Salofalk - instructions for use, analogs, reviews and release forms (rectal foam, rectal suppositories and supplements, 250 mg granules and 500 mg tablets) for chronic colitis in adults, children and pregnancy

In this article, you can read the instructions for using the drug Salofalk. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Salofalk in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Salofalk analogues in the presence of existing structural analogues.Use for the treatment of chronic colitis and Crohn's disease in adults, children, as well as in pregnancy and lactation.

Salofalk - anti-inflammatory intestinal. Has a local anti-inflammatory effect due to inhibition of neutrophilic lipoxygenase and the synthesis of prostaglandins and leukotrienes. Slows migration, degranulation, phagocytosis of neutrophils, as well as secretion of immunoglobulins by lymphocytes. Has antioxidant effects (due to the ability to bind to free oxygen radicals and destroy them). Mesalazine (the active substance of the preparation Salofalk) can also trap radicals formed from reactive oxygen compounds. The results obtained in the studies indicate the possible role of inhibition of lipoxygenase. The effect on the content of prostaglandins in the intestinal mucosa is also shown.

When administered orally, mesalazine exerts 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 mesalazine concentration in plasma is not significant in terms of therapeutic effectiveness, but rather serves as a factor affecting safety.

The fact that Salofalk's granules are resistant to gastric juice and characterized by a pH-dependent (due to a coating in the form of Eudrajit L) and delayed (due to the matrix structure of granules) release of mesalazine helps to release the active ingredient at the right place.

Composition

Mesalazine (5-ASA) + excipients.

Pharmacokinetics

The highest absorption of Salofalk occurs in the rectum and colon. Mesalazine undergoes presystemic metabolism in the intestinal mucosa and systemic metabolism in the liver with the formation of a pharmacologically inactive metabolite of N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). The nature of acetylation does not depend on the acetylating phenotype of the patient. To a small extent, acetylation can be carried out by the action of bacterial microflora of the colon. The connection with the plasma proteins of mesalazine and N-Ac-5-ASA is 43% and 78%, respectively.Mesalazine and its metabolite N-Ac-5-ASA are excreted through the intestine (main part> 90%), up to 7% of the kidneys (0.6% of the total dose is excreted in the form of mesalazine and up to 6.3% in the form of metabolite N-Ac-5 -ASK), the degree of excretion of the drug with bile is minimal.

Indications

• exacerbation of distal forms of ulcerative colitis of moderate and mild degrees of severity;
• maintenance of remission of distal ulcerative colitis (long-term therapy);
• ulcerative colitis (NJA) in the phase of exacerbation (with the involvement of the rectum and the left part of the colon);
• Crohn's disease (prevention, treatment of exacerbations).

Forms of release

Tablets and granules coated with 250 mg, 500 mg and 1000 mg.

Rectal rectal dosed 1 g.

Candles rectal 250 mg and 500 mg.

Rectal suspension 2 g and 4 g.

Instructions for use and how to use them

Pills

The drug is prescribed by adults for 500 mg 3 times a day. In severe forms of the disease, the dose can be increased to 3-4 g per day for 8-12 weeks.

To prevent recurrence, the drug is prescribed 500 mg 3 times a day, if necessary - for several years.

Children with a body weight of up to 40 kg are prescribed a 1/2 day dose for adults - 250 mg three times a day (250 mg tablets should be used), children with a body weight of more than 40 kg should take 500 mg 3 times a day.

For the prevention of recurrence, the drug is prescribed 250 mg 3 times a day, if necessary - for several years.

Tablets should be taken whole, not liquid, after eating and drink with a lot of water. In distal forms of NNC, rectal administration of the drug in the form of suppositories rectal or rectal suspension is preferred.

Granules

The dosing regimen for treating ulcerative colitis exacerbation depends on the clinical need and in each case is individual. Assign 1 packet of 500-1000 mg mesalazine 3 times a day or 3 packets 1 time per day (corresponding to 1.5-3.0 g mesalazine per day).

To maintain remission of ulcerative colitis, 500 mg (1 pack.) Of mesalazine are prescribed 3 times a day or 3 packets of 500 mg once a day (corresponding to 1.5 g of mesalazine per day).

Children older than 6 years and adolescents with an exacerbation of the disease, depending on its severity, mesalazine is prescribed in a dose of 30-50 mg / kg of body weight per day with the distribution of the daily dose for 3 doses or for 1 reception. To maintain remission, mesalazine is prescribed in a dose of 15-30 mg / kg of body weight per day, and the daily dose can be divided into 2 doses. Children with body weight up to 40 kg are usually recommended to appoint a half dose of adults, children with a body weight of more than 40 kg - a dose of adults.

Granules of Salofalk can not be chewed. The prescribed dose of Salofalk in granules should be taken in the morning, at lunch time and in the evening or the entire dose once in the morning. Granules Salofalk should be put on the tongue and swallowed, without chewing, squeezed a lot of liquid.

