Job description of an allergist. Allergozan: instructions for use In what situations should you consult an allergist?

1. General Provisions

1. This job description defines the job duties, rights and responsibilities of an allergist-immunologist.
2. A person who has a higher medical education and has completed postgraduate training or specialization in the specialty “Allergology and Immunology” is appointed to the position of allergist-immunologist.
3. An allergist-immunologist must know the basics of Russian legislation on healthcare; regulatory documents regulating the activities of healthcare institutions; the basics of organizing medical and preventive care in hospitals and outpatient clinics, ambulance and emergency medical care, disaster medicine services, sanitary-epidemiological services, drug provision for the population and health care facilities; theoretical foundations, principles and methods of medical examination; organizational and economic foundations of the activities of healthcare institutions and medical workers in the conditions of budgetary insurance medicine; fundamentals of social hygiene, organization and economics of healthcare, medical ethics and deontology; legal aspects of medical practice; general principles and basic methods of clinical, instrumental and laboratory diagnostics functional state of organs and systems of the human body; etiology, pathogenesis, clinical symptoms, clinical features, principles of complex treatment of major diseases; rules for providing emergency medical care; basics of examination of temporary disability and medical and social examination; basics of health education; internal labor regulations; rules and regulations of labor protection, safety, industrial sanitation and fire protection.
In his specialty, an allergist-immunologist must know modern methods prevention, diagnosis, treatment and rehabilitation; content and sections of allergology and immunology as an independent clinical discipline; tasks, organization, structure, staffing and equipment of the allergological and immunological service; current regulatory, legal, instructional and methodological documents in the specialty; rules for processing medical documentation; the procedure for conducting an examination of temporary disability and medical and social examination; principles of planning activities and reporting of allergy and immunology services; methods and procedures for monitoring its activities.
4. An allergist-immunologist is appointed to the position and dismissed from the position by order of the chief physician of the healthcare facility in accordance with the current legislation of the Russian Federation.
5. An allergist-immunologist is directly subordinate to the head of the department, and in his absence, to the head of the health care facility or his deputy.

2. Job responsibilities

Provides qualified medical care in their specialty, using modern methods of prevention, diagnosis, treatment and rehabilitation, approved for use in medical practice. Determines the tactics of patient management in accordance with established rules and standards. Develops a plan for examining the patient, clarifies the scope and rational methods of examining the patient in order to obtain complete and reliable diagnostic information in the shortest possible time. Based clinical observations and examination, collection of anamnesis, data from clinical, laboratory and instrumental studies establishes (or confirms) the diagnosis, gives a clinical assessment immune system patient. In accordance with established rules and standards, appoints and supervises necessary treatment, organizes or independently carries out the necessary diagnostic, therapeutic, rehabilitation and preventive procedures and measures. In the hospital, he examines the patient daily. Makes changes to the treatment plan depending on the patient's condition and determines the need additional methods examinations. Provides advisory assistance to doctors of other departments of health care facilities on the assessment of immunopathological disorders, when analyzing clinical cases that are difficult for diagnosis and therapy, identifying and analyzing the reasons for discrepancies in data on the immune status obtained various methods, during clinical and pathological examination. Supervises the work of the nursing and junior medical personnel subordinate to him (if any), facilitates the fulfillment of his duties job responsibilities. Monitors the correctness of diagnostic and medical procedures, operation of instruments, apparatus and equipment, rational use of reagents and medications, compliance with safety and labor protection rules by nursing and junior medical personnel. Participates in conducting training courses for medical personnel. Plans his work and analyzes his performance indicators. Ensures timely and high-quality execution of medical and other documentation in accordance with established rules. Conducts sanitary education work. Complies with the rules and principles of medical ethics and deontology. Qualifiedly and timely carries out orders, instructions and instructions from the management of the institution, as well as regulatory legal acts related to his professional activities. Complies with internal regulations, fire and safety regulations, and sanitary and epidemiological regulations. Promptly takes measures, including timely informing management, to eliminate violations of safety regulations, fire safety and sanitary rules that pose a threat to the activities of the healthcare institution, its employees, patients and visitors. Systematically improves his skills.

