Mesacol, pills 400 mg, 50 pcs.

Composition

1 tablet contains as an Active ingredient: mesalazine – 400 mg

Auxiliary substances:

calcium hydrogen phosphate dihydrate,

corn starch,

cellulose microcrystalline,

hypromellose 2208,

povidone K 90,

purified talc,

silica colloidal anhydrous,

carboximetilkrahmal sodium (sodium starch glycolate) (type A),

methacrylic acid and methylmethacrylate copolymer type “C”

(Eudragit L-100-55),

methacrylic acid and methyl methacrylate copolymer type b (Eudragit S-100),

dibutyl phthalate,

titanium dioxide,

iron oxide red,

macrogol 6000 (polyethylene glycol 6000).

Pharmacological action

Pharmacodynamics

It has a local anti-inflammatory effect due to the inhibition of neutrophilic lipoxygenase activity and the synthesis of prostaglandins and leukotrienes. It inhibits migration, degranulation, neutrophil phagocytosis, and the secretion of immunoglobulins by lymphocytes.

It has an antibacterial effect against some cocci and E. coli (manifested in the large intestine).

Pharmacokinetics

After taking the drug inside, mesalazine begins to be released in 110-170 minutes, after 165-225 minutes, the tablets completely dissolve. Due to the presence of a special shell, mesalazine is released mainly in the large intestine (60-79%). In the jejunum,15-30% of the Active ingredient is released, while only about 10% enters the systemic circulation.

The plasma concentration is low. In the body, mesalazine is metabolized to form N-acetyl-5-aminosalicylic acid. Binding to plasma proteins is 43%, and N – acetyl-5-aminosalicylic acid is 73-83%. The drug and its metabolite pass into the mother’s milk. The half-life is 0.5-2 hours, depending on the dose taken, and the metabolite is 5-10 hours.

Excretion by the kidneys (50%), through the intestines (40%). Accumulates in chronic renal failure.

Indications

Non-specific ulcerative colitis, Crohn’s disease (prevention and treatment of exacerbations).

Use during pregnancy and lactation

Currently, there is no clear information about the safety of using Mesacol in pregnant women.

Prescribe Mesacol to pregnant women only if the possible benefit to the woman exceeds the potential risk to the fetus.

When prescribing Mesacol, a nursing woman should stop breastfeeding.

Contraindications

Hypersensitivity to salicylates and other components of the drug, blood diseases, peptic ulcer of the stomach and duodenum, glucose-6-phosphate dehydrogenase deficiency, hemorrhagic diathesis, severe renal / hepatic insufficiency, childhood. With caution – hepatic and / or renal failure.

Side effects

From the digestive system: nausea, vomiting, heartburn, diarrhea, especially when using high doses of the drug (however, diarrhea is not always a consequence of the side effect of the drug, but can be a manifestation of the underlying disease); decreased appetite, abdominal pain, dry mouth, stomatitis; increased activity of “liver” transaminases in plasma, hepatitis, pancreatitis.

From the cardiovascular system: palpitations, tachycardia, hypertension or hypotension, pain behind the sternum, shortness of breath. There are separate reports of the development of pericarditis, cardiac conduction disorders.

From the central nervous system: headache, tinnitus, dizziness, polyneuropathy, tremor, seizures, insomnia, depression, hallucinations.

From the genitourinary system: proteinuria, hematuria, crystalluria, oliguria, anuria, nephrotic syndrome, oligospermia. Individual cases of impotence are described.

From the side of the hematopoietic system: eosinophilia, anemia (hemolytic, megablastic, aplastic), leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia.

Allergic reactions: skin rash, pruritus, erythema, dermatosis, bronchospasm.

Other services: weakness, mumps, photosensitivity, lupus-like syndrome, alopecia, decreased production of tear fluid.

Interaction

Increases the hypoglycemic effect of sulfonylurea derivatives, the ulcerogenicity of glucocorticosteroids, and the toxicity of methotrexate.

Weakens the activity of furosemide, spironolactone, sulfonamides, rifampicin.

Increases the effect of anticoagulants, increases the effectiveness of uricosuric drugs (tubular secretion blockers). Slows down the absorption of cyancobapamine.

How to take, course of administration and dosage

Inside. If the disease worsens, take 1-2 tablets (400-800 mg) 3 times a day for 8-12 weeks.

For the prevention of exacerbations,1 tablet (400 mg) is prescribed 3 times a day.

Mesacol tablets should be taken whole, after meals, with plenty of water.

Children are prescribed mesalazine in the form of a suspension, suppositories or microclysters.

Overdose

Symptoms: nausea, vomiting, gastralgia, weakness, drowsiness.

Treatment: gastric lavage, laxative administration, symptomatic therapy.

Special instructions

It should be borne in mind that diarrhea that may occur during treatment is not always the result of a side effect of the drug, but may be a manifestation of the underlying disease.

It is advisable to regularly conduct a general blood test (before, during, and after treatment), and urine (monitoring the excretory function of the kidneys). Patients who are “slow acelators” have an increased risk of developing side effects.

There may be staining of urine and tear fluid in yellow-orange color, staining of soft contact lenses. If you miss taking the drug, the missed dose should be taken at any time or together with the next dose. If several doses are missed, then you should consult a doctor without stopping treatment. If the development of acute intolerance syndrome is suspected, Mesacol should be discontinued.

Since the Active ingredient is not released from the tablet at low pH values, Mesacol should not be administered simultaneously with pH-lowering drugs.

Storage conditions

In a dark place, at a temperature not exceeding 25°C.

Shelf life

4 years

Active ingredient

Mesalazine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults

Indications

Colitis, Crohn

‘s Disease Weight

Weight: 58 gr.