Salofalc, rectal dosed foam 1 g/application 14 pcs

Salofalc – anti-inflammatory.

Pharmacodynamics

It has a local anti-inflammatory effect due to inhibition of cyclooxygenase and synthesis of PG and leukotrienes. It inhibits migration, degranulation, phagocytosis of neutrophils as well as immunoglobulin secretion by lymphocytes. It has an antioxidant effect (due to the ability to bind with free oxygen radicals and destroy them).

Mesalazine can also trap radicals formed from reactive oxygen compounds. Results obtained in in vitro studies indicate a possible role of lipooxygenase inhibition.

The effect on the GH content in the intestinal mucosa has also been shown. When administered orally, mesalazine has predominantly local effects in the intestinal mucosa and submucosa layer, acting on the intestinal lumen side.

It is therefore important that mesalazine is accessible to the area of inflammation. The ratio of systemic bioavailability to plasma concentration of mesalazine is not significant in terms of therapeutic efficacy, but rather serves as a factor influencing safety.

The fact that Salofolk granules are resistant to gastric juice and are characterized by pH-dependent (due to Eudragit L coating) and delayed (due to matrix structure of the granules) release of mesalazine helps ensure that the active ingredient is released at the desired location.

Indications

An exacerbation of distal forms of moderate to mild ulcerative colitis; maintenance of remission of distal forms of ulcerative colitis (long-term therapy).

Active ingredient

Composition

1 application contains:

Active substance:

mesalazine1 g;

Associates:

Propylene glycol – 3.4364 g;

sodium disulfite – 0,05 g;

Polysorbate 60 – 0,0364 g;

Dinatrium edetate – 0.0136 g;

Cetoasteryl alcohol – 00091 g;

Propellant (propane 7%,/isobutane 88%/butane 5% at 2.5 bar) – 0.176 g.

How to take, the dosage

Unless otherwise prescribed by a physician, in adults and children over 12 years of age the drug is usually administered once a day before bedtime (1 dose corresponds to 2 applications/pressures). If it is difficult to retain this amount of foam in the colon, the drug should be administered in two steps: 1 time at night, and 1 more time at night or early in the morning (after defecation).

Injection after bowel movement (defecation) is recommended for best results.

At the time of administration Salofalk rectal foam must be at room temperature (20-25 °C).

If you are admitted to the hospital or consult with other doctors, you should tell them about the use of this medication.

Therapeutic effect is achieved with regular use of Salofalc rectal foam.

The duration of the course of treatment is chosen by the doctor individually.

As a rule, an exacerbation of mild forms of ulcerative colitis can be stopped within 4-6 weeks. After this period, it is recommended to visit the attending physician to decide on the prescription of oral form of mesalazine for maintenance therapy.

Interaction

When concomitant administration may increase the effect of coumarin anticoagulants, increased toxicity of methotrexate, decreased diuretic effect of spironolactone and furosemide, decreased effectiveness of probenecid and rifampicin.

It increases hypoglycemic effect of oral antidiabetic agents – sulfonylurea derivatives.

Special Instructions

Salofalc is recommended to be used only under the supervision of a doctor.

Blood and urine tests should be performed before treatment, during therapy (14 days after the start of therapy and then every 4 weeks), and after the end of therapy (every 3 months).

In order to control kidney function it is recommended to determine serum urea and creatinine levels, urine sediment examination.

Contraindications

With caution: pregnancy (1st trimester), mild to moderate renal/liver failure, lung diseases (especially bronchial asthma).

Side effects

Gastrointestinal disorders: diarrhea, nausea, abdominal pain, flatulence, loss of appetite, vomiting, increased level of liver enzymes in blood, hepatitis.

CNS disorders: headache, depression, dizziness, sleep disturbance, malaise, paresthesias, seizures, tremors, tinnitus.

Reactions associated with hypersensitivity: skin rash, itching, erythema, fever, bronchospasm, pericarditis and myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome.

In isolated cases of allergic alveolitis and pancolitis have been observed. Under certain conditions, mesalazine and drugs with a similar chemical structure may lead to the development of a syndrome similar to systemic lupus erythematosus.

Other side effects: rarely – tachycardia, arterial hypertension or hypotension, pain behind the chest, shortness of breath; myalgia, arthralgia. In individual cases proteinuria, hematuria, crystalluria, oliguria, anuria; anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia; decreased tear fluid production, alopecia.

Overdose

Symptoms: nausea, vomiting, weakness, drowsiness.

Treatment: symptomatic therapy.

Pregnancy use

In case of pregnancy, suspected pregnancy, pregnancy planning, breastfeeding, consult the attending physician. The drug should not be used in the last 4 weeks of pregnancy.

Salofolk may be used during pregnancy only if the potential benefit to the mother exceeds the possible risk to the fetus.

You should not use rectal forms of the drug while breastfeeding – the active substance and its metabolites may penetrate into the breast milk. If it is necessary to prescribe Salofalk during lactation, the question of stopping breastfeeding should be decided.

Similarities