Salofalk (Suppozitorii)

Active material: Mesalazine
When ATH: A07EC02
CCF: The drug with anti-inflammatory action, used to treat Crohn's disease and ulcerative colitis
ICD-10 codes (testimony): K51
When CSF: 11.13.01
Manufacturer: Dr. FALK PHARMA GmbH (Germany)

Pharmaceutical form, composition and packaging

Rectal Suppositories white to cream color, torpedo, uniform consistency, with undamaged flat surface.

Excipients: fat solid.

5 PC. – blisters (2) – packs cardboard.
5 PC. – blisters (6) – packs cardboard.

Rectal Suppositories white to cream color, torpedo, uniform consistency, with undamaged flat surface.

Excipients: fat solid, cetyl alcohol, sodium docusate.

5 PC. – blisters (2) – packs cardboard.
5 PC. – blisters (6) – packs cardboard.

Rectal suspension grayish to light brown, with a characteristic odor.

Excipients: Sodium benzoate, potassium metabisulfite, sodium edetate, carbomer 934R, potassium acetate, xanthan gum, nitrogen, water distillirovannaya.

30 ml – plastic bottles (7) – packaging.

Rectal suspension grayish to light brown, with a characteristic odor.

Excipients: Sodium benzoate, potassium metabisulfite, sodium edetate, carbomer 934R, potassium acetate, xanthan gum, nitrogen, water distillirovannaya.

60 ml – plastic bottles (7) – packaging.

Pharmacological action

The drug with anti-inflammatory action, used to treat Crohn's disease and ulcerative colitis. Anti-inflammatory effect. It inhibits the synthesis of metabolites of arachidonic acid (prostaglandins), Activity neutrophil lipoxygenase, inhibits migration, neutrophil degranulation and phagocytosis, secretion of immunoglobulin by lymphocytes; It binds and destroys free oxygen radicals.

Pharmacokinetics

Absorption

The release of mesalazine occurs in the rectum and colon.

Metabolism

It is metabolized in the N-acetyl-5-aminosalicylic acid in the intestinal mucosa and liver, therefore, the plasma concentration is relatively low (after a single application – 0.5-1.5 ug / ml). Plasma protein binding – 43% (metabolite – 75-83%). The mother's milk enters (It saw in the metabolite) 0.1% dose.

Testimony

- distal forms of ulcerative colitis (prevention and treatment of exacerbations) – rectal suppository;

- nonspecific ulcerative colitis in the acute phase (involving the rectum and left colon) – for rectal suspension.

Dosage regimen

Rectal Suppositories adult appoint 1 suppozitoriû 500 mg or 2 suppozitoriâ 250 mg 3 times / day. At heavy forms of the disease the dose can be doubled.

At long-term maintenance treatment and to prevent relapse – by 1 suppozitoriû 250 mg 3 times / day.

Children weighing up 40 kg appointed 1/2 Daily doses for adults – by 1 suppozitoriû 250 mg 3 times / day, Children weighing more than 40 kg – by 1 suppozitoriû 500 mg or 2 suppozitoriâ 250 mg 3 times / day.

The contents of one vial (rectal suspension) administered rectally 1 time / day before bedtime (it is recommended to cleanse the intestines beforehand).

To relapse prevention Oral administration of Salofalk is recommended in the form of tablets in a dose 15-30 mg / kg body weight / day. The daily dose should be divided into 2 admission.

Side effect

From the digestive system: diarrhea, nausea, stomach ache, flatulence, loss of appetite, vomiting, increased liver enzymes in the blood, hepatitis.

CNS: headache, depression, dizziness, sleep disorders, malaise, paresthesia, convulsions, tremor, noise in ears.

Cardio-vascular system: rarely – tachycardia, hypertension or hypotension, chest pain, breathlessness.

On the part of the musculoskeletal system: mialgii, artralgii.

From the hematopoietic system: in some cases – anemia, leukopenia, agranulocytosis, thrombocytopenia.

From the blood coagulation system: in some cases – gipoprotrombinemii.

From the urinary system: in some cases – proteinuria, hematuria, kristallurija, oligurija, anurija.

Other: in some cases – decrease in production of tear fluid, alopecia.

Reaction, associated with hypersensitivity: skin rash, itch, эritema, fever, bronchospasm, perikardit, miokardit, acute pancreatitis, interstitial nephritis, nephrotic syndrome. There were isolated cases of allergic alveolitis and pankolita. Under certain circumstances, drugs and mesalazine, having a similar chemical structure, can lead to the syndrome, syndrome similar to systemic lupus erythematosus.

In view of the chemical structure of the active ingredient can not exclude the possibility of increasing the level of methemoglobin.

If you experience acute symptoms of intolerance to treatment must be stopped immediately.

Contraindications

- Severe hepatic impairment;

- Severe renal impairment;

- Gastric ulcer and duodenal ulcer in the acute phase;

- Gyemorragichyeskii diatyez (with a propensity to bleed);

- Children up to age 2 years;

- Hypersensitivity to salicylic acid and its derivatives.

FROM caution should be given Salofalk to patients with impaired renal excretory function, impaired breathing (especially in patients with bronchial asthma), in the definition, glucose-6-fosfatdegidrogenazы, patients with hypersensitivity to sulfasalazine.

Pregnancy and lactation

In the I trimester of pregnancy, use of the drug is possible only under strict indications. If you allow the disease, in the last 2-4 week of pregnancy the drug should be discontinued.

If necessary, the appointment of Salofalk lactation should decide the issue of termination of breastfeeding.

Before a planned pregnancy is recommended, possibly, salofalk discontinue treatment or use the drug in small doses.

Cautions

–

Overdose

No cases of overdose have been identified.

In case of overdose symptomatic treatment.

Drug Interactions

With simultaneous use of Salofalk cause potentiation of anticoagulation.

With simultaneous use of Salofalk enhances hypoglycemic effect of sulfonylureas.

With simultaneous use of Salofalk increases the toxicity of methotrexate.

With simultaneous use of Salofalk intensifies the damaging effect of corticosteroids on the gastric mucosa.

With simultaneous use of Salofalk reduces tuberculostatic effect of rifampicin.

With simultaneous use of Salofalk reduces the uricosuric action of probenecid and sulfinpirazona.

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

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in the dark, inaccessible to children at temperature not exceeding 25 ° C. Shelf life of rectal suppositories – 3 year, rectal suspension – 2 year.