Expiration date: 05/2026
Description pharmaceutical form:
Suppositories: torpedo, from white to cream colored, smooth, intact, smooth surface.
Rectal suspension: grayish to light brown color with a characteristic odor.
Pharmacokinetics:
The release of mesalazine occurs in the rectum and colon. Already metabolized in the intestinal mucosa and liver to N-acetyl-5-ASA, therefore the concentration in plasma is relatively low (after a single injection of 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 in acute phase (involving the rectum and left colon).
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 2 years).
Caution: patients with violation excretory function of the kidneys, impaired breathing (especially asthma patients), patients with hypersensitivity to sulfasalazine.
To suppositories in addition:
Be wary appoint salofalk worth us patients with a deficit glukozo-6-fosfatdegidrogenaza.
Application of pregnancy and breast-feeding:
In the first trimester of pregnancy the drug is possible only under strict indications. If allows individual course of the disease in the last 2-4 weeks of pregnancy the drug should be discontinued.
At the time of treatment should stop 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 suppositories for advanced — 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, weakness, chest pain, shortness of breath, myalgia, arthralgia. In some cases, proteinuria, hematuria, crystalluria, oliguria, anuria, anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia reduction of slezna liquid suppositories for advanced — 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:
Rectal.
Suppositories
Adults. 2 supp. 250 mg or 1 supp. 500 mg 3 times a day. In severe forms of the disease dose can be doubled.
With long-term maintenance treatment and relapse prevention — 1 supp. 250 mg 3 times a day.
Children. With a body weight of 40 kg is assigned to about half the dose recommended for adults (1 supp. 250 mg 3 times a day) with body weight over 40 kg — the usual dose for adults.
Suspension rectal
The contents of one reservoir is administered rectally 1 time per day before bedtime (it is recommended to pre-clean the intestines).
The daily dose is 30-50 mg/kg the Maximum daily dose is 3 g.
To prevent recurrence it is recommended that oral ingestion of Salofalk in pill form in the dose of 15-30 mg/kg/day. The daily dose should be divided into 2 doses.
Overdose:
Cases of overdose have not been identified. In case of overdose, symptomatic treatment.
