Salofalk

General characteristics. Structure:

Active agent: месалазин - 250 mg, 500 mg.

Excipients: sodium a carbonate — 110/110 mg; MKTs — 50/50 mg; povidone — 10/20 mg; a kroskarmelloza — 0/15 mg; glycine — 10/10 mg; silicon dioxide colloid — 5/5 mg; calcium stearate — 5/5 mg;

cover:  methacrylic acid and methacrylate copolymer 1:1 — 42,82/90,468 mg; talc — 10.2/19,824 mg; a macrogoal — 4,98/9,372 mg; titanium dioxide — 1,2/2,52 mg; a gipromelloza — 2/1,9 mg; dye ferrous oxide yellow (E172, CFR21) — 0,6/1,092 mg; butylmethacrylate — 0,9/0,4 mg.

Pharmacological properties:

Pharmacodynamics.

Possesses antiinflammatory action. Inhibits synthesis of metabolites of arachidonic acid (PG), activity of a neutrophylic lipoxygenase, slows down migration, degranulation and phagocytosis of neutrophils, secretion of immunoglobulins lymphocytes; connects and destroys free radicals of oxygen.

Pharmacokinetics.

Release of a mesalazin happens in terminal department thin and in a large intestine. Tablets begin to be dissolved in a small bowel in 110–170 min. and are completely dissolved 165–225 min. later after reception. The speed of dissolution is not influenced by changes рН the Wednesdays caused meal or other drugs. It is metabolized in N-acetyl-5-aminosalicylic acid already in a mucous membrane of intestines and a liver therefore concentration in plasma rather low (after reception of 250 mg — 0,5–1,5 mkg/ml). Contacts proteins of plasma for 43% (a metabolite — for 75–83%). 0,1% of a dose get into maternal milk (in the form of a metabolite).

Indications to use:

- nonspecific ulcer colitis;

- disease Krone (prevention, treatment of aggravations).

Route of administration and doses:

Drug is used strictly on doctor's orders.

Inside, entirely, without chewing, after food, washing down with a large amount of water.

The adult — on 500 mg (2 tab. on 250 mg or 1 tab. on 500 mg) 3 times a day. At severe forms of a disease the dose can be increased to 3–4 g/days for the term of 8–12 weeks.

For prevention of a recurrence drug is appointed on 500 mg (2 tab. on 250 mg or 1 tab. on 500 mg) by 3 times a day, if necessary, within several years.

To children. At body weight to 40 kg appoint a half of a daily dose for adults (1 tab. of 250 mg 3 times a day), more than 40 kg — a daily dose for adults (2 tab. on 250 mg or 1 tab. on 500 mg) 3 times a day.

For prevention of a recurrence drug is appointed on 250 mg by 3 times a day, in need of a current of several years.

At distal forms of nonspecific ulcer colitis preferably rectal administration of drug in the form of suppositories or enemas.

Features of use:

Reasonablly regular performing the general blood test (before the beginning, in time, and also after treatment) and urine, control of secretory function of kidneys. Patients, being "slow acetylizers", have the increased risk of development of side effects. Coloring of urine and tears in yellow-orange color, a prokrashivaniye of soft contact lenses can be observed. If several doses are passed, follow, without stopping treatment, to see a doctor.

Influence on ability to drive the car or to perform the works demanding the increased speed of physical and mental reactions. Any influence of administration of drug on ability to control of vehicles or to use of mechanisms was not noted.

Side effects:

From a GIT: diarrhea, nausea, abdominal pains, a meteorism, appetite loss, vomiting, increase in level of liver enzymes in blood, hepatitis.

From TsNS: headache, depression, dizziness, sleep disorder, indisposition, paresthesias, spasms, tremor, sonitus.

The reactions connected with hypersensitivity: skin rash, itch, erythema, fever, bronchospasm, pericardis and myocarditis, acute pancreatitis, intersticial nephrite, nephrotic syndrome. Separate cases of an allergic alveolitis and pan-colitis were observed. Under certain conditions месалазин and the drugs having similar chemical structure can lead to development of a syndrome similar to a syndrome of a system lupus erythematosus.

Other side effects: seldom — tachycardia, arterial hypertension or hypotension, pains behind a breast, an asthma; mialgiya, arthralgias. The proteinuria, a hamaturia, a crystalluria, an oliguria, an anury were in some cases observed; anemia, leukopenia, agranulocytosis, thrombocytopenia, prothrombinopenia; reduction of products of the lacrimal liquid, alopecia.

Taking into account chemical structure of the operating component it is impossible to exclude a possibility of increase in level of a methemoglobin.

At emergence of acute signs of intolerance treatment needs to be stopped immediately.

Interaction with other medicines:

Causes strengthening of effect of anticoagulants, hypoglycemic action of derivatives of sulphonylurea; increases toxicity of a methotrexate, strengthens the damaging action of GKS on a mucous membrane of a stomach, reduces tuberculostatic effect of rifampicin, uricosuric action of a probenetsid and Sulfinpyrazonum, diuretic effect of Spironolactonum and furosemide.

Contraindications:

- hypersensitivity to salicylic acid and its derivatives;

- the expressed abnormal liver functions and/or kidneys;

- peptic ulcer of a stomach and duodenum;

- hemorrhagic diathesis (with bent to bleedings);

- children's age (up to 3 years).

With care appoint Salofalk sick with disturbance of secretory function of kidneys, breath dysfunction (especially to patients with bronchial asthma), at deficit glyukozo-6-fosfatdegidrogenazy (insignificant risk of hemolysis at the recommended dosage), the patient with hypersensitivity to Sulfasalazinum.

Overdose:

Cases of overdose are not revealed. In case of overdose carry out a symptomatic treatment.

Storage conditions:

In the place protected from light, at a temperature not above 25 °C.

To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

The tablets covered with a kishechnorastvorimy film cover, 250, 500 mg. According to 10 tab. in the aluminum/PVC/PVDH blister; on 5 or 10 blisters in a pack cardboard.