Salazopyrine EN-TABS

Salazopyrin EN-TABS is a bacteriostatic anti-inflammatory drug of the sulfanilamide group, it is an analogue of such drugs as Sulfasalazine, CAS. 500, Salazosulfapyridine, Sulfasalazin-EN, Enteric 500. The active ingredient is sulfasalazine.

[1], [2]

Indications Salazopyrine EN-TABS

In clinical therapy, Salazopyrin EN-TABS is used for inflammatory bowel diseases caused by conditionally pathogenic microorganisms: granulomatous colitis (Crohn's disease) in the active stage, ulcerative colitis, inflammation of the rectal mucosa (ulcerative proctitis).

The drug is used in rheumatology - for the treatment of rheumatoid arthritis in adults and inflammatory joint diseases in children under 16 years old (juvenile rheumatoid arthritis).

[3], [4], [5]

Release form

The form of this drug - tablets with enteric-soluble coating (100 pieces per bottle); the active ingredient in one tablet is 500 mg.

[6], [7], [8]

Pharmacodynamics

Entering the intestine, the active substance of Salazopyrin EN-TABS sulfasalazine is split into sulfapyridine (80%) and 5-aminosalicylate (5-ASA, mesalazine). The antimicrobial effect of sulfapyridine is due to its ability to penetrate into the intestinal tissues, to accumulate there and to suppress the synthesis of folic acid salts in the cells of pathogenic microorganisms. The active ingredient of the preparation also prevents oxidation by the enzyme lipoxygenase of unsaturated fatty acids in the cells of the inflammatory focus. Thus, a violation of the cellular metabolism of bacteria and microbes leads to their death.

Poorly absorbed 5-ASA, for its part, has a local anti-inflammatory effect due to the inherent in all salicylates oppression of the production of prostaglandins - hormone-like substances that regulate cellular metabolism. As a result of this biochemical process, the intensity of inflammatory phenomena decreases.

[9], [10]

Pharmacokinetics

Absorption of Salazopyrin EN-TABS occurs quickly: almost 25% of the drug is absorbed in the upper GI tract. At the same time, during the cyclic circulation of bile acids in the digestive organs, half of the taken medicinal product is returned to the intestine. So up to the large intestine reaches over 90% of the dose. In the systemic blood stream, up to 10% of the active substance is ingested.

Salazopyrine EN-TABS is partially oxidized in the liver, the main way of excretion of metabolites is through the urinary system. Unoxidized sulfasalazine binds to blood plasma proteins, where its maximum concentration is reached after 12 hours after ingestion. The complete absence of Salazopyrin in the blood serum is observed only three days after discontinuation of the drug.

20% 5-ASA is excreted from the body with urine, the rest is retained in the large intestine, and then is excreted unchanged and partly in the form of a metabolite.

[11], [12], [13], [14]

Dosing and administration

The dosage and dose of Salazopyrin EN-TABS is determined and prescribed by the physician - depending on the nature of the disease and the individual characteristics of the patient.

In acute inflammatory bowel diseases, adults are treated with an increasing regimen of administration: 500 mg 4 times the first day, 1 g 4 times - on the second day, 1.5-2 g 4 times a day - from the third to the ninth day. Tablets are drunk in their entirety, after eating.

During the period of signs of acute ulcerative colitis, Salazopyrin EN-TABS is taken three times a day by a pill (500 mg) - before the drug is withdrawn by the doctor.

Children under 7 years of age take this medicine 250 mg three times a day, the elderly 500 mg each.

With rheumatoid arthritis and with previous long-term therapy with non-steroidal anti-inflammatory drugs, Salazopyrin-EN-TABS is prescribed in this dosage: the first week - 1 tablet a day, the second week - 1 tablet twice a day, etc., until the daily intake of the drug increases 4 times on one tablet.

With juvenile rheumatoid arthritis, the daily dose for children is 30-50 mg per kilogram of body weight (in 4 divided doses). The maximum daily intake in childhood is 2000 mg.

Use Salazopyrine EN-TABS during pregnancy

The negative effect of this drug, which interferes with embryonic development, is not established, but the use of Salazopyrin EN-TABS during pregnancy is possible only according to the doctor's testimony, as the drug reduces the level of absorption of folic acid. Substances of the drug enter the breast milk, therefore, during the treatment during lactation, breastfeeding should be abandoned.

Contraindications

Salazopyrin EN-TABS is contraindicated in the presence of blood diseases, liver function disorders and genetic pathology of the liver (porphyria), with severe renal dysfunction, as well as hypersensitivity to sulfonamides and salicylates. The drug is not used to treat children under 6 years.

[15], [16]

Side effects Salazopyrine EN-TABS

The list of possible negative effects of this medication includes: indigestion, nausea, abdominal pain, vomiting, nephrotic syndrome, dizziness, headache, ringing in the ears, taste changes, stomatitis, cough, hyperemia of the mucosa and sclera of the eyeball, insomnia .

[17], [18], [19]

Overdose

Overdosage of Salazopyrin EN-TABS is expressed in nausea, vomiting, pain in the abdominal cavity and is treated symptomatically - gastric lavage, alkalizing urine to pH 7.8-8.5; in case of severe overdose - detoxification therapy in the form of forced diuresis.

[20], [21], [22]

Interactions with other drugs

Simultaneous reception of Salazopyrin EN-TABS with drugs that prevent the formation of thrombi (anticoagulants), as well as with oral hypoglycemic antidiabetics (sulfonylureas) enhances their effect.

The therapeutic effect of Salazopyrin EN-TABS decreases with the simultaneous use of its drugs group of antibiotics, which inhibit the flora of the intestine up to dysbiosis.

Storage conditions

Storage conditions of the preparation - at temperatures up to + 25 ° C, out of reach of children.

[23], [24], [25]

Shelf life

Shelf life is indicated by the manufacturer on the package, after its expiration, Salazopyrin EN-TABS should not be used.

[26], [27], [28], [29]