Salofalk, 2 g/30 ml, rectal suspension, 7 pcs.
Rectally.
Rectal suppositories
Adults.
2 supp. 250 mg or 1 supp. 500 mg 3 times a day. In severe forms of the disease, the dose can be doubled.
For long-term maintenance treatment and to prevent relapses
- 1 sup. 250 mg 3 times a day.
Children.
For body weights up to 40 kg, approximately half the dose recommended for adults is prescribed (1 supp. 250 mg 3 times a day); for body weight over 40 kg - the usual dose for adults.
Rectal suspension
The contents of one reservoir are administered rectally once a day before bedtime (it is recommended to cleanse the intestines first). The daily dose is 30–50 mg/kg. The maximum daily dose is 3 g.
To prevent relapses, 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.
Rectal foam dosed
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 maintain such a volume of foam in the intestine, 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 to administer the drug after bowel movement (defecation).
At the time of administration, Salofalk rectal foam should be at room temperature (20–25 °C).
1. Place the applicator firmly on the cylinder head
2. Shake the container for 20 seconds to mix its contents.
3. When using for the first time, remove the protective tab from the base of the dosing head.
4. Turn the cap so that the semicircular cutout on the safety ring is in line with the nozzle.
5. Place your index finger on the cap and turn the can upside down.
6. Insert the applicator into the rectum as deeply as possible. It is best to place your foot on a chair or stool. In order to administer the first part of the dose of the drug, press the cap all the way and slowly release it. To administer the second dose of the drug, press the cap again and release slowly. Wait 10–15 seconds, then slowly remove the applicator from the rectum.
7. After introducing the foam, remove the applicator and throw it away in a plastic bag. For each new dose of the drug, a new applicator should be used.
8. After the procedure, wash your hands. You should try not to have a bowel movement until the next morning.
When you go to hospital or consult with other doctors, you should tell 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 by the doctor individually.
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 your doctor to decide whether to prescribe an oral form of mesalazine for maintenance therapy.
Salofalk suspension for rectal administration 4g/60ml enema No. 7
A country
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Active substance
Mesalazine
Compound
The active ingredient is mesalazine.
pharmachologic effect
Pharmacological action - anti-inflammatory. Inhibits PG synthesis, inhibits chemotaxis, degranulation and phagocytosis of neutrophils, secretion of immunoglobulins by lymphocytes, has antioxidant properties. Plasma concentration is low. It forms N-acetyl-5-aminosalicylic acid in the intestinal mucosa and liver. It is effective in the treatment of colitis, ileitis in Crohn's disease, for the prevention of exacerbations of ulcerative colitis in patients with hypersensitivity to sulfasalazine, and is well tolerated. Reduces the risk of relapse in Crohn's disease, especially in patients with ileitis and long duration of the disease.
Indications for use
Inflammatory bowel diseases (ulcerative colitis, Crohn's disease), in the acute stage and prevention of their relapses.
Mode of application
In the form of enemas (60 or 30 ml of suspension depending on the extent of the lesion) - once a day before bedtime (you must first cleanse the intestines); The daily dose is 30-50 mg/kg body weight, in 2 divided doses. To prevent relapses of ulcerative colitis limited to the rectum, the use of suppositories of 250 mg 3 times a day is usually effective.
Interaction
Increases the ulcerogenicity of glucocorticoids, the toxicity of methotrexate, the hypoglycemic effect of sulfonylurea derivatives, and the hypoprothrombinemic effect of anticoagulants. Slows down the absorption of cyanocobalamin. Reduces the activity of furosemide, spironolactone, rifampicin.
Side effect
Feeling of discomfort, abdominal pain, nausea, flatulence, frequent urge to defecate, exacerbation of hemorrhoids, hyperthermia, flu-like syndrome and acute intolerance syndrome (colic, bloody diarrhea, fever, headache, rash), asthenia, drug-induced lupus-like syndrome, arthralgia, alopecia, methemoglobinemia, increased levels of transaminases, alkaline phosphatase, creatinine, urea nitrogen, allergic skin rashes.
