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Salofalk
Medical expert of the article
Last reviewed: 03.07.2025

Salofalk is a medicinal product belonging to a group of drugs with anti-inflammatory and antimicrobial properties. It is used mainly in the treatment of non-specific ulcerative colitis, as well as Crohn's disease.
The effect of Salofalk on the human body is a local reduction in the intensity of inflammatory processes in the intestine. Such a beneficial therapeutic effect is achieved due to the fact that the drug acts as an inhibitor in relation to neutrophil lipoxygenase, and also helps to reduce the degree of activity with which leukotrienes and prostaglandins are synthesized. In addition, it causes a slowdown in the processes of neutrophil degranulation, migration and phagocytosis, and lymphocytic secretion of immunoglobulins.
In addition, Salofalk produces a pronounced antioxidant effect. This is due to the fact that, by binding free oxygen radicals, the drug causes their destruction. Mesalazine, which is the main component of this drug, when taken orally, actualizes its effect in the intestinal mucosa, and also affects the submucosal layer, producing an effect from the intestinal lumen. Due to this, the availability of mesalazine in the area where inflammation is localized is a very important point.
To a large extent, the fact that Salofalk in the form of granules exhibits greater resistance to the effects of gastric juice contributes to the onset of action of the main active substance precisely in those areas of the body where it is needed. Granules also have a matrix structure, which ensures the delayed release of mesalazine for the appropriate required time period.
ATC classification
Active ingredients
Pharmacological group
Pharmachologic effect
Indications Salofalk
Indications for the use of Salofalk imply the use of its various dosage forms depending on certain clinical cases of diseases and disorders of the body's functioning.
Thus, the drug is included in the list of medical appointments for non-specific ulcerative colitis in its distal forms. At the same time, for treatment, as well as for preventive purposes to prevent exacerbation, it is advisable to use rectal suppositories.
Salofalk rectal suspension is indicated in cases where there is an exacerbation of nonspecific ulcerative colitis, when the left colon and rectum are involved in pathological processes.
Tablets are the most justified dosage form of the drug for nonspecific ulcerative colitis. As another case suggesting the use of Salofalk in this form, Crohn's disease should be mentioned. This medication is intended both for prevention and is used to treat exacerbations.
Mild to moderate ulcerative colitis in the acute phase requires the use of granules. They are also used in long-term therapeutic courses for ulcerative colitis, and in addition, they are used to maintain this disease in remission.
When there is an exacerbation of ulcerative colitis of the distal form in mild and moderate severity, resort to the use of Salofalk in the form of foam. In addition, this dosage form helps maintain remission of distal ulcerative colitis through long-term therapy.
Thus, indications for the use of Salofalk are determined by a number of factors, among which the most significant are the localization and size of the lesion area in the intestine. Based on this, a doctor makes a prescription for the use of the drug form most applicable to the clinical picture of the disease in each specific case.
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Release form
The form of release of Salofalk differs quite a large variety: from tablets for oral administration, to medicines that are used rectally - suppositories and suspensions. The drug is also presented in the form of foam.
Most often, tablets are used for non-specific ulcerative colitis in its common forms - total and subtotal. They have a round, convex on both sides shape, the color is light yellow, which can vary in the range to light brown. The main component - mesalazine 5-ASA can be present in a total amount of either 250 mg or 500 mg. It should be noted that tablets with a 500-milligram content of mesalazine are distinguished by an oval shape.
In both cases, the composition contains a number of auxiliary substances: butyl methacrylate, glycine, hypromellose, titanium dioxide, sodium carbonate, colloidal silicon dioxide, calcium stearate, talc, microcrystalline cellulose, iron oxide yellow dye.
The tablets are packed in blisters of 10 pieces. There can be 5 or 10 blisters in a cardboard box, where they are placed together with instructions for use.
Salofalk in the form of granules has a soluble pH-dependent shell Eudragit L, due to which a slow release of the main active substance is ensured, which occurs due to this exactly at the required destination. Granules of a white-grayish shade have a rounded spherical or cylindrical shape. The content of mesalazine 5-ASA in granules is 500 mg. The inner shell is formed by hypromellose, a copolymer of methacrylic acid and methyl methacrylate, eurajit, triethyl citrate, talc, magnesium stearate, titanium dioxide. In the outer shell there is sodium caramellose, titanium dioxide, aspartame, anhydrous citric acid, povidone K25-5, talc, vanilla flavoring. Polyethylene packages of 930 or 1860 mg, respectively, laminated with aluminum foil are in cardboard packs.
Salofalk rectal suppositories are white to cream in colour, have an elongated shape, pointed on one side and a uniform consistency.
One suppository contains mesalazine 5-ASA 500 mg. The presence of auxiliary substances is represented by solid fat, cetyl alcohol, sodium diocusate. Suppositories are packed in blisters of 5 pcs. and placed in a cardboard box.