An allergist-immunologist has the right to:
1. Establish an immunopathological diagnosis, determine methods of correction and prevention of immunological disorders based on clinical observations and clinical laboratory studies; determine patient management tactics in accordance with established rules and standards; assign the necessary for comprehensive survey patient methods of instrumental, functional and laboratory diagnostics; carry out diagnostic, therapeutic, rehabilitation and preventive procedures using approved diagnostic and treatment methods; involve, when necessary, doctors of other specialties for consultations, examination and treatment of patients;
2. make proposals to the management of the institution to improve the treatment and diagnostic process, improve the work of administrative, economic and paraclinical services, issues of organization and conditions of their work;
3. control the work of subordinate employees (if any), give them orders within the framework of their official duties and demand their strict execution, make proposals to the management of the institution for their encouragement or imposition of penalties;
4. request, receive and use information materials and regulatory documents necessary to perform their official duties;
5. take part in scientific and practical conferences and meetings at which issues related to his work are discussed;
6. undergo certification in the prescribed manner with the right to receive the appropriate qualification category;
7. improve your qualifications through advanced training courses at least once every 5 years.
An allergist-immunologist enjoys all labor rights in accordance with the Labor Code of the Russian Federation.

4. Responsibility

An allergist-immunologist is responsible for:
1. timely and high-quality implementation of the official duties assigned to him;
2. organization of its work, timely and qualified execution of orders, instructions and instructions from management, regulations on its activities;
3. compliance with internal regulations, fire safety and safety regulations;
4. timely and high-quality execution of medical and other official documentation provided for by current regulatory documents;
5. provision of statistical and other information on its activities in the prescribed manner;
6. ensuring compliance with executive discipline and performance of their official duties by employees subordinate to him (if any);
7. promptly taking measures, including timely informing management, to eliminate violations of safety regulations, fire safety and sanitary rules that pose a threat to the activities of a healthcare institution, its employees, patients and visitors.
For violation of labor discipline, legislative and regulatory acts, an allergist-immunologist may be subject to disciplinary, material, administrative and criminal liability in accordance with current legislation, depending on the severity of the offense.

This job description has been automatically translated. Please note that automatic translation is not 100% accurate, so there may be minor translation errors in the text.

Preface to the job description

0.1. The document comes into force from the moment of approval.

0.2. Document developer: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.

0.3. The document has been approved: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.

0.4. Periodic verification of this document is carried out at intervals not exceeding 3 years.

1. General Provisions

1.1. The position "Immunologist" belongs to the "Professionals" category.

1.2. Qualification requirements - complete higher education (specialist, master's degree) in the field of training "Medicine", specialty "General Medicine". Completing an internship in the specialty “Therapy” with subsequent specialization in “Immunology”. Availability of a medical specialist certificate. No work experience requirements.

1.3. Knows and applies in practice:
- current legislation on health protection and regulatory documents regulating the activities of government bodies and healthcare institutions;
- fundamentals of law in medicine;
- organization of immunological and allergological care;
- rights, duties and responsibilities of an immunologist;
- performance indicators of the immunological service, ambulance and emergency care for patients with immunological pathology;
- basics of immunogenetics, infectious immunology, immuno-oncology, neuroimmunology, immunoendocrinology, transplantation immunology, immunobiotechnology, immunohematology, clinical immunology, allergology, etc.;
- structure and functions of the hematopoietic organs, immune system, structure and functions of individual immunocompetent organs;
- antigens, their properties, varieties;
- antibodies, classes and subclasses, their significance in immune processes;
- age characteristics functioning of the immune system;
- etiology, pathogenesis, clinical picture of immune-related diseases, including acquired immunodeficiency syndrome (AIDS);
- modern classification, epidemiology of immune-related diseases;
- adverse effects on the immune system environmental factors, side effects of medications;
- methods for assessing the immune system using level I and II tests;
- modern methods of prevention, specific and differential diagnosis, immunotherapy, immunomodulation, alternative therapy, rehabilitation and medical examination for immune-related diseases;
- methods of diagnosis and treatment, prognosis and prevention of immune conflicts during organ and tissue transplants, pathological pregnancy, infertility;
- research methods, general and special;
- basics of pharmacotherapy, methods of detoxification therapy, physiotherapy, climatotherapy, physical therapy, diet therapy, indications and contraindications for sanatorium-resort treatment;
- organizing and conducting preventive vaccinations;
- emergency assistance if post-vaccination complications occur;
- methods for determining temporary and permanent disability, the work of medical advisory and medical and social expert commissions;
- rules for processing medical documentation;
- modern literature in the specialty and methods of its generalization.

