Pharmacy No. 84. Delivery of medicines to your home and office.

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Sulfasalazin

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 the results of blood tests are obtained (see section "Special Instructions", subsection "Influence on laboratory results").

Life-threatening skin reactions: SSD and TEN have been reported with the use of the drug Sulfasalazine. 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 occur (eg, progressive skin rash, often with blistering or mucosal involvement), treatment with Sulfasalazine 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 taking Sulfasalazine, sulfasalazine therapy should not be restarted in that patient.

Impact on laboratory results

In patients exposed to sulfasalasia or its metabolite (mesalamine/mesalazine), there have been several reports of possible false-positive urinary normeganephrine liquid chromatography results.

Sulfasalazine or its metabolites may interfere with ultraviolet absorption, especially 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 tests may include: determination of concentrations of urea, ammonia, lactate dehydrogenase (LDH), α-hydroxybutyrate dehydrogenase and glucose.

When using sulfasalazine in high doses, changes in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muscle/brain (CK-MB), glutamate dehydrogenase, or serum thyroxine concentrations may occur.

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

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.

Sulfasalazine 500 mg No. 50 tablets

Trade name: Sulfasalazine International nonproprietary name: Sulfasalazine Dosage form: Film-coated tablets 500 mg Composition: One tablet contains the active substance - sulfasalazine, povidone-coated 535 mg, equivalent to sulfasalazine 500 mg, excipients: pregelatinized starch, magnesium stearate, silicon dioxide colloidal anhydrous, film shell: hypromellose, propylene glycol. Description: Round, biconvex tablets with a bevel, brownish-yellow in color, coated with a colorless film coating. Pharmacotherapeutic group: Aminosalicylic acid and similar drugs.

Pharmacokinetics After taking the drug, 30% of sulfasalazine is absorbed in the small intestine, the remaining 70% is broken down by intestinal flora in the colon to sulfapyridine and 5-aminosalicylic acid. Differences in the maximum concentrations of sulfasalazine and its metabolites in the blood serum from different patients vary significantly: in patients in whom the acetylation process is slow, the concentration of metabolites is increased and this causes a more frequent occurrence of undesirable effects. Sulfasalazine binds well to plasma proteins and connective tissue. A significant part of the absorbed sulfasalazine returns to the intestinal lumen with bile, a small part is excreted unchanged in the urine. Metabolized in the liver by acetylation, oxidation and binding to glucuronic acid. A significant part of the released sulfapyridine is absorbed and reaches maximum concentration in the blood serum 12-24 hours after taking the drug. It is metabolized in the liver and excreted as metabolites by the kidneys. The half-life ranges from 6 to 14 hours and depends on the rate of acetylation. Only about 30% of 5-aminosalicylic acid is absorbed into the blood, acetylated in the liver and excreted by the kidneys. The remaining part is excreted unchanged in the feces.