And finally, the drug may be released in the form of a foam dosed for rectal use. It has a white-grayish or reddish-violet hue, and has a stable creamy consistency. Mesalazine 5-ASA in 1 application is present in the amount of 1 g. Of the excipients, there is propylene glycol, sodium disulfite, polysorbate, disodium edetate, cetostearyl alcohol, propellants. 7 doses, which is equal to 14 applications - one aluminum cylinder lacquered inside, have a dosing device. For this, special 14 pcs. PVC applicators with protective caps are used. Polyethylene bags are provided for used applicators - 14 pcs. cardboard packs.
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Pharmacodynamics
Pharmacodynamics Salofalk is characterized primarily by the anti-inflammatory action of the drug. As a result of its entry into the body, inhibition of the processes of synthesis of prostaglandins, which are metabolites of arachidonic acid, occurs. It also acts as an inhibitor in relation to the level of activity of neutrophil lipoxygenase, as well as immunoglobular secretion by lymphocytes. In addition, it causes a slowdown in neutrophil migration, degranulation and phagocytosis.
Salofalk helps bind and destroy free oxygen radicals. The main component of the drug, mesalazine, has the ability to capture radicals arising from reactive oxygen compounds. In vitro studies indicate that it may be important in inhibiting lipoxygenase. It has also been established that it affects the extent to which prostaglandins are present in the intestinal mucosa.
What needs to be said about how systemic bioavailability is related to the concentration of mesalazine in the blood plasma is that this factor does not represent a significant value associated with therapeutic efficacy, but is mainly one of the factors determining the level of safety.
The pharmacodynamics of Salofalk is such that oral administration of the drug promotes the actualization of the local effect produced by mesalazine in the intestinal mucosa, which manifests its action from the intestinal lumen. Based on this, the availability of mesalazine in the area of localization of the inflammatory process is important.
Pharmacokinetics
Pharmacokinetics of Salofalk, concerning the processes of absorption of the drug and its distribution in the body, is as follows. The release of mesalazine - the main active component occurs in the terminal section in the large and small intestine.
Salofalk tablets begin to dissolve in the small intestine after 110 to 170 minutes after they have been taken orally. It takes 165-225 minutes for them to completely dissolve after ingestion. The rate of dissolution may directly depend on changes in the acid-base balance pH due to food intake or other medications.
The dosage form of granules is characterized by a time delay of 120-180 minutes preceding the onset of mesalazine release. It takes 4 to 5 hours to reach Cmax in blood plasma. After the drug has been taken orally, approximately 15-25 percent systemic bioavailability of mesalazine is noted. When the drug is taken after meals, the onset of absorption is delayed by 60-120 minutes, but the rate and extent of absorption remain unchanged.
Small granule sizes - approximately 1 mm facilitate their rapid transit from the stomach to the small intestine. Movement in the large intestine occurs over a total time of approximately 20 hours. In this case, about 80% of the dose taken orally enters the large, sigmoid rectum.
Mesalazine is metabolized in the intestinal mucosa (presystemic metabolism), and in addition, systemic metabolic processes occur in the liver, as a result of which it forms pharmacologically inactive N-acetyl-5-aminosalicylic acid. Acetylation is of a nature independent of the acetylating phenotype of the patient, and may be associated with the action produced by bacterial microflora in the colon.
When mesalazine enters the body three times a day in a dose of 500 mg under the condition of saturating concentration, approximately 25% of it together with N-acetyl-5-aminosalicylic acid is eliminated by the kidneys. The part of mesalazine that is not metabolized is excreted in an amount of no more than 1 percent of the dose that was taken orally. In this case, T1/2 is, as studies show, 4.4 hours.
The pharmacokinetics of Salofalk, when administered as a single 20 mg/kg dose to children aged approximately 6 to 16 years, were similar to those observed in adults. The pharmacokinetic properties of the drug have not been studied in elderly patients.
Dosing and administration
The method of administration and dosage of the drug, as well as its most appropriate dosage form, are selected based on the localization and area of coverage of the intestine characterized by the lesion.
In cases of widespread forms of diseases, Salofalk in tablets is usually prescribed. In distal forms - proctosigmoiditis, proctitis, the drug is justified for use as a rectal remedy.
The tablet regimen for adult patients provides for a dose of 500 mg three times a day. Severe forms of the disease may require increasing the dosage to 3-4 g per day in courses lasting from 8 to 12 weeks.
For children weighing less than 40 kg, the daily dose should be half that of adults, or 250 mg three times a day. For children weighing more than 40 kg, 500 mg.
As a preventive measure to avoid the possibility of relapse, 250 mg of the drug should be taken 3 times a day. Such a preventive course can last, if necessary, several years.