1.4. An immunologist is appointed and dismissed by order of the organization (enterprise/institution).

1.5. The immunologist reports directly to _ _ _ _ _ _ _ _ _ _ .

1.6. The immunologist supervises the work of _ _ _ _ _ _ _ _ _ _ .

1.7. During an absence, an immunologist is replaced by a person appointed in accordance with the established procedure, who acquires the appropriate rights and is responsible for the proper performance of the duties assigned to him.

2. Characteristics of work, tasks and job responsibilities

2.1. It is guided by the current legislation of Ukraine on health care and regulations that determine the activities of governing bodies and health care institutions, the organization of immunological and allergy care.

2.2. Provides specialized medical care to patients with immunosuppressive pathology, including ambulance and emergency care.

2.3. Applies modern methods of prevention, diagnosis, treatment, rehabilitation, organizes and conducts medical examinations, according to the established list of nosological forms.

2.4. Monitors adverse reactions/effects of medications.

2.5. Carries out examination of disability, takes part in the work of medical advisory and medical and social expert commissions.

2.6. Works closely with doctors of other specialties; organizes and conducts consultations with patients.

2.7. Participates in anti-epidemic measures in the event of an outbreak of infection.

2.8. Supervises the work of nursing staff.

2.9. Adheres to the principles of medical deontology.

2.10. Plans work and analyzes its results.

2.11. Maintains medical documentation.

2.12. Takes an active part in disseminating medical knowledge among the population on the prevention of immune-related diseases.

2.13. Constantly improves his professional level.

2.14. Knows, understands and applies current regulations relating to his activities.

2.15. Knows and complies with the requirements of regulations on labor protection and environment, complies with the standards, methods and techniques of safe work performance.

3. Rights

3.1. The immunologist has the right to take actions to prevent and eliminate cases of any violations or inconsistencies.

3.2. An immunologist has the right to receive all social guarantees provided for by law.

3.3. An immunologist has the right to demand assistance in the performance of his official duties and the exercise of his rights.

3.4. An immunologist has the right to demand the creation of organizational and technical conditions necessary for the performance of official duties and the provision necessary equipment and inventory.

3.5. An immunologist has the right to familiarize himself with draft documents relating to his activities.

3.6. An immunologist has the right to request and receive documents, materials and information necessary to fulfill his official duties and management orders.

3.7. An immunologist has the right to improve his professional qualifications.

3.8. An immunologist has the right to report all violations and inconsistencies identified in the course of his activities and make proposals for their elimination.

3.9. An immunologist has the right to familiarize himself with documents defining the rights and responsibilities of his position, and criteria for assessing the quality of performance of official duties.

4. Responsibility

4.1. The immunologist is responsible for non-fulfillment or untimely fulfillment of the requirements of this job description obligations and (or) non-use of granted rights.

4.2. The immunologist is responsible for failure to comply with internal labor regulations, labor protection, safety precautions, industrial sanitation and fire protection.

4.3. An immunologist is responsible for disclosing information about an organization (enterprise/institution) that is a trade secret.

4.4. The immunologist is responsible for failure to comply or improper fulfillment of the requirements of internal regulatory documents of the organization (enterprise/institution) and legal orders of management.

4.5. An immunologist is responsible for offenses committed in the course of his activities, within the limits established by the current administrative, criminal and civil legislation.

4.6. An immunologist is responsible for causing material damage to an organization (enterprise/institution) within the limits established by current administrative, criminal and civil legislation.

4.7. The immunologist is responsible for the unlawful use of the granted official powers, as well as their use for personal purposes.

Round, white, film-coated, biconvex tablets.

Compound

Each tablet contains:

active substance: levocetirizine dihydrochloride – 5 mg;

Excipients: microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate, colloidal anhydrous silicon dioxide.

shell composition: opadry II 85F18422 white (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol, talc).

Release form

Film-coated tablets.

Pharmacotherapeutic group

Systemic antihistamines. Piperazine derivatives.

ATX code

Indications for use

In adults and children over 6 years of age for the treatment of the following diseases:

• allergic rhinitis, seasonal, year-round or persistent (hay fever, hay fever);
• allergic conjunctivitis;
• chronic idiopathic urticaria.

In children under 6 years of age, levocetirizine in the form of drops is recommended for the treatment of seasonal allergic rhinitis.

