Universal reference book for medicines
Product name: SALOFALK

Active substance: mesalazine

Type: Anti-inflammatory drug used to treat Crohn's disease and NUC

Manufacturer: Dr.
FALK PHARMA (Germany)
Composition, form of production and packaging
Suppositories rectal
from white to cream color, torpedo, homogeneous consistency, with intact flat surface.

1 supp.

mesalazine (5-ASA) 250 mg

[PRING] fat is solid.

5 pieces.
- blisters (2) - packs of cardboard.
5 pieces.
- blisters (6) - packs of cardboard.
Suppositories rectal from white to cream color, torpedo, homogeneous consistency, with intact flat surface.

1 supp.

mesalazine (5-ASA) 500 mg

[PRING] fat solid, cetyl alcohol, sodium docusate.

5 pieces.
- blisters (2) - packs of cardboard.
5 pieces.
- blisters (6) - packs of cardboard.
Rectal suspension from light gray to brown color, free from foreign inclusions.

1 f.

mesalazine (5-ASA) 2 g

[PRING] gum xanthan, carbomer, sodium ethylaminoacetate, sodium benzoate, potassium disulphite, potassium acetate, purified water, nitrogen gaseous.

30 ml - polyethylene bottles (1) - contoured packages (7) - cardboard packs.

Rectal suspension from light gray to brown color, free from foreign inclusions.

1 f.

mesalazine (5-ASA) 4 g

[PRING] gum xanthan, carbomer, sodium ethylaminoacetate, sodium benzoate, potassium disulphite, potassium acetate, purified water, nitrogen gaseous.

60 ml - polyethylene bottles (1) - contoured packages (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

The drug has an anti-inflammatory effect.
Inhibits the synthesis of arachidonic acid metabolites (prostaglandins), the activity of neutrophilic lipoxygenase, inhibits the migration, degranulation and phagocytosis of neutrophils, the secretion of immunoglobulins by lymphocytes; binds and destroys the free radicals of oxygen.
PHARMACOKINETICS

Suction

The release of mesalazine occurs in the rectum and colon.

Metabolism

Metabolized in N-acetyl-5-aminosalicylic acid in the intestinal mucosa and in the liver, so the concentration in the plasma is relatively low (after a single application - 0.5-1.5 μg / ml).
Binding to plasma proteins - 43% (metabolite - 75-83%). The mother's milk penetrates (in the form of a metabolite) 0.1% of the dose.
INDICATIONS

For rectal suppositories

- Distal forms of nonspecific ulcerative colitis (prevention and treatment of exacerbations).

For a rectal suspension

- nonspecific ulcerative colitis in the phase of exacerbation (involving the rectum and the left part of the colon).

DOSING MODE

Rectal suppositories

Adults prescribe 1 suppository 500 mg or 2 suppositories 250 mg 3 times / day.
In severe forms of the disease, the dose can be doubled.
With long-term maintenance treatment and for the prevention of relapses - 1 suppository 250 mg 3 times / 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 / day, children weighing more than 40 kg - 1 suppository 500 mg or 2 suppositories 250 mg 3 times / day.

Rectal suspension

The contents of one vial are administered rectally 1 time / day before bedtime (it is recommended to clean the intestine).
The daily dose is 30-50 mg / kg body weight.The maximum daily dose is 3 g.
To prevent relapses , oral intake of Salofalk in the form of tablets in a dose of 15-30 mg / kg of body weight / day is recommended.
The daily dose should be divided into 2 divided doses.
SIDE EFFECT

On the part of the digestive system: diarrhea, nausea, abdominal pain, flatulence, loss of appetite, vomiting, increased levels of hepatic enzymes in the blood, hepatitis.

From the side of the central nervous system: headache, depression, dizziness, sleep disorders, malaise, paresthesia, convulsions, tremor, tinnitus.

From the cardiovascular system: rarely - tachycardia, hypertension or hypotension, chest pain, dyspnea.

From the musculoskeletal system: rarely - myalgia, arthralgia.

From the hemopoietic system: in some cases - anemia, leukopenia, agranulocytosis, thrombocytopenia.

From the coagulation system: in some cases - hypoprothrombinemia.

From the urinary system: in some cases - proteinuria, hematuria, crystalluria, oliguria, anuria.

Other: in some cases - a decrease in the production of tear fluid, alopecia.

Reactions associated with hypersensitivity: skin rash, itching, erythema, fever, bronchospasm, pericarditis, myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome.
There were individual cases of allergic alveolitis and pancolitis. Under certain conditions, mesalazine and preparations having a similar chemical structure can lead to the development of a syndrome similar to that of systemic lupus erythematosus.
Taking into account the chemical structure of the active ingredient, it is impossible to exclude the possibility of increasing the level of methemoglobin.

If acute signs of intolerance arise, treatment should be stopped immediately.

CONTRAINDICATIONS

- pronounced violations of the liver;

- severe renal dysfunction;

- Stomach ulcer and duodenal ulcer in the phase of exacerbation;

- hemorrhagic diathesis (with a tendency to bleeding);

- Children under 2 years;

- Hypersensitivity to salicylic acid and its derivatives.

Caution should be given to Salofalk patients with impaired renal excretion, impaired breathing (especially in patients with bronchial asthma), with a deficiency of glucose-6-phosphate dehydrogenase, patients with increased sensitivity to sulfasalazine.

PREGNANCY AND LACTATION

In the first trimester of pregnancy, the prescription of the drug is only possible on strict indications.
If the course of the disease allows, in the last 2-4 weeks of pregnancy the drug should be stopped.
If necessary, the appointment of Salofalk during lactation should resolve the issue of stopping breastfeeding.

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

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is contraindicated in severe impairment of kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is contraindicated in severe violations of liver function.

APPLICATION FOR CHILDREN

The drug is contraindicated in children under 2 years.

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 / day, children weighing more than 40 kg - 1 suppository 500 mg or 2 suppositories 250 mg 3 times / day.

OVERDOSE

Cases of an overdose have not been revealed.

In case of an overdose, symptomatic treatment is performed.

DRUG INTERACTION

With the simultaneous use of Salofalk causes an increase in the effect of anticoagulants.

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

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

With the simultaneous use of Salofalk enhances the damaging effect of GCS on the gastric mucosa.

With simultaneous application, Salofalk reduces the tuberculostatic effect of rifampicin.

With simultaneous application, Salofalk reduces the uricosuric effect of probenecid and sulfinpyrazone.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a place protected from light, inaccessible to children, at a temperature of no higher than 25 ° C.
Shelf life of suppositories rectal - 3 years, rectal suspension - 2 years.
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