Instructions for use SULFASALAZIN-EN
The side effects of sulfasalazine are mainly due to high concentrations of sulfapyridine in the blood, especially among people who break down sulfapyridine more slowly (slow acetylators). Side effects are more common in patients with rheumatoid arthritis.
Determination of side effect frequency categories:
- very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), rarely (≥1/10,000 to <1/1000), very rare (<1/10,000), unknown (cannot be estimated based on available data).
Within each group, side effects are presented in descending order of severity. The incidence of side effects is listed for individual organ systems.
From the hematopoietic system:
often - leukopenia, neutropenia, macrocytosis;
- uncommon - megaloblastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenia;
- very rarely - aplastic anemia, methemoglobinemia, anemia with Heinz bodies, hypoprothrombinemia, lymphadenopathy, eosinophilia.
- uncommon - in patients with porphyria, taking sulfasalazine may lead to an exacerbation of the disease.
- rarely - hallucinations.
- rarely - peripheral neuropathy, dizziness, convulsions, ataxia;
- very rarely - aseptic meningitis.
- very rarely - fibrous alveolitis.
- infrequently - diarrhea, stomatitis, mumps;
- rarely - pancreatitis.
- yellow-orange discoloration of urine, skin, or soft contact lenses.
From the immune system:
very rarely - serum sickness, generalized skin rash, exanthema multiforme, exfoliative dermatitis, photosensitivity, drug-induced fever, periorbital edema, polyarteritis nodosa of the conjunctiva or cornea, urticaria, itching, redness.
From the side of metabolism:
often - anorexia;
Mental disorders:
infrequently - depression, insomnia;
From the nervous system:
often - headache;
From the organ of hearing and balance:
infrequently - ringing in the ears.
From the respiratory system:
rarely - pulmonary infiltration, dyspnea, cough;
From the digestive system:
often - nausea, vomiting;
Hepatobiliary disorders:
rarely - hepatitis;
From the urinary system:
rarely - nephrotic syndrome, hematuria, proteinuria, crystalluria.
From the skin and subcutaneous tissue:
very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the reproductive system and mammary gland:
infrequently - reversible oligospermia, reversible male infertility.
Laboratory research:
infrequently - increased serum concentrations of amylase, bilirubin, alkaline phosphatase and hepatic transaminase activity.
If serious side effects are observed, treatment should be stopped.
Sulfasalazine-EN tablets for intestinal tract 500 mg No. 50
special instructions
A complete clinical blood count, including white blood cell count, red blood cell and platelet counts, and biochemical liver function tests should be performed before starting sulfasalazine and every other week for the first three months of therapy.
Over the next three months, the same laboratory tests should be performed monthly, then once every three months and in accordance with clinical indications.
Assessment of renal function (including urinalysis) should be performed in all patients before starting therapy and at least monthly during the first three months of treatment. Thereafter, monitoring should be performed as clinically indicated.
The presence of clinical signs such as sore throat, fever, pale skin, purpura or jaundice during sulfasalazine therapy may indicate myelosuppression, hemolysis or hepatotoxicity. Treatment with sulfasalazine should be discontinued until results of blood tests are available (see subsection “Effects on laboratory results”).
Sulfasalazine is recommended to be prescribed with caution to patients with systemic forms of juvenile rheumatoid arthritis, since there is a risk of developing undesirable effects, including serum sickness (fever, nausea, vomiting, headache, skin rash and liver dysfunction).
Life-threatening skin reactions: SSD and TEN have been reported during the use of the drug Sulfasalazine-EN.
Patients should be alerted to clinical signs and symptoms and should be closely monitored for the development of skin reactions. The highest risk of developing SJS and TEN is during the first weeks of treatment.
If clinical manifestations or symptoms of SJS and TEN appear (for example, progressive skin rash, often with blisters or lesions of the mucous membrane), treatment with Sulfasalazine-EN should be discontinued.
The best results in the treatment of SJS and TEN are achieved with early diagnosis and immediate discontinuation of any suspicious drug. Early discontinuation of the drug is associated with a better prognosis.
If a patient develops SJS or TEN while using the drug Sulfasalazine-EN, sulfasalazine therapy in this patient cannot be resumed.
Impact on laboratory results
In patients exposed to sulfasalazine or its metabolites (mesalamine/mesalazine), there have been several reports of possible false-positive urinary normetanephrine liquid chromatography results.
Sulfasalazine or its metabolites may affect the absorption of ultraviolet radiation, especially at a wavelength of 340 nm, as well as the results of some laboratory tests using dihydronicotinamide adenine dinucleotide (NADH) or dihydronicotinamide adenine dinucleotide phosphate (NADPH) to measure the absorption of ultraviolet radiation at this wavelength.
Examples of such examinations may include: determination of serum concentrations of urea, ammonia, lactate dehydrogenase (LDH), α-hydroxybutyrate dehydrogenase and glucose. When using sulfasalazine in high doses, changes in the results of determining serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muscle/brain (CK-MB), glutamate dehydrogenase or serum thyroxine concentration may be possible.
Consult with your diagnostic laboratory regarding the laboratory testing technique to be used.
Caution should be used when interpreting these results in patients taking sulfasalazine.
Results should be interpreted in conjunction with clinical data.