Directions for use and doses

It is taken orally with food or on an empty stomach, washed down with a small amount of water, without chewing.

Adults and children over 6 years old: daily dose– 5 mg (1 tablet).

Patients with impaired renal function.

Patients may be given reduced doses individually depending on the severity of renal dysfunction. The dosage regimen must be determined by your doctor.

Children with impaired renal function

The dose should be set individually, taking into account creatinine clearance and the patient's body weight. There are no specific data regarding children with renal impairment.

Patients with impaired liver function. Upon appointment medicine patients with impaired liver function do not require any dose changes. For patients with concomitant hepatic and renal dysfunction, it is recommended that the dose be clarified with a doctor.

Duration of taking the drug

For intermittent allergic rhinitis (the presence of symptoms on less than 4 days a week for less than 4 weeks in a row), the duration of treatment depends on the type, duration and symptoms. After symptoms disappear, treatment can be stopped and resumed if they reappear

For persistent allergic rhinitis (symptoms lasting more than 4 days per week for more than 4 weeks), ongoing treatment is recommended as long as the patient is exposed to allergens. There is currently clinical experience with the use of levocetirizine in tablet form for 6 months in adults with persistent allergic rhinitis.

If you have any doubts or questions, contact your healthcare provider.

Side effect

Clinical trial data

In clinical trials, adverse reactions were observed in 14.7% of patients receiving levocetirizine 5 mg, compared with 11.3% of patients in the placebo group. 95% of these adverse reactions were weak or moderate.

According to the results of therapeutic studies with levocetirizine 5 mg, 0.7% (4/538) of patients dropped out of the study due to adverse reactions, which was comparable to the frequency in the placebo group - 0.8% (3/382).

A total of 538 patients took part in clinical therapeutic studies of levocetirizine at a dose of 5 mg/day. The generalized safety data for this drug lists the following common adverse reactions:

Although somnolence was more common in the levocetirizine group, it was mild to moderate in nature compared with the placebo group.

In addition to the above adverse reactions, abdominal pain was infrequently observed.

Post-marketing experience

Metabolic and nutritional disorders: increased appetite;

Mental disorder: anxiety, aggressiveness, agitation, hallucinations, depression, insomnia, suicidal thoughts;

Violations by nervous system : convulsions, sinus thrombosis, paresthesia, vertigo, dizziness, fainting, tremor, impaired taste perception;

Visual disorders: inflammation, blurred vision, blurred vision;

Heart disorders: angina pectoris, palpitations, tachycardia;

Vascular disorders: jugular vein thrombosis;

Violation by respiratory system, organs chest and mediastinum: increased rhinitis, respiratory distress;

Disorders of the liver and biliary tract: hepatitis;

Skin and subcutaneous tissue disorders: angioedema, fixed toxicoderma, itching, skin rash, urticaria, hypotrichosis, fissures, photosensitivity/toxicity;

Musculoskeletal and connective tissue : myalgia;

Renal and urinary tract disorders: urinary incontinence, urinary retention;

General and administration site disorders: swelling, ineffectiveness of the drug, dry mucous membranes, weight gain;

Influence on the results of laboratory and instrumental studies: cross-reactivity.

Safety data based on post-marketing monitoring of cetirizine racemate

The following side effects have been reported:

Rare (<1/1000 и ≥1/10000) :

Mild and transient side effects such as fatigue, difficulty concentrating, drowsiness, headache, dizziness (vertigo), agitation, dry mouth and gastrointestinal problems (eg, constipation).

In some cases, hypersensitivity reactions have been observed, accompanied by skin reactions and angioedema. In isolated cases, there have been reports of seizures, photosensitivity reactions, liver damage, anaphylactic shock, circulatory failure, deafness, malaise, itching, vasculitis and visual impairment.

If any adverse reactions occur, including those not listed in this instruction, you must stop taking the medicine and consult a doctor.

Contraindications

Hypersensitivity to any of the components of the drug or piperazine derivatives. Severe form of chronic renal failure (creatine clearance less than 10 ml/min). Children's age (up to 6 years).

With caution - chronic renal failure (correction of the dosage regimen is required), old age (possible decrease in glomerular filtration).

The drug should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or glucose-galactose malabsorption syndrome.

Overdose

Symptoms: may be accompanied by signs of intoxication in the form of drowsiness; in children, an overdose of the drug may be accompanied by anxiety and increased irritability.

