been reported, accompanied by increased liver enzymes and bilirubin levels. In most cases, adverse events resolved after discontinuation of cetirizine.
List of unwanted side effects
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 (n=3260) | Placebo (n=3061) |
| General disorders and disorders at the injection site | ||
| Fatigue | 1,63 % | 0,95 % |
| Nervous system | ||
| 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 % |
| 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 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, during post-registration use of the drug,
no unwanted reactions follow.
Adverse events are presented below by MedDRA organ system class and incidence, based on post-marketing data.
drug.
The incidence of adverse events was defined as follows: “uncommon” (≥ 1/1000, < 1/100); “rare” (≥ 1/10000, < 1/1000); “very rare” (< 1/10000): - frequency unknown” (cannot be estimated based on available data).
Blood and lymphatic system disorders:
very rarely - thrombocytopenia.
Immune system disorders:
rarely - hypersensitivity reactions; very rarely - anaphylactic shock.
Metabolic and nutritional disorders:
frequency unknown - increased appetite.
Mental disorders:
infrequently - excitement; rarely - aggression, confusion, depression, hallucinations; very rarely - tic; frequency unknown - suicidal ideation, sleep disturbances (including nightmares).
Nervous system disorders:
infrequently - paresthesia; rarely - convulsions; very rarely - taste perversion, dyskinesia, dystonia, fainting, tremor; frequency unknown - memory impairment, including amnesia, deafness.
Visual disorders:
very rarely - disturbance of accommodation, blurred vision, nystagmus: frequency unknown - vasculitis.
Hearing and labyrinth disorders:
frequency unknown - vertigo.
Cardiovascular system disorders:
rarely - tachycardia.
Gastrointestinal disorders:
infrequently - diarrhea.
Disorders of the liver and bile ducts:
rarely - liver failure with changes in liver function tests (increased activity of transaminases, alkaline phosphatase, gamma-glutamyltransferase and bilirubin); frequency unknown - hepatitis.
Disorders of the skin and subcutaneous tissues:
uncommon - rash, itching; rarely urticaria; very rarely - angioedema, persistent drug erythema; frequency unknown - acute generalized exanthematous pustulosis.
Renal and urinary tract disorders:
very rarely - dysuria, enuresis; frequency unknown - urinary retention.
Musculoskeletal and connective tissue disorders:
frequency unknown - arthralgia.
Common disorders:
infrequently - asthenia, malaise; rarely - peripheral edema.
Influence on the results of laboratory and instrumental studies:
rarely - weight gain.
Description of selected adverse reactions:
Cases of pruritus, including intense itching and/or urticaria, have been reported following discontinuation of cetirizine.
It is important to report the development of adverse reactions to ensure 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. Healthcare professionals report adverse drug reactions through national adverse reaction reporting systems .
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.