Sulfasalazine-en tablet p/o intestinal dissolved film 500 mg 50 pcs
A complete clinical blood count, including white blood cell count, red blood cell and platelet counts, and biochemical liver function tests should be performed before starting sulfasalazine and every other week for the first three months of therapy. Over the next three months, the same laboratory tests should be performed monthly, then once every three months and in accordance with clinical indications. Assessment of renal function (including urinalysis) should be performed in all patients before starting therapy and at least monthly during the first three months of treatment. Thereafter, monitoring should be performed as clinically indicated. The presence of clinical signs such as sore throat, fever, pale skin, purpura or jaundice during sulfasalazine therapy may indicate myelosuppression, hemolysis or hepatotoxicity. Treatment with sulfasalazine should be discontinued until results of blood tests are available (see subsection “Effects on laboratory results”). Sulfasalazine is recommended to be prescribed with caution to patients with systemic forms of juvenile rheumatoid arthritis, since there is a risk of developing undesirable effects, including serum sickness (fever, nausea, vomiting, headache, skin rash and liver dysfunction).
Life-threatening skin reactions: SSD and TEN have been reported during the use of the drug Sulfasalazine-EN. Patients should be alerted to clinical signs and symptoms and should be closely monitored for the development of skin reactions. The highest risk of developing SJS and TEN is during the first weeks of treatment. If clinical manifestations or symptoms of SJS and TEN appear (for example, progressive skin rash, often with blisters or lesions of the mucous membrane), treatment with Sulfasalazine-EN should be discontinued. The best results in the treatment of SJS and TEN are achieved with early diagnosis and immediate discontinuation of any suspicious drug. Early discontinuation of the drug is associated with a better prognosis. If a patient develops SJS or TEN while using the drug Sulfasalazine-EN, sulfasalazine therapy in this patient cannot be resumed.
Effect on laboratory results: In patients exposed to sulfasalazine or its metabolites (mesalamine/mesalazine), there have been several reports of possible false-positive test results when determining normetanephrine in urine by liquid chromatography. Sulfasalazine or its metabolites may interfere with ultraviolet absorption, particularly at 340 nm, as well as with some laboratory tests using dihydronicotinamide adenine dinucleotide (NADH) or dihydronicotinamide adenine dinucleotide phosphate (NADPH) to measure ultraviolet absorption at this wavelength. Examples of such examinations may include: determination of serum concentrations of urea, ammonia, lactate dehydrogenase (LDH), alpha-hydroxybutyrate dehydrogenase and glucose. When using sulfasalazine in high doses, it is possible to change the results of determining serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muscle/brain (CK-MB), glutamate dehydrogenase or serum thyroxine concentration. Consult with your diagnostic laboratory regarding the laboratory testing technique to be used. Caution should be used when interpreting these results in patients taking sulfasalazine. Results should be interpreted in conjunction with clinical data.
Impact on driving vehicles and machinery Care must be taken when driving vehicles and working with complex technical devices due to the possibility of dizziness.
Sulfasalazine
Sulfasalazine is an anti-inflammatory and antibacterial agent used in gastroenterology and rheumatology. Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) are a pressing problem in gastroenterological practice. However, despite certain successes in the development of new methods for diagnosing and treating these diseases, there is still a lack of knowledge in the field of the etiology of the development of inflammatory processes in the intestine. Thus, one of the issues facing scientists that needs to be addressed is increasing the effectiveness of already known drugs. The principle “the new is the well-forgotten old,” as it turns out, also works in relation to pharmacology. Sulfasalazine is far from new on the pharmaceutical front: it has been used for more than 50 years. This drug was synthesized by linking two substances with a nitrogen group: aminosalicylic acid and sulfapyridine. The pharmacological effect of the drug is based on the properties of both of its structural components. Salicylic acid with an amino group in position 5 has anti-inflammatory activity, inhibits the synthesis of inflammatory mediators prostaglandins and neutralizes the effect of cyclooxygenase. Sulfapyridine, in turn, has an antibacterial (bacteriostatic) effect aimed at streptococci, gonococci, diplococci and Escherichia coli. After taking sulfasalazine tablets, approximately 25% of the dose is absorbed in the upper gastrointestinal tract, and due to the portal-biliary circulation of bile acids, more than half of this amount is subsequently returned to the intestine.
As a result, about 90% of the drug enters the colon, which should be considered a very high figure. Clinical trials of sulfasalazine showed the effectiveness of the drug in treating mild and moderate forms of ulcerative colitis (improvement was observed in 64-80% of patients, with a 30% improvement when taking placebo). The same studies demonstrated a dose-dependence of the effect of sulfasalazine, with increasing doses often associated with an increased risk of certain adverse reactions.
Another area of application of sulfasalazine is the treatment of rheumatoid arthritis. This is one of the most common chronic joint diseases, which is based on the inflammatory process. In recent years, the capabilities of rheumatologists in the fight against this disabling disease have increased, incl. thanks to the emergence of new drugs. From this point of view, sulfasalazine can be considered as a “new old” drug with antirheumatic activity again proven in the 80s. The positive effect of this drug is associated with its ability to influence the microflora of the large intestine. Clinical studies have shown 63% success in treating patients with the articular form of rheumatoid arthritis after a year of taking the drug.
Sulfasalazine is available only in tablet form. The drug should be taken after meals. The dose and frequency of administration are determined by the attending physician.