As in the treatment of exacerbation of the inflammatory process, and with prolonged use to maintain remission, granules should be taken regularly and consistently, which allows to achieve the desired therapeutic effect. Exacerbation of ulcerative colitis usually subsides in 8-12 weeks, after which the dose of mesalazine in most patients can be reduced to 1.5 g per day.

Rectal foam

The drug is applied rectally.

Adults and children over 12 years of age the drug is usually prescribed 1 time per day before bedtime (1 dose corresponds to 2 applications / strokes). If such a volume of foam is difficult for the patient to keep in the rectum, the drug should be administered in two stages: once a night, and once again - at night or early in the morning (after defecation).

To achieve the best result, it is recommended to administer the drug after bowel movement (defecation).

The duration of the course of treatment is selected by the doctor individually.As a rule, exacerbation of mild forms of ulcerative colitis can be stopped within 4-6 weeks. At the end of this period, the doctor decides on the appointment of mesalazine for oral administration as maintenance therapy.

The therapeutic effect is achieved with regular use of the drug.

Rules for the administration of the drug (how to use foam)

At the time of administration, it is necessary that the salofalk rectal foam preparation be at room temperature (20-25 ° C).

1. Attach the applicator tightly to the cylinder head.
2. Shake the can for 20 seconds to mix its contents.
3. For first use: remove the protective tab from the bottom of the dosing head.
4. Turn the cap so that the semi-circular cutout on the safety ring is aligned with the nozzle.
5. Place the index finger on the cap and turn the cylinder upside down.
6. Introduce the applicator into the rectum as deeply as possible. It is best to put your foot on a chair or a stool. In order to enter the first part of the dose / application of the drug, push the cap all the way to the stop and slowly release. To enter the second part of the dose / application of the drug, press the cap again and release slowly.Wait 10-15 seconds, then slowly remove the applicator from the rectum.
7. After the introduction of foam, remove the applicator and discard it, packed in a plastic bag. For each new dose of the drug, a new applicator should be used.
8. Wash hands after the procedure. The patient should not empty the intestines until the next morning.

Rectal Candles

Adults prescribe 1 suppository 500 mg or 2 suppositories 250 mg 3 times a day. In severe forms of the disease, the dose can be doubled.

With prolonged maintenance treatment and for the prevention of relapses - 1 suppository 250 mg 3 times a day.

Children with a body weight of up to 40 kg are prescribed a 1/2 day dose for adults - 1 suppository 250 mg 3 times a day, children weighing more than 40 kg - 1 suppository 500 mg or 2 suppositories 250 mg 3 times a day.

Rectal suspension

The contents of one vial are administered rectally 1 time per day before bedtime (it is recommended to clean the intestine first). The daily dose is 30-50 mg / kg body weight. The maximum daily dose is 3 g.

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

Side effect

• skin rash;
• itching;
• erythema;
• fever;
• bronchospasm;
• pericarditis;
• myocarditis;
• acute pancreatitis;
• interstitial nephritis;
• nephrotic syndrome;
• allergic alveolitis;
• diarrhea;
• nausea, vomiting;
• stomach ache;
• flatulence;
• jaundice and abdominal pain due to bile duct disorders;
• hepatitis;
• headache;
• dizziness;
• peripheral neuropathy;
• depression;
• sleep disorders;
• paresthesia;
• convulsions;
• tremor;
• noise in ears;
• tachycardia;
• arterial hypertension or hypotension;
• pain behind the sternum;
• dyspnea;
• myalgia;
• arthralgia;
• Anemia, leukopenia, agranulocytosis, thrombocytopenia;
• proteinuria;
• hematuria;
• oliguria;
• anuria;
• reduction of tear fluid production;
• alopecia;
• fever;
• reversible decrease in motility of spermatozoa.

Contraindications

• blood diseases;
• peptic ulcer of the stomach and duodenum;
• hemorrhagic diathesis (with a tendency to bleeding);
• severe renal insufficiency;
• severe hepatic impairment;
• deficiency of glucose-6-phosphate dehydrogenase;
• phenylketonuria (for granules);
• children under 3 years (for tablets);
• children under 6 years (for pellets);
• children's age to 2 years (suppositories and rectal suspension);
• hypersensitivity to the components of the drug and other derivatives of salicylic acid.

Application in pregnancy and lactation

In the first trimester of pregnancy, the prescription of the drug is possible only on strict indications. If the course of the disease allows, in the last 2-4 weeks of pregnancy the drug should be stopped.

In the 2nd and 3rd trimesters, Salofalk should be used only in cases where the potential benefit of therapy for the mother exceeds the possible risk to the fetus.

Salofalk in the form of granules can be used during breastfeeding only if the potential effect of its use on the mother exceeds the possible risk of adverse effects on the child. If a newborn breastfed has diarrhea, breastfeeding should be discontinued.