Pharmacodynamics Sulfasalazine has immunosuppressive, anti-inflammatory and antibacterial effects. Its effect is mainly due to the action of its two active metabolites, acting both locally and systemically. Sulfapyridine inhibits the action of natural killer cells and the transformation of lymphocytes. The anti-inflammatory effect of 5-aminosalicylic acid is most important for the treatment of inflammatory bowel diseases, since it inhibits cyclooxygenase and lipoxygenase in the intestinal wall, which prevents the formation of prostaglandins, leukotrienes and other inflammatory mediators. There is also the possibility of binding free oxygen radicals. Sulfasalazine does not have an analgesic effect. Indications for use: Crohn's disease, ulcerative colitis and proctitis (treatment and prevention of relapses), rheumatoid arthritis and juvenile arthritis. Directions for use and dosage: Take the tablets whole, without breaking or chewing, with a glass of water during meals. If a dose of the drug is missed, then take only one dose at the next dose. Crohn's disease, ulcerative colitis and proctitis. For adults and adolescents over 16 years of age, on the 1st day, 500 mg (1 tablet) 4 times a day; on the 2nd day, 1 g (2 tablets) 4 times a day; on the 3rd and subsequent days, 1.5-2 g (3-4 tablets) 4 times a day. Children from 10 to 16 years old and/or with a body weight of 35-50 kg are prescribed 500 mg 4 times a day. For children from 6 to 10 years old, the recommended dose is 40-60 mg of sulfasalazine per kilogram of body weight per day. Prevention of relapses of ulcerative colitis and proctitis. After the acute clinical symptoms of ulcerative colitis have subsided, adults and adolescents and/or those weighing more than 65 kg are prescribed a maintenance dose of 500 mg 3-4 times a day for several months. Maintenance therapy for children and adolescents under 16 years of age and/or weighing less than 65 kg is not recommended. Rheumatoid arthritis and juvenile arthritis not responding to non-steroidal anti-inflammatory drugs. Adults and children over 16 years of age: during the first week - 500 mg 1 time per day, during the second - 500 mg 2 times per day, during the third - 500 mg 3 times per day, etc. The therapeutic dose can be 1.5-3 g per day. The clinical effect appears after 6-10 weeks of therapy. The course of treatment is 6 months or more. Children from 6 to 8 years old and/or with a body weight of 20-29 kg: 500 mg 2 times a day. Children from 8 to 12 years old and/or with a body weight of 30-39 kg: 500 mg 2-3 times a day. Children from 12 to 16 years old and/or with a body weight of 40-50 kg: 500 mg 3 times a day or 1 g 2 times a day. Children over 16 years old and/or weighing more than 50 kg: 1 g 2 times a day. The maximum daily dose for children is 2 g or 40-50 mg/kg body weight. Side effects: Side effects are associated mainly with high concentrations of sulfapyridine in the blood, especially in patients with slow metabolism (slow acetylation), in patients with rheumatoid arthritis: Often (? 1/100 to - leukopenia, neutropenia, macrocytosis - headache pain - nausea, vomiting - anorexia Uncommon (? 1/1000 to - increased levels of amylase and bilirubin, alkaline phosphatase and liver transaminases - megaloblastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenia - tinnitus - diarrhea, stomatitis, mumps - exacerbation of porphyria - depression, insomnia - reversible oligospermia, reversible male infertility Rarely (? 1/10,000 to - peripheral neuropathy, dizziness, convulsions, ataxia, hallucinations, seizures - pancreatitis - pulmonary infiltrate, shortness of breath, cough - nephrotic syndrome, hematuria, proteinuria, crystalluria - hepatitis, orange-yellow staining of urine, skin or soft contact lenses Very rare ( - aplastic anemia, including hemolytic anemia with Heinz-Ehrlich bodies, methemoglobinemia, eosinophilia - hypoprothrombinemia - enlarged lymph nodes - aseptic meningitis - fibrosing alveolitis - toxic epidermal necrolysis, Stevens-Johnson syndrome, serum sickness, skin rash, exanthema multiforme, exfoliative dermatitis, photosensitivity reactions, drug fever, periorbital edema, nodular arteritis of the sclera and conjunctiva or cornea, urticaria, itching and hyperemia of the skin Contraindications : - hypersensitivity to sulfonamide , salicylic acid esters or any of the components of the drug - liver and/or renal failure - porphyria - granulocytopenia, anemia - lactation period - congenital deficiency of glucose-6-phosphate dehydrogenase - children under 6 years of age Drug interactions: Sulfasalazine reduces the absorption of folic acid and digoxin. Sulfasalazine enhances the effect of anticoagulants and oral hypoglycemic agents (sulfonylurea derivatives), antiepileptic drugs, as well as the side effects of cytostatics, immunosuppressants, hepato- and nephrotoxic drugs. Concomitant use with drugs that inhibit bone marrow hematopoiesis increases the risk of myelosuppression. Antibiotics may reduce the effectiveness of Sulfasalazine. Sulfasalazine can be used concomitantly with corticosteroids and metronidazole. Special instructions: Sulfasalazine should be prescribed with caution to patients with impaired renal and liver function, bronchial asthma, allergies and glucose-6-phosphate dehydrogenase deficiency. Before starting treatment (before taking sulfasalazine) and during treatment with sulfasalazine (monthly for the first two months and subsequently every 3-6 months), it is necessary to conduct a blood test (monitoring the level of liver enzymes, complete blood count). Patients with renal failure should undergo a general urinalysis. Patients should be well hydrated during treatment. Possible cross-hypersensitivity with furosemide, thiazide diuretics, sulfonylurea derivatives, carbonic anhydrase inhibitors. The drug is not recommended for systemic forms of juvenile rheumatoid arthritis, as it often causes an undesirable phenomenon resembling serum sickness. Typical symptoms of this condition are fever, nausea, vomiting, headache, rash, and deterioration of liver function. Pregnancy and lactation. Prescribing the drug to pregnant women is possible only according to strict indications and in the minimum effective dose. Taking the drug in the last trimester of pregnancy should be discontinued. Breastfeeding is not recommended during treatment with sulfasalazine. Peculiarities of the drug's effect on the ability to drive a vehicle or potentially dangerous machinery. No negative effects of sulfasalazine on the ability to drive a vehicle or potentially dangerous machinery have been reported. However, caution should be exercised when performing activities that require concentration. Overdose: Symptoms: nausea, vomiting and abdominal pain. When taking the drug in very large doses - anuria, crystalluria and signs of intoxication of the central nervous system (convulsions). Toxicity is proportional to the serum concentration of sulfapyridine. Treatment: induction of vomiting, gastric lavage, intestinal cleansing, forced diuresis, alkalization of urine, symptomatic therapy. In case of anuria and/or renal failure, fluid and electrolyte intake should be limited. The effectiveness of measures taken can be monitored by determining the concentration of sulfapyridine in the blood serum. Release form and packaging: 10 tablets are placed in a blister pack made of polyvinyl chloride film and aluminum foil. 5 blister packs together with instructions for use in the state and Russian languages are placed in a cardboard pack. Storage conditions: Store at a temperature not exceeding 25°C. Store in original packaging. Keep out of the reach of children! Shelf life: 5 years. Do not use after expiration of shelf life Conditions for dispensing from pharmacies: By prescription