Salofalk (Pills)

Active material: Mesalazine
When ATH: A07EC02
CCF: The drug with anti-inflammatory action, used to treat Crohn's disease and ulcerative colitis
ICD-10 codes (testimony): K50, K51
When CSF: 11.13.01
Manufacturer: Dr. FALK PHARMA GmbH (Germany)

Pharmaceutical form, composition and packaging

Pills, enteric-coated film-coated from light yellow to yellow-brown, round, lenticular.

Excipients: sodium carbonate, glycine, povidone, microcrystalline cellulose, colloidal silicon dioxide, calcium stearate, gipromelloza, a copolymer of methacrylic acid and methacrylate (1:1), diʙutilftalat, talc, Titanium dioxide, dye iron oxide yellow, macrogol, ʙutilmetakrilat.

10 PC. – blisters (5) – packs cardboard.
10 PC. – blisters (10) – packs cardboard.

Pills, enteric-coated film-coated from light yellow to yellow-brown, Oval, lenticular.

Excipients: sodium carbonate, glycine, povidone, microcrystalline cellulose, Croscarmellose sodium, colloidal silicon dioxide, calcium stearate, gipromelloza, a copolymer of methacrylic acid and methacrylate (1:1), diʙutilftalat, talc, Titanium dioxide, dye iron oxide yellow, macrogol, ʙutilmetakrilat.

10 PC. – blisters (5) – packs cardboard.
10 PC. – blisters (10) – packs cardboard.

Pharmacological action

The drug with anti-inflammatory action, used to treat Crohn's disease and ulcerative colitis. Anti-inflammatory effect. It inhibits the synthesis of metabolites of arachidonic acid (prostaglandins), Activity neutrophil lipoxygenase, inhibits migration, neutrophil degranulation and phagocytosis, secretion of immunoglobulin by lymphocytes; It binds and destroys free oxygen radicals.

Pharmacokinetics

Absorption

Mesalazine release occurs in the terminal part of the small and large intestine. Tablet begin to dissolve in the small intestine through 110-170 min and fully dissolved after 165-225 minutes after administration. The rate of dissolution is not affected by changes in pH, caused by the intake of food or other drugs.

Metabolism

It is metabolized in the N-acetyl-5-aminosalicylic acid in the intestinal mucosa and liver, therefore, the plasma concentration is relatively low (after administration 250 mg – 0.5-1.5 ug / ml). Plasma protein binding – 43% (metabolite – 75-83%). The mother's milk enters (It saw in the metabolite) 0.1% dose.

Testimony

- Nespetsificheskiy yazvennыy colitis (NYAK);

- Crohn's disease (prevention, treatment exacerbations).

Dosage regimen

The drug is prescribed inside adult by 500 mg 3 times / day. At severe forms of the disease the dose may be increased to 3-4 g / day for 8-12 weeks.

To relapse prevention the drug is prescribed for 500 mg 3 times / day, if necessary – for several years.

Children weighing up 40 kg appointed 1/2 Daily doses for adults – by 250 mg 3 times / day (should be used for tablets 250 mg), Children weighing more than 40 kg – by 500 mg 3 times / day.

To relapse prevention the drug is prescribed for 250 mg 3 times / day, if necessary – for several years.

Tablets should be taken as a whole, without chewing, after a meal and drink plenty of water. When distal forms of UC preferably rectal administration of the drug in the form of rectal suppositories or rectal suspension.

Side effect

From the digestive system: diarrhea, nausea, stomach ache, flatulence, loss of appetite, vomiting, increased liver enzymes in the blood, hepatitis.

CNS: headache, depression, dizziness, sleep disorders, malaise, paresthesia, convulsions, tremor, noise in ears.

Cardio-vascular system: rarely – tachycardia, hypertension or hypotension, chest pain, breathlessness.

On the part of the musculoskeletal system: mialgii, artralgii.

From the hematopoietic system: in some cases – anemia, leukopenia, agranulocytosis, thrombocytopenia.

From the blood coagulation system: in some cases – gipoprotrombinemii.

From the urinary system: in some cases – proteinuria, hematuria, kristallurija, oligurija, anurija.

Other: in some cases – decrease in production of tear fluid, alopecia.

Reaction, associated with hypersensitivity: skin rash, itch, эritema, fever, bronchospasm, perikardit, miokardit, acute pancreatitis, interstitial nephritis, nephrotic syndrome. There were isolated cases of allergic alveolitis and pankolita. Under certain circumstances, drugs and mesalazine, having a similar chemical structure, can lead to the syndrome, syndrome similar to systemic lupus erythematosus.

In view of the chemical structure of the active ingredient can not exclude the possibility of increasing the level of methemoglobin.

If you experience acute symptoms of intolerance to treatment must be stopped immediately.

Contraindications

- Severe hepatic impairment;

- Severe renal impairment;

- Gastric ulcer and duodenal ulcer;

- Gyemorragichyeskii diatyez (with a propensity to bleed);

- Children up to age 3 years;

- Hypersensitivity to salicylic acid and its derivatives.

FROM caution should be given Salofalk to patients with impaired renal excretory function, impaired breathing (especially in patients with bronchial asthma), in the definition, glucose-6-fosfatdegidrogenazы (negligible risk of hemolysis at the recommended dosage), patients with hypersensitivity to sulfasalazine.

Pregnancy and lactation

In the I trimester of pregnancy, use of the drug is possible only under strict indications. If you allow the disease, in the last 2-4 week of pregnancy the drug should be discontinued.

If necessary, the appointment of Salofalk lactation should decide the issue of termination of breastfeeding.

Before a planned pregnancy is recommended, possibly, salofalk discontinue treatment or use the drug in small doses.

Cautions

It is advisable regular blood count (before, during, and after treatment) and urine, monitoring of renal excretory function.

Sick, are “slow acetylators”, have an increased risk of side effects.

There may be discoloration of urine and tears in the yellow-orange color, staining of soft contact lenses.

If you miss a few doses, then, without stopping treatment, the patient should seek medical advice.

Overdose

No cases of overdose have been identified.

In case of overdose symptomatic treatment.

Drug Interactions

With simultaneous use of Salofalk cause potentiation of anticoagulation.

With simultaneous use of Salofalk enhances hypoglycemic effect of sulfonylureas.

With simultaneous use of Salofalk increases the toxicity of methotrexate.

With simultaneous use of Salofalk intensifies the damaging effect of corticosteroids on the gastric mucosa.

With simultaneous use of Salofalk reduces tuberculostatic effect of rifampicin.

With simultaneous use of Salofalk reduces the uricosuric action of probenecid and sulfinpirazona.

With simultaneous use of Salofalk reduces the diuretic effect of furosemide and spironolactone.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in the dark, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 3 year.