Treatment: if symptoms of overdose appear (especially in children), the drug should be stopped, gastric lavage, activated charcoal, and symptomatic therapy are necessary. There is no specific antidote. Hemodialysis is not effective.

Precautionary measures

Prescribing the drug Allergoloc film-coated tablets to children under 6 years of age is not recommended, since this dosage form does not allow the dose to be adjusted accordingly. For children aged 2-6 years, levocetirizine is recommended to be used in a dosage form intended for children.

In patients with impaired renal function, the dose should be adjusted accordingly.

Concomitant use with alcohol requires caution, as it may cause increased drowsiness.

Particular caution should be exercised in patients with factors predisposing to urinary retention (eg, spinal cord injury or prostatic hyperplasia), as levocetirizine may increase the risk of urinary retention.

Use during pregnancy and lactation

Pregnancy

There are no data from clinical studies of levocetirizine during pregnancy. Studies conducted on animals did not reveal a direct or indirect toxic effect on the course of pregnancy, the development of the embryo or fetus. The potential risk to humans is unknown. Caution should be exercised when prescribing this drug to pregnant women.

Breast-feeding

Levocetirizine should not be taken during breastfeeding as it is expected to be excreted in breast milk.

Impact on the ability to drive vehicles or potentially dangerous mechanisms

Levocetirizine may cause increased drowsiness and, therefore, may affect the ability to drive vehicles or operate potentially dangerous machinery.

Interaction with other drugs

There have been no studies of interactions of levocetirizine with other drugs. Interaction studies with the racemic substance cetirizine did not reveal clinically significant adverse interactions (with pseudoephedrine, cimetidine, ketocanazole, erythromycin, azithromycin, glipizide and diazepam). A slight decrease in the clearance of cetirizine (16%) was observed after repeated administration of theophylline (400 mg once daily) and cetirizine at different doses. At the same time, the excretion of theophylline did not change with simultaneous administration of cetirizine.

In a repeated-dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg/day), cetirizine exposure was increased by approximately 40%, and ritonavir disposition was slightly changed (-11%) when coadministered with cetirizine.

The extent of absorption of levocetirizine is not reduced in the presence of food, but the rate of absorption is reduced.

After completion of treatment, the level of levocetirizine in the blood plasma decreases with a half-life of about 8 hours. Allergy tests can be performed again three days after discontinuation of the drug.

Concomitant use of levocetirizine with alcohol or other drugs that inhibit the function of the central nervous system may lead to drowsiness, decreased concentration and productivity, although cetirizine racemate has not been shown to potentiate the effects of alcohol (at a blood alcohol level of 0.5 g/l ).

Storage conditions

In a place protected from moisture and light at a temperature not exceeding 25 ºС.

Keep out of the reach of children.

Best before date

Do not use after the expiration date stated on the packaging.

Package

7, 10 or 14 tablets in blister packs made of polyvinyl chloride film and aluminum foil.

One or two blister packs of 7, 10 or 14 tablets together with instructions for medical use in a cardboard pack.

Three blister packs of 10 tablets each along with instructions for medical use in a cardboard pack.

• Instructions for use Allergozan
• Composition of the drug Allergozan
• Indications for the drug Allergozan
• Storage conditions for the drug Allergozan
• Shelf life of the drug Allergozan

ATX code: Respiratory system (R) > Antihistamines for systemic use (R06) > Antihistamines for systemic use (R06A) > Substituted ethylenediamines (R06AC) > Chloropyramine (R06AC03)

Release form, composition and packaging

Film-coated tablets round, biconvex, regular in shape with a glossy white surface.

Excipients: lactose monohydrate, wheat starch, microcrystalline cellulose (type 101), carmellose sodium, talc, magnesium stearate, colloidal anhydrous silica.

Shell composition: Basic butyl methacrylate copolymer, polysorbate 80, talc, titanium dioxide (E171), sucrose, gelatin, gum arabic (spray dried), macrogol 6000, glycerol.

20 pcs. - blisters (1) - cardboard packs.

Description medicinal product ALLERGOZAN tablets based on officially approved instructions for use of the drug and made in 2013. Update date: 02/15/2013

pharmachologic effect

Chloropyramine is an ethylenediamine derivative, a histamine H1 receptor blocker. As a competent reversible antagonist of histamine H1 receptors, it blocks the action of histamine.