Contraindications
Hypersensitivity (including to other derivatives of salicylic acid), severe dysfunction of the liver and kidneys, blood diseases, hemorrhagic diathesis, peptic ulcer of the stomach and duodenum, pregnancy, breastfeeding (stop during treatment), children's age (up to 2 years).
Overdose
No information available.
special instructions
The choice of dosage form depends on the location of the intestinal lesion and its prevalence. For common forms of ulcerative colitis (total and subtotal), as well as for Crohn's disease with damage to the small intestine, tablets are used. For distal forms (proctitis, proctosigmoiditis), rectal use of the drug in the form of suppositories or enemas is preferable. For left-sided lesions of the colon, therapy using only suppositories or enemas, or their combination with tablets, is possible. Before, during, and after treatment, the composition of peripheral blood, the level of urea, creatinine, and a general urine test should be monitored. If the development of acute intolerance syndrome is suspected, mesalazine should be discontinued.
Dispensing conditions in pharmacies
On prescription
Salofalk rectal suspension
INSTRUCTIONS for medical use of the drug SALOFALK®
INN: Mesalazine
General characteristics Homogeneous rectal suspension from light brown to brown color, does not contain foreign particles.
Composition of the medicinal product Each bottle (= 60 ml of rectal suspension) contains the active substance: mesalazine (5-aminosalicylic acid) 4 g; excipients: potassium metabisulfite (E 224), sodium benzoate (E 211), carbomer 934P (carbopol 974P), disodium edetate (in the form of disodium edetate dihydrate), potassium acetate (E 261), xanthan gum (E 415), purified water .
Dosage form Rectal suspension
Pharmacotherapeutic group: intestinal anti-inflammatory drugs, aminosalicylic acid and similar active ingredients ATC code: A07EC02
Pharmacological properties Pharmacodynamics The mechanism of anti-inflammatory action is unknown. In vitro studies have demonstrated that inhibition of the enzyme lipoxygenase may play a role. An effect on prostaglandin concentrations in the intestinal mucosa has also been demonstrated. Mesalazine (5-aminosalicylic acid/5-ASA) may also act as a radical scavenger of reactive oxygen species. When administered rectally into the intestinal lumen, mesalazine has a significant local effect on the intestinal mucosa and submucosal layers. Pharmacokinetics General properties of mesalazine: Absorption Mesalazine is absorbed most effectively in the proximal parts of the intestine and least effectively in the distal parts of the intestine. Biotransformation Mesalazine undergoes first-pass metabolism with the formation of inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA) both in the intestinal mucosa and in the liver. Acetylation appears to be independent of the patient's acetylation phenotype. Some mesalazine is also acetylated by colonic bacteria. Plasma protein binding is 43% for mesalazine and 78% for N-Ac-5-ASA. Excretion/excretion Mesalazine and its metabolite N-Ac-5-ASA are excreted in feces (most of them), kidneys (the amount varies from 20 to 50% depending on the route of administration, dosage form and mechanism of release of the active substance) and along with bile ( smaller part). It is excreted by the kidneys mainly in the form of N-Ac-5-ASA. Approximately 1% of an oral dose of mesalazine is excreted in breast milk, mainly as N-Ac-5-ASA.
Specific features of the drug Salofalk® rectal suspension 4 g/60 ml: Distribution: Radiological studies have established that when used in patients with mild or moderate ulcerative colitis, the suspension at the beginning of treatment and during remission after 12 weeks of treatment is distributed mainly according to the rectum and sigmoid colon, and to a lesser extent in the descending colon. Absorption and excretion: It was found that when used in patients with ulcerative colitis in remission, the highest plasma concentration was 0.92 μg/ml 5-ASA and 1.62 μg/ml N-Ac-5-ASA, it was achieved approximately after 11–12 hours under equilibrium conditions. The elimination rate was approximately 13% (45-hour value), with the majority (about 85%) of the administered dose excreted as the metabolite N-Ac-5-ASA. The plasma concentrations of 5-ASA and N-Ac-5-ASA in children with chronic inflammatory bowel disease treated with Salofalk® rectal suspension 4 g/60 ml were 0.5–2.8 μg/ml and 0.9 –4.1 µg/ml, respectively, under equilibrium conditions. Preclinical Safety Data: Preclinical data from standard pharmacological safety, genotoxicity, carcinogenicity (in rats) and reproductive toxicity studies did not indicate any particular hazard to humans. In toxicity studies, nephrotoxicity (medullary necrosis of the kidney and damage to the epithelium of the proximal convoluted tubule (pars convoluta) or the entire nephron) was observed with repeated oral administration of high doses of mesalazine. The clinical significance of the findings is unclear.