Salofalk in the form of granules is usually prescribed in the amount of 1 sachet containing 500 to 100 mg of mesalazine three times a day. Or 3 sachets at a time once a day, which is equal to 1.5-3.0 grams. Children weighing up to 40 kg should take half the dose of the drug, but if the child's body weight is over 40 kg, Salofalk is prescribed in the same dosage as for adults.
Tablets and granules are taken orally, after meals, without chewing, and with plenty of water.
Rectal suppositories Salofalk for adults should be used three times a day, 1 piece - 500 mg or 2 pieces of 25 mg, respectively. Severe forms of diseases suggest the possibility of doubling the dose.
As part of maintenance treatment, 1 suppository of 250 mg is prescribed three times a day. Children under 40 kg are prescribed half the daily adult dose, and with a body weight of more than 40 kg - the adult dose.
Rectal suspension of the drug is administered from 1 bottle once a day before going to bed. Before this, it is advisable to cleanse the intestines. The dosage is determined as follows: 30-50 mg per 1 kg of body weight. The maximum permissible amount per day is 3 grams.
Rectal foam Salofalk is administered once a day before bedtime. 2 presses on the applicator correspond to one dose. If the patient has difficulty retaining this volume of foam in the rectum, it can be administered in several doses - one administration before bedtime and again at night or after defecation early in the morning. To relieve exacerbations of ulcerative colitis in mild forms using foam, 4-6 weeks of use of the drug in this dosage form may be sufficient.
Here are some rules for using Salofalk in foam form.
At the time of introduction, the foam should have a temperature corresponding to room temperature, that is, from 20 to 25 degrees Celsius.
The applicator is fixed onto the head of the can, after which it is necessary to shake it for about 20 seconds to mix the contents.
If this is the first use, remove the protective tab at the base of the dosing head.
The cap should be turned so that the nozzle is aligned with the semicircular cutout on the safety ring.
With the index finger on the cap, turn the can upside down.
The applicator is inserted into the rectum as deeply as possible. To do this, you can stand with your foot on some elevated surface, such as a stool or chair.
The first part of the dose (application) will be introduced by pressing the cap. When it reaches the stop, it is slowly released. For the second dose, this action should be repeated once more. After waiting 10-15 seconds, the applicator is removed from the rectum.
After the foam has been applied, the used applicator, previously packed in a plastic bag, is discarded.
Each subsequent dose of Salofalk foam requires the use of a new applicator.
The procedure should be followed by thorough hand washing. The patient should refrain from bowel movements until the following morning.
The method of application and dosage depend on a number of factors. Among them, one of the main ones is the dosage form of the drug that is most appropriate in each individual specific clinical case. Each of them has its own dosage features and a corresponding specific method by which the therapeutic effect is achieved with their help.
Use Salofalk during pregnancy
The use of Salofalk during pregnancy, as well as the use of many other drugs during that rather difficult period in which a woman bears a child, must be most carefully weighed and all the pros and cons assessed. The main criterion for the appropriateness of using the drug should first of all be a comprehensive objective assessment of the degree of the expected positive effect for the expectant mother, taking into account all possible existing risks in relation to the processes of normal intrauterine growth and development of the fetus.
Even at the stage of planning a child, before the expected conception, medical specialists recommend, if possible, to completely stop using Salofalk, or to reduce the dosage in which it is used to a minimum.
It is permissible to continue the course of treatment with the drug during the first trimester of pregnancy. However, in this case, Salofalk should be prescribed only on the basis of strict indications.
During the last 2 to 4 weeks of pregnancy, you should stop taking the drug.
As for the period of lactation and breastfeeding, it is necessary to take into account that the composition of mother's milk may contain about 0.1% of the dose taken. In view of this, if there is a justification for the use of this remedy by a nursing mother, the question of the possible need to stop breastfeeding becomes relevant. In particular, one of the factors testifying in favor of refusing breastfeeding is the appearance of diarrhea in the baby.
As we can see, the use of Salofalk during pregnancy, as well as during lactation and breastfeeding seems possible mainly if it is expected to have a more significant positive effect on the mother than this drug is capable of producing any negative effect on the child during the period of intrauterine development and after birth.
Contraindications
Contraindications to the use of Salofalk in connection with the state of various organs and systems in the patient's body can be given as follows.
First of all, we note that the drug is not suitable for use in cases of existing kidney dysfunction that is severe.
An equally prohibitive factor for the use of Salofalk is the presence of any pronounced liver dysfunction. In this regard, it should also be noted that taking the drug is not recommended to be combined with a dietary regimen in cases of liver disease.
In addition, contraindications of a gastroenterological nature include reflux exophagitis, intestinal dysbacteriosis, gastric ulcer and duodenal ulcer in the acute stage.
Salofalk is excluded from the list of medications approved for prescription to patients who have a tendency to bleeding - with hemorrhagic diathesis.
