Suprastin - instructions for use, dose, side effects, contraindications

Each tablet contains: 25 mg of active substance of chloropyramine hydrochloride, as well as auxiliary substances: stearic acid, gelatin, sodium carboxymethyl starch (type A), talc, potato starch, lactose monohydrate (116 mg).

Description:White, or grayish-white tablets in the form of a disc with a bevel, with an engraving "SUPRASTIN" on one side of the tablet and risk on the other side, without or almost no odor.

Pharmacotherapeutic group:antiallergic agent - H1 - histamine receptor blocker

ATX: & nbsp

D.04.A.A.09 Chloropyramine

R.06.A. C.03 Chloropyramine

Pharmacodynamics:

Chloropyramine - a chlorinated analogue of tripelenamine (pyribenzamine) is a classic antihistamine drug belonging to the group of ethylenediaminic antihistamines.

The H1-histamine receptor blocker has antihistamine and m-cholinoblocking action, has antiemetic effect, moderate spasmolytic and peripheral cholinoblocking activity.

Pharmacokinetics:

When taken orally, it is almost completely absorbed from the gastrointestinal tract (GIT). The therapeutic effect of chloropyramine develops during 15-30 minutes after ingestion, reaches a maximum within the first hour after administration and lasts a minimum of 3-6 hours. It is well distributed in the body, including the central nervous system (CNS). Intensively metabolized in the liver. It is excreted mainly by the kidneys.

In children, excretion occurs faster than in adult patients.

Indications:

urticaria, angioedema, Quincke's edema, serum sickness, seasonal and year-round allergic rhinitis, conjunctivitis, contact dermatitis, skin itching, acute and chronic eczema, atopic dermatitis, food and drug allergies, allergic reactions to insect bites.

Contraindications:

- hypersensitivity to the components of the drug,

- an acute attack of bronchial asthma,

- Newborn children (full and premature),

- pregnancy,

lactation period.

Carefully:

closed-angle glaucoma, urinary retention, prostatic hyperplasia, liver and / or kidney dysfunction, cardiovascular diseases, elderly patients.

Pregnancy and lactation:

There have been no adequate, with proper control, studies of the use of antihistamines in pregnant women. In accordance with this, taking Suprastin during pregnancy (especially in the first trimester and in the last month) should only be if the potential benefit to the mother exceeds the possible risk to the fetus. If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be resolved.

Dosing and Administration:

Tablets are taken orally during meals, without chewing and drinking with sufficient water.

Adults: appoint 1 tablet 3-4 times a day (75-100 mg per day).

For children:

At the age of 1 to 12 months: 1/4 tablets (6.5 mg) 2-3 times a day (in grated to powder form together with baby food);

At the age of 1 to 6 years: 1/4 tablets 3 times a day or 1/2 tablets 2 times a day;

At the age of 6 up to 14 years: 1/2 tablet (12.5 mg) 2-3 times a day.

The dose can be gradually increased in the absence of side effects in the patient, but the maximum dose should never exceed 2 mg / kg of body weight.

Special groups of patients:

Elderly, emaciated patients: The use of Suprastin® requires extreme caution. In these patients, antihistamines often cause side effects (dizziness, drowsiness).

Patients with impaired hepatic function: may require a dose reduction due to a decrease in the metabolism of the active component of the drug in liver diseases.

Patients with impaired renal function: It may be necessary to change the regimen of the drug and reduce the dose due to the fact that the active component is mainly released through the kidneys.

Side effects:

Side effects usually occur extremely rarely, are temporary, go through with the withdrawal of the drug.

From the side of the central nervous system: drowsiness, fatigue, dizziness, nervous excitement, tremor, headache, euphoria.

From the gastrointestinal tract: discomfort in the abdomen, dry mouth, nausea, vomiting, diarrhea, constipation, loss or increase in appetite, pain in the upper abdomen.

From the cardiovascular system: decrease in arterial pressure, tachycardia, arrhythmia. It was not always established a direct relationship of these side effects with the drug.

On the part of the hematopoiesis system: Very rarely: leukopenia, agranulocytosis.

Other: difficulty urinating, muscle weakness, increased intraocular pressure, photosensitivity.

If any of the above effects occur, you should stop taking the drug and immediately consult a doctor.

Overdose:

Symptoms: hallucinations, anxiety, ataxia, movement coordination disorders, athetosis, convulsions. In young children, excitement, anxiety, dry mouth, fixed dilated pupils, redness of the face, sinus tachycardia, urinary retention, fever, coma.In adults, fever and redness of the face are not constant, after a period of excitement followed by convulsions and post-convulsive depression, coma.

Treatment: in the period up to 12 hours after taking the drug, gastric lavage is necessary (it should be borne in mind that the anticholinergic effect of the drug prevents the emptying of the stomach). Also shown is the use of activated carbon. It is necessary to control the parameters of blood pressure and respiration. Symptomatic therapy. Resuscitative measures. The specific antidote is not known.

Interaction:

The drug should be used with caution with: sedatives, tranquilizers, analgesics, MAO inhibitors, tricyclic antidepressants, atropine and / or sympatholytics, since with the simultaneous application of the effects of these drugs can increase.

Special instructions:

Each tablet contains 116 mg of lactose monohydrate. This amount can cause unwanted reactions in patients with lactose deficiency or rare metabolic disorders - galactoseemia or glucose / galactose absorption disorder syndrome.

When combined with ototoxic drugs, Suprastin® can mask the early signs of ototoxicity.

Diseases of the liver and kidneys may require a change (decrease) in the dose of the drug, in connection with which the patient should inform the doctor about the presence of a liver or kidney disease. Taking the drug at night can increase the symptoms of reflux esophagitis.

Suprastin can strengthen the effect of alcohol on the central nervous system, in connection with which during the reception of the drug Suprastin should avoid the use of alcoholic beverages.

Effect on the ability to drive transp. cf. and fur:

The drug, especially in the initial period of treatment, can cause drowsiness, fatigue and dizziness. Therefore, in 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 this, the degree of restriction on driving and the work with the mechanisms of the doctor should determine for each patient individually

Form release / dosage:Tablets of 25 mg.

Packaging:

For 20 tablets in bottles of brown glass with PE caps. The bottle is packed in a cardboard box together with instructions for medical use.

10 tablets per blister.Two blisters are packed in a cardboard box together with instructions for medical use.

For 20 tablets per blister. 1 blister is packed in a cardboard box together with the instruction on mmedical use.

Storage conditions:

At a temperature of 15-25 ° C, out of reach of children.

Shelf life:

5 years. Do not use after the date shown on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N012426 / 01

Date of registration:23.08.2010

The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Manufacturer: & nbsp

EGIS Pharmaceutical Plant, ZAO Hungary

Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Information update date: & nbsp29.09.2015

Illustrated instructions

Instructions

Suprastin® (Suprastin®)