Indications for use Treatment of acute attacks of inflammatory disease of the large intestine, known in medicine as ulcerative colitis.
Directions for use and dosage Adults and elderly people When used to treat patients with an acute attack of inflammation, the contents of one bottle (= 60 ml of rectal suspension) are administered into the intestines as an enema once a day before bedtime.
Children and adolescents There is little experience with the drug in children and limited literature on the effectiveness of the drug in children.
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General information for all patients Salofalk® rectal suspension 4 g/60 ml should be used once a day before bedtime. The drug Salofalk® rectal suspension 4 g/60 ml should be used regularly and systematically, since only in this case can a positive result be achieved. The duration of treatment is determined by the attending physician.
Route of administration: Apply rectally. The best results will be achieved if the patient has a bowel movement before using Salofalk® rectal suspension 4 g/60 ml.
Preparation for administration: Shake the bottle for 30 seconds. Remove the protective cap of the applicator. Hold the bottle at the top and bottom.
Correct posture when administering a rectal suspension: The patient should lie on his left side, with his left leg extended and his right leg bent at the knee. This position makes it easier to administer the enema and allows you to achieve greater effect. Administration of the rectal suspension: Insert the tip of the applicator deep into the rectum. Point the tip of the applicator slightly downward, then squeeze the bottle slowly and evenly. When the bottle is empty, slowly remove the applicator tip from your rectum. The patient should remain in a horizontal position for at least 30 minutes after administration to ensure even distribution of the drug throughout the rectum. If possible, the enema should be left overnight.
Side effects The following side effects have been reported in connection with the use of mesalazine:
Organ system/organ/category Frequency in accordance with the medical dictionary of regulatory activities Rarely (≥1/10,000, <1/1,000) Very rarely (<1/10,000) Disorders of the circulatory and lymphatic systems Changes in the blood formula ( aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia) Nervous system disorders Headaches, dizziness Peripheral neuropathies Cardiovascular system disorders Myocarditis, pericarditis Respiratory tract and mediastinal disorders Allergic and fibrous pulmonary reactions (including shortness of breath, cough, bronchospasm, alveolitis, pulmonary eosinophilia, pulmonary infiltration, pneumonitis) Gastrointestinal disorders Abdominal pain, diarrhea, bloating, nausea and vomiting Acute pancreatitis Renal disorders Renal dysfunction, including acute and chronic interstitial nephritis and renal deficiency Skin and subcutaneous tissue disorders Photosensitivity (increased sensitivity of the skin to light)
Alopecia (hair loss) Musculoskeletal and connective tissue disorders Myalgia, arthralgia Immune system disorders Hypersensitivity reactions such as allergic exanthema, drug fever, drug-induced lupus erythematosus syndrome, pancolitis Liver and biliary disorders Changes in functional parameters liver (increased levels of transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis Disorders of the reproductive system Oligospermia (reversible)
Photosensitivity (increased sensitivity of the skin to light) More severe reactions have been reported in patients with underlying skin conditions such as atopic dermatitis and atopic eczema.
Contraindications The drug Salofalk® rectal suspension 4 g/60 ml is contraindicated in patients with: - known hypersensitivity to salicylic acid and its derivatives or to any of the excipients included in the drug; - severe liver or kidney dysfunction.
Overdose There is very limited information on mesalazine overdose (for example, when ingesting high doses for suicidal purposes), which does not indicate nephro- or hepatotoxicity of the drug. No specific antidote is known. Treatment is symptomatic and supportive.
