Salofalk granules 1000mg #50

Salofalk instruction for use

You can buy Salofalk here

Composition

The composition of tablets includes active substance mesalazine, as well as additional components: sodium carbonate, povidone, glycine, MCC, calcium stearate, silicon dioxide colloid, titanium dioxide, hypromellose, talc, methacrylic acid-methacrylate copolymer, dye, butyl methacrylate, macrogol.
The granules contain the active component of mesalazine and auxiliary components: MCC, hypromellose, euromatic NE40D, silicon dioxide colloidal anhydrous, simethicone emulsions, magnesium stearate. The inner shell of the capsule consists of hypromellose, triethyl citrate, methacrylic acid copolymer and methyl methacrylate, magnesium stearate, talc, titanium dioxide. The outer shell of the capsule consists of titanium dioxide, aspartame, carmellose sodium, citric acid anhydrous, talc, povidone K25, flavor.
The composition of suppositories includes the active ingredient mesalazine and solid fat as an auxiliary component.
Rectal suspension contains mesalazine and a number of additional substances: carbomer, xanthan gum, sodium benzoate, sodium ethylaminoacetate, potassium acetate, potassium disulphite, nitrogen gas, water.
Rectal foam contains active substance mesalazine and a number of additional components: sodium disulfite, polysorbate 60, propylene glycol, edetate disodium, cetostearyl alcohol, propellants.

Form of issue

There are several different forms of the drug Salofalk.
    Salofalk tablets are round, biconvex, have a color from light yellow to brownish-yellow. The tablet is coated with an enteric film membrane film. Contains tablets in blisters for 5 and 10 pcs., Which are put in packs of cardboard. Tablets of 250 mg and 500 mg are produced.
    Granules Salofalk prolonged action rounded, have a white-gray hue, cylindrical or spherical shape. Contained in polyethylene bags, laminated aluminum foil, 930 mg or 1860 mg, which are embedded in carton boxes.
    Rectal suppositories can have a color from white to cream, the shape is torpedo-shaped with an even surface, the consistency is uniform. The blisters contain 5 suppositories each, 2 or 6 blisters are put into cardboard packs.
    Rectal suspension has a color from light gray to brown, with no foreign inclusions. Packed in polyethylene bottles of 30 ml., Which are put in packs of cardboard.
    Rectal foam may have a shade from gray-white to violet-reddish. Consistency is persistent, creamy. Contained in aluminum cylinders, which are equipped with a dispensing device. Also included in the composition are special PVC applicators with protective caps and packages for used applicators.

pharmachologic effect

Salofalk is an intestinal anti-inflammatory drug that provides a local anti-inflammatory effect associated with the inhibition of neutrophilic lipoxygenase, as well as the synthesis of leukotrienes and prostaglandins.
The active component stops the degranulation, migration, phagocytosis of neutrophils and the process of secretion of immunoglobulins by lymphocytes. There is an antioxidant effect due to the fact that mesalazine is capable of binding to free oxygen radicals and their destruction.
Also, the substance can catch those radicals that are formed from the reactive oxygen compounds.
When administered orally, mesalazine acts mainly locally in the intestinal mucosa and submucosal layer, it acts from the side of the intestinal lumen. Therefore, it is very important that the active constituent is directly in the region of the inflammatory process.
Since the granules are resistant to gastric juice, and the release of mesalazine is pH-dependent and slow, the active ingredient is released precisely in the right place.

Pharmacokinetics and pharmacodynamics

After oral administration, mesalazine is released in the terminal section of the small and large intestine. The action begins 110-170 minutes after taking Salofalk tablets inside. Complete dissolution of the tablets is noted 165-225 minutes after administration.
From the granules, the active substance is released with a deceleration of 2-3 hours. Absorption slows down for 1-2 hours on condition of ingestion. This process is not affected by changes in pH. The greatest concentration in plasma is observed after 4-5 hours. But since the absorption of mesalazine is low, and the process of its transformation into a metabolite occurs rapidly, a relatively small concentration of the active component is noted in the plasma. The level of systemic bioavailability is approximately 15-25%. Communication with blood proteins - 75-83%.
Metabolism of mesalazine in N-acetyl-5-aminosalicylic acid occurs in the liver and in the intestinal mucosa.
The half-life of mesalazine is 0.5 to 2 hours, depending on the dose that was taken.
In breastmilk, 0.1% of mesalazine enters the metabolite. It is excreted through the kidneys mainly in acetylated form.

Indications for use

Tablets are used for non-specific ulcerative colitis, as well as for Crohn's disease - for the purpose of therapy of exacerbations and prevention.
Granules of Salofalk are used for moderate and severe exacerbations of ulcerative colitis, as well as to maintain remission and for long-term treatment of ulcerative colitis.
Candlesticks of Salofalk are used in the distal forms of ulcerative colitis, both for the purpose of treatment and for prevention.
Rectal and foam suspensions are used for ulcerative colitis during the exacerbation period, if the rectum and the left colon are involved in the process.

