Expiration date: 11/2026
Description pharmaceutical form:
Tablets 250 mg: round, biconvex, film-coated from light-yellow to yellow-brown.
Tablets 500 mg: oval, biconvex, film-coated from light-yellow to yellow-brown.
Pharmacokinetics:
The release of mesalazine occurs in the terminal small intestine and in the colon. Pills begin to dissolve in the small intestine via 110-170 min, and completely dissolved after 165-225 min after administration. The dissolution rate is not affected by changes in pH caused by food intake or other drugs. Metabolised in N-acetyl-5-aminosalicylic acid already in the intestinal mucosa and liver, therefore the plasma concentration is relatively low (after administration of 250 mg — 0, 5-1, 5 µg/ml). Associated with the plasma protein by 43% (metabolite — 75-83%). The mother's milk penetrates (as metabolites) 0, 1% of the dose.
Description pharmacological action:
Has anti-inflammatory action. Inhibits the synthesis of metabolites of arachidonic acid (PG), the activity of neutrophil lipoxygenase, inhibits migration, degranulation and phagocytosis of neutrophils, the secretion of immunoglobulins by b lymphocytes binds and destroys free radicals of oxygen.
Indications:
ulcerative colitis (UC)
Crohn's disease (prevention, treatment of exacerbations).
Contraindications:
- hypersensitivity to salicylic acid and its derivatives
- expressed human liver and/or kidney
- ulcers disease stomach and duodenal ulcer in acute phase
- hemorrhagic diathesis (tendency to bleed)
- children's age (up to 3 years).
Be wary appoint salofalk worth us patients with violation excretory function of the kidneys, impaired breathing (especially asthma patients), the deficit glukozo-6-fosfatdegidrogenaza (slight risk of haemolysis at recommended doses), patients with hypersensitivity to sulfasalazine.
Application of pregnancy and breast-feeding:
In the first trimester of pregnancy the drug is possible only under strict indications. If you have the disease, in the last 2-4 weeks of pregnancy the drug should be discontinued.
If necessary, the appointment of Salofalk in the lactation period should solve the issue of termination of breastfeeding.
Before the planned pregnancy it is recommended to discontinue treatment with Salofalk or to use the drug in small doses.
Side effects:
Gastrointestinal: diarrhea, nausea, abdominal pain, flatulence, loss of appetite, vomiting, increase in liver enzymes in the blood, hepatitis.
CNS: headache, depression, dizziness, insomnia, malaise, paresthesia, seizures, tremor, tinnitus.
Reactions associated with hypersensitivity: skin rash, itching, erythema, fever, bronchospasm, pericarditis and myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome. Observed isolated cases of allergic alveolitis and pancolitis. Under certain conditions, mesalazine, and drugs with similar chemical structure, can lead to the development of a syndrome similar to the syndrome of systemic lupus erythematosus.
Other side effects: rarely — tachycardia, hypertension or hypotension, chest pain, shortness of breath, myalgia, arthralgia. In some cases, there were proteinuria, hematuria, crystalluria, oliguria, anuria, anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia reduction of slezna liquid, alopecia.
Given the chemical structure of the current component, we cannot exclude the possibility of increasing the level of methemoglobin.
In the event of acute signs of intolerance to treatment should be immediately discontinued.
Drug interactions:
Causes the increased action of anticoagulants, hypoglycemic action of sulfonylureas increases the toxicity of methotrexate, increases the damaging effects of corticosteroids on the gastric mucosa, reduce the tuberculostatic action of rifampicin, the uricosuric action of probenecid and sulfinpirazon, the diuretic effect of spironolactone and furosemide.
Method of application and dose:
The drug is used strictly on prescription.
Inside is not liquid, after eating, drinking plenty of water.
Adults — 500 mg (2 table. 250 mg or 1 tab. 500 mg) 3 times a day. In severe forms of the disease dose can be increased to 3-4 g/day for a period of 8-12 weeks.
Prevention of relapse the drug is administered at 500 mg (2 table. 250 mg or 1 tab. 500 mg) 3 times a day, if necessary, within a few years.
Children. Weighing up to 40 kg appoint half the daily adult dosage (1 tabl. 250 mg 3 times a day), more than 40 kg the daily dose for adults (2 table. 250 mg or 1 tab. 500 mg) 3 times a day.
For relapse prevention, are prescribed 250 mg 3 times a day, if necessary, within a few years.
In the distal forms of ulcerative colitis is preferably rectal administration of the drug in the form of suppositories or enemas.
Overdose:
Cases of overdose have not been identified. In case of overdose, symptomatic treatment.
Special instructions:
Appropriate regular holding of General blood analysis (before, during, and after treatment) and urine, control of excretory function of the kidneys. Patients who are "slow acetylators" have an increased risk of side effects. There may be urine staining and tears in the yellow-orange color, the painting of soft contact lenses. If you skipped several doses, it should not stop treatment and consult a doctor.