Precautions At the discretion of the physician, a blood test (blood test with differential leukocyte count), determination of indicators of the functional state of the liver (levels of ALT or AST enzymes, plasma creatinine levels) and a urine test (test strips) should be performed before starting treatment and during treatment. . It is recommended to conduct these studies 14 days after the start of treatment and then 2-3 times with an interval of 4 weeks. If the results obtained are normal, then it is sufficient to carry out these tests every three months. If additional manifestations of the disease appear, additional studies should be performed immediately. Use with caution when treating patients with reduced liver function. Salofalk® rectal suspension 4 g/60 ml should not be used in the treatment of patients with reduced renal function. If a decrease in renal function occurs during treatment, mesalazine-related nephrotoxicity should be considered. Careful monitoring of patients with respiratory system disorders, especially asthma, is necessary when prescribing Salofalk® rectal suspension 4 g/60 ml. Patients with known hypersensitivity to drugs containing sulfasalazine should only be treated under close medical supervision. If symptoms of acute intolerance appear, such as cramps, acute abdominal pain, fever, severe headaches and skin rash, treatment should be stopped immediately. Due to the content of potassium metabisulfite as an excipient, allergic reactions with symptoms of anaphylaxis and bronchoconstriction (bronchospasm) may occur in sensitive patients, especially those suffering from asthma or other allergies. Due to the content of sodium benzoate as an excipient, hypersensitivity reactions may occur in susceptible patients in the form of irritation of the skin, eyes and mucous membranes.
Period of pregnancy and lactation Pregnancy At the moment, there is insufficient data on the use of the drug Salofalk® rectal suspension 4 g/60 ml for pregnant women. However, no adverse effects on pregnancy or fetal/newborn health were observed. There is no other information available at this time. There is one case of renal failure in a newborn born to a woman who received high doses of mesalazine for a long time during pregnancy (2-4 g per day orally). Animal studies of the oral route of mesalazine have demonstrated no direct or indirect adverse effects on gestation, embryo/fetal development, parturition or postnatal development. Salofalk® rectal suspension 4 g/60 ml should be prescribed during pregnancy only if the expected benefit outweighs the potential risk. Breastfeeding N-acetyl-5-aminosalicylic acid and small amounts of mesalazine are secreted into breast milk. To date, there is limited experience with the use of mesalazine during breastfeeding. The development of hypersensitivity reactions in infants cannot be ruled out, one of the manifestations of which may be diarrhea. Thus, the drug Salofalk® rectal suspension 4 g/60 ml should be prescribed during breastfeeding only if the expected benefit outweighs the potential risk. If the baby develops diarrhea, breastfeeding should be stopped.
Effect on the ability to drive a car and operate complex equipment The use of the drug Salofalk® rectal suspension 4 g/60 ml either has no effect or has an insignificant effect on the ability to drive a car and operate complex equipment.
Interaction with other medicinal products No specific interaction studies have been conducted. The possibility of increasing the suppressive effect of azathioprine, 6-mercaptopurine or thioguanine on the bone marrow should be taken into account during treatment with simultaneous use of the drug Salofalk® rectal suspension 4 g/60 ml. There is weak evidence that mesalazine may reduce the effect of the anticoagulant warfarin.
Storage conditions and shelf life Does not require special storage conditions. Keep out of the reach of children. Store in sealed contour packaging in a dark place. Shelf life – 2 years. Do not use after the expiration date stated on the packaging.
Dispensing conditions Prescription
Packaging Rectal suspension 4 g/60 ml: 60 ml in white, round, compressible low-density polyethylene bottles, closed with a lubricated rectal applicator tip and a green protective cap. The bottle is placed in a contour package made of heat-sealable polyvinyl chloride film and laminated paper with aluminum coating. 7 bottles each, placed in contour packaging, with instructions for use in a cardboard pack.
Applicant/manufacturer Dr. Falk Pharma GmbH Leinenweberstr. 5 79108 Freiburg Germany
Vifor AG Brüchlstrasse 50 4107 Oettingen Switzerland
Representative in the Republic of Belarus Representative office of Alpen Pharma AG JSC in the Republic of Belarus 220053, Minsk, st. Parkhomenko 3, office 1-B Tel./fax: (+375 17) 3350644