If it is necessary to prescribe Salofalk in the form of tablets during lactation, breastfeeding should be discontinued.

Before the planned pregnancy, it is recommended, if possible, to stop Salofalkom treatment or to apply the drug in reduced doses.

Use in children

The drug is contraindicated in children under the age of 3 years (tablets) and 6 years (for pellets).

Children with a body weight of up to 40 kg are prescribed 1/2 of the daily dose for adults - 250 mg 3 times a day, children with a body weight of more than 40 kg - 500 mg 3 times a day.

For the prevention of recurrence, the drug is prescribed 250 mg 3 times a day, if necessary - for several years.

The drug in candles and suspensions is contraindicated in children under 2 years of age.

Children weighing up to 40 kg the daily dose administered 1/2 adult - 1 suppository 250 mg 3 times daily, for children weighing more than 40 kg - 1 suppository 500 mg or 250 mg of 2 spark 3 times a day.

special instructions

Before the beginning of treatment, during, and after treatment, a general analysis of blood and urine is necessary.

Before and during the treatment, it is necessary to determine the parameters of the functional state of the liver (such as ALT or ACT activity) and monitor urinalysis (by dipping test strips). The control is recommended usually 14 days after the start of treatment, then 2-3 more times with an interval of 4 weeks. If the results of the tests are normal, control studies should be performed every 3 months.If additional symptoms appear, follow-up studies should be performed immediately.

Use with caution in patients with impaired liver function.

Purpose Salofalka is not recommended for patients with severe renal dysfunction. If renal dysfunction has developed during treatment, one should think about the nephrotoxic effect of mesalazine. During the treatment should monitor the function of the kidneys.

When Salofalk is prescribed to patients with lung diseases, in particular bronchial asthma, careful monitoring is necessary during the treatment.

Patients with a history of indication of adverse reactions when prescribing drugs containing Sulfasalazine are subject to close monitoring during the initial period of treatment with Salofalkom. If Salofalk treatment is associated with acute intolerance, such as convulsions, acute abdominal pain, fever, severe headache and rash, the drug should be discontinued immediately.

Patients who are "slow acetylators" have an increased risk of side effects.

There can be staining of urine and tears in a yellow-orange color, staining of soft contact lenses.

If multiple doses are missed, the patient should consult a doctor without discontinuing treatment.

When prescribing the drug for patients with phenylketonuria, it should be remembered that Salofalk in the pellets contains aspartame in doses equivalent to the following amount of phenylalanine: 0.56 mg (Salofalk granules 500 mg), 1.12 mg (Salofalk granules 1 g).

Impact on the ability to drive vehicles and manage mechanisms

Care should be taken when driving a vehicle and engaging in potentially dangerous activities that require increased concentration and speed of the psychomotor reaction.

Drug Interactions

With the simultaneous use of Salofalk causes an increase in the effect of anticoagulants of indirect action (increased risk of gastrointestinal bleeding).

With the simultaneous use of glucocorticosteroids (GCS) with Salofalkom may increase unwanted reactions from the mucous membrane of the stomach.

With the simultaneous use of Salofalk increases the toxicity of methotrexate.

With the simultaneous use of probenecid and sulfinpyrazone with Salofalkom, a reduction in the excretion of uric acid is possible.

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

At simultaneous application with Salofalkom weakening of tuberculostatic action of rifampicin is possible.

With the simultaneous use of Salofalk enhances the hypoglycemic effect of sulfonylurea derivatives.

When used simultaneously with lactulose or other drugs that lower the pH of the intestinal contents, it is possible to reduce the release of mesalazine from the granules due to a decrease in the pH due to the metabolism of the bacteria.

In patients who are simultaneously receiving treatment with azathioprine or 6-mercaptopurine, the possible increase in the myelosuppressive effect of azathioprine and 6-mercaptopurine should be borne in mind.

Analogues of the drug Salofalk

Structural analogs for the active substance:

• 5-ACA;
• Asakol;
• Mézavant;
• Mesakol;
• Mesalazine;
• Pentasa;
• Salosinol.

Analogues on the curative effect (agents for the treatment of chronic ulcerative colitis):

• 5-ACA;
• Azathioprine;
• Alginatol;
• Betamethasone;
• Hydrocortisone;
• Dexamethasone;
• Diprospan;
• Irmalax;
• Yogulact;
• Lactobacterin;
• Lemodus;
• Mézavant;
• Mesakol;
• Methyluracil;
• Metizred;
• Neonatrix;
• Pentasa;
• Prednisolone;
• Probiophore;
• Reopoliglyukin;
• Salosinol;
• Sulfasalazine;
• Triamcinolone;
• Urbazon;
• Fortecortin;
• Phthalazole;
• Celeston;
• Eglonyl;
• Enterosan.

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