In addition, the reason for the inadmissibility of using Salofalk is the presence of increased sensitivity of the patient to salicylic acid, along with its derivatives.
A cautious and carefully considered approach is required when prescribing the drug to patients with impaired renal excretory function, respiratory disorders - this is especially true for patients with bronchial asthma. Also, a factor against the use of Salofalk is increased sensitivity to sulfasalazine and glucose-6-phosphate dehydrogenase deficiency.
There are categorical contraindications to the use of Salofalk for children under 2 years of age.
Side effects Salofalk
Side effects of Salofalk are reflected in the development of all sorts of negative phenomena that can occur in various systems and organs of the human body.
Thus, the digestive system's reaction to the drug's effect can be the appearance of abdominal pain, diarrhea, flatulence, loss of appetite, nausea and vomiting. Increased liver enzymes are observed in the blood, and in some cases, hepatitis may develop.
The central nervous system, as a result of Salofalk entering the body, often reacts in the form of headaches, dizziness, and tinnitus. General weakness appears, sleep is disturbed, tremors occur, convulsions may occur, and paresthesias occur.
The cardiovascular system responds to the drug intake with individual cases of tachycardia, arterial hypotension or hypertension. In addition, shortness of breath and chest pain may occur.
In the musculoskeletal system affected by the negative effects of Salofalk, arthralgia and myalgia may occasionally occur.
Disturbances in the functioning of the hematopoietic system are possible, manifested in rare cases of anemia, agranulocytosis, leukopenia and thrombocytopenia.
The use of the drug can adversely affect blood clotting processes, causing hypoprothrombinemia.
In the genitourinary system, in connection with the use of Salofalk, anuria, oliguria, hematuria, crystalluria, and proteinuria may occur.
In some cases, a decrease in the level of tear production and alopecia are observed.
Due to hypersensitivity, skin rashes, itching, bronchospasm, fever and erythema may occur. The possibility of myocarditis and pericarditis, interstitial nephritis and nephrotic syndrome, acute pancreatitis cannot be ruled out.
Under certain circumstances, mesalazine can provoke a syndrome similar to systemic lupus erythematosus.
If the side effects of Salofalk manifest as acute signs of intolerance, immediate discontinuation of its use is required.
Overdose
Overdose of Salofalk, which comes in the form of rectal suppositories and rectal suspension, has not been recorded in any case of drug use.
The likelihood of adverse effects caused by this drug is primarily associated with its oral administration in the form of tablets, as the most common form used in medical prescriptions for a number of intestinal diseases.
The symptoms that appear as a result of the negative impact on the body of critically exceeded doses of Salofalk are reflected in the following.
Attacks of nausea are observed, vomiting appears, gastralgia phenomena are observed, characterized by painful contractions in the stomach area. There is a general decrease in the body's tone, muscle weakness, drowsiness.
Treatment of overdose with Salofalk involves symptomatic therapeutic measures. Laxatives are prescribed, and gastric lavage may be necessary. In addition, when an overdose with this drug occurs, forced diuresis with infusion of electrolytic solutions may be a justified measure.
Interactions with other drugs
The interaction of Salofalk with other drugs is that when it is used in combination with such drugs as furosemide, rifampicin, spironolactone, sulfonamides, it leads to a decrease in their diuretic activity and effectiveness.
Salofalk increases the anticoagulant effect of coumarin anticoagulants.
The next effect produced by the drug is that as a result of its action, the effectiveness of uricosuric blockers of tubular secretion increases, and the rate of cyanocobalamin absorption processes decreases.
When Salofalk and methotrexate are used simultaneously, the latter has a stronger effect and its toxicity increases.
With regard to agents that are sulfonylurea derivatives and have antidiabetic properties, this drug helps to enhance the hypoglycemic effect they produce.
The use of Salofalk in the same course of treatment together with glucocorticosteroids can lead to an increase in the degree of negative reactions manifested by the gastric mucosa.
To sum it up, let us say that in some cases, interactions between Salofalk and other drugs lead to an increase in the effect they produce in the body, or, on the contrary, can act on them in an unfavorable way. On the other hand, the drug itself, entering into various interactions, can be either strengthened or weakened in its effectiveness. Therefore, all prescribed combinations of drugs, taking into account all their strengths and weaknesses, should be selected by a competent specialist in the field of medicine.
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Storage conditions
Shelf life
The shelf life of the drug varies depending on the dosage form in which it is presented.
Tablets are suitable for use when stored in appropriate conditions - 3 years from the date of manufacture. Granules - 4 years.
Rectal suppositories – 3 years. Rectal suspension is valid for 2 years from the date of manufacture.
Foam - 2 years. However, there is an important point here - after the can has been opened, its shelf life is 12 weeks.
Manufacturer
Attention!
To simplify the perception of information, this instruction for use of the drug "Salofalk" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.
Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.