Composition
1 tablet contains the Active ingredient: sulfasalazine-500.0 mg
Pharmacological action
Sulfasalazine selectively accumulates in the connective tissue of the intestine with the release of 5-aminosalicylic acid (5-ASA), which has anti-inflammatory activity, and sulfapyridine, which has antimicrobial bacteriostatic activity.
Indications
* Ulcerative colitis (treatment of exacerbations and maintenance therapy in remission);• Crohn’s disease (mild to moderate forms in the acute phase); * Rheumatoid arthritis; juvenile rheumatoid arthritis when nonsteroidal anti-inflammatory drugs (NSAIDs) are ineffective.
Contraindications
* Hypersensitivity to sulfasalazine or other components of the drug, as well as sulfonamides or salicylates• * porphyria;• granulocytopenia;• aplastic anemia;• congenital glucose-6-phosphate dehydrogenase deficiency (risk of jaundice);• hepatic and / or renal insufficiency;• children under 10 years of age and/or weighing 35 kg or less, with chronic inflammatory bowel diseases (for this dosage form and dosage);• obstruction of the bowel or urinary tract;• children under 6 years of age with juvenile rheumatoid arthritis (efficacy and safety have not been established);• breast-feeding period.
Side effects
Nervous system disorders: Â headache, dizziness, tinnitus, ataxia, seizures, sleep disturbances, hallucinations, peripheral neuropathy.
From the urinary system: Â renal dysfunction, interstitial nephritis.
From the digestive system: Â nausea, vomiting, diarrhea, abdominal pain, anorexia, hepatitis, pancreatitis.
Respiratory system disorders: Â interstitial pneumonitis and other lung tissue lesions.
From the hematopoietic system: Â anemia, leukopenia, thrombocytopenia, agranulocytosis.
From the side of the reproductive system: Â transient oligospermia, infertility.
Allergic reactions: Â skin rash, toxic epidermal necrolysis, malignant exudative erythema, fever, anaphylactic shock.
Other services: Â possible yellow staining of the skin, urine, soft contact lenses.
Interaction
Increases the effect of anticoagulants, antiepileptic and oral hypoglycemic drugs, as well as the side effects of cytostatics, immunosuppressants, hepatotoxic and nephrotoxic drugs.
Concomitant use with sulfasalazine increases the toxicity of azathioprine and mercaptopurine.
When used concomitantly with ampicillin or rifampicin, the release of 5-aminosalicylic acid from the sulfasalazine molecule in the colon decreases (due to the suppression of the activity of anaerobic bacteria under the influence of ampicillin and rifampicin, with the participation of which this process occurs). In this regard, it is possible to reduce the effectiveness of sulfasalazine. It is believed that the interaction of sulfasalazine with neomycin is manifested in the same way.
When used concomitantly with digoxin, its absorption may decrease; with talinolol, talinolol absorption decreases; with folic acid, folic acid absorption may decrease.
How to take, course of use and dosage
Inside, after a meal. Ulcerative colitis, Crohn’s disease. Adults and children over 16 years of age: on the 1st day-500 mg 4 times a day; on the 2nd-1 g 4 times a day; on the 3rd and subsequent days-1.5-2 g 4 times a day. After the acute clinical symptoms of ulcerative colitis subside, adults and adolescents and/or weighing more than 65 kg are prescribed a maintenance dose of 500 mg 3 to 4 times a day for several months. Children from 10 to 16 years of age and / or body weight from 35 to 50 kg – 500 mg 4 times a day. Maintenance therapy for children and adolescents under 16 years of age and / or weighing less than 65 kg is not recommended. The maximum daily dose for adults is 8 g, for children under 16 years of age — 2 g. Rheumatoid arthritis and juvenile rheumatoid arthritis for Adults and children over 16 years of age: during the first week — 500 mg 1 time a day, during the second-500 mg 2 times a day, the third and further-500 mg 3 times a day. The therapeutic dose may range from 1.5 to 3 g / day. The clinical effect manifests itself after 6-10 weeks of therapy. The course of treatment is 6 months or more. Children aged 6 to 8 years and / or weighing 20-29 kg: 1 table. 2 times a day; Children from 8 to 12 years and / or weighing 30-39 kg: 1 table 2-3 times a day; Children from 12 to 16 years and / or weighing 40-50 kg: 1 table 3 times a day or 2 tables. 2 times a day; Children over 16 years of age and / or weighing more than 50 kg: 2 tables. 2 times a day. The maximum daily dose for children is 2 g or 40-50 mg / kg of body weight.
Special instructions
Use with caution in patients with impaired liver and/or kidney function, patients with bronchial asthma, allergic reactions.
During the treatment period, it is recommended to use an increased amount of fluid.
During treatment, the level of liver enzymes, a general blood and urine test should be monitored.
Active ingredient
Sulfasalazine
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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