Mesacol (mesalazine) coated enteric tablets 400 mg. №50

Description

Mesacol composition
active substance: mesalazine;
1 tablet contains mesalamine (mesalazine) 400 mg;
Excipients: calcium hydrogen phosphate, corn starch, microcrystalline cellulose, hydroxypropylmethylcellulose, povidone, talc, colloidal anhydrous silica, sodium starch glycolate (type A), methacrylate copolymer (type C), dibutyl, methacrylate 171), iron oxide red (E 172), polyethylene glycol 6000.

Dosage form
Coated tablets are enteric.

Pharmacological properties
Mesacol is an anti-inflammatory agent. The drug inhibits the synthesis of prostaglandins, inhibits chemotaxis, phagocytosis and degranulation of neutrophils, inhibits the secretion of immunoglobulins by lymphocytes, has antioxidant properties. Has an antibacterial effect (manifested in the large intestine) relative to E. coli, some cocci.

Indications
Mesacol is used:

• with nonspecific ulcerative colitis;
• with Crohn’s disease (for the prevention and treatment of exacerbations);
• with chronic colitis;
• at the proct.

Contraindications:

• with an allergy to an active ingredient;
• with intolerance to auxiliary components;
• with past allergies to salicylic acid derivatives;
• with severe violations of liver / kidney function;
• with blood diseases;
• with hemorrhagic diathesis;
• with gastric ulcer, duodenal ulcer;
• in the last weeks of pregnancy;
• when breastfeeding;
• children under 6 years old.

Carefully:

• with liver / kidney dysfunction;
• in the first trimester of pregnancy.

Application during pregnancy and lactation
Fetal Action Category (FDA) – B.
In the first trimester of pregnancy, the use of the drug is possible only on strict indications, in the last 2-4 weeks of pregnancy, the administration should be discontinued.
At the time of admission, it is required to stop breastfeeding (there is no sufficient clinical experience of use during this period).

Method of administration and dosage
Mesakol is used internally.
The standard dose for adults during exacerbations is 500-1000 mg 3-4 times a day for 8-12 weeks, for the prevention of exacerbations – 250-500 mg 3-4 times a day.
With long-term therapy, you should regularly monitor the general analysis of blood, urine.
The standard dose for children over 6 years of age during exacerbations is 30-50 mg / kg / day, divided into several doses. The maximum dose is 75 mg / kg / day (not more than 4000 mg / day), for maintenance therapy – 15-30 mg / kg / day (not more than 2000 mg / day).

Overdose
Symptoms: drowsiness, nausea, gastralgia, vomiting, weakness.
Treatment: gastric lavage (when ingested), the use of enterosorbents, laxatives, symptomatic therapy.

Side effects:

• Digestive disorders: nausea, decreased appetite, vomiting, heartburn, abdominal pain, increased levels of liver transaminases, diarrhea, flatulence, hepatitis, mumps, pancreatitis.
• Cardiovascular disorders: shortness of breath, palpitations, increased or decreased blood pressure, tachycardia, chest pain, anemia (megaloblastic, hemolytic, aplastic), thrombocytopenia, agranulocytosis, hypoprothrombinemia, leukopenia.
• Neurological disorders: headache, sleep disturbance, dizziness, depression, paresthesia, malaise, convulsions, tinnitus, tremors.
• Genitourinary disorders: proteinuria, oliguria, hematuria, crystalluria, anuria, oligospermia, nephrotic syndrome.
• Allergic reactions: erythema, skin rash, itching, bronchospasm.
• Others: lupus-like syndrome, fever, photosensitivity, alopecia, increased methemoglobin levels, decreased production of tear fluid.

Storage conditions and periods
Store Mesacol at temperatures up to + 25 ° С for no more than 4 years.
Store the drug in its original packaging.
It is forbidden to use the medicine after the expiration date.