Composition, form of production and packaging
? Hard gelatin capsules, size No. 0, with a white casing and pink lid; contents of capsules - granules and white powder with a creamy shade of color, prone to clumping; a slight specific odor is allowed.
1 caps.
sodium dimercaptopropanesulfonate (unitiol) 150 mg
calcium pantothenate 7 mg
Excipients: microcrystalline cellulose - 113.5 mg, citric acid - 9.1 mg, pregelatinized starch - 29.3 mg, magnesium hydrophosphate trihydrate - 30 mg, povidone - 6.1 mg, silicon dioxide colloid (aerosil) - 5 mg.
The composition of hard gelatin capsules: gelatin, titanium dioxide (E171), azorubin (E122).
10 pieces. - packings of cellular contour (1) - packs cardboard.
? Capsules hard gelatinous, size в„–00, with white body and pink lid; contents of capsules - granules and white powder with a creamy shade of color, prone to clumping; a slight specific odor is allowed.
1 caps.
sodium dimercaptopropanesulfonate (unitiol) 250 mg
calcium pantothenate 10 mg
Excipients: microcrystalline cellulose - 120.2 mg, citric acid monohydrate - 12.2 mg, pregelatinized starch - 40.2 mg, magnesium hydrophosphate trihydrate - 50 mg, povidone - 9.4 mg, silicon dioxide colloid - 8 mg.
The composition of hard gelatin capsules: gelatin, titanium dioxide (E171), azorubin (E122).
2 pcs. - packings of cellular contour (1) - packs cardboard.
5 pieces. - packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Complexing agent. Donator of sulfhydryl (thiol) groups. Has detoxification (including in relation to the products of the half-life of ethanol, heavy metals and their compounds, arsenic compounds) action. In clinical studies, hepatoprotective and antioxidant effects of unithiol are shown.
Active sulfhydryl groups of unithiol, interacting with thiol poisons and alcohol (ethanol) half-life products, which are in the blood and tissues, form nontoxic compounds (complexes) with them, which are excreted in the urine.
When taking the drug inside unitiol with portal bloodstream penetrates the liver, where it quickly and physiologically irreversibly binds to acetaldehyde, which causes the subsequent removal of ethyl alcohol from other organs and tissues. Zorex В® also activates alcohol dehydrogenase, enhancing the process of ethanol oxidation and detoxification of its toxic agents by the enzyme system of the liver.
The presence in the formulation of Zorex В® calcium pantothenate enhances the detoxication effect of unithiol. Calcium pantothenate is well absorbed from the intestine and is cleaved, releasing pantothenic acid, which participates in carbohydrate and fat metabolism, stimulates the formation of corticosteroids, accelerates regeneration processes.
PHARMACOKINETICS
Suction
After ingestion of a capsule containing 250 mg of unithiol, the Cmax of the latter in the blood is reached after 1.5 hours and is 90-140 mg / l. The average time of finding the drug in the body is 9-11 h (10.16 В± 0.39 h), incl. in the gastrointestinal tract - 15-20 minutes.
Calcium pantothenate is well absorbed from the intestine and is cleaved, releasing pantothenic acid.
Excretion
T 1/2 is 7.5 В± 0.46 h.
About 60% of the drug is excreted in the urine, in part - with feces.
INDICATIONS
- alcohol abstinence syndrome (for the prevention and treatment of hangovers);
- chronic 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.
DOSING MODE
The drug is prescribed inside. Capsules should be taken 30 minutes before meals, without chewing, washing with water.
For prophylaxis of a hangover - after reception of alcohol 1 caps. (250 mg + 10 mg) in the evening before bedtime.
For the treatment of alcohol withdrawal syndrome - 1 caps. (250 mg + 10 mg) 1-2 times / day (the doses are given in terms of unitiol and calcium pantothenate). If necessary, the daily dose can be increased to 750 mg (unithiol), and the frequency of reception should be increased to 3 times / day. The drug should be taken 3-7 days before the symptoms of intoxication stop.
With chronic alcoholism , one capsule is prescribed. (150 mg + 7 mg) 1-2 times / day for 10 days (the doses are given in terms of unitiol and calcium pantothenate).
When poisoning with arsenic compounds and heavy metal salts, 300-1000 mg / day (unithiol) are prescribed, divided into 2-3 doses for 7-10 days.
SIDE EFFECT
Allergic reactions: rarely - skin itching, urticaria, rashes on the skin and mucous membranes, swelling of the mucous membranes, genital itching, stomatitis; very rarely - the appearance of an allergic reaction like angioneurotic edema or Stephen-Johnson syndrome (sudden rise in body temperature, malaise, spotty vesiculosis or bullous rashes on the skin, mucous membranes of the mouth, genital organs, in the anus). 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.
CONTRAINDICATIONS
- severe liver disease in the stage of decompensation;
- severe kidney disease at the stage of decompensation;
- children's age till 18 years;
- Hypersensitivity to the components of the drug.
With caution , use the drug with low blood pressure.
PREGNANCY AND LACTATION
Data on the use of Zorex В® during pregnancy and lactation (breastfeeding) are not available. In connection with the lack of necessary information, use during pregnancy and during breastfeeding is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in cases of severe kidney disease in the stage of decompensation.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is contraindicated in cases of severe liver disease in the stage of decompensation.
APPLICATION FOR CHILDREN
Contraindicated in children under the age of 18 years.
SPECIAL INSTRUCTIONS
Impact on the ability to drive vehicles and manage mechanisms
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.).
OVERDOSE
Symptoms of overdose may appear if the recommended dose is exceeded by more than 10 times.
Symptoms: dyspnea, hyperkinesis, inhibition, lethargy, deafness, short-term convulsions.
Treatment: gastric lavage, the appointment of activated carbon, laxatives. Conduct symptomatic therapy, in acute cases, oxygen therapy, the introduction of dextrose.
DRUG INTERACTION
It is not compatible with drugs containing salts of heavy metals, as well as with alkalis (rapidly decomposes).
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, dry, protected from light and moisture at a temperature of no higher than 25 В° C. Shelf life - 2 years.
