Sulfasalazin-EN tabs 500mg #50

Sulfasalazin-EN user manual

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Dosage form, composition

The drug Sulfasalazin-EN is manufactured in the dosage form of an enteric coated tablet intended for oral administration. They have a round shape, biconvex surface, yellow or light brown color. The main active substance of the drug is Sulfasalazin, its content in one tablet is 500 mg. It also includes additional components, which include:
    Carmellose sodium.
    Titanium dioxide.
    Magnesium stearate.
    Copolymer of methacrylic acid.
    Pregelatinized starch.
    Macrogol-6000.
    Silica colloidal anhydrous.
    The iron oxide is yellow.
    Titanium dioxide.
    Starch.
Tablets Sulfasalazin-EH are contained in a blister of 10 pieces. Cardboard pack contains 5 blisters with tablets (50 pieces), as well as instructions for use.

Exposure to the medicinal product

The main active component of Sulfasalazin-EH tablets is a combination of sulfonamide and salicylic acid. Salicylic acid has a pronounced anti-inflammatory effect, which consists in blocking the enzymatic systems responsible for the synthesis of mediators of the inflammatory process. Sulfanilamide has an antimicrobial effect and promotes suppression of growth and reproduction of pathogenic (pathogenic) and opportunistic microorganisms in the lumen of the intestine. After taking the Sulfasalazin-EN tablets, the active ingredient of the drug is partially absorbed into the systemic bloodstream, evenly distributed in the tissues of the body, and also absorbed by the mucous membrane of the lower parts of the digestive tract, where it has a therapeutic effect.

Indications

Sulfasalazin-EN tablets are taken for several medical indications, including non-specific ulcerative colitis (nonspecific inflammation accompanied by the formation of small erosions or ulcers in the mucous membrane), Crohn's disease (a pathology of the large intestine having a similar origin and developmental mechanism with ulcerative colitis) . Also, the drug is used as an anti-inflammatory agent in the development of autoimmune pathology, which includes rheumatoid arthritis (including juvenile).

Contraindications

There are several different conditions of the patient's body, mostly pathological, in which the use of Sulfasalazin-EH tablets is contraindicated, they include:
    Different pathology of the blood system and red bone marrow.
    Porphyria is an inborn violation of the metabolism of pigments in the body.
    Severe impairment of the functional state of the kidneys or liver.
    Significant deficiency of the enzyme glucose-6-phosphate dehydrogenase.
    Individual intolerance to sulfonamides and salicylic acid, as well as any other components of the drug.
    The patient's age is up to 5 years.
Before starting taking Sulfasalazin-EH tablets, it is important to make sure there are no contraindications to their use.

Method of use, dose

Sulfasalazin-EN tablets are intended for oral administration. They are taken after meals, entirely, not chewed and washed down with enough water. For adults, the recommended therapeutic regimen for the use of the medicinal product is established:
    1 day course of therapy - 500 mg 4 times a day.
    2 day of treatment - 1 g 4 times a day.
    3 day, and also in the subsequent - 1,5-2 g 4 times a day.
In the future, as the intensity of manifestations of the pathological process subsides, they pass to a maintenance dose, which is 500 mg 3-4 times a day for several months. For children aged 5-7 years, an average dose of 250-500 mg is administered 3 to 6 times a day. Children older than 7 years are recommended taking 500 mg 3-6 times a day.

Negative reactions

Against the background of the reception of tablets Sulfasalazin-EN, the development of pathological reactions from various organs and systems is possible:
    The digestive system - nausea, accompanied by periodic vomiting, abdominal pain, lack of appetite (anorexia), diarrhea, pancreatic inflammation (pancreatitis), liver (hepatitis).
    Nervous system - headache, tinnitus, periodic dizziness, gait disturbance (ataxia), sleep with nightmarish dreams, auditory or visual hallucinations, peripheral nerve damage (peripheral neuropathy).
    The respiratory system is a lesion of the lung tissue, accompanied by its inflammation (interstitial pneumonitis).
    Blood and red bone marrow - a decrease in the number of platelets (thrombocytopenia), granulocytes (agranulocytosis), leukocytes (leukopenia) in the blood.
    The urinary system is a rich yellow color of urine, a violation of the functional activity of the kidneys, inflammation of their tissues (nephritis).
    The reproductive system is a decrease in the number of spermatozoa per unit volume of sperm (oligospermia), male or female infertility.
    Allergic reactions - a rash on the skin, itching, fever, a systemic reaction with a critical drop in blood pressure and multiple organ failure (anaphylactic shock).
When there is a manifestation of negative reactions against the background of taking Sulfasalazin-EN tablets, the doctor in charge determines the need to stop the use of this medication or adjust the dosage.

Special Recommendations

Before the appointment of this medication, the attending physician carefully reads the instruction and draws attention to a few specific recommendations regarding its use, which include:
    With concomitant impairment of the functional activity of the kidneys or liver of moderate severity, the drug can be used with extreme caution.
    It is recommended to use an increased volume of fluid during the course of therapy with the drug.
    With long-term administration of Sulfasalazin-EN tablets, it is important to conduct periodic laboratory monitoring of indicators of the functional state of the liver, kidneys, peripheral blood.
    The use of medication for pregnant women is possible only on strict medical indications in the minimum effective dosage and under the constant supervision of a physician.
    The active ingredient of Sulfasalazin-EH tablets can interact with drugs from other pharmacological groups, so if this is the case, the treating doctor should be warned.
    The medication and its components do not have a direct effect on the functional activity of the nervous system, but in connection with the possibility of developing headaches, dizziness, it is not recommended to perform potentially dangerous work against the background of its application.
In pharmacies tablets Sulfasalazin-EH are released without prescription.

Excess concentration in the body

In the event of a significant excess of the recommended therapeutic dosage of Sulfasalazin-EH tablets, nausea occurs, accompanied by vomiting, abdominal pain, dizziness. Treatment of an overdose is symptomatic, since there is no specific antidote for the drug. It is conducted in the conditions of a medical hospital.

Proper storage

The shelf life of Sulfasalazin-EN tablets is 5 years. It is important to keep them in intact original packaging, dark, dry, inaccessible to children at an air temperature of no more than + 25 ° C.