Contraindications

Contraindicated the use of the drug Salofalk in the form of tablets and granules in such cases:
    blood diseases;
    stomach ulcer and duodenal ulcer;
    hemorrhagic diathesis, in which the tendency to bleeding is noted;
    renal or hepatic insufficiency in severe form;
    lack of glucose-6-phosphate dehydrogenase;
    phenylketonuria (for granules);
    age of child under 3 years - tablets, age up to 6 years - granules;
    a high level of sensitivity to the components of the remedy.
Carefully prescribe medication for mild and moderate renal and hepatic insufficiency, for lung diseases, in particular, for bronchial asthma, and also in the first trimester of pregnancy.
Rectal forms of the drug (enema, Salofalk candles) are not used in such diseases and conditions:
    serious violations of the liver and kidneys;
    exacerbation of stomach and duodenum ulcers;
    hemorrhagic diathesis, in which there is a tendency to bleeding;
    age of child under 2 years;
    high sensitivity to the components of the drug.
The drug Salofalk in chronic colitis is cautiously prescribed for violations of respiratory function, kidneys, as well as for lack of glucose-6-phosphate dehydrogenase.

Side effects of Salofalk

When applying the drug Salofalk may appear the following side effects:
    Reactions of high sensitivity: skin rash, itching, fever, erythema, acute pancreatitis, myocarditis, bronchospasm, nephrotic syndrome, interstitial nephritis, etc. Sometimes, under certain conditions, mesalazine can provoke the development of a syndrome similar to the systemic lupus erythematosus syndrome.
    Digestive system: deterioration of appetite, nausea, diarrhea, flatulence, abdominal pain, vomiting; in very rare cases, very severe abdominal pain develops, severe diarrhea, jaundice, hepatitis, an increase in the level of hepatic enzymes in the blood.
    Nervous system: dizziness, headaches; in very rare cases - peripheral neuropathy, sleep disturbances, depression, tremors, convulsions, a sense of noise in the ears, paresthesia.
    Heart and blood vessels: hypertension or hypotension, tachycardia; in very rare cases - dyspnea, pain behind the sternum.
    Hemopoiesis: leukopenia, anemia, thrombocytopenia, agranulocytosis.
    Musculoskeletal system: arthralgia, myalgia.
    Blood coagulation system: hypoprothrombinemia.
    Urinary system: hematuria, proteinuria, oliguria, anuria, crystalluria.
    Other manifestations: decreased lacrimal fluid production; in very rare cases - fever, alopecia, tonsillitis, decreased motility of spermatozoa.
Considering the chemical structure of the active ingredient, one should take into account the possibility of increasing the level of methemoglobin. With the development of acute side effects, therapy should be suspended.

Instructions for use Salofalk (Method and dosage)

Tablets to adult patients are prescribed at a dose of 500 mg three times a day. If patients have severe forms of illness, the daily dose can be increased to 3-4 grams of medication per day, treatment is carried out for 8-12 weeks. In order to prevent recurrence of the disease, a dose of 500 mg per day should be taken, if necessary, taking the tablets takes several years.
Children weighing up to 40 kg should receive half of the "adult" daily dose - that is, 250 mg three times a day. Children and adolescents, whose weight is from 40 kg, take the drug at the dose that adults. To ensure prevention in children, 250 mg of the drug are administered three times a day, this scheme can be practiced for several years.
It is important to take pills without chewing them, drink after eating, with plenty of liquid.
The reception of granules is carried out in those doses, which the doctor determines individually. When peptic ulcer is exacerbated, the patient is given 1 packet 500-1000 mg mesalazine three times a day or three packs. once a day.
To support remission of ulcerative colitis, it is indicated to drink 500 mg of the drug 3 times a day or 3 packs. 1 per day.
If the disease worsens, children after 6 years and adolescents are prescribed 30-50 mg of funds per 1 kg of the child's weight. Thus the daily dose can be distributed both on one, and on three receptions. In order to support remission, the dose is 15-30 mg mesalazine per 1 kg of body weight, this dose can be divided into two. Children weighing up to 40 kg, are prescribed half of the dose given to adults.
You can not chew granules. If the whole dose is taken once, this should be done in the morning. It is necessary to swallow the granules whole and drink them with a copious amount of liquid.

Suppositories Salofalk, instructions for use

Adult patients receive three times a day for 1 supp. 500 mg or 2 supp. 250 mg. Children weighing up to 40 kg receive half the dose for adult patients. Children and adolescents weighing 40 kg receive the same dose as adults.
Rectal suspension is administered once a day, just before bedtime, using the contents of one vial. Before putting enemas or microclysters, it is recommended to clean the intestines. The dose of knocking is 30-50 mg per 1 kg of the patient's weight.

