Suprilamin pills 25mg, 20pcs

Composition

Active ingredient:  Chloropyramine hydrochloride-25.0 mgm Auxiliary substances:  lactose monohydrate (milk sugar), microcrystalline cellulose, sodium carboxymethyl starch (sodium starch glycolate, primogel), povidone K 25 (collidone K 25), magnesium stearate.

Pharmacological action

Pharmacotherapeutic group:

anti-allergic agent-H1-histamine receptor blocker

ATX code: R06AC03

Pharmacological properties

Pharmacodynamics

Chloropyramine-a chlorinated analog of tripelenamine (piribenzamine) is a first-generation antihistamine belonging to the group of ethylenediamine antihistamines.

A blocker of H1-histamine receptors, it has an antihistamine and m-holinoblokiruyushchy effect. This drug also affects smooth muscles, capillary permeability, and the central nervous system (CNS).

When taken orally, the effect appears after 15-30 minutes, the maximum effect develops within 1 hour and lasts approximately 3-6 hours.

Pharmacokinetics

Suction

When taken orally, it is almost completely absorbed from the gastrointestinal tract (GIT). The therapeutic effect of chloropyramine develops within 15-30 minutes after ingestion, reaches a maximum within the first hour after ingestion and lasts at least 3-6 hours.

Distribution

It is well distributed in the body, including the central nervous system.

Metabolism

It is intensively metabolized in the liver.

Deduction

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

Special patient populations

Children and teenagers

In children, the drug is eliminated faster than in adult patients.

Patients with impaired liver function

In patients with impaired liver function, the metabolism of chloropyramine decreases, so the dose of the drug can be reduced.

Patients with impaired renal function

In patients with impaired renal function, the excretion of chloropyramine decreases, so the dose of the drug can be reduced.

Indications

Urticaria, serum sickness, seasonal and year-round allergic rhinitis, allergic conjunctivitis, contact dermatitis, pruritus, acute and chronic eczema, atopic dermatitis, food and drug allergies, allergic reactions to insect bites.

Use during pregnancy and lactation

Pregnancy No adequate controlled clinical studies have been conducted on the use of antihistamines in pregnant women. However, cases of retrolental fibroplasia have been reported in newborns whose mothers took antihistamines in the last months of pregnancy. Accordingly, the use of chloropyramine during pregnancy is contraindicated. Breast-feedingthe use of chloropyramine is contraindicated during breastfeeding. If it is necessary to use the drug during lactation, stop breastfeeding.

Contraindications

Hypersensitivity to chloropyramine and other components of the drug, acute asthma attack, lactose intolerance, lactase deficiency or glucose-galactose malabsorption, pregnancy, lactation, children under 3 years of age (for this dosage form).

With caution

Angle-closure glaucoma, urinary retention, prostatic hyperplasia, impaired liver and/or kidney function, cardiovascular diseases elderly patients.

Side effects

Side effects, as a rule, occur extremely rarely, are temporary, and pass after the drug is discontinued. Side effects are presented in accordance with the lesion of organs and organ systems in the sequence of the Medical Dictionary for Regulatory activities (MedDRA). There are no clinical studies to determine the frequency of adverse reactions. Disorders of the blood and lymphatic system:  leukopenia, agranulocytosis, hemolytic anemia, and other changes in the cellular composition of the blood (for example, thrombocytopenia with prolonged use of the drug). Immune system disorders:  allergic reactions. Nervous system disorders:  drowsiness, fatigue, dizziness with a sense of rotation (vertigo), nervous excitement, ataxia, tremor, headache, euphoria, convulsions, encephalopathy. Visual disturbances:  blurred vision, glaucoma attacks, increased intraocular pressure. Disorders of the cardiovascular system:  reduced blood pressure, tachycardia, arrhythmia. Disorders of the gastrointestinal tract:  abdominal discomfort, dry mouth, nausea, vomiting, diarrhea, constipation, loss or increased appetite, upper abdominal pain. Musculoskeletal and connective tissue disorders:  myopathy. Kidney and urinary tract disorders:  difficulty urinating, urinary retention. Skin and subcutaneous tissue disorders:  photosensitization. If you experience any of the above effects, you should stop taking the drug and immediately consult a doctor. Reports of Side effects If you experience side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor. In the post-marketing period, any information about possible adverse reactions is important, as these reports help to assess the safety of the drug. Health care workers are required to report any suspected adverse reactions to the contacts indicated at the end of the instructions, as well as to the local pharmacovigilance authorities.

