Kansalazin rectal suppositories 500mg, No. 10

• Treatment of ulcerative colitis (distal colon) during an exacerbation, as well as maintenance therapy during remission

Before the introduction of the suppository, the intestines should be emptied.

Adults
For the treatment of exacerbations of ulcerative colitis:
1 suppository 500 mg 3 times a day (corresponds to 1500 mg mesalazine per day), rectally.

1 suppository contains:

Active ingredient: mesalazine 500.00 mg.

Excipients: solid fat Witepsol N-15 1680.00 mg, sodium docusate 2.00 mg, cetyl alcohol 18.00 mg.

• Hypersensitivity to the components of the drug and other derivatives of salicylic acid,

• Severe renal / hepatic impairment

• Peptic ulcer of the stomach or duodenum in the acute phase,

• Hemorrhagic diathesis (with a tendency to bleed)

• Children under the age of 18.

Carefully

With caution, the drug should be prescribed to patients with impaired respiratory function (especially with bronchial asthma), with increased sensitivity to mesalazine, with impaired liver and kidney function, with a deficiency of glucose-6-phosphate dehydrogenase.

Trade name:

KansalazinЃ

International non-proprietary name:

mesalazine

Dosage form:

rectal suppositories

Composition:

1 suppository contains:
Active ingredient: mesalazine 500.00 mg.
Excipients: solid fat Witepsol N-15 1680.00 mg, sodium docusate 2.00 mg, cetyl alcohol 18.00 mg.

Description

Torpedo-shaped suppositories from almost white to light gray, with a possible light pink tint.

Pharmacotherapeutic group:

antimicrobial and anti-inflammatory intestinal agent

Pharmacological properties

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

The therapeutic effect of mesalazine after oral or rectal administration is more due to the local effect on the inflammatory intestinal tissue than to the systemic effect.

The therapeutic effect of mesalazine is manifested by local contact with the affected mucosa. Mesalazine inhibits leukocyte chemotaxis, reduces the production of cytokines and leukotriene, as well as the formation of free radicals in inflamed intestinal tissue.

Pharmacokinetics
Absorption
Mesalazine is released in the rectum and colon.

Metabolism
Metabolized in the intestinal mucosa and in the liver to N-acetyl-5-aminosalicylic acid, therefore the plasma concentration is relatively low.

Distribution
Plasma proteins bind 43% of mesalazine and 73-83% of its main metabolite. Mesalazine and its metabolites do not cross the blood-brain barrier, but penetrate into breast milk (as a metabolite) 0.1% of the dose.

Excretion
Mesalazine and its metabolites are excreted from the body by the kidneys and through the intestines.

Indications for use

Treatment of ulcerative colitis (distal colon) during an exacerbation, as well as maintenance therapy during remission.

Contraindications

• Hypersensitivity to the components of the drug and other derivatives of salicylic acid,

• Severe renal / hepatic impairment

• Peptic ulcer of the stomach or duodenum in the acute phase,

• Hemorrhagic diathesis (with a tendency to bleed)

• Children under the age of 18.

Carefully

With caution, the drug should be prescribed to patients with impaired respiratory function (especially with bronchial asthma), with increased sensitivity to mesalazine, with impaired liver and kidney function, with a deficiency of glucose-6-phosphate dehydrogenase.

Application during pregnancy and during breastfeeding

There is no sufficient data on the use of the drug KansalazinЃ rectal suppositories in pregnant women. However, data on the use of mesalazine in several pregnant women indicate that there is no undesirable effect of mesalazine on pregnancy or on the health of the fetus / newborn.

Studies in animals in which mesalazine was administered orally do not indicate the presence of a direct or indirect negative effect on pregnancy, embryo / fetal development, childbirth and postpartum development. The drug KansalazinЃ rectal suppositories should be used during pregnancy only in cases where the potential benefit of its use to the mother outweighs the possible risk to the fetus.

If it is necessary to use the drug KansalazinЃ during breastfeeding, breastfeeding should be discontinued.

Method of administration and dosage

Before the introduction of the suppository, the intestines should be emptied.

Adults
For the treatment of exacerbations of ulcerative colitis:
1 suppository 500 mg 3 times a day (corresponds to 1500 mg mesalazine per day), rectally.

Overdose

Overdose cases are rare. In case of an overdose, there are no signs of nephrotoxicity or hepatotoxicity, but symptoms of salicylate poisoning, nausea, vomiting, weakness, drowsiness, hyperventilation and pulmonary edema may appear.

The specific antidote is pet. In case of overdose, symptomatic and supportive therapy is performed.

Interaction with other medicinal products

Studies of the interaction of the drug KansalazinЃ with other drugs have not been conducted.

In patients who are simultaneously receiving treatment with azathioprine, 6-mercaptopurine, or thioguanine, it should be remembered that the myelomupremmive effect of azathioprine-and-6-mercaptopurine or thioguanine may increase.

The use of mesalazine together with anticoagulants, for example, warfarin, can reduce the anticoagulant effect of the latter. If it is necessary to use such a combination, the prothrombin time should be carefully monitored.

special instructions

Before starting treatment and in the process of its implementation, at the discretion of the attending physician, the following examinations should be carried out: blood test (complete blood count, indicators of the functional state of the liver (such as ALT and ACT activity), creatinine content in the blood plasma) and urinalysis.

A follow-up examination is usually recommended 14 days after the start of treatment and then 2-3 times with an interval of 4 weeks. If the results obtained correspond to the norms of values, then it is enough to carry out these analyzes every 3 months. If additional symptoms appear, follow-up examinations should be carried out immediately.

Caution should be exercised in patients with impaired liver function. The use of KansalazinЃ rectal suppositories is not recommended for patients with impaired renal function.

If during treatment there is a decrease in renal function, the effect of nephrotoxicity associated with mesalazine should be assumed.

When using KansalazinЃ by patients with impaired lung function, in particular those suffering from bronchial asthma, it is necessary to carefully monitor during treatment.

Treatment of patients with known hypersensitivity to drugs containing sulfasalazine should only be initiated under close medical supervision. If symptoms of acute intolerance appear, such as cramps, acute abdominal pain, fever, severe headaches and skin rashes, treatment should be stopped immediately.

Influence on the ability to drive vehicles and mechanisms

The drug has no effect on driving and maintaining moving machinery. If the described adverse events (such as dizziness, etc.) appear, you should refrain from performing these activities.

Release form

Rectal suppositories 500 mg.
5 suppositories in a blister made of polyvinyl chloride film laminated with polyethylene.
2 or 6 blisters, together with instructions for use, are placed in a carton box.

Storage conditions

At a temperature not exceeding 25 ? C in the manufacturer's packaging.
Keep out of reach of children.

Shelf life

3 years.
Do not use after the expiration date.

Vacation conditions

Dispensed by prescription.