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SUPRASTINUM

Препарат СУПРАСТИН. ОАО "Фармацевтический завод ЭГИС" Венгрия


Producer: JSC EGIS Pharmaceutical Plant Hungary

Code of automatic telephone exchange: R06AC03

Release form: Firm dosage forms. Tablets.

Indications to use:


General characteristics. Structure:

Active ingredient: 1 tablet contains 25 mg of Chloropyraminum of a hydrochloride, and also auxiliary ingredients: lactose, starch, talc, sodium amylopectin, gelatin, stearic acid.

Description of a dosage form: Tablets - white or grayish-white color, a round form, one party smooth, on another is available SUPRASTIN engraving.




Pharmacological properties:

Is antihistaminic drug from group of blockers H1 receptors. On a chemical structure treats ethylene diamine derivatives. Suprastinum prevents development and facilitates the course of allergic reactions, has the sedative and expressed antipruritic effect. Has peripheral anticholinergic activity, moderate spasmolytic properties. Pharmacokinetics: Chloropyraminum the hydrochloride is quickly and completely soaked up from digestive tract. The therapeutic effect of Chloropyraminum develops within 15-30 minutes after intake. The maximum concentration in blood is reached within the first hour, the therapeutic level of concentration remains within 3-6 hours. Drug is distributed in different bodies, including TsNS. Metabolism of drug happens in a liver; drug preferential through kidneys with urine in the form of decomposition products is emitted. Release of drug at children can quicker happen, than at adults. Linkng of Chloropyraminum with proteins of a blood plasma makes 7,9%. The peak of binding is noted at рН 6,8 - 7,4.


Indications to use:

Allergic diseases, including: small tortoiseshell, serum disease, Quincke's disease, pollinosis (hay fever) and other allergic rhinopathies and conjunctivitis. Skin diseases, including: atopic dermatitis, contact dermatitis, acute and chronic eczema, medicinal rashes, pruritic dermatosis. Itch and stings of insects.


Route of administration and doses:

Pill is taken inside during food.

Adult:
appoint on 1 tablet 3-4 times a day (75-100 mg a day)

To children:
At the age of 1-12 months on 1/4 tablets (6,25 mg) 2-3 times a day (in the look pounded to powder together with baby food). At the age of 1-6 years on 1/4 tablets (8,3 mg) 3 times a day or on 1/2 tablets 2 times a day. At the age of 6-14 years on 1/2 tablets (12,5 mg) 2-3 times a day.


Features of use:

Drug should be used with care to aged persons, patients with insufficiency of function of a liver and/or heart diseases, and also at closed-angle glaucoma, at patients with an ischuria and a hypertrophy of a prostate.
At reception for the night drug can strengthen symptoms a reflux esophagitis.
During drug use, especially in an initial phase of treatment, the arising drowsiness and depression can interfere with some types of activity. Therefore driving of vehicles and control of mechanisms during treatment is forbidden. During treatment the use of alcoholic beverages is forbidden.


Side effects:

• From TsNS: are possible - slackness, drowsiness, weakness, an easy tremor, dizziness. At children some promoting effect on TsNS which is shown concern, the increased irritability, sleeplessness can be noted.
• From digestive tract: are possible - dryness in a mouth, nausea, vomiting, a diarrhea or a lock.
• Other: can seldom arise - difficulty of an urination, lowering of arterial pressure (is more often at elderly patients), tachycardia, arrhythmia, allergic reaction


Interaction with other medicines:

Drug should be used carefully with:
• sedatives, tranquilizers,
• analgetics,
• MAO inhibitors, tricyclic antidepressants,
• atropine and/or sympatholytics since at simultaneous use all effects of these means can amplify.


Contraindications:

• Individual hypersensitivity to drug;
• Newborn children (full-term and premature);
• Bad asthmatic attack;
• Pregnancy and period of a lactation.


Overdose:

Symptoms: There can be symptoms intoxications, similar to symptomatology, atropine.

Treatment: There are no specific antidotes therefore the symptomatic treatment is carried out. During the period till 12 o'clock after administration of drug the gastric lavage is necessary (it is necessary to consider that gastric emptying is interfered by anticholinergic effect of drug). Also use of absorbent carbon is shown. Control of parameters of arterial pressure and breath is necessary.


Storage conditions:

To store drug at the room temperature (15-25 °C). To store in the place, unavailable to children. Period of validity: 5 years. It is impossible to use drug after the expiry date specified on packaging.


Issue conditions:

Without recipe


Packaging:

The tablets containing 25 mg of Chloropyraminum of a hydrochloride are packed up on 20 pieces in bottles from brown glass with PE covers and together with the application instruction (information for patients) invest in a cardboard box.
The tablets containing 25 mg of Chloropyraminum of a hydrochloride are packed up also on 10 pieces in the blister and 2 blisters together with the application instruction (information for patients) invest in a cardboard box.



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