Interaction

Monoamine oxidase inhibitors enhance and prolong the anticholinergic effects of chloropyramine. Special care should be taken when concomitant use of chloropyramine tablets with barbiturates, sleeping pills, anxiolytics and sedatives, tranquilizers, opioid analgesics, tricyclic antidepressants, atropine, muscarinergic parasympatholytics (chloropyramine and any of these drugs may enhance the effects of each other). During treatment, the use of alcoholic beverages is prohibited (alcohol increases the depressing effect of chloropyramine on the central nervous system). When combined with ototoxic drugs, chloropyramine may mask early signs of ototoxicity. Antihistamines suppress skin reactions in response to allergic skin tests, so the use of chloropyramine should be discontinued a few days before the skin tests are performed.

How to take, course of use and dosage

Tablets are taken orally with meals, without chewing and with a sufficient amount of water. Adults are prescribed 1 tablet 3-4 times a day (75-100 mg per day). For children:

• aged 3 to 6 years:  1/2 tablet (12.5 mg) 2 times a day; daily dose-25 mg;
• at the age of 6 to 14 years:  1/2 tablet (12.5 mg) 2-3 times a day; daily dose-25-37.5 mg;
• at the age of 14 to 18 years:  1 tablet (25 mg) 3-4 times a day; daily dose-75-100 mg.

The dose for children can be gradually increased if there are no side effects in the patient, but the maximum dose should never exceed 2 mg/kg of body weight. The duration of the course of treatment depends on the nature, symptoms of the disease, the degree of their manifestation, duration and course of the disease. Special patient groupprivileged patients and patients with severe body mass deficitsapplication of chloropyramine requires special caution, since in these patients antihistamines often cause side effects (dizziness, drowsiness, drop in blood pressure (BP)). Patients with impaired liver function may need to reduce the dose due to a decrease in the metabolism of chloropyramine in liver diseases. Patients with impaired renal function may need to change the drug regimen and reduce the dose due to the fact that chloropyramine is mainly excreted by the kidneys.

Overdose

Overdose of antihistamines, especially in children, can lead to death, especially in infants. Symptoms:  when overdosed, chloropyramine causes symptoms similar to atropine poisoning, such as hallucinations, anxiety, ataxia, impaired coordination of movements, athetosis, convulsions. Arousal prevails in young children. Sometimes there is dry mouth, fixed dilation of the pupils, hyperemia of the facial skin, sinus tachycardia, urinary retention, fever. In adults, fever and flushing of the facial skin may be absent, followed by a period of agitation followed by convulsions and post-convulsive depression with the possible development of coma and cardiovascular and respiratory failure, which can lead to death of the patient within 2-18 hours. Treatment:  due to the anticholinergic effect of this drug, gastric emptying slows down. Therefore, inducing vomiting, gastric lavage, and use of activated charcoal is recommended within 12 hours of overdose. It is recommended to monitor the parameters of the cardiovascular and respiratory systems, as well as symptomatic therapy. The specific antidote is unknown.

Special instructions

The use of chloropyramine in the late evening hours may increase the symptoms of gastroesophageal reflux disease.

When combined with ototoxic drugs, chloropyramine may mask early signs of ototoxicity.

Liver and kidney diseases may require a change (reduction) in the dose of the drug, and therefore, the patient should inform the doctor about the presence of liver and kidney diseases.

Due to its anticholinergic and sedative effects, chloropyramine should be used with caution in elderly patients, patients with impaired liver function, cardiovascular diseases, angle-closure glaucoma, urinary retention and prostatic hyperplasia.

Chloropyramine can increase the effect of alcohol on the central nervous system, and therefore, the use of alcoholic beverages is prohibited while taking the drug.

Prolonged use of antihistamines can lead to disorders of the blood system and hematopoiesis (leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia). If during prolonged use there is an unexplained increase in body temperature, laryngitis, pallor of the skin, jaundice, formation of ulcers in the mouth, the appearance of hematomas, unusual and prolonged bleeding, it is necessary to conduct a clinical blood test with determination of the number of shaped elements. If the test results indicate a change in the blood formula, the drug is discontinued.

Each tablet contains 130 mg of lactose monohydrate. The drug is contraindicated in patients with lactase deficiency, lactose intolerance, glucose / galactose malabsorption.

Influence on the ability to drive vehicles and mechanisms

The drug, especially in the initial period of treatment, can cause drowsiness, fatigue and dizziness. Therefore, during the initial period, the duration of which is determined individually, it is prohibited to drive vehicles or perform work associated with an increased risk of accidents. After that, the doctor must determine the degree of restriction on driving vehicles and working with mechanisms for each patient individually.

Storage conditions

In a dark place at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Chloropyramine

Dosage form

Tablets