Instruction for foam rectal

According to the instructions foam to teenagers after 12 years and adults are injected once a day in the evening. To enter one dose, you need to make two clicks. People who find it difficult to keep such a dose in the rectum are recommended to divide it twice - one depression in the evening, and one - in the morning after defecation. As a rule, treatment of ulcerative colitis lasts 4-6 weeks. To obtain the desired effect, the use of the agent should be regular.

Overdose

In case of overdose, nausea, vomiting, weakness, drowsiness may occur. In this case, it is necessary to wash the stomach, give the patient laxatives, conduct symptomatic treatment. If necessary, forced diuresis is practiced.

Interaction

When applied simultaneously, Salofalk increases the effect of indirect anticoagulants, and the likelihood of bleeding of the gastrointestinal tract increases.
When applied simultaneously with SCS, negative manifestations from the gastric mucosa may increase.
If Salofalk and Methotrexate are used simultaneously, the toxicity of the latter increases.
If Salofalk and probenecid, sulfinpyrazone are taken in parallel, the excretion of uric acid may decrease.
When applied simultaneously reduces the diuretic effect of Furosemide and spironolactone.
If you simultaneously take Salofalk and Rifampicin, the tuberculostatic effect of the latter is reduced.
Salofalk activates the hypoglycemic effect of sulfonylurea derivatives.
If the drug is used with lactulose or with other drugs that lower the pH of the intestinal contents, the release of mesalazine from the granules may decrease.
In the case of simultaneous use of azathioprine or 6-mercaptopurine, the myelosuppressive effect of azathioprine and 6-mercaptopurine may be enhanced.

Terms of sale

To buy Salofalk you don't need a prescription.

Storage conditions

All forms of Salofalk are stored at a temperature of no more than 25 ° C. The drug should be protected from access of children, do not allow the influence of light and moisture.

Shelf life

Tablets are stored for 3 years, pellets - 4 years, suppositories - 3 years, rectal suspension - 2 years.

special instructions

Before starting treatment with the drug, you need to conduct a general analysis of urine and blood.
Before the beginning of the course of treatment, as well as in its process, it is important to ensure control of liver function and conduct urine tests. It is recommended to control these indicators 14 days after the start of therapy, then the study is conducted at intervals of 14 days. Provided that 2-3 times the tests are normal, such studies are further carried out once every three months. If negative symptoms are present, it is necessary to conduct such studies immediately.
It is not recommended to prescribe medication for people with marked renal impairment. If such disorders are noted during the treatment, the nephrotoxic effect of mesalazine can be tolerated.
If the medicine is prescribed for people suffering from bronchial asthma, it is important to carefully monitor their condition during therapy.
It is necessary immediately to stop treatment if against its background cramps, fever, sharp pains in the abdomen, rash, etc. develop.
In the process of therapy, urine can be colored yellow or orange, as well as dyeing soft contact lenses.
If several doses of medication were missed during the treatment, the patient should consult a specialist about further treatment.
People who suffer from phenylketonuria, you need to take into account that the composition of pellets of Salofalk is aspartame in doses of 0.56 mg (granules 500 mg), 1.12 mg (granules 1 g).
During the application of any form of medication, care must be taken when performing actions requiring increased concentration of attention.

Salofalk or Pentasa?

The preparation of Pentasa is also produced in several dosage forms, the active substance is Mesalazine. Accordingly, and the action of the drug, and the testimony is analogous to Salofalk. But the final decision on the choice of the drug should only be taken by a doctor.

Children

Drugs in tablets are not prescribed for children under 3 years, in granules - for patients up to 6 years. Rectal forms of the drug are not used to treat children under 2 years old. When applied to children of any form of Salofalk should be clearly observed instruction.

In pregnancy and lactation

The agent is prescribed in the first trimester of pregnancy only if there are strict indications. In the subsequent months of pregnancy, Salofalk is prescribed if the intended benefit is higher than the probable risk. Doctors recommend, if possible, to stop treatment in the last weeks of pregnancy.
With lactation, prescribe the medicine strictly according to the indications. If diarrhea develops during the treatment of a nursing mother, the therapy should be stopped immediately. At the planning stage of pregnancy, it is recommended to stop therapy or reduce the dosage of the drug.

Reviews about Salofalk

Those users who come to the forum to leave feedback about the Salofalk candles and other forms of this medication often write about the fact that the drug is quite effective. Some patients call it the most effective cure for ulcerative colitis. But, despite the fact how effective is Salofalk, patients' reviews often indicate that the medicine is very expensive, so it is not always available.