Chloropyramine relieves histamine-induced vasodilation, increased vascular permeability and tissue edema. Along with the antihistamine effect, chloropyramine has anticholinergic properties and can cause undesirable muscarinic effects when used systemically, such as dryness of the oral mucosa, constipation, visual disturbances and increased intraocular pressure, urinary retention.

Penetrates the BBB and binds to histamine H1 receptors in the central nervous system. As a result, its action, like that of other H1 receptor antagonists, can cause drowsiness, a feeling of weakness and fatigue, and dizziness. May have a weak antiemetic effect.

After ingestion therapeutic effect occurs within 15-30 minutes, the maximum therapeutic effect is achieved after 1 hour, duration of action is 3-6 hours.

Pharmacokinetics

Suction

When administered orally, it is quickly and completely absorbed from the gastrointestinal tract. Cmax is reached in 1-2 hours.

Distribution

Regardless of the route of administration, chloropyramine is evenly distributed in the body, penetrates the BBB, where it binds to histamine H1 receptors. Approximately 7.9% bound to plasma proteins.

Metabolism

Metabolized in the liver.

Removal

It is mainly excreted by the kidneys in the form of inactive metabolites.

Pharmacokinetics in special clinical situations

The elimination of chloropyramine in children may be more accelerated than in adults.

Patients with liver disease due to decreased hepatic metabolism require the use of more low doses medicine.

For patients with renal failure, the use of lower doses of the drug is also required.

Indications for use

Symptomatic treatment:

• seasonal allergic rhinitis and conjunctivitis;
• hives;
• itching;
• contact dermatitis;
• insect bite;
• dermographism;
• drug and food allergies.

Additional treatment for systemic anaphylactic reactions and angioedema.

When used systemically, chloropyramine exhibits a pronounced sedative effect.

Dosage regimen

Inside. The tablets are taken with food, without chewing, with water. Recommended dose:

Adults and children over 14 years old - 1 tab. 3-4 times/day. The maximum daily dose is 6 tablets. (2 tablets 3 times/day).

If necessary, the dose can be increased with caution and supervision clinical picture and should not exceed 2 mg/kg.

For anaphylactic shock, severe allergic reactions Treatment begins with intravenous administration of the drug. If the condition improves, you can switch to oral administration of the drug.

The duration of treatment depends on the type and severity of symptoms.

Elderly patients over 65 years of age and malnourished patients: the use of the drug in this category of patients requires special caution due to increased sensitivity to antihistamines in relation to their side effects.

For patients with liver dysfunction It is recommended to use a dose lower than the recommended daily dose.

Patients with renal failure it is necessary to reduce the recommended daily dose.

Children under 14 years old This dosage form should not be used.

Side effects

Side effects presented by organ-class system and frequency. The frequency is determined as follows:

• very common (>1/10), frequent (>1/100 to<1/10), нечастые (>1/1000 to<1/100), редкие (>1/10,000 to<1/1000), очень редкие (<1/10 000), с неизвестной частотой (на основании существующих данных нельзя сделать оценку).

With systemic use of chloropyramine, the following side effects are possible:

From the hematopoietic system: rare - leukopenia, agranulocytosis, hemolytic anemia, other blood dyscrasias.

From the immune system: with unknown frequency - allergic reactions.

From the nervous system: rare - sedation, fatigue, dizziness, ataxia, nervousness, tremor, convulsions, headache, euphoria, encephalopathy.

From the side of the organ of vision: rare - blurred vision, increased intraocular pressure and an attack of glaucoma.

From the cardiovascular system: rare - arrhythmia, tachycardia, hypotension.

From the digestive system: very rare - epigastric discomfort, dry mouth, nausea, vomiting, constipation, diarrhea, anorexia or increased appetite, stomach pain.

For the skin and subcutaneous tissue: very rare - photosensitivity.

From the musculoskeletal system: with unknown frequency - myopathy.

From the kidneys and urinary tract: rare - difficulty urinating, urinary retention.

Children

In rare cases, paradoxical reactions are possible (increased excitability, nervousness, irritability, insomnia), more frequent and more pronounced in children and elderly patients.

