Active substanceSodium dimercaptopropanesulfonate + Calcium pantothenateSodium dimercaptopropanesulfonate + Calcium pantothenate
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  • Zorex®
    capsules inwards 
    VALENTA PHARM, PAO     Russia
  • Dosage form: & nbspcapsules
    Composition:

    One capsule contains:

    Active substances: sodium dimercaptopropanesulfonate monohydrate (unitiol) 150.0 mg or 250.0 mg and calcium pantothenate 7.0 mg or 10.0 mg.

    Excipients: microcrystalline cellulose 113.5 mg or 120.2 mg, citric acid monohydrate 9.1 mg or 12.2 mg pregelatinized starch 29.3 mg or 40.2 mg magnesium hydrophosphate trihydrate 30.0 mg or 50 mg , 0 mg, povidone - 6.1 mg or 9.4 mg, silicon dioxide colloid -5.0 mg or 8.0 mg.

    Hard gelatine capsules:

    housing: titanium dioxide E171- 2.0000%, gelatin up to 100%.

    cap: titanium dioxide E171- 1.0000% dye azorubin E122 - 0,0500%, gelatin up to 100%.

    Description:Capsules No. 0 for a dosage of 150 mg + 7 mg and capsule No. 00 for a dosage of 250 mg + 10 mg, body white, cap pink. The contents of the capsules are granules and white powder with a creamy shade of color, prone to clumping. A weak specific odor is allowed.
    Pharmacotherapeutic group:Complexing agent
    ATX: & nbsp

    V.03.A.B   Antidotes

    Pharmacodynamics:

    Has detoxification (including in relation to the products of the metabolism of ethyl alcohol, heavy metals and their compounds, arsenic compounds), action.Clinical studies have shown the hepatoprotective and antioxidant properties of sodium dimercaptopropanesulfonate.

    Pharmacodynamics

    Active sulfhydryl groups of sodium dimercaptopropanesulfonate, interacting with thiol poisons and products of alcohol (ethanol) metabolism, which are in the blood and tissues, form nontoxic compounds (complexes) with them, which are excreted in the urine. When taking the drug inside the active substance sodium dimercaptopropanesulfonate with portal bloodstream penetrates the liver, where it quickly and irreversibly binds to acetaldehyde, which causes the subsequent removal of ethyl alcohol from other organs and tissues. Sodium dimercaptopropanesulfonate activates also acetaldehyde dehydrogenase, enhancing the process of ethanol oxidation and detoxification of its toxic products by the enzyme system of the liver. The presence of calcium pantothenate in the formulation enhances the detoxification effect of sodium dimercaptopropanesulfonate. Pantothenic acid is involved in carbohydrate and fat metabolism, stimulates the formation of corticosteroids, accelerates regeneration processes.

    Pharmacokinetics:After taking a capsule containing 250 mg of 2,3-dimercaptopropanesulfonate, the maximum concentration in the blood is reached after 1.5 hours and is within 90-140 mg / l. The average time of the drug in the body is 9-11 h (10.16 ± 0.39 h), incl. in the gastrointestinal tract - 15-20 min. The half-life of the preparation (T1 / 2) is 7.5 ± 0.46 h. Calcium pantothenate is well absorbed in the intestine and is cleaved, releasing pantothenic acid. About 60% of the drug is excreted in the urine, partly with feces.
    Indications:

    - Alcohol abstinence syndrome (for the prevention and treatment of hangovers);

    - alcoholism (as part of complex therapy);

    - acute and chronic poisoning by organic and inorganic compounds of arsenic, mercury, gold, chromium, cadmium, cobalt, copper, zinc, nickel, bismuth, antimony, intoxication with cardiac glycosides.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Severe decompensated diseases of the liver and kidneys.

    The occurrence of allergic reactions with the previous administration of the drug.

    Children under 18 years.

    Carefully:Use with caution in low blood pressure.
    Pregnancy and lactation:There are no data on the use of the drug during pregnancy and during lactation. In connection with the lack of necessary information, use during pregnancy and during breastfeeding is contraindicated.
    Dosing and Administration:

    Inside. Capsules are swallowed 30 minutes before meals, without chewing, washing with water.

    For prophylaxis of a hangover - after reception of alcohol 1 capsule (250 mg + 10 mg) in the evening before a dream.

    For the treatment of alcohol withdrawal syndrome: 1 capsule (250 mg + 10 mg) 1-2 times per day (the doses are given in terms of sodium dimercaptopropanesulfonate and calcium pantothenate). If necessary, the daily dose can be increased to 750 mg (sodium dimercaptopropanesulfonate), and the frequency of administration should be increased to 3 times a day. The drug should be taken 3-7 days, until the symptoms of intoxication stop. With alcoholism: 1 capsule (150 mg + 7 mg) 1-2 times a day, for 10 days (the doses are given in terms of sodium dimercaptopropanesulfonate and calcium pantothenate). When poisoning with arsenic compounds and heavy metal salts 300-1000 mg (sodium dimercaptopropanesulfonate) per day for 2-3 doses, for 7-10 days.

    Side effects:

    Rarely: allergic reactions (skin itching, urticaria, rash on the skin and mucous membranes, mucosal edema, genital itching, stomatitis).

    Very rarely: the appearance of an allergic reaction such as angioedema or Stephen-Johnson syndrome (sudden rise in body temperature, malaise, spotty vesiculosis or bullous rashes on the skin, oral mucosa, genital organs, in the anus), Lyell's syndrome, conjunctivitis . In this case, stop taking the medication and consult a doctor.

    The risk of developing allergic reactions is higher in people with bronchial asthma or having an allergy in history.

    When used in high doses: nausea, dizziness, tachycardia, pale skin.

    Overdose:

    Manifestations of an overdose may appear when the recommended dose is exceeded by more than 10 times.

    Symptoms: shortness of breath, hyperkinesia, inhibition, lethargy, deafness, short-term convulsions.

    Treatment: gastric lavage, the use of activated carbon, laxatives, symptomatic therapy, in acute cases of oxygen therapy, the introduction of dextrose.

    Interaction:Incompatible with drugs containing salts of heavy metals, as well as with alkalis (rapidly decomposes).
    Special instructions:When postregistered use of the drug is "very rare", severe allergic reactions are registered: Stephen-Johnson syndrome and Lyell's syndrome (see "Side effect" section). Taking the drug in case of allergic reactions at its previous reception, is contraindicated (see the section "Contraindications") in connection with the risk of increasing the severity of the allergic reaction due to sensitization (increasing the sensitivity of the organism to the stimulus that causes an allergic reaction due to the production of antibodies).
    Effect on the ability to drive transp. cf. and fur:The drug does not affect the performance of potentially hazardous activities requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work, etc.).
    Form release / dosage:
    Capsules 150 mg + 7 mg or 250 mg + 10 mg.
    Packaging:

    For 2, 5, 10 capsules (250 mg + 10 mg) or 10 capsules (150 mg + 7 mg) into the contiguous cell package,10 capsules (250 mg + 10 mg) or 10 capsules (150 mg + 7 mg) into a contoured cell package with a perforation made of a polyvinylchloride film and aluminum foil printed lacquer.

    1 contour cell pack of 10 capsules (150 mg + 7 mg), 1 outline cell pack of 2 or 10 capsules (250 mg + 10 mg), 2 out-of-round packs of 5 capsules (250 mg + 10 mg), along with instructions for application is placed in a pack of cardboard.

    Storage conditions:Store in a place protected from light and moisture at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LS-000886
    Date of registration:25.11.2010 / 15.03.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Information update date: & nbsp18.10.2017
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