Description
Latin name
Salofalk
Release form
Rectal foam
Packing
7-dose spray can.
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 a potential role for lipoxygenase inhibition. 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 to 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 dehydrogenous 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.
Dosage and administration
Unless otherwise prescribed by a doctor, in adults and children over 12 years of age, the drug is usually used once a day at bedtime (1 dose corresponds to 2 applications / pressures). If it is difficult to keep such a volume of foam in the gut, the drug should be administered in two stages: 1 time at night, and 1 more time at night or early in the morning (after defecation).
To achieve the best result, it is recommended that the drug be administered after bowel movement (bowel movement).
At the time of administration, Salofalk rectal foam should be at room temperature (20 25 ° C).
Fit the applicator firmly onto the cylinder head
Shake the cylinder for 20 s to mix its contents.
At first use, remove the protective tab from the base of the dosing head.
Turn the cap so that the semicircular cut-out on the safety ring is in line with the nozzle.
Place your index finger on the cap and turn the balloon upside down.
Insert the applicator into the rectum as deep as possible. It is best to put your foot on a chair or stool. In order to introduce the first part of the dose, press the cap all the way and slowly release. To enter the second part of the dose, press the cap again and slowly release. Wait 10-15 seconds, then slowly remove the applicator from the rectum.
After introducing the foam, remove the applicator and discard it, packing in a plastic bag. For each new dose of the drug, a new applicator should be used.
Wash hands after the procedure. You should try not to empty the intestines until the next morning.
If you are admitted to a hospital or consulted with other doctors, you should inform them about the use of this drug.
The therapeutic effect is achieved with regular use of the drug Salofalk rectal foam.
The duration of the course of treatment is selected individually by the doctor.
As a rule, 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 appointment of the oral form of mesalazine for maintenance therapy.
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.
Cases of allergic alveolitis and pancolitis have been observed. Under certain conditions, mesalazine and preparations having 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 ° C.
Shelf suitability
3 Year
Deystvuyuschee substances
mesalazane
pharmacy terms and conditions
Possible product names
SALOFALK1 / 14 SALOFALK 7 DOSE / FOAM RECTAL
Salofalk 1g / application foam rect. dosing 14 applications (7 doses) Balloon M
Salofalk 1g / application foam rect. dosing 14 applications (7 doses) Cylinder M / up to 06.15g /
SALOFALK FOAM RECTAL. DOS. 1G / APPLICATION 14 APPL. CYLINDER 1
Salofalk rectal foam 1000 mg, 7 doses