Use during pregnancy and breastfeeding

The drug is contraindicated during pregnancy and breastfeeding. If treatment with chloropyramine is necessary for breastfeeding women, breastfeeding should be discontinued.

special instructions

Due to the presence of atropine-like effects in chloropyramine, it should be used with caution in patients with glaucoma, hyperthyroidism, cardiovascular diseases, liver diseases, bronchial asthma, and prostate adenoma.

When taking the drug orally in patients over 65 years of age, dizziness, sedation and hypotension are more likely to occur.

Systemic treatment with chloropyramine may increase the symptoms of gastroesophageal reflux disease.

With systemic use of chloropyramine, the toxic symptoms of ototoxic drugs may be masked.

The suppressive effects of chloropyramine on the central nervous system may be enhanced by alcohol, so you should not consume alcohol-containing products during treatment with the drug.

When treated with antihistamines, although rarely, hematological disorders (leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia) are possible. If fever, laryngitis, redness of the throat, jaundice, pallor, subcutaneous hemorrhages, unexpected bleeding, or changes in the blood picture occur, treatment with chloropyramine should be stopped immediately.

The drug contains lactose as an excipient. Patients with rare hereditary conditions of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not use Allergozan.

The drug contains wheat starch. Wheat starch may contain only traces of gluten and is considered safe for use by patients with celiac disease.

The shell contains sucrose. Patients with rare hereditary conditions of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not use Allergozan.

Use in pediatrics

Treatment with chloropyramine in children should be carried out under the supervision of a physician, since in them the atropine-like effects of chloropyramine stimulation are more pronounced.

Impact on the ability to drive vehicles and operate machinery

When used systemically, Allergozan moderately affects the ability to drive vehicles and operate machinery. When taken orally, drowsiness, loss of coordination and slow reactions may occur. If treatment with Allergozan is necessary, vehicle drivers and machine operators are advised to stop activities that require increased attention and speed of reactions.

Preclinical safety data

Studies on experimental animals revealed that chloropyramine does not have embryotoxic, teratogenic or mutagenic effects. No other information available.

Overdose

Symptoms: Intentional or accidental overdose of antihistamines can cause death, especially in children. An overdose of chloropyramine causes symptoms similar to atropine poisoning, such as hallucinations, overexcitation, ataxia, incoordination, athetosis, and convulsions. In young children, overexcitation predominates. In addition, you can observe dry mouth, fixed and dilated pupils, facial flushing, sinus tachycardia, urinary retention, and fever. In adults, high fever and facial redness may be absent; the phase of overexcitation is followed by convulsions and postictal depression. At the end, coma occurs, respiratory and circulatory failure, which can result in death within 2-18 hours.

Treatment: due to the anticholinergic effect, gastric emptying is slowed down, therefore, in case of overdose in the first 12 hours, it is necessary to induce vomiting, perform gastric lavage, and use activated charcoal. Monitoring of blood circulation and respiration and symptomatic treatment are recommended. There is no specific antidote.

Drug interactions

With systemic use of chloropyramine, a number of drug interactions are possible that would be clinically significant.

Pharmacodynamic interactions

Chloropyramine may potentiate the effects of other drugs that depress the central nervous system (sedatives, hypnotics (including barbiturates), anxiolytics, opioid analgesics).

Its simultaneous use with other antihistamines can lead to mutual potentiation of their side effects.

Tricyclic antidepressants may potentiate the sedative effect and atropine-like side effects of chloropyramine.

With the simultaneous use of atropine, drugs with atropine-like effects (muscarinic parasympathicolytics) and chloropyramine, the risk of side effects such as urinary retention, constipation, and dry mouth increases.

Concomitant use of chloropyramine with MAO inhibitors may cause increased side effects. To eliminate this risk, a two-week interval is required after stopping the use of MAO inhibitors.

Ethanol enhances the depressive effect of chloropyramine on the central nervous system.

The toxic effects of ototoxic drugs may be masked by chloropyramine.

When using antihistamines, it is possible to suppress reactions when performing skin tests to identify allergens, so they should not be performed for several days after stopping drug treatment.

Pharmacokinetic interactions

There are no data on pharmacokinetic drug interactions of chloropyramine.

Contacts for inquiries

SOPHARMA JSC, representative office, (Bulgaria)

SOPHARMA PLC

A 16 Iliensko Shosse Str.
1220 Sofia, Bulgaria
Tel.: (+359 2) 938 31 23
Fax: (+359 2) 938 13 44
Email: [email protected]
http://www.sopharma.bg