mesalazane | Salofalk rectal suspension 4 g 60 ml 7 pcs.

Release form

Suspension rectal

Packing

7 pcs

Pharmacological action

Salofalk - anti-inflammatory.

Pharmacodynamics

It has a local anti-inflammatory effect due to inhibition of cyclooxygenase and the synthesis of PG and leukotrienes. Slows down migration, degranulation, phagocytosis of neutrophils, as well as the secretion of immunoglobulins by lymphocytes. It has an antioxidant effect (due to the ability to bind to free oxygen radicals and destroy them). Mesalazine can also trap radicals formed from reactive oxygen compounds.

Results from in vitro studies, indicate the possible role of inhibition of lipoxygenase. The effect on the content of GHG in the intestinal mucosa was also shown. When taken orally, mesalazine has a predominantly local effect in the intestinal mucosa and submucosal layer, acting from the side of the intestinal lumen.

Therefore, it is important that mesalazine is available in the area of ​​inflammation. The ratio of systemic bioavailability and plasma concentration of mesalazine is not significant in terms of therapeutic efficacy, but rather serves as a factor affecting safety. Ensuring the release of the active substance in the right place helps that Salofalk granules are resistant to gastric juice and are pH-dependent (due to the coating in the form of Eudrajit L) and slow (due to the matrix structure of the granules) release of mesalazine.

Indications

Exacerbation of distal forms of ulcerative colitis of moderate and mild severity maintaining remission of distal forms of ulcerative colitis (long-term therapy).

Contraindications

hypersensitivity to drug components and other salicylic acid derivatives

blood disease

gastric ulcer and duodenal ulcer

glucose-6-phosphate dehydrogenase deficient senile chronic disease

Precautions: pregnancy (I trimester), renal / hepatic insufficiency of mild to moderate severity, lung disease (especially bronchial asthma).

Use during pregnancy and lactation

In pregnancy, suspected pregnancy, planning a pregnancy, while breastfeeding, consult your doctor. The drug should not be used in the last 4 weeks of pregnancy.

Salofalk can be used during pregnancy only in cases where the potential benefit of its use to the mother outweighs the potential risk to the fetus.

When breast-feeding, rectal forms of the drug should not be used - the active substance and its metabolites can pass into breast milk. If necessary, the appointment of Salofalk during lactation should decide on the termination of breastfeeding.

Composition of

1 enema contains:

Active ingredient:

mesalazine 4 g 60 ml

Excipients:

purified water

potassium acetate

potassium disulfite

kamenan sodium srdl sodium srdl srdl srdl srdl srd

Dosage and administration

The contents of one reservoir are administered rectally 1 time per day at bedtime (previously it is recommended to clean the intestines).

The daily dose is 30–50 mg / kg. The maximum daily dose is 3 g.

For the prevention of relapse, oral administration of Salofalk in the form of tablets at a dose of 15-30 mg / kg / day is recommended. The daily dose should be divided into 2 doses.

Side effects of

From the gastrointestinal tract: diarrhea, nausea, abdominal pain, flatulence, loss of appetite, vomiting, increased levels of liver enzymes in the blood, hepatitis.

From the side of the central nervous system: headache, depression, dizziness, sleep disturbance, malaise, paresthesia, cramps, tremors, tinnitus.

Hypersensitivity reactions: skin rash, itching, erythema, fever, bronchospasm, pericarditis and myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome. Individual cases of allergic alveolitis and pancolitis have been observed. Under certain conditions, mesalazine and drugs that have a similar chemical structure can lead to the development of a syndrome similar to systemic lupus erythematosus syndrome.

Other side effects: rarely - tachycardia, arterial hypertension or hypotension, chest pain, shortness of breath myalgia, arthralgia. In some cases, there was observed proteinuria, hematuria, crystalluria, oliguria, anuria, anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia, a decrease in the production of lacrimal fluid, alopecia.

Overdose

Symptoms: nausea, vomiting, weakness, drowsiness.

Treatment: symptomatic therapy.

Storage conditions

In the dark place at a temperature of no higher than 25 РC.

Shelf suitability

3 Year

Deystvuyuschee substances

mesalazine

dosage form

Dosage

form rectal suspension

Dr. Falyk, Germany