Pharmacodynamics. Chloropyramine, a chlorinated analog of tripelenamine (pyribenzamine), is a first generation antihistamine belonging to the group of ethylenediamines. In preclinical and clinical studies, as well as with the use of tripelenamine, the efficacy of chloropyramine in the treatment of hay fever and other allergic diseases has been revealed.
The mechanism of action of the preparation is to block histamine H1 receptors.
Suprastin reduces the severity of the general symptoms of allergic diseases, in addition to antiallergic, has a sedative, hypnotic and antipruritic effect.
The very low doses of chloropyramine given to guinea pigs protected the animals from the effects of histamine, which was 120 times the lethal dose. The preparation also acts on smooth muscle, capillary permeability and the central nervous system.
Pharmacokinetics. After oral administration, chloropyramine is rapidly absorbed in the gastrointestinal tract. The therapeutic effect develops within 15-30 minutes after application, reaches a maximum within the first hour after administration and persists for 3-6 hours. Chloropyramine is metabolized in the liver. It is excreted mainly in the urine in the form of metabolites. In children, the preparation can be excreted faster than in adults.
In case of impaired renal function, the excretion of the active substance may slow down.
In case of liver failure, a dose adjustment of the preparationpreparation is necessary due to a decrease in the metabolism of chloropyramine.
Allergic diseases - seasonal allergic rhinitis, conjunctivitis, urticaria, dermographism, contact dermatitis, food allergy; allergic reactions caused by preparations; an allergy caused by an insect bite; itching; as an auxiliary therapy for systemic anaphylactic reactions and angioedema.
Suprastin can only be administered by a doctor or nurse. Injections are administered intramuscularly. In case of anaphylactic shock or acute, severe allergic reactions, treatment is recommended to start with IV administration of Suprastin, and then switch to i / m injections or oral pills. The duration of therapy is determined by the doctor.
Adults. The daily dose for adults is usually 1–2 ml.
Children. Recommended starting dose:
children aged 1–12 months: ¼ ampoules (0.25 ml);
children aged 1–6 years: ½ ampoule (0.5 ml);
children aged 6-14 years: ½ – 1 ampoule (0.5–1 ml).
In this case, it is necessary to use an insulin syringe with a long needle for intramuscular injection.
The daily dose for a child should not exceed 2 mg / kg of body weight.
Liver dysfunction. A dose reduction may be required, since with liver disease, the metabolism of the active substance is reduced.
Impaired renal function. In case of impaired renal function, a decrease in the dose of the preparation is necessary, since the active substance is excreted mainly by the kidneys.
Hypersensitivity to any ingredient in the preparation; acute attack of asthma; acute myocardial infarction, arrhythmias; benign prostatic hyperplasia; angle-closure glaucoma; simultaneous administration of MAO inhibitors.
From the side of the central nervous system: sedation, increased fatigue, dizziness, ataxia, nervousness, tremors, convulsions, headache, euphoria, encephalopathy, blurred vision, drowsiness, deterioration of psychomotor functions.
From the side of the cardiovascular system: arterial hypotension, tachycardia, arrhythmia.
From the digestive tract: pain and discomfort in the epigastric region, dry mouth, nausea, vomiting, diarrhea, constipation, anorexia, increased and decreased appetite, increased severity of symptoms of gastroesophageal reflux.
From the side of the blood: leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, other pathological changes in the blood.
From the side of the organs of vision: increased intraocular pressure, glaucoma.
From the kidneys and urinary system: dysuria, urinary retention.
On the part of the skin and subcutaneous tissue: photosensitivity, allergic reactions.
On the part of the musculoskeletal system and connective tissue: myopathy.
From the immune system: allergic reactions, including skin flushing, rashes, itching, urticaria, angioedema.
For the preparation in the form of an injection solution also: changes at the injection site.
Elderly patients, debilitated patients. with extreme caution, the preparation is prescribed to these patients, since they are more sensitive to certain side effects of antihistamines (dizziness, drowsiness, decreased blood pressure).
Liver dysfunction. A dose reduction may be required, since with liver disease, the metabolism of the active substance is reduced.
Due to the anticholinergic and sedative effects of the preparation, special care should be taken when using it in elderly patients with impaired liver function or cardiovascular diseases.
If the preparation is used late in the evening, an increase in the severity of symptoms of gastroesophageal reflux is possible.
When chloropyramine hydrochloride is used in combination with ototoxic agents, the symptoms of ototoxicity may be masked.
Alcohol enhances the sedative effect of chloropyramine on the central nervous system, therefore, during treatment, alcoholic beverages should be avoided.
Long-term use of antihistamines can rarely cause disorders of the hematopoietic system (leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia). If undesirable effects are noted during long-term use of the preparation (fever, laryngitis, ulceration of the oral mucosa, pallor, jaundice, hematoma, bleeding), it is necessary to stop treatment and monitor blood counts.
One tablet contains 116 mg of lactose. Patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use this preparation.
Application during pregnancy or lactation. There are no preclinical data for use in animals. The use of the preparation during pregnancy and lactation is contraindicated.
Adequate and well-controlled clinical studies in pregnant women have not been performed, although it has been described that newborns whose mothers received antihistamines during the last 2 weeks of pregnancy developed retrolental fibroplasia.
The ability to influence the reaction rate when driving or working with other mechanisms. During the use of the preparation, especially during the first period of treatment, the preparation may cause drowsiness and deterioration of psychomotor functions (see SPECIAL INSTRUCTIONS). Thus, given the possible adverse reactions from the nervous system, it is prohibited to drive vehicles or other mechanisms at the beginning of therapy for a period set individually.
Children. Suprastin can be used in children from 1 month. It is contraindicated for use in newborns and premature babies.
MAO inhibitors increase and prolong the anticholinergic effect of suprastin. special care must be taken when prescribing the preparation simultaneously with sedatives, barbiturates, hypnotics, tranquilizers, opioid analgesics, tricyclic antidepressants, atropine, muscarinic parasympatholytics due to the possibility of mutual potentiation of each other's effects.
Alcohol increases the severity of the depressive effects of the preparation on the central nervous system, therefore, during treatment, alcohol should be avoided.
In combination with ototoxic preparations, warning signs of ototoxicity can be masked.
Antihistamines can prevent skin reactions in allergy testing and should be stopped a few days before a scheduled skin allergy test.
Intentional or accidental overdose of antihistamines can be fatal, especially in children. in case of an overdose of the preparation, symptoms similar to atropine intoxication develop: hallucinations, anxiety, ataxia, impaired coordination of movements, athetosis, convulsions. the state of excitement dominates in children. may also detect dry mouth, dilated pupils, hot flashes, sinus tachycardia, urinary retention, and fever. in adults, fever and hot flashes are not always noted; the period of arousal is accompanied by convulsions and postictal depression. in addition, coma and cardiopulmonary collapse may develop, which can be fatal within 2-18 hours.
Due to the anticholinergic effect of the preparation, the motor activity of the stomach may slow down, therefore, within 12 hours after an overdose, gastric lavage and intake of activated charcoal are necessary.
Monitoring of cardiopulmonary function is recommended. Treatment is symptomatic. The specific antidote is unknown.
At a temperature not exceeding 25 ° c.
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